CN102028923B - Quality control method of Wujiashenghua capsules - Google Patents
Quality control method of Wujiashenghua capsules Download PDFInfo
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- CN102028923B CN102028923B CN2009100730003A CN200910073000A CN102028923B CN 102028923 B CN102028923 B CN 102028923B CN 2009100730003 A CN2009100730003 A CN 2009100730003A CN 200910073000 A CN200910073000 A CN 200910073000A CN 102028923 B CN102028923 B CN 102028923B
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- syringin
- liquiritin
- isofraxidin
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Abstract
The invention relates to a detection method of Wujiashenghua capsules. The quality control method of Wujiashenghua capsules provided by the invention improves, revises and supplements the quality standards of the original Wujiashenghua capsules, increases the identification of syringin and liquiritin, and increases the content measurement of syringin, ferulic acid and liquiritin. The thin layer chromatography (TLC) is used for identifying syringin and isofraxidin, the high performance liquid chromatography (HPLC) is used for identifying liquiritin, and the dual-wavelength method of the HPLC is used for measuring the content of syringin, ferulic acid, isofraxidin and liquiritin. The method provided by the invention can be used for measuring four components once, realizes the purpose of efficiently and quickly measuring various effective components, is simple, convenient and quick, can improve the accuracy and effectiveness of quality control, and is favorable for effectively controlling the quality of the finished products of the Wujiashenghua capsules so that the content of the produced medicines in each batch can be kept consistent.
Description
Technical field: the detection method that the present invention relates to the biochemical capsule of a kind of slender acanthopanax.
Background technology: the biochemical capsule of slender acanthopanax is a kind of menstrual period and stream of people's postoperative of being used for; Postpartum, qi deficiency to blood stasis institute bled to vagina; Color is purple dark or clot arranged, underbelly pain by do not subtract aching pain in waist and back, spontaneous perspiration, palpitation, light, the double Chinese medicine of seeing petechia, forceless deep pulse etc. of tongue.This medicine is made up of Extractum Acanthopanacis Senticosi, Ligusticum wallichii, Radix Angelicae Sinensis, Radix Glycyrrhizae, rhizoma zingiberis, peach kernel Six-element medicinal material.Recording in the method for quality control of ministerial standard WS3-262 (Z-43)-2001 (Z); Lack the discriminating that has or not liquiritin in Syringin and the Radix Glycyrrhizae to having or not in the Extractum Acanthopanacis Senticosi; Lack and measure containing content of ferulic acid in Syringin, liquiritin and Ligusticum wallichii, the Radix Angelicae Sinensis; So just be not enough to be controlled to the accuracy and the validity that guarantees medicine of quality, the content of drug of every batch of production is consistent.
Summary of the invention: the objective of the invention is to overcome above-mentioned shortcoming; The detection method of the biochemical capsule of a kind of slender acanthopanax is provided; It can differentiate and its content is measured, guarantee the accuracy and the validity of quality control the plurality of active ingredients of the biochemical capsule of slender acanthopanax.The method of quality control of the biochemical capsule of slender acanthopanax of the present invention is achieved in that it comprises that existing its method is to get these article content 2g to having or not the discriminating of Ligusticum wallichii, Radix Angelicae Sinensis, and 10ml adds diethyl ether; Flooded liquid, filtered, the filtrating evaporate to dryness; Residue adds chloroform 1ml makes dissolving, as need testing solution.Other gets Ligusticum wallichii, each 1g of Radix Angelicae Sinensis control medicinal material, shines medicinal material solution in pairs with legal system respectively.Get the forulic acid reference substance again, chlorination is copied into the solution that every 1ml contains 0.5mg, as reference substance solution.Test according to thin-layered chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005); Drawing each 2 μ l of above-mentioned four kinds of solution, put respectively on same silica gel g thin-layer plate, is developping agent with benzene-chloroform one glacial acetic acid (6: 5: 1); Launch; Take out, dry, spray is with 1% liquor ferri trichloridi of new system and the mixed solution of 1% potassium ferricyanide solution (1: 1).In the test sample chromatogram, with reference substance, the corresponding position of control medicinal material chromatogram on, show the spot of same color.Method of the present invention is: 1, to having or not the discriminating of Syringin and isofraxidin in the Extractum Acanthopanacis Senticosi, get the biochemical capsule 's content 2g of these article slender acanthopanax, porphyrize adds