CN101518619B - Compound brain activation and comfort capsule and quality control method thereof - Google Patents
Compound brain activation and comfort capsule and quality control method thereof Download PDFInfo
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- CN101518619B CN101518619B CN2009103012921A CN200910301292A CN101518619B CN 101518619 B CN101518619 B CN 101518619B CN 2009103012921 A CN2009103012921 A CN 2009103012921A CN 200910301292 A CN200910301292 A CN 200910301292A CN 101518619 B CN101518619 B CN 101518619B
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Abstract
The invention relates to a traditional Chinese medicine preparation, in particular to a compound brain activation and comfort capsule and a quality control method thereof. The method comprises one of the following steps or some of the following steps: (1) ginseng authentication, (2) medlar authentication, (3) Salvia miltiorrhiza authentication, (4) total nitrogen content measurement, (5) amino nitrogen content measurement and (6) shizandra berry content measurement. In the Salvia miltiorrhiza authentication process, positions on a chromatogram of a tested sample, which correspond to the positions on a chromatogram of a contrast sample show spots with same colors; in the total nitrogen content measurement process, the nitrogen (N) content of each capsule is no less than 15 mg; in the amino nitrogen content measurement process, the amino nitrogen content of each capsule is no less than 1.0 mg; and in the shizandra berry content measurement process, the shizandra berry content counted as shizandra berry schizandrin (C24H32O7) of each capsule is not less than 30 microgrammes. The quality control method has more quality control items so as to better control the quality of the product and effectively supervise the production, is beneficial to the supervision of the quality of the product and ensure the stability of the quality of the product and the safety of patients taking medicined.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation, i.e. compound brain activation and comfort capsule and method of quality control thereof.
Background technology
In prior art, the accurate word Z20026288 of compound brain activation and comfort capsule (Fufang Huonaoshujiaonang) traditional Chinese medicines, prescription: Medulla sus domestica 2000g, Fructus Schisandrae Chinensis 200g, Radix Ophiopogonis 100g, Radix Ginseng 50g, Fructus Lycii 50g, Radix Rehmanniae 50g, Radix Salviae Miltiorrhizae 50g, dextrin 2.5g, pepsin 60g.Method for making: above seven flavors, the Radix Ginseng powder is broken into fine powder, and is standby.Medulla sus domestica adds water 1100ml homogenate, regulates pH value to 1.5-2.0 with hydrochloric acid, adds pepsin, stirs evenly, and 37 ℃-40 ℃ insulations 8-10 hour, 100 ℃ of insulations 40 minutes, leaves standstill again, and is centrifugal, gets supernatant, and spray drying is standby.Five tastes medical materials such as all the other Fructus Schisandrae Chinensis decoct with water secondary, and 3 hours for the first time, the 22 hour, collecting decoction, filter, filtrate is concentrated into the thick paste that relative density is 1.30-1.35 (50 ℃), and drying is ground into fine powder, sieve,, make 1000, promptly with above-mentioned fine powder and dextrin mixing.Function cures mainly: foster the spirit of nobility and enrich blood, nourishing the brain and improving intelligence.Be used for forgetful deficiency of qi and blood disease, hypomnesis, fatigue and weakness, dizzy cardiopalmus, and the improvement of the above symptom of alzheimer disease.Usage and dosage: oral, one time 3 (5 of serious symptoms), 2 times on the one, taking medicine after meal; 15 days is a course of treatment.Every dress of specification 0.25g.
The proper mass standard is not differentiated or assay this medicine, is unfavorable for production control and quality monitoring to product, is unfavorable for patient's drug safety.
Summary of the invention
The objective of the invention is provides a kind of compound brain activation and comfort capsule and method of quality control thereof that improves quality control at above-mentioned deficiency.
