CN101417081A - Quality control method of Longfengbao capsule - Google Patents
Quality control method of Longfengbao capsule Download PDFInfo
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- CN101417081A CN101417081A CNA2007100309941A CN200710030994A CN101417081A CN 101417081 A CN101417081 A CN 101417081A CN A2007100309941 A CNA2007100309941 A CN A2007100309941A CN 200710030994 A CN200710030994 A CN 200710030994A CN 101417081 A CN101417081 A CN 101417081A
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Abstract
The invention relates to a quality control method for Long Feng Bao capsule, which comprises identifications of borneol and tree peony bark. The quality control method is characterized in that the utilization of thin layer chromatography is added. With assaying methods of identifying herba epimedii qualitatively by positive control of icariin and measuring astragaloside by thin layer chromatography scanning, the invention improves the specificity of the qualitative identification method of the quality control method for Long Feng Bao capsule and simultaneously provides a quantitative test method for astagaloside to control the product quality more effectively, thereby insuring the safety and validity of the medication of human bodies. The quality control method can also be adopted as quality control methods for other oral preparations of the same prescription (crude drug of the same proportion), curative oral solutions, tablets and granules.
Description
Technical field
The present invention relates to the method for quality control of pharmaceutical composition, what relate in particular to is the method for quality control of LONGFENGBAO JIAONANG.
Background technology
LONGFENGBAO JIAONANG is a kind of Chinese medicinal composition preparation, is a kind of compound Chinese medicinal preparation.It is go on the market for many years, medicine that the clinical practice curative effect is sure.Function with kidney invigorating and YANG supporting, invigorating the spleen and benefiting QI, the mind calming and mentality promoting is used for climacteric syndrome and neurasthenia.Taken in China national the Sanitation Ministry medicine standard, standard No. WS
3-B-3393-98, this medicine is pressed the preparation of Chinese medicine common process by the Radix Astragali, Radix Codonopsis, Herba Cistanches, Herba Epimedii, Radix Aconiti Lateralis Preparata, Rhizoma Polygonati Odorati, Fructus Crataegi, Cortex Moutan, Borneolum Syntheticum.This medicine only has the qualitative identification method of the thin layer chromatography of Borneolum Syntheticum, Cortex Moutan in aforementioned national standard, specificity is relatively poor, and without any the method for assay, is unfavorable for controlling the quality of medicine.
Summary of the invention
Purpose of the present invention is exactly in order to overcome present LONGFENGBAO JIAONANG qualitative identification, specificity is poor, quality control is not good shortcoming only to be arranged, and a kind of existing qualitative detection is provided, again the method for quality control of the good LONGFENGBAO JIAONANG of the quality control of detection by quantitative is arranged.
Technical scheme of the present invention is: increase outside the discriminating item of the Borneolum Syntheticum of proper mass control criterion, Cortex Moutan: adopt thin layer chromatography, icariin positive control to differentiate in the LONGFENGBAO JIAONANG and contain Herba Epimedii; Other increases the content of tlc scanning determination astragaloside, and every of this product contains the Radix Astragali with astragaloside (C
41H
68O
14) meter, must not be less than 0.07mg.
The discriminating item of Borneolum Syntheticum of the present invention, Cortex Moutan, as solvent, its concrete operations step is constant with the acetone in the former discriminating item of ethyl acetate replacement for reference substance and test sample:
(1) contain the discriminating of Borneolum Syntheticum in the LONGFENGBAO JIAONANG: get this product content, the jolting that adds diethyl ether, the room temperature dipping filters, and filtrate volatilizes, and residue adds the ethyl acetate dissolving, as need testing solution.It is an amount of that other gets the Borneolum Syntheticum reference substance, adds ethyl acetate and make the solution that every 1ml contains 2mg, in contrast product solution.Drawing above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, is developing solvent with toluene-acetone (18:1), launches, and takes out, and dries, and spray is with 10% vanillin sulfuric acid solution, and 105 ℃ of heating make the speckle colour developing clear.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) contain the discriminating of Cortex Moutan in the LONGFENGBAO JIAONANG: get the Cortex Moutan control medicinal material, add diethyl ether, jog, the room temperature dipping filters, and filtrate volatilizes, and residue adds ethyl acetate dissolving, medical material solution in contrast.Need testing solution under absorption control medicinal material solution and [discriminating] (1) item is respectively put respectively on same silica gel g thin-layer plate, is developing solvent with thiacyclohexane-chloroform-ethyl acetate (7:3:0.5), launches, and taking-up is dried, and spray is with 10% ferric chloride alcoholic solution.In the test sample chromatograph, with control medicinal material chromatograph relevant position on, show the speckle of same color.
