车前子

English text reference: Chinese Pharmacopoeia (2020 Edition)

Overview

Plantain Seed is the dried mature seed of Plantago asiatica L. or Plantago depressa Willd. (Fam. Plantaginaceae). The drug is collected in summer and autumn when the seed is ripe, removed from the spike, dried, and the impurities are removed.

Description

Seeds elliptical, irregularly oblong or triangular oblong, slightly compressed, about 2 mm long and about 1 mm wide. Surface yellowish-brown to blackish-brown, with fine wrinkles, one side with grayish-white depressed hilum. Texture hard. Odour, slight; taste, bland.

Identification

(1)

Seed of Plantago asiatica

Plantain Powder dark yellowish brown. The outer epidermal cells of the testa are square or slightly tangentially prolonged in cross-section, and the cell walls are mucilaginous. The inner epidermal cells of the testa are oblong in surface view, 5-19 μm in diameter, about 83 μm in length, thin-walled, microwave-like, often arranged in a mosaic. The endosperm cell wall is very thick, full of fine powdery grains.

Seed of Plantago depressa

The inner epidermal cells of the seed coat of Plantago depressa are small, 5-15 μm in diameter and 11-45 μm long.

(2) Take 1 g of crude powder of this product, add 10 ml of methanol, ultrasonic treatment for 30 minutes, filtration, filtrate evaporation, residue add 2 ml of methanol to dissolve, as a test solution. Another take jingnipin sapogenins control product, mullein control product, add methanol were made into 1 ml each containing 1 mg of solution, as a control solution. According to the thin layer chromatography (General rule 0502) test, absorb the above three solutions of 5 μl, were spotted on the same silica gel GF254 thin layer plate, ethyl acetate - methanol - formic acid - water (18:2:1.5:1) as an unfolding agent, unfolding, take out, drying, and placed in the ultraviolet light (254 nm) under the examination. In the chromatogram of the test article, spots of the same colour were shown on the corresponding positions with the chromatogram of the control article; sprayed with 0.5% vanillin sulfuric acid solution, heated at 105℃ until the spots showed clear colour.

Examination

Water

Not more than 12.0 per cent <0832,method 2>.

Total ash

Not more than 6.0 per cent <2302>.

Acid-insoluble ash

Not more than 2.0 per cent <2302>.

Swelling index

Take 1 g of the sample, weigh accurately, and determine the swelling index according to the method for determination of swelling index <2101>. It should not be less than 4.0.

Assay

Determine by high-performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

Use octadecylsilane-bonded silica gel as the filler; use methanol as mobile phase A and 0.5% acetic acid solution as mobile phase B. Perform gradient elution according to the specified conditions in the table; detect at a wavelength of 254 nm. The theoretical plate number calculated based on the peak of artemisinic acid should not be less than 3000.

Preparation of reference solution

Take an appropriate amount of artemisinic acid reference substance and artemisinin reference substance, weigh accurately, place them in a brown volumetric flask, and add 60% methanol to prepare a mixed solution containing 0.1 mg of each substance per 1 ml.

Preparation of test solution

Take about 1 g of the powder of the sample (passed through a No. 2 sieve), weigh accurately, place it in a stoppered conical flask, accurately add 50 ml of 60% methanol, weigh accurately, heat under reflux for 2 hours, cool, weigh accurately again, make up for the weight loss with 60% methanol, shake well, filter, and take the filtrate.

Assay method

Accurately draw 10 μl of the reference solution and the test solution, respectively, inject them into the liquid chromatograph, and determine.

Calculated on the dried product, the content of artemisinic acid (C16H22O10) should not be less than 0.50%, and the content of artemisinin (C29H36O15) should not be less than 0.40%.

Prepared slices

Plantago seed

Processing

Remove impurities.

Appearance

Same as the crude drug.

Identification

Same as the crude drug.

Examination

Same as the crude drug.

Assay

Same as the crude drug.

Prepared Plantago seed with salt

Processing

Take the clean psyllium, according to the salt water roast method (General rule 0213) fried until the sound of bursting, sprayed with salt water, fried dry.

Appearance

This product is shaped like psyllium, with dark brown surface. Slightly fragrant, slightly salty taste.

Examination

Water

Same as the crude drug, not more than 10.0 per cent.

Total ash

Same as the crude drug, not more than 9.0 per cent.

Acid-insoluble ash

Same as the crude drug, not more than 3.0 per cent.

Swelling index

Take 1 g of the sample, weigh accurately, and determine the swelling index according to the method for determination of swelling index <2101>. It should not be less than 3.0.

Assay

Same as the crude drug, the content of artemisinic acid (C16H22O10) should not be less than 0.40%, and the content of artemisinin (C29H36O15) should not be less than 0.30%.

Identification

Same as the crude drug.

Property

Cold.

Flavor

Sweet.

Meridian tropism

Meridian tropism: liver, kidney, lung, and small intestine.

Actions

Clear heat, diuretic, promote urination, and relieve stranguria; leach dampness and stop diarrhea; improve vision and eliminate phlegm.

Indications

Used for hot stranguria with pain, edema and fullness, summer dampness diarrhea, red and swollen eyes, and phlegm-heat cough.

Dosage

9-15 g.

Administration

Decocted in a wrapped package.

Storage

Store in a well-ventilated and dry place, and protect from moisture.

大腹皮

English text reference: Chinese Pharmacopoeia (2020 Edition)

Overview

Areca Peel is the dried pericarp of the fruit of Areca catechu L. (Fam. Palmae). The unripe fruit is collected in winter to early spring, boiled and dried, longitudinally split into two halves, and the pericarp is peeled off, known as "Dafupi"; the ripe fruit is collected in late spring to early autumn, boiled and dried, the pericarp is peeled off, loosened, and dried in the sun, known as "Dafumao".

Description

###大腹皮 | Dafupi

It is slightly oval or oblong-shaped, measuring 4-7 cm in length, 2-3.5 cm in width, and 0.2-0.5 cm in thickness. The outer pericarp is dark brown to nearly black, with irregular longitudinal wrinkles and raised transverse ridges. The top has the remnants of the stigma, and the base has the fruit stalk and remnants of the calyx. The inner pericarp is concave, brown or dark brown, smooth, and hard-shelled. It is light in weight and hard in texture. When longitudinally torn, the fibrous middle pericarp can be seen. It has a slight odor and a slightly astringent taste.