Technical solution of the present invention is: the compound brain activation and comfort capsule method of quality control, compound brain activation and comfort capsule is by Medulla sus domestica 2000g, Fructus Schisandrae Chinensis 200g, Radix Ophiopogonis 100g, Radix Ginseng 50g, Fructus Lycii 50g, Radix Rehmanniae 50g, Radix Salviae Miltiorrhizae 50g, dextrin 2.5g, pepsin 60g crude drug is made 1000, it is characterized in that comprising in this method following any or several combination:
(1) Radix Ginseng is differentiated: get this product content 4g, add chloroform 40ml, supersound process 20 minutes, discard chloroform layer, residue volatilizes solvent, adds water saturated n-butyl alcohol 30ml, supersound process 40 minutes, draw supernatant, add the washing of 2 times of amount ammonia solutions once, add water 20ml washing again, discard water layer, n-butyl alcohol liquid evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution.Other gets ginsenoside Rg l, Re reference substance, adds methanol and makes the mixed solution that every 1ml contains 2mg, in contrast product solution.According to appendix VIB test of thin layer chromatography Chinese Pharmacopoeia version in 2005, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform-methanol-water=7: 2.5: 0.5 was 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 reference substance chromatograph on, show the speckle of same color;
(2) Fructus Lycii is differentiated: get this product content 2.5g, porphyrize adds water 30ml, boils 30 minutes, puts coldly, filters, and filtrate is extracted 2 times with the ethyl acetate jolting, each 20ml, and merge extractive liquid,, evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution.Other gets Fructus Lycii control medicinal material 2g, shines medical material solution in pairs with legal system.According to appendix VIB test of thin layer chromatography Chinese Pharmacopoeia version in 2005, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform-acetone-methanol-liquor ammoniae fortis=13: 4: 3: 0.5 was developing solvent, launch, take out, dry, put under the ultra-violet lamp 365nm and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
(3) Radix Salviae Miltiorrhizae is differentiated: get this product content 4g, add water 20ml, warm dissolving adds dilute hydrochloric acid and regulates pH value about 4, with ether extraction 3 times, each 20ml merges ether solution, uses anhydrous sodium sulfate dehydration, fling to ether, residue makes dissolving with dehydrated alcohol 1ml, as need testing solution.Other gets Radix Salviae Miltiorrhizae control medicinal material 7g, decocts with water 3 hours, filters, and filtrate is concentrated into about 20ml, add dilute hydrochloric acid and regulate pH value about 4, use ether extraction 3 times, each 20ml merges ether solution, use anhydrous sodium sulfate dehydration, fling to ether, residue makes dissolving with dehydrated alcohol 1ml, in contrast medical material solution.According to appendix VIB test of thin layer chromatography Chinese Pharmacopoeia version in 2005, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with benzene-ethyl acetate-formic acid=8: 5: 0.5 was developing solvent, launched, and took out, dry, spray is with 3% iron chloride alcoholic solution; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color;
(4) assay: total nitrogen
Get the content under the content uniformity item, mixing, precision takes by weighing in right amount, is equivalent to nitrogenous 2mg, measures according to appendix IXL second method of N2 method Chinese Pharmacopoeia version in 2005, promptly; This product every nitrogenous (N) must not be less than 15mg;
(5) assay: amino nitrogen
Get the content under the content uniformity item, mixing is got 0.8g, and accurate the title decides, add water 30ml, jolting 5 minutes, 0.1mol/L regulates pH to 7.0 with the sodium hydroxide volumetric solution, adds to use sodium hydroxide volumetric solution (0.1mol/L) to regulate the formalin 10ml of pH to 9.0 in advance, mixing, with sodium hydroxide titration 0.1mol/L, titration is to pH value of solution to 9.0, promptly; Every 1ml sodium hydroxide volumetric solution (0.1mol/L) is equivalent to the amino nitrogen of 1.401mg; Every of this product contains amino nitrogen must not be less than 1.0mg;
(6) assay: Fructus Schisandrae Chinensis
An appendix VID measures according to high performance liquid chromatography Chinese Pharmacopoeia version in 2005;
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile-0.5% phosphoric acid solution=45: 55 is a mobile phase; The detection wavelength is 250nm; Number of theoretical plate is pressed the schisandrin peak and is calculated, and should be not less than 2000;
The preparation of reference substance solution: it is an amount of that precision takes by weighing the schisandrin reference substance, adds methanol and make the solution that every 1ml contains 25 μ g, promptly;
The preparation of need testing solution: get content under the content uniformity item, porphyrize, precision takes by weighing 4g, in the tool plug conical flask, accurate methanol solution 25ml, the close plug of adding, claim to decide weight, supersound process 40 minutes is taken out, put coldly, claim again to decide weight, supply the weight that subtracts mistake with methanol solution, shake up, filter, get subsequent filtrate, promptly;
Algoscopy: accurate respectively need testing solution and each 10 μ l of reference substance solution of drawing, inject chromatograph of liquid, measure, promptly; Every of this product contains Fructus Schisandrae Chinensis with schisandrin (C
24H
32O
7) meter, must not be less than 30 μ g.
