CN101732608A - Method for detecting quality of mulberry and chrysanthemum lonicera and forsythia powder - Google Patents
Method for detecting quality of mulberry and chrysanthemum lonicera and forsythia powder Download PDFInfo
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- CN101732608A CN101732608A CN201010101794A CN201010101794A CN101732608A CN 101732608 A CN101732608 A CN 101732608A CN 201010101794 A CN201010101794 A CN 201010101794A CN 201010101794 A CN201010101794 A CN 201010101794A CN 101732608 A CN101732608 A CN 101732608A
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Abstract
The invention relates to a method for detecting quality of mulberry and chrysanthemum lonicera and forsythia powder according to standards described in volume XI of Medicament Standard of Ministry of Health of the People's Republic of China (Chinese medicinal set prescription preparation), which comprises a microscopic identification method of chrysanthemum, lonicera confuse and great burdock achene, a thin-layer chromatography identification method of forsythia, a thin-layer chromatography identification method of liquoric root and a content measuring method of arctigenin in medicaments. The quality detection method of the mulberry and chrysanthemum lonicera and forsythia powder improves the quality control standard of the mulberry and chrysanthemum lonicera and forsythia powder, establishes content measuring indexes in the preparation and a detection method thereof, improves the thin-layer chromatography identification method of the forsythia and the liquoric root by making the thin-layer chromatography identification method of the forsythia and the liquoric root more specific and accurate, increases microscopic characteristics of the chrysanthemum and the great burdock achene, revises the microscopic characteristic of the lonicera confuse to make the description of the lonicera confuse more standard and accurate, and ensures the high quality standard level of the compound preparation.
Description
Technical field
The present invention relates to the quality determining method of the ten mulberry and chrysanthemum lonicera and forsythia powder of " Drug Standard of Ministry of Public Health of the Peoples Republic of China " (Chinese traditional patent formulation preparation).
Technical background
Medicine mulberry and chrysanthemum lonicera and forsythia powder in the 11 in " Drug Standard of Ministry of Public Health of the Peoples Republic of China " (Chinese traditional patent formulation preparation) has the cool completely effect of table, lung qi dispersing cough-relieving, heat-clearing and toxic substances removing of suffering, is used for affection due to external wind and heat, loathing of cold high fever, headache cough, laryngopharynx swelling and pain.This compound preparation is made up of Chinese crude drug Folium Mori 60g, Flos Chrysanthemi 60g, Flos Lonicerae 60g, Fructus Forsythiae 60g, Bulbus Fritillariae Cirrhosae 60g, Radix Platycodonis 30g, Herba Menthae 40g, Herba Lophatheri 40g, Herba Schizonepetae 40g, Fructus Arctii 40g, Semen Armeniacae Amarum 40g, Rhizoma Phragmitis 60g, Periostracum Cicadae 60g, Bombyx Batryticatus 30g, Talcum 60g, Semen phaseoli radiati 60g, Semen Sojae Preparatum 20g, Radix Glycyrrhizae 40g, and above-mentioned raw materials is made 860g altogether.Folium Mori are the dried leaves of moraceae plants Mulberry Morus alba L., have dispelling wind and heat pathogens, clearing away lung-heat and moistening for dryness, the effect of liver heat removing and eyesight improving; Flos Chrysanthemi is the dry capitulum of feverfew chrysanthemum Chrysanthemum morifolium Ramat., has diffusing wind heat clearing away, the effect that suppressing the hyperactive liver makes eye bright; Flos Lonicerae is the dry flower of caprifoliaceae plant largeflower-like honeysuckle flower Lonicera macranthoides Hand.-Mazz., Flos Lonicerae Lonicera hypoglauca Miq. or Lonicera confusa Lonicera confusa DC. or the flower that band is just opened, the tool heat-clearing and toxic substances removing, the effect of wind-heat dissipating; Fructus Forsythiae is the dry fruit of Oleaceae plant Fructus Forsythiae Forsythia suspensa (Thunb.) Vahl, has heat-clearing and toxic substances removing, the effect of dispersing swelling and dissipating binds; Bulbus Fritillariae Cirrhosae is the dry bulb of liliaceous plant Bulbus Fritillariae Cirrhosae Fritillaria cirrhosa D.Don, dark violet Bulbus Fritillariae Uninbracteatae Fritillaria unibracteata Hsiao et K.C.Hsia, Gansu Bulbus Fritillariae Uninbracteatae Fritillaria przewalskii Maxim. or Bulbus Fritillariae cirrhosae Fritillaria