###大腹毛 | Dafumao

It is slightly oval or gourd-shaped. The outer pericarp is mostly shed or remains. The middle pericarp is brown and hairy, yellowish-white or light brown, loose and soft in texture. The inner pericarp is hard-shelled, yellowish-brown or brown, with a smooth inner surface, and sometimes longitudinally cracked. It has a slight odor and a mild taste.

Identification

(1) The powder of Dafupi is yellowish-white or yellowish-brown. The fibres of the middle pericarp are bundled, slender, with a diameter of 8-15 μm, slightly lignified, and have obvious pits. The surrounding cells contain round clusters of silica, with a diameter of about 8 μm. The cells of the inner pericarp are irregularly polygonal, nearly circular, or elliptical, with a diameter of 48-88 μm, and have obvious pits.

(2) Take 5 g of the powder, add 50 ml of methanol, sonicate for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 2 ml of methanol, filter, and continue to filter to obtain the test solution. Take 5 g of the reference drug Dafupi, prepare the reference drug solution using the same method. Carry out the method for thin layer chromatography<0502>, using silica gel G as the coating substance and a mixture of chloroform-methanol-formic acid (7:0.1:0.02) as the mobile phase. Apply separately to the plate 5 μl of each of the above two solutions. After developing and removal of the plate, dry in air. Spray with a 10% solution of sulfuric acid in ethanol, heat at 105°C to the spots clear. Examine under ultraviolet light at 365 nm. The fluorescent spot in the chromatogram obtained with the test solution corresponds in position and colour to the spot in the chromatogram obtained with the reference drug solution.

Examination

Water

Not more than 12.0 per cent <0832,method 2>.

Total ash

Not more than 7.0 per cent <2302>.

Extractives

Carry out the method for determination of ethanol-soluble Extractives <2201,the hot maceration method>, using diluted ethanol as the solvent,not less than 9.0 per cent.

Prepared slices

Dafupi

Processing

Eliminate Foreign matter,wash clean, cut into sections, and dry in the sun.

Identification

Same as the crude drug.

Dafumao

Processing

Eliminate Foreign matter,wash clean, and dry in the sun.

Identification

Same as the crude drug.

Property

Slightly warm.

Flavor

Pungent.

Meridian tropism

Spleen, stomach, large intestine, and small intestine meridians.

Actions

To promote qi circulation, regulate the middle burner, promote diuresis, and reduce edema.

Indications

Dampness obstructing qi movement, distension and fullness in the epigastrium and abdomen, difficult defecation, edema and distension, edema in the lower limbs, and difficulty in urination.

Dosage

5-10 g.

Administration

None.

Storage

Preserve in a dry place.

菊花

English text reference: Chinese Pharmacopoeia (2020 Edition)

Overview

Chrysanthemum Flower is the dried flower head of Chrysanthemum morifolium Ramat. (Fam. Compositae). It is collected in batches when the flowers are in full bloom from September to November, removed from the stems, and dried in the shade or by baking, fumigating, steaming, and drying. According to different places of origin and processing methods, the drug is divided into "Boju", "Chuju", "Gongju", "Hangju", and "Huaiju".

Description

Boju

Obconic or cylindrical, sometimes slightly compressed and flabellate, 1.5 to 3 cm in diameter, discrete. Involucre discoid; involucral bracts 3-4-layered, ovate or elliptic, herbaceous, yellowish green or brownish green, outside pilose, margin membranous. Receptacle hemispherical, without hypanthium or stipular hairs. Ligules several-layered, female, situated peripherally, whitish, straight, uplifted, longitudinally folded, scattered golden-yellow glandular dots; tubular flowers numerous, bisexual, situated centrally, hidden by ligules, yellow, apically 5-toothed. Achenes rudimentary, without crown hairs. Body light, texture soft, crunchy when dry. Aromatic, with a sweet, slightly bitter flavour.

Chuju

Irregularly spherical or oblate, 1.5-2.5 cm in diam. ligulate flowers whitish, irregularly twisted, involute, margins crinkled, sometimes pale brown glandular dots visible; tubular flowers mostly hidden.

Gongju

Compressed or irregularly spherical, 1.5-2.5 cm in diam. ligule white or whitish, obliquely ascending, distally reflexed, margin slightly involute and crumpled, usually without glandular dots; tubular flowers few, exserted.

Hangju

Disc-shaped or oblate, 2.5-4 cm in diameter, often connected in sheets. Ligules whitish or yellow, spreading or slightly folded, adherent to each other, usually without glandular dots; tubular flowers numerous, exserted.

Huaiju

Irregularly spherical or oblate, 1.5-2.5 cm in diam. Mostly ligulate, ligule-like white or yellow, irregularly twisted, involute, margins crumpled, glandular dots sometimes visible; tubular flowers mostly hidden.

Identification

(1) The powder of this product is yellowish white. The pollen grains are spherical, 32-37 μm in diameter, with reticulation and short spines on the surface, with 3 pore grooves. t-shaped hairs are more numerous, the apical cells are growing, the two arms are nearly equal in length, and the stalks are 2-4 cells. The head of glandular hairs is shoestring-like, with 6-8 cells arranged two by two opposite to each other. Calcium oxalate clusters more numerous, fine.

(2) Take 1 g of this product, cut, add petroleum ether (30 ~ 60 ℃) 20 ml, ultrasonic treatment for 10 minutes, discard petroleum ether, dregs volatile dry, add 1 ml of dilute hydrochloric acid and ethyl acetate 50 ml, ultrasonic treatment for 30 minutes, filtration, filtrate evaporation, residue with methanol 2 ml to make dissolved, as a test solution. Another take chrysanthemum control herb 1 g, the same method into the control herb solution. Then take chlorogenic acid control product, add ethanol to make a solution containing 0.5 mg per 1 ml, as a control solution. According to the thin-layer chromatography (General rule 0502) test, absorb the above three solutions of 0.5 ~1 μl, were spotted on the same polyamide film, with toluene - ethyl acetate - formic acid - glacial acetic acid - water (1:15: 1:1:2) of the upper solution as the unfolding agent, unfolding, take out, drying, and placed in the ultraviolet lamp (365 nm) to see. In the chromatogram of the test article, fluorescent spots of the same colour were found in the corresponding positions of the chromatogram of the control herb and the control article.