Advantage of the present invention is: 1, the discrimination method result of the test feminine gender of Radix Ginseng is noiseless among the present invention, the discrimination method of Fructus Lycii, and the result of the test feminine gender is noiseless, and the discrimination method of Radix Salviae Miltiorrhizae is negative noiseless.Increased Fructus Schisandrae Chinensis HPLC assay in this kind, formulated rational schisandrin assay scope by test, this content assaying method feminine gender is noiseless, and recovery test requirement all up to specification.2, an assay item and the discriminating energy by increasing above-mentioned principal agent, the control project is more, can control the quality of this kind better, work under supervision effectively, to prevent that mistake from feeding intake, miscarrying material or throwing the generations of throwing few phenomenon more, more help the supervision of product quality, guarantee the stable of product quality, patient's medication is safer.3, method is easy, accurate, favorable reproducibility.
Below in conjunction with embodiment embodiments of the present invention are described in further detail.
The specific embodiment
Embodiment 1
Compound brain activation and comfort capsule (the accurate word Z20026288 of traditional Chinese medicines) method of quality control comprises:
(1) Radix Ginseng is differentiated: get this product content 4g, add chloroform 40ml, supersound process 20 minutes, discard chloroform layer, residue volatilizes solvent, adds water saturated n-butyl alcohol 30ml, supersound process 40 minutes, draw supernatant, add the washing of 2 times of amount ammonia solutions once, add water 20ml washing again, discard water layer, n-butyl alcohol liquid evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution.Other gets ginsenoside Rg l, Re reference substance, adds methanol and makes the mixed solution that every 1ml contains 2mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform-methanol-water (7: 2.5: 0.5) 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 reference substance chromatograph on, show the speckle of same color.
(2) Fructus Lycii is differentiated: get this product content 2.5g, porphyrize adds water 30ml, boils 30 minutes, puts coldly, filters, and filtrate is extracted 2 times with the ethyl acetate jolting, each 20ml, and merge extractive liquid,, evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution.Other gets Fructus Lycii control medicinal material 2g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform-acetone-methanol-liquor ammoniae fortis (13: 4: 3: 0.5) be developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(3) Radix Salviae Miltiorrhizae is differentiated: get this product content 4g, add water 20ml, warm dissolving adds dilute hydrochloric acid and regulates pH value about 4, with ether extraction 3 times, each 20ml merges ether solution, uses anhydrous sodium sulfate dehydration, fling to ether, residue makes dissolving with dehydrated alcohol 1ml, as need testing solution.Other gets Radix Salviae Miltiorrhizae control medicinal material 7g, decocts with water 3 hours, filters, and filtrate is concentrated into about 20ml, add dilute hydrochloric acid and regulate pH value about 4, use ether extraction 3 times, each 20ml merges ether solution, use anhydrous sodium sulfate dehydration, fling to ether, residue makes dissolving with dehydrated alcohol 1ml, in contrast medical material solution.According to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005) test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with benzene-ethyl acetate-formic acid (8: 5: 0.5) is developing solvent, launches, and takes out, dry, spray is with 3% iron chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
(4) assay: total nitrogen
Get the content under the content uniformity item, mixing, precision takes by weighing in right amount (being equivalent to nitrogenous 2mg approximately), measures according to N2 method (appendix IXL second method of Chinese Pharmacopoeia version in 2005), promptly.This product every nitrogenous (N) must not be less than 15mg.