delavayi Franch., have clearing heat and moistening lung, the effect of preventing phlegm from forming and stopping coughing; Radix Platycodonis is the dry root of campanulaceae plant Platycodon grandiflorum (Jacq.) A.DC., has lung qi dispersing, sore-throat relieving, the effect of evacuation of pus; Herba Menthae is the dry aerial parts of labiate Menthahaplocalyx Briq., has dispelling wind-heat, refresh oneself, the effect of rash; Herba Lophatheri is the dry stem and leaf of grass Herba Lophatheri Lophatherum gracile Brongn., has clearing heat and relieving fidgetness, the effect of diuresis; Herba Schizonepetae is the dry aerial parts of labiate Herba Schizonepetae Schizonepeta tenuifolia Briq., has the diffusing wind that induces sweat, the effect of rash; Fructus Arctii is the dry mature fruit of feverfew Fructus Arctii Arctium lappa L, has dispelling wind and heat pathogens, lung qi dispersing rash, the effect of resolving toxin and disinhibiting the throat; Semen Armeniacae Amarum is the dry mature seed of rosaceous plant Prunus armeniaca L.var.ansu Maxim. Prunus armeniaca L.var.ansuMaxim., Siberia Fructus Pruni Prunus sibirica L., prunus mandshuricaKoehne Prunus mandshurica (Maxim.) Koehne or Fructus Pruni Prunus armeniaca L., has the sending down the abnormal ascending QI relieving cough and asthma, the effect of loosening bowel to relieve constipation; Rhizoma Phragmitis is the fresh or dry rhizome of grass phragmites communis Phragmites communis Trin., has clearing away heat and promoting production of body fluid, the effect of relieving restlessness; Periostracum Cicadae is the nymph of cicada Cryptotympana atrata Fabr. Cryptotympana pustulata Fabricius exuviae shell when sprouting wings, and has diffusing wind heat extraction, sore-throat relieving, the effect of rash; Bombyx Batryticatus is that the larva in Bombycidae insecticide silkworm Bombyx mori Linnaeus4～5 ages infects (or artificial vaccination) muscardine Beauveria bassiana (Bals) Vuillant and lethal dry body has expelling wind for relieving convulsion, the effect of dissipating phlegm and resolving masses; Talcum is a silicates mineral talc family Talcum, the main hydrous magnesium silicate (Mg that contains
3(Si
4O
10) (OH)
2), have inducing diuresis for treating stranguria syndrome, clearing away summer-heat, the effect of skin ulcer is held back in damp eliminating; Semen phaseoli radiati is the dry seed of leguminous plant Semen phaseoli radiati Phaseolus radiatus L., has heat-clearing and toxic substances removing, relieves summer heat the effect of diuretic; Tasteless preserved soybean is the fermentation processed goods of the mature seed of legume soybean Glycine max (L.) Merr., has and induces sweat, relieving restlessness, the effect that a surname sends out hot and suffocating; Radix Glycyrrhizae is the dry root and rhizome of glycyrrhizic legume Glycyrrhiza inflata Bat., Glycyrrhiza inflata Bat. Glycyrrhiza in flataBat or Glycyrrhiza glabra L. Glycyrrhiza glabra L., have invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, the effect of coordinating the actions of various ingredients in a prescription." Drug Standard of Ministry of Public Health of the Peoples Republic of China " the 11 issued the quality control standard (WS3-B-2219-96) of mulberry and chrysanthemum lonicera and forsythia powder, but in the existing mulberry and chrysanthemum lonicera and forsythia powder method of quality control that Ministry of Public Health is issued, have only microscopical identification and thin layer chromatography to differentiate, limitation is very big, is difficult to accurately control the quality of mulberry and chrysanthemum lonicera and forsythia powder;
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art, a kind of quality determining method of mulberry and chrysanthemum lonicera and forsythia powder is provided, to improve the quality control standard of mulberry and chrysanthemum lonicera and forsythia powder.
The pharmaceutical formulation of mulberry and chrysanthemum lonicera and forsythia powder is: Folium Mori 60g, Flos Chrysanthemi 60g, Flos Lonicerae 60g, Fructus Forsythiae 60g, Bulbus Fritillariae Cirrhosae 60g, Radix Platycodonis 30g, Herba Menthae 40g, Herba Lophatheri 60g, Herba Schizonepetae 40g, Fructus Arctii 40g, Semen Armeniacae Amarum 40g, Rhizoma Phragmitis 60g, Periostracum Cicadae 60g, Bombyx Batryticatus 30g, Talcum 60g, Semen phaseoli radiati 60g, Semen Sojae Preparatum 20g, Radix Glycyrrhizae 40g.More than 18 the flavor, be ground into fine powder, sieve, mixing, promptly.This product is that lark is to filemot powder; Bitter in the mouth, sweet, little puckery.