Examination

Water

Not more than 15. 0 per cent <0832, method 2>.

Content determination

Determined by high performance liquid chromatography <0512>.

Chromatographic system and system suitability

Octadecylsilane-bonded silica gel was used as filler; acetonitrile was used as mobile phase A, and 0.1% phosphoric acid solution was used as mobile phase B. Gradient elution was carried out according to the following table; the detection wavelength was 348 nm. the theoretical plate number should be not less than 8000 based on the peak of 3, 5-O-dicaffeoylquinic acid.

Preparation of reference solution

Take chlorogenic acid control, lignocaine control, 3,5-O-dicaffeoylquinic acid control, weigh precisely, put in a brown measuring flask, add 70% methanol to make a mixed solution containing 35 μg of chlorogenic acid, 25 μg of lignocaine, and 80 μg of 3,5-O-dicaffeoylquinic acid per 1 ml, and then it will be obtained (preserved at below 10 ℃).

Preparation of test solution

Take the powder of this product (through the first sieve) about 0.25 g, precision weighing, placed in a stoppered conical flask, precision add 25 ml of 70% methanol, tightly stoppered, weighing, ultrasonic treatment (power 300 W, frequency of 45 kHz) for 40 minutes, cooled, and then weighing, with 70% methanol to make up for the loss of weight, shaking, filtration, and take the filtrate, that is, the product.

Assay method

Pipette 5 μl each of control solution and test solution, inject into the liquid chromatograph, and then determine, that is, obtain.

This product contains not less than 0.20% of chlorogenic acid (C16H18O9), not less than 0.080% of lignoceroside (C21H20O11), and not less than 0.70% of 3,5-O-dicaffeoylquinic acid (C25H24O12) when calculated from the dried product.

Property

Slightly cold.

Flavor

Sweet and bitter.

Meridian tropism

Lung and liver meridians.

Actions

Dispersing wind and clearing heat, calming the liver and improving eyesight, clearing heat and removing toxins.

Indications

It is used for wind-heat cold, headache and dizziness, redness and swelling of the eyes, blurred vision, sores, carbuncles and poisons.

Dosage

5-10 g.

Administration

None.

Storage

Keep in a cool and dry place, airtight, mould-proof and moth-proof.

鹿角胶

English text reference: Chinese Pharmacopoeia (2020 Edition)

Overview

Deer Horn Glue is the solid glue made by decocting and concentrating deer horn.

Processing

Cut deer horn into sections, wash and soak, decoct in water in several portions, filter, combine the filtrate (or add a small amount of alum powder), let it stand, filter the glue liquid, concentrate (may add appropriate amount of yellow rice wine, rock sugar, and soybean oil) to a thick paste, condense, cut into pieces, and dry to obtain the product.

Description

It is flat square or cuboid. Yellowish-brown or reddish-brown, semi-transparent, some with yellowish-white foam on the surface. Brittle, easily broken, with a shiny fracture. Slight odor, slightly sweet taste.

Identification

To 0.1 g of the powder add 50 ml of 1% ammonium bicarbonate solution, treat with ultrasound for 30 minutes, filter through a microporous membrane, take 100 μl of the filtrate, place it in a microsampling bottle, add 10 μl of trypsin solution (take trypsin for sequence analysis, prepare a solution containing 1 mg per ml with 1% ammonium bicarbonate solution before use), shake well, and incubate at 37°C for 12 hours as the test solution. Take 0.1 g of the reference drug deer horn glue and prepare the reference drug solution by the same method. Perform the test according to the high-performance liquid chromatography-mass spectrometry method (General Rule 0512 and General Rule 0431), using octadecylsilane-bonded silica gel as the filling material (column inner diameter 2.1 mm); use acetonitrile as mobile phase A and 0.1% formic acid solution as mobile phase B, and perform gradient elution according to the specified conditions in the table; the flow rate is 0.3 ml per minute. Use a mass spectrometry detector, electrospray ionization positive ion mode (ESI+), and perform multiple reaction monitoring (MRM), selecting the mass-to-charge ratio (m/z) 765.4 (double charge)→554.0 and m/z 765.4 (double charge)→733.0 as the detection ion pairs. Inject 5 μl of the deer horn glue reference drug solution, and the signal-to-noise ratio of the MRM chromatographic peak determined by the above detection ion pairs should be greater than 3:1.

Take 5 μl of the test solution, inject it into the high-performance liquid chromatography-mass spectrometry system, and determine it. In the ion flow chromatogram extracted by the mass-to-charge ratio (m/z) 765.4 (double charge)→554.0 and m/z 765.4 (double charge)→733.0 ion pairs, a chromatographic peak that is consistent with the retention time of the reference drug should be simultaneously present.

Examination

Water

Weigh accurately 1 g of the product, add 2 ml of water, dissolve by heating, place it on a water bath and evaporate until the thickness does not exceed 2 mm, and determine the water content according to the method for water determination (General Rule 0832, method 2), which should not exceed 15.0%.

Total ash

Take 1.0 g of the product and examine it according to the regulations (General Rule 2302), which should not exceed 3.0%.

Heavy metals

Take the residue under the total ash item and examine it according to the regulations (General Rule 0821, method 2), which should not exceed 30 mg/kg.

Arsenic salts

Take 1.0 g of the product, add 1 g of calcium hydroxide, mix, add a small amount of water, stir well, dry, first carbonize with low heat, then incinerate at 500-600°C to complete ashing, cool, add 5 ml of hydrochloric acid and 2 ml of water, and examine it according to the regulations (General Rule 0822), which should not exceed 2 mg/kg.

Insoluble matter in water

Weigh accurately 1.0 g of the product, add 10 ml of water, dissolve by heating, transfer the solution to a 10 ml centrifuge tube that has been weighed, centrifuge, remove the oil floating on the tube wall, pour off the supernatant, add warm water along the tube wall to the mark, centrifuge, wash 3 times as before, pour off the supernatant, heat the centrifuge tube at 105°C for 2 hours, take it out, cool it in a desiccator for 30 minutes, weigh accurately, and calculate to obtain the result.