(5) assay: amino nitrogen
Get the content under the content uniformity item, mixing, get 0.8g, the accurate title, decide, and adds water 30ml, jolting 5 minutes, regulate pH to 7.0 with sodium hydroxide volumetric solution (0.1mol/L), add and use sodium hydroxide volumetric solution (0.1mol/L) to regulate the formalin 10ml of pH to 9.0, mixing in advance, with sodium hydroxide titration (0.1mol/L) titration to pH value of solution to 9.0, promptly.Every 1ml sodium hydroxide volumetric solution (0.1mol/L) is equivalent to the amino nitrogen of 1.401mg.Every of this product contains amino nitrogen must not be less than 1.0mg.
(6) assay: Fructus Schisandrae Chinensis
Measure according to high performance liquid chromatography (appendix VID of Chinese Pharmacopoeia version in 2005).
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile-0.5% phosphoric acid solution (45: 55) is a mobile phase; The detection wavelength is 250nm.Number of theoretical plate is pressed the schisandrin peak and is calculated, and should be not less than 2000.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the schisandrin reference substance, adds methanol and make the solution that every 1ml contains 25 μ g, promptly.
Content under the content uniformity item is got in the preparation of need testing solution, porphyrize, and precision takes by weighing 4g, in the tool plug conical flask, accurate methanol solution 25ml, the close plug of adding, claim to decide weight, supersound process 40 minutes is taken out, put coldly, claim again to decide weight, supply the weight that subtracts mistake with methanol solution, shake up, filter, get subsequent filtrate, promptly.
Accurate respectively need testing solution and each the 10 μ l of reference substance solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
Every of this product contains Fructus Schisandrae Chinensis with schisandrin (C
24H
32O
7) meter, must not be less than 30 μ g.
Embodiment 2
Compound brain activation and comfort capsule (the accurate word Z20026288 of traditional Chinese medicines) method of quality control comprises:
(1) Radix Ginseng is differentiated: with embodiment 1.
(2) Fructus Lycii is differentiated: with embodiment 1.
(3) Radix Salviae Miltiorrhizae is differentiated: with embodiment 1.
Embodiment 3
Compound brain activation and comfort capsule (the accurate word Z20026288 of traditional Chinese medicines) method of quality control comprises:
(1) total nitrogen assay: with embodiment 1.
(2) amino nitrogen content is measured: with embodiment 1.
(3) Fructus Schisandrae Chinensis assay: with embodiment 1.
Embodiment 4
Compound brain activation and comfort capsule (the accurate word Z20026288 of traditional Chinese medicines) method of quality control comprises:
(1) Fructus Schisandrae Chinensis assay: with embodiment 1.
Claims (1)
1. a compound brain activation and comfort capsule is differentiated and content assaying method, and compound brain activation and comfort capsule is by Medulla sus domestica 2000g, Fructus Schisandrae Chinensis 200g, Radix Ophiopogonis 100g, Radix Ginseng 50g, Fructus Lycii 50g, Radix Rehmanniae 50g, Radix Salviae Miltiorrhizae 50g, dextrin 2.5g, pepsin 60g crude drug is made 1000; The Radix Ginseng powder is broken into fine powder, and is standby; Medulla sus domestica adds water 1100ml homogenate, to 1.5-2.0, adds pepsin with hydrochloric acid adjusting pH value, stirs evenly, and 37 ℃-40 ℃ insulations 8-10 hours, 100 ℃ of insulations 40 minutes, leaves standstill again, and is centrifugal, gets supernatant, spray drying, and it is standby to get fine powder; Fructus Schisandrae Chinensis, Radix Ophiopogonis, Fructus Lycii, Radix Rehmanniae, Radix Salviae Miltiorrhizae five tastes medical material decocts with water secondary, 3 hours for the first time, the 22 hour, collecting decoction filtered, and filtrate is concentrated into the thick paste that relative density is 1.30-1.35, drying is ground into fine powder, sieves, with above-mentioned fine powder and dextrin mixing, encapsulated making; It is characterized in that detection method is as follows:
(1) Radix Ginseng is differentiated: get this product content 4g, add chloroform 40ml, supersound process 20 minutes, discard chloroform layer, residue volatilizes solvent, adds water saturated n-butyl alcohol 30ml, supersound process 40 minutes, draw supernatant, add the washing of 2 times of amount ammonia solutions once, add water 20ml washing again, discard water layer, n-butyl alcohol liquid evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution.Other gets ginsenoside Rg l, Re reference substance, adds methanol and makes the mixed solution that every 1ml contains 2mg, in contrast product solution.According to appendix VIB test of thin layer chromatography Chinese Pharmacopoeia version in 2005, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform-methanol-water=7: 2.5: 0.5 was 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 reference substance chromatograph on, show the speckle of same color;
(2) Fructus Lycii is differentiated: get this product content 2.5g, porphyrize adds water 30ml, boils 30 minutes, puts coldly, filters, and filtrate is extracted 2 times with the ethyl acetate jolting, each 20ml, and merge extractive liquid,, evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution.Other gets Fructus Lycii control medicinal material 2g, shines medical material solution in pairs with legal system.According to appendix VIB test of thin layer chromatography Chinese Pharmacopoeia version in 2005, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform-acetone-methanol-liquor ammoniae fortis=13: 4: 3: 0.5 was developing solvent, launch, take out, dry, put under the ultra-violet lamp 365nm and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
(3) Radix Salviae Miltiorrhizae is differentiated: get this product content 4g, add water 20ml, warm dissolving adds dilute hydrochloric acid and regulates pH value about 4, with ether extraction 3 times, each 20ml merges ether solution, uses anhydrous sodium sulfate dehydration, fling to ether, residue makes dissolving with dehydrated alcohol 1ml, as need testing solution.Other gets Radix Salviae Miltiorrhizae control medicinal material 7g, decocts with water 3 hours, filters, and filtrate is concentrated into about 20ml, add dilute hydrochloric acid and regulate pH value about 4, use ether extraction 3 times, each 20ml merges ether solution, use anhydrous sodium sulfate dehydration, fling to ether, residue makes dissolving with dehydrated alcohol 1ml, in contrast medical material solution.According to appendix VIB test of thin layer chromatography Chinese Pharmacopoeia version in 2005, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with benzene-ethyl acetate-formic acid=8: 5: 0.5 was developing solvent, launched, and took out, dry, spray is with 3% iron chloride alcoholic solution; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color;
(4) assay: total nitrogen
Get the content under the content uniformity item, mixing, precision takes by weighing in right amount, is equivalent to nitrogenous 2mg, measures according to appendix IXL second method of N2 method Chinese Pharmacopoeia version in 2005, promptly;
(5) assay: amino nitrogen
Get the content under the content uniformity item, mixing is got 0.8g, and accurate the title decides, add water 30ml, jolting 5 minutes, 0.1mol/L regulates pH to 7.0 with the sodium hydroxide volumetric solution, adds to use sodium hydroxide volumetric solution (0.1mol/L) to regulate the formalin 10ml of pH to 9.0 in advance, mixing, with sodium hydroxide titration 0.1mol/L, titration is to pH value of solution to 9.0, promptly;
(6) assay: Fructus Schisandrae Chinensis
An appendix VID measures according to high performance liquid chromatography Chinese Pharmacopoeia version in 2005;
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile-0.5% phosphoric acid solution=45: 55 is a mobile phase; The detection wavelength is 250nm; Number of theoretical plate is pressed the schisandrin peak and is calculated, and should be not less than 2000;
The preparation of reference substance solution: it is an amount of that precision takes by weighing the schisandrin reference substance, adds methanol and make the solution that every 1ml contains 25 μ g, promptly;
The preparation of need testing solution: get content under the content uniformity item, porphyrize, precision takes by weighing 4g, in the tool plug conical flask, accurate methanol solution 25ml, the close plug of adding, claim to decide weight, supersound process 40 minutes is taken out, put coldly, claim again to decide weight, supply the weight that subtracts mistake with methanol solution, shake up, filter, get subsequent filtrate, promptly;
Algoscopy: accurate respectively need testing solution and each 10 μ l of reference substance solution of drawing, inject chromatograph of liquid, measure, promptly.
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