methyl alcohol 20ml; Sonicated 30 minutes filters, the filtrating evaporate to dryness, and residue adds methyl alcohol 1ml makes dissolving; As need testing solution, other gets the Syringin reference substance, adds methyl alcohol and processes the solution that every 1ml contains 0.8mg, as reference substance solution; Get the isofraxidin reference substance again, add methyl alcohol and process the solution that every 1ml contains 0.5mg,, test according to thin-layered chromatography (2005 editions appendix VIB of Chinese Pharmacopoeia) as reference substance solution; Draw need testing solution 10 μ l, each 5 μ l of reference substance solution put respectively on same silica gel g thin-layer plate, are developping agent with chloroform-methanol-water (8: 1: 0.1); Launch, take out, dry, put under the ultraviolet lamp (365nm) and inspect; In the test sample chromatogram, with the corresponding position of isofraxidin reference substance chromatogram on, show the fluorescence spot of same color, spray again with 10% sulfuric acid ethanol liquid; Be heated to clear spot at 105 ℃, in the test sample chromatogram, with the corresponding position of Syringin reference substance chromatogram on, show the spot of same color.2, to having or not the discriminating of liquiritin in the Radix Glycyrrhizae, in the high-efficient liquid phase chromatogram of record, the retention time at liquiritin peak should be consistent with reference substance peak retention time in the test sample under the assay item.3, according to the double wave regular way of high performance liquid chromatography effective constituent Syringin, forulic acid, isofraxidin, liquiritin in the biochemical capsule finished product of slender acanthopanax being carried out assay, use octadecylsilane chemically bonded silica to be filling agent, is that moving phase is carried out gradient elution [0min (6%A) → 15min (6%A) → 18min (12%A) → 35min (12%A) → 40min (50%A) → 45min (6%A) → 50min (6%A)] with acetonitrile (A)-2% glacial acetic acid (B); Flow velocity is 1.0ml/min, and column temperature is 30 ℃, and detection wavelength forulic acid, isofraxidin are 324nm; Syringin, liquiritin are 276nm, and number of theoretical plate calculates by the isofraxidin peak and should be not less than 6000, and accurate respectively 12 hours the Syringin of drying under reduced pressure, forulic acid, isofraxidin, liquiritin reference substance of taking by weighing in phosphorus pentoxide desiccator is an amount of; Put in the brown measuring bottle, add 70% methyl alcohol and process that every 1ml contains 0.26,0.012,0.03 respectively, the mixed solution of 0.07mg, promptly get reference substance solution; Get the biochemical capsule 's content of these article slender acanthopanax under the content uniformity item, porphyrize is got 2g; The accurate title, decide, and puts in the tool plug conical flask, the accurate methyl alcohol 25ml that adds; Close plug claims to decide weight, sonicated 30 minutes; Put coldly, claim again to decide weight, add methyl alcohol and supply the weight that subtracts mistake; Shake up, leave standstill, filter, get subsequent filtrate, as need testing solution, accurate respectively reference substance mixed solution and each 10 μ l of need testing solution of drawing; Inject liquid chromatograph, measure, promptly get: calculate according to the biochemical capsule finished product of slender acanthopanax; Every total amount that contains Extractum Acanthopanacis Senticosi, Ligusticum wallichii, Radix Angelicae Sinensis, Radix Glycyrrhizae in Syringin, forulic acid, isofraxidin, liquiritin, it is qualified being no less than setting value.4, calculate according to the biochemical capsule finished product of slender acanthopanax, every total amount that contains Extractum Acanthopanacis Senticosi, Ligusticum wallichii, Radix Angelicae Sinensis, Radix Glycyrrhizae in Syringin, forulic acid, isofraxidin, liquiritin, setting value is 1.2mg.5, above-mentioned method of quality control can be used for the quality control of other formulation of the biochemical medicine of slender acanthopanax.Quality standard that the method for quality control of the biochemical capsule of slender acanthopanax of the present invention improves revision and replenished the biochemical capsule of original slender acanthopanax has increased discriminating and Syringin, the forulic acid of Syringin, liquiritin, the assay of liquiritin.It adopts thin-layered chromatography to differentiate Syringin, isofraxidin; Adopt high performance liquid chromatography to differentiate liquiritin, the double wave regular way of employing high performance liquid chromatography is measured the content of Syringin, forulic acid, isofraxidin, liquiritin, can once measure four kinds of compositions; Realized efficient quick mensuration to plurality of active ingredients; Have simple and rapid advantage, accuracy and validity that this method can improve the quality and control, the quality that helps improving the biochemical capsule finished product of slender acanthopanax control effectively.