The insoluble matter in water of the product should not exceed 2.0%.

Others

It should comply with the relevant regulations under the adhesive item (General Rule 0184).

Assay

Determine by high-performance liquid chromatography (General Rule 0512).

Chromatographic conditions and system suitability test

Use octadecylsilane-bonded silica gel as the filling material; use acetonitrile-0.1 mol/L sodium acetate solution (adjust the pH value to 6.5 with acetic acid) (7:93) as mobile phase A, and use acetonitrile-water (4:1) as mobile phase B. Perform gradient elution according to the specified conditions in the table; the detection wavelength is 254 nm. The column temperature is 43°C. The theoretical plate number calculated based on the peak of L-hydroxyproline should not be less than 4000.

Preparation of reference solution

Take an appropriate amount of L-hydroxyproline reference substance, glycine reference substance, alanine reference substance, and L-proline reference substance, weigh accurately, and add 0.1 mol/L hydrochloric acid solution to prepare a mixed solution containing 70 μg of L-hydroxyproline, 0.14 mg of glycine, 60 μg of alanine, and 70 μg of L-proline per 1ml.

Preparation of test solution

Take about 0.25 g of the crude powder of the product, weigh accurately, place it in a 25 ml volumetric flask, add 20 ml of 0.1 mol/L hydrochloric acid solution, treat with ultrasound (power 300 W, frequency 40 kHz) for 30 minutes, cool, add 0.1 mol/L hydrochloric acid solution to the mark, shake well. Accurately measure 2 ml, place it in a 5 ml ampoule, add 2ml of hydrochloric acid, hydrolyze at 150°C for 1 hour, cool, transfer to an evaporating dish, wash with water in portions of 10 ml, pour the washing liquid into the evaporating dish, evaporate to dryness, dissolve the residue in 0.1 mol/L hydrochloric acid solution, transfer to a 25 ml volumetric flask, add 0.1 mol/L hydrochloric acid solution to the mark, shake well.

Accurately measure 5 ml of the above reference solution and test solution, place them in separate 25 ml volumetric flasks, add 2.5 ml of acetonitrile solution of 0.1 mol/L phenyl isothiocyanate (PITC) and 2.5 ml of acetonitrile solution of 1 mol/L triethylamine, shake well, and let it stand at room temperature for 1 hour. Add 50% acetonitrile to the mark, shake well. Take 10 ml, add 10 ml of n-hexane, shake, let it stand for 10 minutes, take the lower layer solution, filter, and take the subsequent filtrate.

Assay method

Accurately suck 5 μl of the derivatized reference solution and test solution, inject them into the liquid chromatograph, and determine.

Calculated on the basis of the dried product, the content of L-hydroxyproline should not be less than 6.6%, glycine should not be less than 13.3%, alanine should not be less than 5.2%, and L-proline should not be less than 7.5%.

Property

Warm.

Flavor

Sweet and salty.

Meridian tropism

Kidney and liver meridians.

Actions

It warms and tonifies the liver and kidney, nourishes essence and blood.

Indications

It is used for lumbago and coldness of the waist and knees caused by liver and kidney deficiency, impotence and premature ejaculation, weakness and emaciation, excessive uterine bleeding, bloody stools, bloody urine, and swelling and pain of carbuncle.

Dosage

3-6 g.

Administration

Decocted and taken orally.

Specification

Each piece weighs 6g.

Storage

Store in a sealed container.

羌活

English text reference: Chinese Pharmacopoeia (2020 Edition)

Overview

Notopterygium Rhizome and Root is the dried rhizome and root of Notopterygium incisum Ting ex H. T. Chang or Notopterygium franchetii H. de Boiss. (Fam. Umbelliferae). The drug is collected in spring and autumn, removed from rootlets and sand, and dried in the sun.

Description

Notopterygium Rhizome and Root

It is cylindrical and slightly curved, 4-13 cm long, 0.6-2.5 cm in diameter, with a stem scar at the top. The surface is brownish-brown to blackish-brown, with the outer skin peeling off and appearing yellow at the peeled area. The internodes are shortened, forming closely raised rings, resembling silkworms, commonly known as "silkworm Qiang"; the internodes are elongated, resembling bamboo nodes, commonly known as "bamboo node Qiang". There are numerous point-like or tuberous root scars and brown broken scales on the nodes. The body is light, brittle, easily broken, with an uneven fracture surface and numerous cracks. The bark is yellowish-brown to dark brown, oily, with brown oil spots; the wood is yellowish-white, with obvious rays; the pith is yellow to yellowish-brown. It has a fragrant odor, slightly bitter and pungent taste.

Notopterygium franchetii

It is the rhizome and root. The rhizome is cylindrical, with a stem and leaf sheath residue at the top, and the root is conical, with longitudinal wrinkles and skin pores; the surface is brownish-brown, with dense rings near the rhizome, 8-15 cm long, 1-3 cm in diameter, commonly known as "striped Qiang". Some rhizomes are thick and irregularly nodular, with several stem bases at the top, and the roots are thinner, commonly known as "big-headed Qiang". It is soft and brittle, easily broken, with a slightly flat fracture surface, light brown bark, and yellowish-white wood. It has a mild odor.

Identification

To 1 g of the powder add 5 ml of methanol, treat with ultrasound for 20 minutes, let stand, and take the supernatant as the test solution. Take paeoniflorin CRS, add methanol to make a solution containing 0.5 mg per ml as the reference solution. Carry out the method for thin layer chromatography<0502>, using silica gel G as the coating substance and a 3% solution of sodium acetate as the mobile phase. Apply separately to the plate 2-4 μl of each of the above two solutions. After developing and removal of the plate, dry in air. Examine under ultraviolet light at 365 nm. The blue fluorescent spot in the chromatogram obtained with the test solution corresponds in position and colour to the spot in the chromatogram obtained with the reference solution.

Examination

Total ash

Not more than 8.0 per cent <2302>.

Acid-insoluble ash

Not more than 3.0 per cent <2302>.