Differentiate that with the icariin positive control the preferable chromatographic condition that contains Herba Epimedii in the LONGFENGBAO JIAONANG is: the preparation of (1) need testing solution: get this product content, add methanol, supersound process, filter, the filtrate evaporate to dryness, the residue water makes dissolving, in the dislocation separatory funnel, extract with the ether jolting, discard ether solution, water liquid extracts with the ethyl acetate jolting, merges ethyl acetate liquid, evaporate to dryness, residue adds methanol makes dissolving, as need testing solution.(2) preparation of reference substance solution: it is an amount of to get the icariin reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution.(3) thin layer chromatography condition: draw reference substance solution and need testing solution, put respectively on same silica gel g thin-layer plate, placing the lower floor's solution that spends the night below 10 ℃ with chloroform-methanol-water (13:7:2) is developing solvent, launches, and takes out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ to be heated to the speckle colour developing clear, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
The preferable condition of measuring with Astragaloside content is:
(1) preparation of need testing solution: get this product capsule 's content, grind mixed, accurate claim fixed, put in the apparatus,Soxhlet's, add methanol, be back to colourless, extracting solution reclaims methanol and is concentrated into driedly, and residue is dissolved in water, with water saturated n-butyl alcohol jolting extraction, merge n-butanol extracting liquid,, discard ammoniacal liquor with the ammonia solution washing, n-butyl alcohol liquid evaporate to dryness, residue is dissolved in water, and puts coldly, passes through D
101The type macroporous adsorptive resins with water elution, discards water liquid, and reuse 40% ethanol elution discards 40% ethanol elution, continues and uses 70% ethanol elution, collects eluent, and evaporate to dryness is used dissolve with methanol, as need testing solution; (2) preparation of reference substance solution: get the astragaloside reference substance, add the solution that the every 1ml of methanol system contains 0.5mg, in contrast product solution; (3) assay: according to the thin layer chromatography test, accurate need testing solution, the reference substance solution drawn put respectively on same silica gel g thin-layer plate, placing the lower floor's solution that spends the night below 10 ℃ with chloroform-methanol-water (13:6:2) is developing solvent, launches, and takes out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to speckle colour developing at 100 ℃, take out, scan wavelength with thin layer chromatography scanning: 530nm, measure test sample trap integrated value and reference substance trap integrated value, calculate, promptly.Every of this product contains the Radix Astragali with astragaloside (C
41H
68O
14) meter, must not be less than 0.07mg.
Every of this product contains the Radix Astragali with astragaloside (C
41H
68O
14) meter, preferable range is 0.07-0.5mg.
This content assaying method verifies that through methodology negative sample is noiseless to measuring.Measure ten batches in the LONGFENGBAO JIAONANG sample that the applicant produces with this method, the content of every astragaloside is respectively: (mg of unit).
| Lot number | Content | Lot number | Content |
| 5001 | 0.07 | 6001 | 0.13 |
| 5002 | 0.08 | 6002 | 0.12 |
| 5003 | 0.12 | 6003 | 0.14 |
| 5004 | 0.12 | 6004 | 0.13 |
| 5005 | 0.28 | 6005 | 0.23 |
The present invention has improved the specificity of qualitative identification method of the method for quality control of LONGFENGBAO JIAONANG, and the quantitative detecting method of astragaloside is provided simultaneously, has more effectively controlled the quality of product, has guaranteed the safety and the effectiveness of human body medication.
The specific embodiment
The invention will be further described below in conjunction with embodiment.
It is 6003 LONGFENGBAO JIAONANG that embodiment gets lot number that the applicant produces, detects, and comprises discriminating, inspection and assay, wherein checks to meet every regulation relevant under the capsule item.