The quality determining method of mulberry and chrysanthemum lonicera and forsythia powder of the present invention is:
1, the microscopical identification method of Flos Chrysanthemi, Flos Lonicerae and Fructus Arctii: get mulberry and chrysanthemum lonicera and forsythia powder and put the microscopically observation: the pollen grain yellow, the class sphere, outer wall is thicker, tool bastard, 3 germinal aperatures of tool (Flos Chrysanthemi); The pollen grain yellow, sphere, outer wall is thin, 3 germinal aperatures of tool (Flos Lonicerae); The endocarp stone cell is slightly flat, and the surface is seen and is sharp fusiformis, oblong, and sharp oval is inlayed closely (Fructus Arctii);
2, the thin layer chromatography discrimination method of Fructus Forsythiae: get mulberry and chrysanthemum lonicera and forsythia powder 10g, add ethanol 40-60ml, supersound process 20-40 minute, filter, filtrate evaporate to dryness, residue add water 15-25ml makes dissolving, and absorbent cotton filters, filtrate is extracted 2-3 time with the ethyl acetate jolting, each 15-25ml, combined ethyl acetate liquid, evaporate to dryness, residue adds ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Fructus Forsythiae control medicinal material 0.5g, adds ethyl acetate 15-25ml, and supersound process 20-40 minute, filter, filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, in contrast medical material solution; According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B) test, draw above-mentioned need testing solution 5～10 μ l, control medicinal material solution 5 μ l, put respectively on same silica gel g thin-layer plate, with normal hexane-ethyl acetate (volume proportion 17-23: 0.9-1.1) be developing solvent, launch, take out, dry, spray is with 10% (g/ml) ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color;
3, the thin layer chromatography discrimination method of Radix Glycyrrhizae: get need testing solution under above-mentioned 2 as need testing solution, extracting liquorice control medicinal material 1g adds ethanol 20ml in addition, reflux 1 hour filters the filtrate evaporate to dryness, residue adds dehydrated alcohol 1ml makes dissolving, filters, and filtrate is medical material solution in contrast; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 10 μ l of need testing solution and above-mentioned control medicinal material solution, put respectively on same silica gel g thin-layer plate, with chloroform-methanol-water (volume proportion 36-44: 9-11: 0.8-1.2) be developing solvent, launch, take out, dry, spray is with 10% (g/ml) ethanol solution of sulfuric acid, it is clear to be heated to speckle colour developing at 105 ℃, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical yellow spotting.
4, the content assaying method of Arctiin in the medicine: measure according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 D).
1) chromatographic condition and system suitability test: with the octadecylsilane chemically bonded silica is filler; With methanol-water by volume proportioning be at 35: 65 mobile phase, the detection wavelength is 280 ± 2nm.Number of theoretical plate calculates by Arctiin should be not less than 2000.
2) preparation of reference substance solution: it is an amount of to get the Arctiin reference substance, and accurate the title decides, and adds 50% (g/ml) methanol and makes the solution that every 1ml contains 0.1mg, promptly.
3) preparation of need testing solution: get the about 1g of this product, the accurate title, decide, and puts in the tool plug conical flask, accurate 50% (g/ml) methanol 25ml that adds claims to decide weight, supersound process (power 160w, frequency 50KHz) 20-40 minute, take out, put cold, weigh, supply weight with 50% (g/ml) methanol, shake up, filter, get subsequent filtrate, promptly.
4) algoscopy: accurate respectively above-mentioned two kinds of reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.The every 1g of this product contains Fructus Arctii with Arctiin (C
27H
34O
11) meter, must not be less than 1.9mg.
Wherein, contain the some grams of solute among the every 100ml of " % (g/ml) " expression solution.
The quality determining method of mulberry and chrysanthemum lonicera and forsythia powder of the present invention, improved the quality control standard of mulberry and chrysanthemum lonicera and forsythia powder, assay index and detection method thereof in the preparation have been set up, improved the thin layer chromatography discrimination method of Fructus Forsythiae and Radix Glycyrrhizae, make its method have more specificity, more accurate, increased the microscopic features of Flos Chrysanthemi and Fructus Arctii, revised the microscopic features of Flos Lonicerae, make it describe more standard, more accurate, guaranteed this compound preparation higher quality standard level.