Chromatographic fingerprint

Determine by high performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

Use octadecylsilane bonded silica gel (non-polar) as the filler (column length 250 mm, inner diameter 4.6 mm, particle size 5 μm); use acetonitrile as mobile phase A, 0.1% phosphoric acid solution as mobile phase B, and perform gradient elution according to the specified conditions in the table; column temperature is 25°C; detection wavelength is 246 nm. The theoretical plate number calculated based on the peak of artemisinin should not be less than 18000.

Preparation of reference extract solution

Take 10 mg of reference extract of Artemisia annua, accurately weigh, place it in a 5 ml volumetric flask, dissolve it in methanol and dilute to the mark, shake well, and obtain.

Preparation of test solution

Take the test solution under the "content determination" section, and obtain.

Determination method

Precisely draw 10 μl of the reference extract solution and the test solution, inject them into the liquid chromatograph, determine, record the chromatogram, and obtain.

The test chromatographic fingerprint should present chromatographic peaks corresponding to the retention times of the four major characteristic peaks in the reference extract.

Extractives

Carry out the method for determination of ethanol-soluble extractives <2201>, using ethanol as the solvent, not less than 15.0 per cent.

Content determination

Volatile oil

Determine the volatile oil content by the method for determination of volatile oil <2204>.

The volatile oil content of this product should not be less than 1.4% (ml/g).

Artemisinin and isoimperatorin

Determine artemisinin and isoimperatorin by high performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

Use octadecylsilane bonded silica gel as the filler; use acetonitrile-water (44:56) as the mobile phase; detection wavelength is 310 nm. The theoretical plate number calculated based on the peak of artemisinin should not be less than 5000.

Preparation of reference solution

Take an appropriate amount of artemisinin reference standard and isoimperatorin reference standard, accurately weigh, add methanol to prepare a mixed solution containing 60 μg of artemisinin and 30 μg of isoimperatorin per ml, and obtain.

Preparation of test solution

Take about 0.4 g of the powder of this product (passed through a No. 3 sieve), accurately weigh, place it in a stoppered conical flask, accurately add 50 ml of methanol, weigh, subject to ultrasonic treatment (power 250 W, frequency 50 kHz) for 30 minutes, cool, weigh again, make up for the weight loss with methanol, shake well, filter, and take the filtrate, and obtain.

Determination method

Precisely draw 5 μl of the reference solution and 5-10 μl of the test solution, inject them into the liquid chromatograph, determine, and obtain.

Calculated on the dried product, the total content of artemisinin (C21H22O5) and isoimperatorin (C16H14O4) in this product should not be less than 0.40%.

Prepared slices

Artemisia annua

Processing

Remove impurities, wash, soften, cut into thick slices, and dry.

Appearance

This product is round or irregularly shaped transverse or oblique slices, with brownish-brown to blackish-brown skin, brownish-brown outer surface of the cut surface, yellowish-white wood, and some visible radial texture. It is light and brittle. It has a fragrant aroma, a slightly bitter and pungent taste.

Examination

Water

Not more than 9.0 per cent <0832, method 4>.

Total ash

Same as the crude drug.

Acid-insoluble ash

Same as the crude drug.

Identification

Same as the crude drug.

Chromatographic fingerprint

Same as the crude drug.

Extractives

Same as the crude drug.

Content determination

Same as the crude drug.

Property

Warm.

Flavor

Pungent, bitter.

Meridian tropism

Meridian tropism: bladder and kidney meridians.

Actions

Expel exterior cold, dispel wind and dampness, relieve pain.

Indications

Used for wind-cold common cold, severe headache, wind-dampness arthralgia, shoulder and back soreness.

Dosage

3-10 g.

Administration

None.

Storage

Store in a cool and dry place, and protect against moth.

青礞石

English text reference: Chinese Pharmacopoeia (2020 Edition)

Overview

Chlorite Lapis is the black mica schist or chlorite-mica carbonate schist of metamorphic rock. After excavation, remove impurities and sediment.

Description

Black mica schist

It is mainly in the form of flake or flake aggregates. It is irregularly flat or oblique blocks without obvious edges and corners. It is dark brown or greenish black with a glassy luster. The texture is soft, fragile, and the fracture surface is more obvious in layers. The broken powder is mainly greenish-black flakes (black mica), with a star-like flash. It has a slight odor and a mild taste.

Chlorite-mica carbonate schist

It is in the form of flake or granular aggregates. It is gray or greenish-gray with silver or light yellow scales and has a luster. The texture is loose, fragile, and the powder is grayish-green flakes (chlorite-mica carbonate) and particles (mainly carbonate), and the flaky ones have a star-like flash. It produces bubbles when encountering dilute hydrochloric acid, and boils vigorously when heated. It has a slight odor and a mild taste.

Prepared Slices

PChlorite Lapis

Processing

Remove impurities from Chlorite Lapis and crush into small pieces.

Description

It is in the form of flake, irregular fragments, or particles, with a diameter of 0.5-2 cm and a thickness of 0.5-1 cm, without obvious edges and corners. It is dark brown, greenish-brown, or grayish-green with a glassy luster. The fracture surface of the fragments is more obvious in layers. The texture is soft, fragile, with a slight odor and a mild taste.

Calcined Chlorite Lapis

Processing

Take clean Chlorite Lapis and calcine it according to the method of calcination in General Rules for Preparations (0213) until it is red-hot.

Description

It is in the form of irregular fragments or flake-like powder, with a diameter of 0.5-1.5 cm and a thickness of 0.5-1 cm, without obvious edges and corners. It is yellowish-green to bluish-green, and the flake-like powder has a stronger luster. The fracture surface of the fragments is more obvious in layers. The texture is loose, soft, fragile, with a slight odor and a mild taste.

Property

Neutral.

Flavour

Sweet and salty.

Meridian tropism

It enters the Lung, Heart, and Liver meridians.

Functions

It resolves phlegm and descends Qi, calms the Liver and suppresses wind.

Indications

It is used for stubborn phlegm agglutination, coughing and shortness of breath, epileptic frenzy, irritability and chest tightness, and convulsions of convulsions.

Dosage

3-6 g per dose; decoction, 10-15 g per dose.

Usage

It is commonly used in pill or powder form; decoction, wrap in cloth and decoct first.

Storage

Store in a dry place.