Embodiment:
It comprises that existing its method is to get these article content 2g to having or not the discriminating of Ligusticum wallichii, Radix Angelicae Sinensis, and the 10ml that adds diethyl ether flooded liquid; Filter, the filtrating evaporate to dryness, residue adds chloroform 1ml makes dissolving, as need testing solution; Other gets Ligusticum wallichii, each 1g of Radix Angelicae Sinensis control medicinal material, shines medicinal material solution in pairs with legal system respectively, gets the forulic acid reference substance again, and chlorination is copied into the solution that every 1ml contains 0.5mg; As reference substance solution,, draw each 2 μ l of above-mentioned four kinds of solution according to thin-layered chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005) test; Putting respectively on same silica gel g thin-layer plate, is developping agent with benzene-chloroform one glacial acetic acid (6: 5: 1), launches; Take out, dry, spray is with 1% liquor ferri trichloridi of new system and the mixed solution of 1% potassium ferricyanide solution (1: 1); In the test sample chromatogram, with reference substance, the corresponding position of control medicinal material chromatogram on, show the spot of same color.
Method of quality control of the present invention is: 1, to having or not the discriminating of Syringin and isofraxidin in the Extractum Acanthopanacis Senticosi, get the biochemical capsule 's content 2g of these article slender acanthopanax, porphyrize adds methyl alcohol 20ml; Sonicated 30 minutes filters, the filtrating evaporate to dryness, and residue adds methyl alcohol 1ml makes dissolving; As need testing solution, other gets the Syringin reference substance, adds methyl alcohol and processes the solution that every 1ml contains 0.8mg, as reference substance solution; Get the isofraxidin reference substance again, add methyl alcohol and process the solution that every 1ml contains 0.5mg,, test according to thin-layered chromatography (2005 editions appendix VIB of Chinese Pharmacopoeia) as reference substance solution; Draw need testing solution 10 μ l, each 5 μ l of reference substance solution put respectively on same silica gel g thin-layer plate, are developping agent with chloroform-methanol-water (8: 1: 0.1); Launch, take out, dry, put under the ultraviolet lamp (365nm) and inspect; In the test sample chromatogram, with the corresponding position of isofraxidin reference substance chromatogram on, show the fluorescence spot of same color, spray again with 10% sulfuric acid ethanol liquid; Be heated to clear spot at 105 ℃, in the test sample chromatogram, with the corresponding position of Syringin reference substance chromatogram on, show the spot of same color.
2, to having or not the discriminating of liquiritin in the Radix Glycyrrhizae, in the high-efficient liquid phase chromatogram of record, the retention time at liquiritin peak should be consistent with reference substance peak retention time in the test sample under the assay item.
3, according to the double wave regular way of high performance liquid chromatography effective constituent Syringin, forulic acid, isofraxidin, liquiritin in the biochemical capsule finished product of slender acanthopanax being carried out assay, use octadecylsilane chemically bonded silica to be filling agent, is that moving phase is carried out gradient elution [0min (6%A) → 15min (6%A) → 18min (12%A) → 35min (12%A) → 40min (50%A) → 45min (6%A) → 50min (6%A)] with acetonitrile (A)-2% glacial acetic acid (B); Flow velocity is 1.0ml/min, and column temperature is 30 ℃, and detection wavelength forulic acid, isofraxidin are 324nm; Syringin, liquiritin are 276nm, and number of theoretical plate calculates by the isofraxidin peak and should be not less than 6000, and accurate respectively 12 hours the Syringin of drying under reduced pressure, forulic acid, isofraxidin, liquiritin reference substance of taking by weighing in phosphorus pentoxide desiccator is an amount of; Put in the brown measuring bottle, add 70% methyl alcohol and process that every 1ml contains 0.26,0.012,0.03 respectively, the mixed solution of 0.07mg, promptly get reference substance solution; Get the biochemical capsule 's content of these article slender acanthopanax under the content uniformity item, porphyrize is got 2g; The accurate title, decide, and puts in the tool plug conical flask, the accurate methyl alcohol 25ml that adds; Close plug claims to decide weight, sonicated 30 minutes; Put coldly, claim again to decide weight, add methyl alcohol and supply the weight that subtracts mistake; Shake up, leave standstill, filter, get subsequent filtrate, as need testing solution, accurate respectively reference substance mixed solution and each 10 μ l of need testing solution of drawing; Inject liquid chromatograph, measure, promptly get: calculate according to the biochemical capsule finished product of slender acanthopanax; Every total amount that contains Extractum Acanthopanacis Senticosi, Ligusticum wallichii, Radix Angelicae Sinensis, Radix Glycyrrhizae in Syringin, forulic acid, isofraxidin, liquiritin, it is qualified being no less than setting value.