The content of 20 of this product is got in [discriminating] (1), the 20ml that adds diethyl ether, and close plug, jolting gently, room temperature dipping 1 hour filters, and filtrate volatilizes naturally, and residue adds ethyl acetate 0.5ml makes dissolving, as need testing solution.It is an amount of that other gets the Borneolum Syntheticum reference substance, adds ethyl acetate and make the solution that every 1ml contains 2mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 1 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with toluene-acetone (18:1) is developing solvent, launch, take out, dry, spray is with 10% vanillin sulfuric acid solution, and 105 ℃ of heating make the speckle colour developing clear.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) get Cortex Moutan control medicinal material 0.3g, the 5ml that adds diethyl ether, close plug, jog, room temperature dipping 1 hour filters, and filtrate volatilizes naturally, and residue adds ethyl acetate 0.5ml makes dissolving, in contrast medical material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each the 5 μ l of need testing solution under the item of control medicinal material solution and [discriminating] (1), put respectively on same silica gel g thin-layer plate, with thiacyclohexane-chloroform-ethyl acetate (7:3:0.5) is developing solvent, launch, take out, dry, spray is with 10% ferric chloride alcoholic solution.In the test sample chromatograph, with control medicinal material chromatograph relevant position on, show the speckle of same color.
(3) get this product content 3g, add methanol 40ml, supersound process 30 minutes, filter, the filtrate evaporate to dryness, residue water 20ml makes dissolving, in the dislocation separatory funnel, extract 3 times each 20ml with the ether jolting, discard ether solution, water liquid extracts 3 times with the ethyl acetate jolting, each 20ml, merge ethyl acetate liquid, evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution.It is an amount of that other gets the icariin reference substance, adds methanol and make the solution that every 1ml contains 0.5mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, placing the lower floor's solution that spends the night below 10 ℃ with chloroform-methanol-water (13:7:2) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, 105 ℃ to be heated to speckle colour developing clear, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
[inspection] should meet every regulation relevant under the capsule item (appendix I L).
[assay] gets 20 of this product capsules, pours out content, grinds mixed, it is fixed to get the accurate title of 2.5g, puts in the apparatus,Soxhlet's, adds methanol 80ml, be back to colourless (about 5 hours), extracting solution reclaims methanol and is concentrated into driedly, and residue adds water 20ml, slight fever makes dissolving, extracts 6 (15ml, 15ml with water saturated n-butyl alcohol jolting, 15ml, 15ml, 10ml, 10ml), merge n-butanol extracting liquid, extract 4 times with ammonia solution, each 30ml discards ammoniacal liquor, n-butyl alcohol liquid evaporate to dryness, residue adds water 5～8ml slight fever makes dissolving, puts coldly, passes through D
101Type macroporous adsorptive resins (internal diameter 1.5cm, long 15cm) is with water 50ml eluting, discard water liquid, reuse 40% ethanol 50ml eluting discards 40% ethanol elution, continues with 70% ethanol 100ml eluting, collect eluent, evaporate to dryness with dissolve with methanol and be transferred in the 2ml measuring bottle, adds methanol to scale, shake up, as need testing solution.Precision takes by weighing the astragaloside reference substance in addition, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), the accurate need testing solution 2 μ l～4 μ l that draw, reference substance solution 1 μ l and 3 μ l, put respectively on same silica gel g thin-layer plate, placing the lower floor's solution that spends the night below 10 ℃ with chloroform-methanol-water (13:6:2) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, it is clear to be heated to speckle colour developing at 100 ℃, takes out, and covers onesize glass plate on lamellae, use immobilization with adhesive tape on every side, scan wavelength according to thin layer chromatography (appendix VI B thin layer chromatography scanning): 530nm, measure test sample trap integrated value and reference substance trap integrated value, calculate, promptly.
Every of this product contains the Radix Astragali with astragaloside (C
41H
68O
14) meter, every contains 0.14mg.
In qualitative identification of the present invention and the content assaying method, the consumption of the choosing of the composition of the number of times of the consumption of solvent in its extraction conditions and consumption thereof, time, number of times, medicine, filter method and condition, room temperature dip time, extract and consumption thereof, extract (getting final product under the constant situation of pH value keeping), macroporous resin model, eluent all can be chosen in the equivalent technologies scope that those skilled in the art know.
In fact, method of quality control of the present invention not only can be as the method for quality of control LONGFENGBAO JIAONANG, also can be used as other oral formulations of the same prescription crude drug of ratio (same) such as oral liquid, tablet, particulate method of quality control.
Claims (5)
1, a kind of method of quality control of LONGFENGBAO JIAONANG, comprise the discriminating of Borneolum Syntheticum, MUDANPIAN, it is characterized in that having increased and utilize thin layer chromatography, with icariin positive control qualitative identification Herba Epimedii with the content assaying method of tlc scanning determination astragaloside.