The specific embodiment
Embodiment:
The pharmaceutical formulation of mulberry and chrysanthemum lonicera and forsythia powder is: Folium Mori 60g, Flos Chrysanthemi 60g, Flos Lonicerae 60g, Fructus Forsythiae 60g, Bulbus Fritillariae Cirrhosae 60g, Radix Platycodonis 30g, Herba Menthae 40g, Herba Lophatheri 60g, Herba Schizonepetae 40g, Fructus Arctii 40g, Semen Armeniacae Amarum 40g, Rhizoma Phragmitis 60g, Periostracum Cicadae 60g, Bombyx Batryticatus 30g, Talcum 60g, Semen phaseoli radiati 60g, Semen Sojae Preparatum 20g, Radix Glycyrrhizae 40g.More than 18 the flavor, be ground into fine powder, sieve, mixing, promptly.This product is that lark is to filemot powder; Bitter in the mouth, sweet, little puckery.
The quality determining method of mulberry and chrysanthemum lonicera and forsythia powder of the present invention is:
1, the microscopical identification method of Flos Chrysanthemi, Flos Lonicerae and Fructus Arctii: get mulberry and chrysanthemum lonicera and forsythia powder and put the microscopically observation: the pollen grain yellow, the class sphere, outer wall is thicker, tool bastard, 3 germinal aperatures of tool (Flos Chrysanthemi); The pollen grain yellow, sphere, outer wall is thin, 3 germinal aperatures of tool (Flos Lonicerae); The endocarp stone cell is slightly flat, and the surface is seen and is sharp fusiformis, oblong, and sharp oval is inlayed closely (Fructus Arctii);
2, the thin layer chromatography discrimination method of Fructus Forsythiae: get mulberry and chrysanthemum lonicera and forsythia powder 10g, add ethanol 50ml, supersound process 30 minutes, filter, filtrate evaporate to dryness, residue add water 20ml makes dissolving, and absorbent cotton filters, filtrate is extracted 2 times with the ethyl acetate jolting, each 20ml, combined ethyl acetate liquid, evaporate to dryness, residue adds ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Fructus Forsythiae control medicinal material 0.5g, adds ethyl acetate 20ml, and supersound process 30 minutes filters, and filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, in contrast medical material solution; According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B) test, draw above-mentioned need testing solution 5～10 μ l, control medicinal material solution 5 μ l, put respectively on same silica gel g thin-layer plate, with normal hexane-ethyl acetate (volume proportion 20: 1) is developing solvent, launches, and takes out, dry, spray is with 10% (g/ml) ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color;
3, the thin layer chromatography discrimination method of Radix Glycyrrhizae: get need testing solution under above-mentioned 2 as need testing solution, extracting liquorice control medicinal material 1g adds ethanol 20ml in addition, reflux 1 hour filters the filtrate evaporate to dryness, residue adds dehydrated alcohol 1ml makes dissolving, filters, and filtrate is medical material solution in contrast; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), drawing each 10 μ l of need testing solution and above-mentioned control medicinal material solution, put respectively on same silica gel g thin-layer plate, is developing solvent with chloroform-methanol-water (volume proportion 40: 10: 1), launch, take out, dry, spray is with 10% (g/ml) ethanol solution of sulfuric acid, it is clear to be heated to speckle colour developing at 105 ℃, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical yellow spotting.
4, the content assaying method of Arctiin in the medicine: measure according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 D).
1) chromatographic condition and system suitability test: with the octadecylsilane chemically bonded silica is filler; With methanol-water (volume proportion 35: 65) is mobile phase, and the detection wavelength is 280nm.Number of theoretical plate calculates by Arctiin should be not less than 2000.
2) preparation of reference substance solution: it is an amount of to get the Arctiin reference substance, and accurate the title decides, and adds 50% (g/ml) methanol and makes the solution that every 1ml contains 0.1mg, promptly.
3) preparation of need testing solution: get the about 1g of this product, the accurate title, decide, and puts in the tool plug conical flask, accurate 50% (g/ml) methanol 25ml that adds claims to decide weight, supersound process (power 160w, frequency 50KHz) 30 minutes, take out, put cold, weigh, supply weight with 50% (g/ml) methanol, shake up, filter, get subsequent filtrate, promptly.