4, calculate according to the biochemical capsule finished product of slender acanthopanax, every total amount that contains Extractum Acanthopanacis Senticosi, Ligusticum wallichii, Radix Angelicae Sinensis, Radix Glycyrrhizae in Syringin, forulic acid, isofraxidin, liquiritin, setting value is 1.2mg.
5, above-mentioned method of quality control can be used for the quality control of other formulation of the biochemical medicine of slender acanthopanax.
Above-mentioned steps need not carried out according to sequencing; And can also carry out conventional sense simultaneously; Like the observation of proterties, the biochemical capsule of this slender acanthopanax is a capsule, and content is powder, the mildly bitter flavor of pale brown look; This finished product also should meet each item regulation relevant under an appendix ID of Chinese Pharmacopoeia version in 2005 the capsule item, and the biochemical capsule finished product of slender acanthopanax that meets above condition is qualified.
The biochemical capsule ten lot sample article of slender acanthopanax are measured the result
Unit: mg/ grain
| Lot number | Syringin | Forulic acid | Isofraxidin | Liquiritin | Amount to |
| 0801031 | 1.35 | 0.06 | 0.17 | 0.46 | 2.03 |
| 0801111 | 1.37 | 0.04 | 0.17 | 0.33 | 1.91 |
| 0801121 | 1.36 | 0.05 | 0.16 | 0.32 | 1.88 |
| 0801171 | 1.33 | 0.04 | 0.16 | 0.34 | 1.88 |
| 0801201 | 1.35 | 0.04 | 0.16 | 0.33 | 1.88 |
| 0801271 | 1.25 | 0.06 | 0.16 | 0.30 | 1.76 |
| 0801301 | 1.28 | 0.04 | 0.17 | 0.33 | 1.82 |
| 0802191 | 1.34 | 0.03 | 0.17 | 0.34 | 1.88 |
| 0802251 | 1.43 | 0.04 | 0.18 | 0.36 | 2.00 |
| 0802271 | 1.33 | 0.04 | 0.16 | 0.29 | 1.82 |
| Mean value | 1.34 | 0.04 | 0.17 | 0.34 | 1.89 |
Claims (3)
1. the detection method of the biochemical capsule of a slender acanthopanax, it comprises that existing its method is to get these article content 2g to having or not the discriminating of Ligusticum wallichii, Radix Angelicae Sinensis, the 10ml that adds diethyl ether flooded liquid; Filter, the filtrating evaporate to dryness, residue adds chloroform 1ml makes dissolving, and as need testing solution, other gets Ligusticum wallichii, each 1g of Radix Angelicae Sinensis control medicinal material; Shine medicinal material solution in pairs with legal system respectively, get the forulic acid reference substance again, chlorination is copied into the solution that every 1ml contains 0.5mg, as reference substance solution, according to the thin-layered chromatography test; Draw each 2 μ l of above-mentioned four kinds of solution, put respectively on same silica gel g thin-layer plate, be developping agent with benzene-chloroform one glacial acetic acid at 6: 5: 1, launches, and takes out; Dry, spray is with 1% liquor ferri trichloridi and 1: 1 the mixed solution of 1% potassium ferricyanide solution of new system, in the test sample chromatogram, with reference substance, the corresponding position of control medicinal material chromatogram on, show the spot of same color; The invention is characterized in: to having or not the discriminating of Syringin and isofraxidin in the Extractum Acanthopanacis Senticosi, get the biochemical capsule 's content 2g of these article slender acanthopanax, porphyrize adds methyl alcohol 20ml; Sonicated 30 minutes filters, the filtrating evaporate to dryness, and residue adds methyl alcohol 1ml makes dissolving; As need testing solution, other gets the Syringin reference substance, adds methyl alcohol and processes the solution that every 1ml contains 0.8mg, as reference substance solution; Get the isofraxidin reference substance again, add methyl alcohol and process the solution that every 1ml contains 0.5mg,, test according to thin-layered chromatography as reference substance solution; Draw need testing solution 10 μ l, each 5 μ l of reference substance solution put respectively on same silica gel g thin-layer plate, are at 8: 1: 0.1 developping agent with chloroform-methanol-water; Launch, take out, dry, put under the ultraviolet lamp 365nm and inspect; In the test sample chromatogram, with the corresponding position of isofraxidin reference substance chromatogram on, show the fluorescence spot of same color, spray again with 10% sulfuric acid ethanol liquid; Be heated to clear spot at 105 ℃, in the test sample chromatogram, with the corresponding position of Syringin reference substance chromatogram on, show the spot of same color.