全蝎

English text reference: Chinese Pharmacopoeia (2020 Edition)

Overview

Scorpion is the dried body of Buthus martensii Karsch (Fam. Buthidae). It is collected from late spring to early autumn, removed from mud and sand, boiled in boiling water or boiling salt water until the whole body becomes stiff, taken out, and dried in a ventilated place.

Description

The head and thorax of the scorpion are flattened and elongated, and the posterior abdomen is tail-shaped, wrinkled and curved. The intact body is about 6 cm long. The head and thorax are greenish-brown, with a pair of short chelipeds and a pair of longer and larger chelate foot whiskers in the front, resembling crab claws. The back is covered with trapezoidal dorsal plates, and the ventral surface has 4 pairs of legs, all of which have 7 segments, each with 2 claw hooks at the end; the anterior abdomen consists of 7 segments, the 7th segment is darker, and there are 5 ridges on the dorsal plate. The back is greenish-brown, and the posterior abdomen is brownish-yellow, with 6 segments, each with longitudinal grooves, and the terminal segment has sharp hook-like venomous spines, with no distance below the venomous spines. Slightly fishy odor, salty taste.

Identification

The powder of the scorpion is yellowish-brown or light brown. The surface of the body wall fragment epidermis appears as a polygonal grid-like texture, with small particles densely distributed on the surface, visible hair follicles, small round holes, and light brown or nearly colorless wart-like protrusions; the inner epidermis is colorless, with transverse stripes, and the inner and outer epidermis have many short and long micro-pores. The bristles are reddish-brown, mostly broken, with sharp or blunt round tips, longitudinal straight texture, and narrow medullary cavity. The transverse striated muscle fibers are mostly broken, with a wider light band than a dark band, a dark line in the middle of the light band, and a dense short longitudinal texture in the dark band.

Examination

Water

Not more than 20.0 per cent <0832,method 2>.

Total ash

Not more than 17.0 per cent <2302>.

Acid-insoluble ash

Not more than 3.0 per cent <2302>.

Aflatoxin

Determine according to the method for determination of mycotoxins <2351>.

The content of aflatoxin B1 in this product shall not exceed 5 μg per 1000 g, and the total content of aflatoxin G2, aflatoxin G1, aflatoxin B2, and aflatoxin B1 shall not exceed 10 μg.

Extractives

Carry out the method for determination of ethanol-soluble Extractives <2201,the hot maceration method>, using ethanol as the solvent,not less than 18.0 per cent.

Prepared slices

Scorpion

Processing

Eliminate Foreign matter,wash, and dry.

Description

Same as the crude drug.

Identification

Same as the crude drug.

Examination

Same as the crude drug.

Extractives

Same as the crude drug.

Property

Neutral.

Flavor

Pungent.

Toxicity

Toxic.

Meridian tropism

Liver meridian.

Actions

To suppress wind and relieve spasm, promote blood circulation and relieve pain, and eliminate toxins and dissipate nodules.

Indications

It is used for internal movement of liver wind, spasm and convulsion, paediatric convulsions, stroke mouth askew on one side of the mouth , hemiplegia, tetanus, rheumatism and intractable paralysis, migraine headache, sores, scrofula.

Dosage

3-6 g.

Administration

None.

Precautions

Not for use during pregnancy.

Storage

Store in a dry place, and protect from moth.

拳参

English text reference: Chinese Pharmacopoeia (2020 Edition)

Overview

Bistort Rhizome is the dried rhizome of Polygonum bistorta L. (Fam. Polygonaceae). The drug is collected in spring when the sprouts begin to grow or in autumn when the stems and leaves wither, removed from mud and sand, dried in the sun, and the rootlets removed.

Description

Rhizomes long, cylindrical or slightly flattened, curved, some twisted, slightly pointed at both ends or tapering at one end, 6-13 cm long, 1-2.5 cm in diameter. Surface purplish-brown or purplish-black, rough, one side convex, the other side slightly flat or slightly grooved, with coarse annular wrinkles all over, with residual rootlets or root scars. Texture hard, fracture light brownish-red or reddish-brown, vascular bundles yellowish-white, arranged in rings. Odour, slight; taste, bitter and astringent.

Identification

(1)The powder is pale reddish-brown. Cork cells polygonal, containing reddish-brown substances. Calcium oxalate cluster crystals numerous, diameter 15-65 μm. Pitted vessels with bordered pits, diameter 20-55 μm, also with reticulate vessels and spiral vessels. Fibres elongated spindle-shaped, diameter 10-20 μm, thick-walled, lignified, with distinct pits. Starch granules single, elliptical, ovoid or nearly round, diameter 5-12 μm.

(2)To 0.5 g of the powder add 20 ml of methanol, treat with ultrasound for 15 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 5 ml of methanol as the test solution. Take 0.5 g of the reference drug of Bistort Rhizome, prepare the reference drug solution in the same manner. Take gallic acid CRS, add methanol to produce a solution containing 1 mg per ml as the Reference solution. Carry out the method for thin layer chromatography<0502>, using silica gel G as the coating substance and a mixture of dichloromethane, ethyl acetate and formic acid (5:4:1) as the mobile phase. Apply separately to the plate 5 μl of each of the above three solutions. After developing and removal of the plate, dry in air. Expose to ammonia vapour until the spots become clear. The spots in the chromatogram obtained with the test solution correspond in position and colour to the spots in the chromatograms obtained with the reference drug solution and the Reference solution.

Examination

Water

Not more than 15.0 per cent <0832,method 2>.

Total ash

Not more than 9.0 per cent <2302>.

Extractives

Carry out the method for determination of ethanol-soluble Extractives <2201,the cold maceration method>, using ethanol as the solvent,not less than 15.0 per cent.

Content determination

Carry out the method for high performance liquid chromatography<0512>.

Chromatographic conditions and system suitability test

Octadecylsilane-bonded silica gel was used as filler; 0.05% phosphoric acid methanol solution was used as mobile phase A, and 0.05% phosphoric acid solution was used as mobile phase B. Gradient elution was carried out according to the provisions in the following table; the detection wavelength was 272 nm. the theoretical plate counts should be not less than 6000 according to the calculation of gallic acid peak.

Preparation of reference solution

Take the appropriate amount of gallic acid control product, precision weighing, add 30% methanol to make a solution containing 20 μg per 1 ml, that is to obtain.