4) algoscopy: accurate respectively above-mentioned two kinds of reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.The every 1g of this product contains Fructus Arctii with Arctiin (C
27H
34O
11) meter, must not be less than 1.9mg.
Wherein, contain the some grams of solute among the every 100ml of " % (g/ml) " expression solution.
Mulberry and chrysanthemum lonicera and forsythia powder drug standard after the improvement is:
Mulberry and chrysanthemum lonicera and forsythia powder
Sangju?Yinqiao?San
[prescription] Folium Mori 60g Flos Chrysanthemi 60g Flos Lonicerae 60
Fructus Forsythiae 60g Bulbus Fritillariae Cirrhosae 60g Radix Platycodonis 30
Herba Menthae 40g Herba Lophatheri 60g Herba Schizonepetae 40g
Fructus Arctii 40g Semen Armeniacae Amarum 40g Rhizoma Phragmitis 60g
Periostracum Cicadae 60g Bombyx Batryticatus 30g Talcum 60g
Semen phaseoli radiati 60g Semen Sojae Preparatum 20g Radix Glycyrrhizae 40g
[method for making] above 18 flavors are ground into fine powder, sieve, and mixing, promptly.
[character] this product is that lark is to filemot powder; Bitter in the mouth, sweet, little puckery.
This product is got in [discriminating] (1), puts microscopically and observes: the pollen grain yellow, and the class sphere, outer wall is thicker, tool bastard, 3 germinal aperatures of tool (Flos Chrysanthemi).The pollen grain yellow, sphere, outer wall is thin, 3 germinal aperatures of tool (Flos Lonicerae).The endocarp stone cell is slightly flat, and the surface is seen and is sharp fusiformis, oblong, and sharp oval is inlayed closely (Fructus Arctii).
(2) get this product 10g, add ethanol 50ml, supersound process 30 minutes filters the filtrate evaporate to dryness, residue adds water 20ml makes dissolving, and absorbent cotton filters, and filtrate is extracted 2 times with the ethyl acetate jolting, each 20ml, combined ethyl acetate liquid, evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Fructus Forsythiae control medicinal material 0.5g, adds ethyl acetate 20ml, and supersound process 30 minutes filters, and filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, in contrast medical material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw above-mentioned need testing solution 5～10 μ l, control medicinal material solution 5 μ l, putting respectively on same silica gel g thin-layer plate, is developing solvent with normal hexane-ethyl acetate (20: 1), launches, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
(3) get need testing solution under [discriminating] (2) as need testing solution.Extracting liquorice control medicinal material 1g adds ethanol 20ml in addition, and reflux 1 hour filters, and filtrate evaporate to dryness, residue add dehydrated alcohol 1ml makes dissolving, filters, and filtrate is medical material solution in contrast.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 10 μ l of need testing solution and above-mentioned control medicinal material solution, put respectively on same silica gel g thin-layer plate, with chloroform-methanol-water (40: 10: 1) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical yellow spotting.
[inspection] should meet every regulation relevant under the powder item (an appendix I of Chinese Pharmacopoeia version in 2005 B).
[assay] measured according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 D).
Chromatographic condition and system suitability test are filler with the octadecylsilane chemically bonded silica; With methanol-water (35: 65) is mobile phase, and the detection wavelength is 280nm.Number of theoretical plate calculates by Arctiin should be not less than 2000.
It is an amount of that the Arctiin reference substance is got in the preparation of reference substance solution, and accurate the title decides, and adds 50% methanol and makes the solution that every 1ml contains 0.1mg, promptly.
The about 1g of this product is got in the preparation of need testing solution, and accurate the title decides, and puts in the tool plug conical flask, and the accurate 50% methanol 25ml that adds claims to decide weight, supersound process (power 160w, frequency 50KHz) 30 minutes is taken out, and puts coldly, weighs, supply weight with 50% methanol, shake up, filter, get subsequent filtrate, promptly.
Accurate respectively above-mentioned reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
The every 1g of this product contains Fructus Arctii with Arctiin (C
27H
34O
11) meter, must not be less than 1.9mg.
[function with cure mainly] suffering table that cools completely, lung qi dispersing cough-relieving, heat-clearing and toxic substances removing.Be used for affection due to external wind and heat, loathing of cold high fever, headache cough, laryngopharynx swelling and pain.
[usage and consumption] is oral, a 10g, 2～3 times on the one.
[specification] every packed 10g.
[storage] is airtight, protection against the tide.