2. the detection method of the biochemical capsule of the described a kind of slender acanthopanax of claim 1; It is characterized in that: to having or not the discriminating of liquiritin in the Radix Glycyrrhizae; In the high-efficient liquid phase chromatogram of record, the retention time at liquiritin peak should be consistent with reference substance peak retention time in the test sample under the assay item.
3. the detection method of the biochemical capsule of the described a kind of slender acanthopanax of claim 1, it is characterized in that: the double wave regular way according to high performance liquid chromatography is carried out assay to effective constituent Syringin, forulic acid, isofraxidin, liquiritin in the biochemical capsule finished product of slender acanthopanax, uses octadecylsilane chemically bonded silica to be filling agent, is that moving phase is carried out gradient elution [0min with acetonitrile A-2% glacial acetic acid B; 6%A → 15min, 6%A → 18min, 12%A → 35min, 12%A → 40min; 50%A → 45min, 6%A → 50min, 6%A], flow velocity is 1.0ml/min; Column temperature is 30 ℃, and detection wavelength forulic acid, isofraxidin are 324nm, and Syringin, liquiritin are 276nm, and number of theoretical plate calculates by the isofraxidin peak should be not less than 6000; Accurate respectively 12 hours the Syringin of drying under reduced pressure, forulic acid, isofraxidin, liquiritin reference substance of taking by weighing in phosphorus pentoxide desiccator is an amount of, puts in the brown measuring bottle, adds 70% methyl alcohol and processes that every 1ml contains 0.26,0.012,0.03 respectively, the mixed solution of 0.07mg, promptly gets reference substance solution; Get the biochemical capsule 's content of these article slender acanthopanax under the content uniformity item, porphyrize is got 2g, and accurate the title decides; Put in the tool plug conical flask, the accurate methyl alcohol 25ml that adds, close plug claims to decide weight; Sonicated 30 minutes is put coldly, claims to decide weight again, adds methyl alcohol and supplies the weight that subtracts mistake; Shake up, leave standstill, filter, get subsequent filtrate, as need testing solution, accurate respectively reference substance mixed solution and each 10 μ l of need testing solution of drawing; Inject liquid chromatograph, measure, promptly get.
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| CN105806964A (en) * | 2014-12-30 | 2016-07-27 | 洛阳惠中兽药有限公司 | Method for detecting Acanthopanax senticosus and Glycyrrhiza uralensis preparation and application thereof |
| CN104849369B (en) * | 2015-05-13 | 2016-07-13 | 济南康众医药科技开发有限公司 | The attached sweet drug quality detection method of a kind of fiber crops |
| CN106706810B (en) * | 2016-12-27 | 2019-02-22 | 江苏融昱药业有限公司 | Novel biochemical particles quantitative finger print atlas detection method and its finger-print |
| CN108508118A (en) * | 2018-03-26 | 2018-09-07 | 成都中医药大学 | A kind of method of quality control of Fuzi Lizhong Wan |
| CN112816600A (en) * | 2020-12-31 | 2021-05-18 | 多多药业有限公司 | Fingerprint detection method for acanthopanax biochemical capsule |
| CN113514572B (en) * | 2021-04-11 | 2023-07-07 | 多多药业有限公司 | Method for detecting dissolution rate of acanthopanax biochemical capsules |
| CN113237989A (en) * | 2021-05-07 | 2021-08-10 | 上海凯宝药业股份有限公司 | Quality control method of ligusticum wallichii in capsule for dispelling wind and relieving pain |
| CN113552271A (en) * | 2021-07-30 | 2021-10-26 | 湖南新汇制药股份有限公司 | Quality control method of acanthopanax standard decoction |
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