Preparation of test solution

Take the product powder (through the fifth sieve) about 0.25 g, precision weighing, placed in a stoppered conical flask, precision add 25ml of 30% methanol, tightly stoppered, weighed, immersed for 1 hour, ultrasonic treatment (power of 250 W, frequency of 45 kHz) for 20 minutes, cooled, and then weighed, with 30% methanol to make up for the loss of weight, shaking, filtration, and take the filtrate, that is, the product.

Assay method

Pipette 20 μl each of control solution and test solution, inject into the liquid chromatograph, and then determine, that is, obtain.

The content of gallic acid (C7H605) in the drug, calculated with reference to the dried drug, should not be less than 0.12%.

Prepared slices

Bistort Rhizome

Processing

Eliminate Foreign matter, wash clean, soak briefly, soften thoroughly, cut into thin slices, and dry.

Description

This product is in the form of thin tablets of round-like or nearly kidney-shaped. The outer skin is purple-brown or purple-black. The cut surface is brownish-red or light brownish-red, flat, with a ring of yellowish-white dots (vascular bundles) near the edge, with a slight odour and a bitter, astringent taste.

Identification

Same as the crude drug.

Examination

Same as the crude drug.

Extractives

Same as the crude drug.

Assay

Same as the crude drug.

Property

Slightly cold.

Flavor

Bitter and astringent.

Meridian tropism

Lung, liver, and large intestine meridians.

Actions

To clear heat, detoxify, reduce swelling, and stop bleeding.

Indications

Used for dysentery with fever and diarrhea, cough due to lung heat, carbuncles, swelling and lymphadenitis, oral and tongue sores, vomiting and nosebleed due to blood heat, bleeding hemorrhoids, and snake and insect bites.

Dosage

5-10 g. For external use, an appropriate amount.

Administration

None.

Storage

Preserve in a dry place.

熟地黄

English text reference: Chinese Pharmacopoeia (2020 Edition)

Overview

Prepared Rehmannia Root is the processed product of Rehmannia glutinosa Libosch. (Fam. Scrophulariaceae).

Processing

(1) Take raw dihuang, according to the wine stewing method (general rule 0213) stewed until the wine sucked out, take out, drying until the mucus of the outer skin is slightly dry, cut thick slices or blocks, drying, that is, obtained. For every 100 kg of raw dihuang, use 30-50 kg of yellow wine.

(2) Take raw dihuang, according to the method of steaming (Tongzhi 0213) steamed to black moist, take out, sunshine to about eighty percent dry, cut thick slices or blocks, dry, that is, get.

Description

Pieces or fragments of irregular shape, of variable size and thickness. Surface black and glossy, with a large amount of sticky substance. Texture soft and slightly tough, not easily broken; fracture black and glossy. Odour, slight; taste, sweet.

Identification

To 1 g of the powder add 50 ml of 80% methanol, treat with ultrasound for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 5 ml of water. Extract with four 10 ml portions of water-saturated n-butanol, combine the n-butanol extracts, evaporate to dryness. Dissolve the residue in 2 ml of methanol as the test solution. Dissolve catalpol CRS in methanol to produce a solution containing 1 mg per ml as the Reference solution. Carry out the method for thin layer chromatography<0502>, using silica gel G as the coating substance and a mixture of ethyl acetate-methanol-formic acid(16:0.5:2)as the mobile phase. Apply separately to the plate 5 μl of the test solution and 2 μl of the Reference solution. After developing and removal of the plate, dry in air. Spray with a 0.1% solution of 2,2-diphenyl-1-picrylhydrazyl in anhydrous ethanol. Dry. The spot in the chromatogram obtained with the test solution corresponds in position and colour to the spot in the chromatogram obtained with the Reference solution.

Examination

Same as Rehmannia.

Extractives

Same as Rehmannia.

Assay

Determine by high-performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

Use octadecylsilane-bonded silica gel as the filler; use methanol-0.1% phosphoric acid solution (5:95) as the mobile phase, and detect at a wavelength of 203 nm. The theoretical plate number calculated based on the peak of Rehmannioside D should not be less than 5000.

Preparation of reference solution

Take an appropriate amount of Rehmannioside D reference substance, accurately weigh it, add 25% methanol to make a solution containing 70 μg per 1 ml.

Preparation of test solution

Take this product and cut it into small pieces of about 5 mm. After drying under reduced pressure at 80°C for 24 hours, grind it into coarse powder. Take about 1 g, accurately weigh it, place it in a stoppered conical flask, accurately add 25% methanol 25 ml, weigh it, perform ultrasonic treatment (power 400 W, frequency 50 kHz) for 1 hour, let it cool, weigh it again, make up for the weight loss with 25% methanol, shake well, centrifuge at high speed for 10 minutes, take the supernatant and filter it, and take the filtrate.

Assay method

Accurately take 10 μl of the reference solution and the test solution, inject them into the liquid chromatograph, and determine the content.

The content of Rehmannioside D (C27H42O20) in this product should not be less than 0.050%.

Property

Slightly warm.

Toxicity

None.

Flavor

Sweet.

Meridian tropism

Liver and kidney meridians.

Actions

Nourish blood and nourish yin, tonify essence and fill the marrow.

Indications

Used for blood deficiency and withered yellow, palpitations and flustered, irregular menstruation, excessive menstrual flow, liver and kidney yin deficiency, soreness and weakness of the waist and knees, steaming bone and tidal heat, night sweats and spermatorrhea, internal heat and thirst, dizziness, tinnitus, premature graying of hair.

Dosage

9-15 g.

Administration

None.

Storage

Store in a well-ventilated and dry place.

水蛭

English text reference: Chinese Pharmacopoeia (2020 Edition)

Overview

Leech is the dried whole body of Whitmania pigra Whitman, Hirudo nipponica Whitman, or Whitmania acranulata Whitman (Fam. Hirudinidae). It is collected in summer and autumn, killed by boiling water, and dried in the sun or at low temperature.

Description

Whitmania pigra Whitman

It is flat and spindle-shaped, with numerous segments, 4-10 cm long and 0.5-2 cm wide. The dorsal surface is dark brown or blackish-brown, slightly raised, and when soaked in water, black spots arranged in 5 longitudinal stripes can be seen. The ventral surface is flat and brownish-yellow. The sides are brownish-yellow, the anterior end is slightly pointed, and the posterior end is blunt and round. There is a sucker at each end, with the anterior sucker being inconspicuous and the posterior sucker being larger. The texture is brittle, easily broken, and the fracture surface is gelatinous. It has a slight fishy odor.