Claims (1)
1. the quality determining method of a mulberry and chrysanthemum lonicera and forsythia powder, the pharmaceutical formulation of mulberry and chrysanthemum lonicera and forsythia powder is: Folium Mori 60g, Flos Chrysanthemi 60g, Flos Lonicerae 60g, Fructus Forsythiae 60g, Bulbus Fritillariae Cirrhosae 60g, Radix Platycodonis 30g, Herba Menthae 40g, Herba Lophatheri 60g, Herba Schizonepetae 40g, Fructus Arctii 40g, Semen Armeniacae Amarum 40g, Rhizoma Phragmitis 60g, Periostracum Cicadae 60g, Bombyx Batryticatus 30g, Talcum 60g, Semen phaseoli radiati 60g, Semen Sojae Preparatum 20g, Radix Glycyrrhizae 40g; More than 18 the flavor, be ground into fine powder, sieve, mixing, promptly; The quality determining method that it is characterized in that mulberry and chrysanthemum lonicera and forsythia powder is:
1) the microscopical identification method of Flos Chrysanthemi, Flos Lonicerae and Fructus Arctii: get mulberry and chrysanthemum lonicera and forsythia powder and put the microscopically observation: the pollen grain yellow, the class sphere, outer wall is thicker, tool bastard, 3 germinal aperatures of tool (Flos Chrysanthemi); The pollen grain yellow, sphere, outer wall is thin, 3 germinal aperatures of tool (Flos Lonicerae); The endocarp stone cell is slightly flat, and the surface is seen and is sharp fusiformis, oblong, and sharp oval is inlayed closely (Fructus Arctii);
2) the thin layer chromatography discrimination method of Fructus Forsythiae: get mulberry and chrysanthemum lonicera and forsythia powder 10g, add ethanol 40-60ml, supersound process 20-40 minute, filter, filtrate evaporate to dryness, residue add water 15-25ml makes dissolving, and absorbent cotton filters, filtrate is extracted 2-3 time with the ethyl acetate jolting, each 15-25ml, combined ethyl acetate liquid, evaporate to dryness, residue adds ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Fructus Forsythiae control medicinal material 0.5g, adds ethyl acetate 15-25ml, and supersound process 20-40 minute, filter, filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, in contrast medical material solution; According to the thin layer chromatography test, draw above-mentioned need testing solution 5～10 μ l, control medicinal material solution 5 μ l, put respectively on same silica gel g thin-layer plate, by volume proportioning 17-23: 0.9-1.1 is as developing solvent with normal hexane-ethyl acetate, and expansion is taken out, dry, spray is with 10% (g/ml) ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color;
3) the thin layer chromatography discrimination method of Radix Glycyrrhizae: get need testing solution under above-mentioned 2 as need testing solution, other is extracting liquorice control medicinal material 1g, add ethanol 15-25ml, reflux 0.5-1.5 hour, filter, filtrate evaporate to dryness, residue add dehydrated alcohol 1ml makes dissolving, filter, filtrate is medical material solution in contrast; Test according to thin layer chromatography, draw each 10 μ l of need testing solution and above-mentioned control medicinal material solution, put respectively on same silica gel g thin-layer plate, with chloroform-methanol-water proportioning 36-44: 9-11 by volume: 0.8-1.2 is as developing solvent, launch, take out, dry, spray is with 10% (g/ml) ethanol solution of sulfuric acid, it is clear to be heated to speckle colour developing at 105 ℃, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical yellow spotting;
4) content assaying method of Arctiin in the medicine: according to high effective liquid chromatography for measuring
(1) chromatographic condition and system suitability test: with the octadecylsilane chemically bonded silica is filler; With methanol-water by volume proportioning the detection wavelength was 280 ± 2nm as mobile phase in 35: 65;
(2) preparation of reference substance solution: it is an amount of to get the Arctiin reference substance, and accurate the title decides, and adds 50% (g/ml) methanol and makes the solution that every 1ml contains 0.1mg, promptly;
(3) preparation of need testing solution: get the about 1g of this product, the accurate title, decide, and puts in the tool plug conical flask, and accurate 50% methanol (g/ml) 25ml that adds claims to decide weight, supersound process 20-40 minute, take out, put coldly, weigh, supply weight with 50% (g/ml) methanol, shake up, filter, get subsequent filtrate, promptly;
(4) algoscopy: accurate respectively above-mentioned reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, that is, the every 1g of this product contains Fructus Arctii in Arctiin, must not be less than 1.9mg;
Wherein, contain the some grams of solute among the every 100ml of " % (g/ml) " expression solution.
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