2, the method for quality control of a kind of LONGFENGBAO JIAONANG according to claim 1, it is characterized in that qualitative may further comprise the steps of described icariin qualitative identification Herba Epimedii: the preparation of (1) need testing solution: get this product content, add methanol, supersound process, filter, the filtrate evaporate to dryness, the residue water makes dissolving, in the dislocation separatory funnel, extracts with the ether jolting, discard ether solution, water liquid extracts with the ethyl acetate jolting, merges ethyl acetate liquid, evaporate to dryness, residue adds methanol makes dissolving, as need testing solution.(2) preparation of reference substance solution: it is an amount of to get the icariin reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution.(3) thin layer chromatography condition: draw reference substance solution and need testing solution, put respectively on same silica gel g thin-layer plate, is developing solvent with chloroform-methanol-water 13:7:2 placing the lower floor's solution that spends the night below 10 ℃, launches, and takes out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ to be heated to the speckle colour developing clear, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
3, the method for quality control of a kind of LONGFENGBAO JIAONANG according to claim 1, it is characterized in that described content assaying method with the tlc scanning determination astragaloside is: the preparation of (1) need testing solution: get this product capsule 's content, grind mixed, getting accurate the title decides, put in the apparatus,Soxhlet's, add methanol, be back to colourless, extracting solution reclaims methanol and is concentrated into dried, residue is dissolved in water, and extracts with water saturated n-butyl alcohol jolting, merges n-butanol extracting liquid, extract with ammonia solution, discard ammoniacal liquor, n-butyl alcohol liquid evaporate to dryness, residue is dissolved in water, put coldly, pass through D
101The type macroporous adsorptive resins with water elution, discards water liquid, reuse 40% ethanol elution, discard 40% ethanol elution, continue and use 70% ethanol elution, collect eluent, evaporate to dryness, with dissolve with methanol and be transferred in the measuring bottle, add methanol to scale, shake up, as need testing solution; (2) preparation of reference substance solution: get the astragaloside reference substance, add the solution that the every 1ml of methanol system contains 0.5mg, in contrast product solution; (3) assay: according to the thin layer chromatography test, accurate need testing solution, the reference substance solution drawn, put respectively on same silica gel g thin-layer plate, is developing solvent with chloroform-methanol-water 13:6:2 placing the lower floor's solution that spends the night below 10 ℃, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to speckle colour developing at 100 ℃, take out, scan wavelength with thin layer chromatography scanning: 530nm, measure test sample trap integrated value and reference substance trap integrated value, calculate, promptly; Every of this product contains the Radix Astragali in astragaloside, must not be less than 0.07mg.
4, the method for quality control of a kind of LONGFENGBAO JIAONANG according to claim 3 is characterized in that every of this product contains the Radix Astragali in astragaloside with the assay of tlc scanning determination astragaloside, and scope is 0.07-0.5mg.
5, the method for quality control of a kind of LONGFENGBAO JIAONANG according to claim 1 is characterized in that discriminating item, reference substance and the test sample of described Borneolum Syntheticum, Cortex Moutan made solvent with ethyl acetate.
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| CN 200710030994 CN101417081B (en) | 2007-10-22 | 2007-10-22 | Quality detection method of Longfengbao capsule |
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| CN101417081B CN101417081B (en) | 2013-05-29 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104483435A (en) * | 2014-12-03 | 2015-04-01 | 贵阳德昌祥药业有限公司 | Method for detecting gastrodia elata and lucid ganoderma granules |
| CN113117020A (en) * | 2021-04-22 | 2021-07-16 | 广州白云山奇星药业有限公司 | Application of Longfengbao capsule in preparing medicine for preventing and treating cardiovascular disease |
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2007
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| CN1588052A (en) * | 2004-08-27 | 2005-03-02 | 广州中一药业有限公司 | Quality control method for Ruhesanjie table |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104483435A (en) * | 2014-12-03 | 2015-04-01 | 贵阳德昌祥药业有限公司 | Method for detecting gastrodia elata and lucid ganoderma granules |
| CN104483435B (en) * | 2014-12-03 | 2016-08-24 | 贵州汉方药业有限公司 | A kind of detection method of gastrodia-glossy ganoderma granule |
| CN113117020A (en) * | 2021-04-22 | 2021-07-16 | 广州白云山奇星药业有限公司 | Application of Longfengbao capsule in preparing medicine for preventing and treating cardiovascular disease |
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| CN101417081B (en) | 2013-05-29 |
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