Hirudo nipponica Whitman

It is flat and elongated, with a twisted and curved body, 2-5 cm long and 0.2-0.3 cm wide.

Whitmania acranulata Whitman

It is narrow and flat, 5-12 cm long and 0.1-0.5 cm wide.

Identification

To 1 g of the powder add 5 ml of ethanol, treat with ultrasound for 15 minutes, filter, and take the filtrate as the test solution. Take 1 g of the reference drug Hirudo nipponica and prepare the reference drug solution in the same manner. Carry out the method for thin layer chromatography<0502>, using silica gel G as the coating substance and a mixture of cyclohexane and ethyl acetate (4:1) as the mobile phase. Apply separately to the plate 5 μl of each of the above two solutions. After developing and removal of the plate, dry in air. Spray with a 10% solution of sulfuric acid in ethanol, heat at 105°C to the spots clear. The purple-red spot in the chromatogram obtained with the test solution corresponds in position to the spot in the chromatogram obtained with the reference drug solution; under ultraviolet light at 365 nm, the same orange-red fluorescent spot is observed.

Examination

Water

Not more than 18.0 per cent <0832,method 2>.

Total ash

Not more than 8.0 per cent <2302>.

Acid-insoluble ash

Not more than 2.0 per cent <2302>.

pH value

Take about 1 g of the powder (passed through a No. 3 sieve) of the sample, add 10 ml of 0.9% sodium chloride solution, stir well, macerate for 30 minutes with occasional shaking, centrifuge, take the supernatant, and determine the pH value according to the method for pH determination <0631>. It should be 5.0-7.5.

Heavy metals and harmful elements

Determine according to the method for determination of lead, cadmium, arsenic, mercury, and copper <2321> by atomic absorption spectrophotometry or inductively coupled plasma mass spectrometry. The lead content should not exceed 10 mg/kg, the cadmium content should not exceed 1 mg/kg, the arsenic content should not exceed 5 mg/kg, and the mercury content should not exceed 1 mg/kg.

Aflatoxins

Determine according to the method for determination of mycotoxins <2351>.

The content of aflatoxin B1 in the sample should not exceed 5 μg per 1000g , and the total content of aflatoxin G2, aflatoxin G1, aflatoxin B2, and aflatoxin B1 should not exceed 10 μg.

Assay

Take about 1 g of the powder (passed through a No. 3 sieve) of the sample, accurately weigh, accurately add 5 ml of 0.9% sodium chloride solution, stir well, macerate for 30 minutes with occasional shaking, centrifuge, accurately take 100 μl of the supernatant, place it in a test tube (8 mm×38 mm), add 200 μl of tris(hydroxymethyl)aminomethane hydrochloride buffer solution containing 0.5% (bovine) fibrinogen (calculated as solid) <Note 1> (prepared for immediate use), shake well, place it in a water bath at (37℃±0.5℃) for 5 minutes, and add 1 ml of thrombin solution containing 40 units per ml <Note 2> (add 5 μl every 1 minute, gently shake while adding) until coagulation (leech) or add 1ml of thrombin solution containing 10 units per ml <Note 2> (add 2 μl every 4 minutes, gently shake while adding) until coagulation (leech or medicinal leech). Record the volume of consumed thrombin solution and calculate according to the following formula:

U is the content of thrombin activity units per 1 g, U/g;

C1 is the concentration of thrombin solution, μ/ml;

C2 is the concentration of the sample solution, g/ml;

V1 is the volume of consumed thrombin solution, μl;

V2 is the volume of the sample solution added, μl.

The amount of thrombin that neutralizes one unit is one unit of antithrombin activity.

The content of antithrombin activity in the sample should not be less than 16.0 U per 1 g for leeches and not less than 3.0U for medicinal leeches.

Prepared slices

Leech

Processing

Clean the leeches, cut into sections, and dry.

Appearance

The sample is irregular in shape, flat or flat cylindrical. The dorsal surface is blackish-brown and slightly raised, and the ventral surface is brownish-brown with fine transverse annular lines. The cut surface is grayish-white to brownish-yellow and gelatinous. The texture is brittle and the odor is slightly fishy.

Blanched leech

Processing

Take clean leech sections, blanch them with talcum powder according to the method for blanching <0213> until slightly swollen.

Appearance

The sample is irregular in shape, flat or flat cylindrical, slightly swollen, with blackish-brown on the dorsal surface and brownish-yellow to brownish-brown on the ventral surface, with a small amount of white talcum powder attached. The cut surface is spongy, grayish-white to dark yellow. The odor is slightly fishy.

Examination

Water

Not more than 14.0 per cent, same as the crude drug.

Total ash

Not more than 10.0 per cent, same as the crude drug.

Acid-insoluble ash

Not more than 3.0 per cent, same as the crude drug.

pH value

Same as the crude drug.

Heavy metals and harmful elements

Same as the crude drug.

Aflatoxins

Same as the crude drug.

Identification

Same as the crude drug.

Property

Neutral.

Toxicity

Slightly toxic.

Flavor

Salty，bitter.

Meridian tropism

Meridian tropism: Liver meridian.

Actions

To promote blood circulation and remove blood stasis, resolve masses and dissipate nodules.

Indications

Used for blood stasis causing amenorrhea, masses and lumps, stroke with hemiplegia, and traumatic injuries.

Dosage

1-3 g.

Administration

None.

Precautions

Not to be used during pregnancy.

Storage

Store in a dry place, protected from moth.

Note 1: Preparation of tris(hydroxymethyl)aminomethane hydrochloride buffer solution: Take 25ml of 0.2 mol/L tris(hydroxymethyl)aminomethane solution and about 40 ml of 0.1 mol/L hydrochloric acid solution, add water to 100ml, and adjust the pH value to 7.4.

Note 2: Preparation of thrombin solution: Take an appropriate amount of thrombin reagent and prepare a solution containing 40 units or 10 units of thrombin per 1 ml with physiological saline (prepared for immediate use).