CN101274053A - Quality control method of capsules for curing waist pain - Google Patents
Quality control method of capsules for curing waist pain Download PDFInfo
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- CN101274053A CN101274053A CNA2008100845977A CN200810084597A CN101274053A CN 101274053 A CN101274053 A CN 101274053A CN A2008100845977 A CNA2008100845977 A CN A2008100845977A CN 200810084597 A CN200810084597 A CN 200810084597A CN 101274053 A CN101274053 A CN 101274053A
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Abstract
The invention relates to a lumbago relieving capsule which can relax tendons and activate collaterals, remove blood stasis, relieve pain, activate blood and remove rheumatism. The lumbago relieving capsule can be applied to rheumatoid arthritis, hypertrophic ixomyelitis, hypertrophic thoracic inflammation, cervical inflammation, sciatica and lumbar muscle strain. Since the lumbago relieving capsule contains toxic kusnezoff monkshood root, carefulness is needed during clinical use. The quality standard of current lumbago relieving capsules cannot totally meet the purpose of drug safety supervision. The lumbago relieving capsule of the invention aims at providing more perfect quality control method from qualitative and rational aspects.
Description
[technical field]
The invention belongs to technical field of Chinese medicines, be specifically related to the method for quality control of capsules for curing waist pain.
[background technology]
The function of capsules for curing waist pain cures mainly and comprises relaxing muscles and tendons and activating QI and blood in the collateral, stasis-dispelling and pain-killing, the wind dispelling of invigorating blood circulation.Be used for rheumatic arthritis, hypertrophy spondylitis of lumbar vertebra, hypertrophy thoracic vertebra inflammation, cervical spondylitis, sciatica, lumbar muscle strain.Its usage and dosage is oral, one time 2,3 times on the one, taking medicine after meal.
Capsules for curing waist pain should be noted following 3 clinically:
1, heart disease and the careful clothes of gastrointestinal upset person.
2, if occur feeling sick, vomit, suffer from abdominal pain, feel dizzy, dispute, extremity and whole body are numb, cold syndrome of the stomach, and the platycoria that continues, the dimness of vision, dyspnea, tetany, restless and gatism should be withdrawn, and removes hospital admission rapidly.
3, capsules for curing waist pain should not be in a large number, take for a long time.
The prescription of the capsules for curing waist pain that the present invention relates at present, method for making, shape and discrimination method are as follows:
[prescription] Radix Angelicae Dahuricae 78 gram Radix Aconiti Kusnezoffii (system) 52 gram Radix Angelicae Pubescentiss 52 grams
Herba Taxilli 26 gram Radix Dipsacis 52 gram Radix Achyranthis Bidentataes 52 grams
Radix Notoginseng 47 gram Radix Angelicae Sinensis 26 gram Radix Saposhnikoviaes 52 grams
Radix Clematidis 52 gram Radix Gentianae Macrophyllae 52 gram Rhizoma Drynariae 26 grams
River Cortex Acanthopanacis Radicis 52 gram Radixs Stephaniae Tetrandrae 78 gram Caulis Piperis Kadsuraes 52 grams
The Flos Carthami 52 gram Cortexs Eucommiae 46 gram Tu Rhizoma Dioscoreae Septemlobae 26 grams
Radix Polygoni Multiflori 46 gram Rhizoma Homalomenaes 52 gram Radix Paeoniae Rubra 78 grams
Ramulus Cinnamomi 52 gram acetaminophen 100 grams
[method for making] above 23 flavors except that acetaminophen, are got Radix Angelicae Sinensis, Radix Notoginseng and the Radix Angelicae Dahuricae 39 grams, Radix Aconiti Kusnezoffii Preparata 26 grams are ground into coarse powder, 18 flavors such as the residue Radix Angelicae Dahuricae, Radix Aconiti Kusnezoffii Preparata and all the other Radix Angelicae Pubescentiss decoct with water secondary, collecting decoction, filter, filtrate is concentrated into the thick paste that relative density is 1.3～1.35 (80 ℃ of surveys), with above-mentioned coarse powder mix homogeneously, oven dry is ground into fine powder, adds acetaminophen, mixing, incapsulate, make 1000, promptly.
[character] capsules for curing waist pain is a capsule, and content is the powder of taupe brown; Bitter in the mouth, sweet.
Capsules for curing waist pain is got in [discriminating] (1), puts microscopically and observes: stone cell is single be dispersed in or 2-5 class is square, rectangle or ellipse in groups, cell is big, wall is thick slightly, pit is obvious, accidental in the cell have a starch grain.Resin canal fragment yellow, diameter 60-128 micron contains in the tract and drips shape or block secretions.
(2) get capsules for curing waist pain content 0.6 gram, put in 50 milliliters of conical flasks, add 20 milliliters of dehydrated alcohol, little boiling 3 minutes in water-bath, filter, filtrate is waved most ethanol, adds 10 milliliters of dilute hydrochloric acid, puts in the water-bath and heats 30 minutes, put cold, add 0.1mol/L sodium nitrite liquid number droplet, add alkaline betanaphthol test solution number droplet, promptly generate the scarlet precipitation.
(3) get capsules for curing waist pain content 3 grams, add diethyl ether 30 milliliters and flooded 1 hour, jolting constantly, the ether that inclines, residue volatilizes ether, adds 30 milliliters of supersound process of methanol 30 minutes, filter, filtrate evaporate to dryness, residue add water makes dissolving for 30 milliliters, extracts 2 times with water saturated n-butyl alcohol jolting, each 30 milliliters, merge n-butanol extracting liquid, with 50 milliliters of washings of ammonia solution, 50 milliliters of washings of water that n-butanol layer reuse n-butyl alcohol is saturated, divide and get n-butanol layer, evaporate to dryness, residue add methanol makes dissolving for 1 milliliter, as need testing solution.
It is an amount of that other gets ginsenoside Rg1's reference substance, adds methanol and make per 1 milliliter of solution that contains 1 milligram, product solution in contrast.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw above-mentioned two kinds of each 5ul of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, (15: 40: 22: 10) lower floor's solution of placing below 10 ℃ was developing solvent with chloroform-ethyl acetate-methanol-water, 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 under 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(4) get capsules for curing waist pain content 5 grams, add diethyl ether 30 milliliters, water-bath refluxed 1 hour, filtered, and filtrate volatilizes, and residue adds ethyl acetate makes dissolving for 1 milliliter, as need testing solution.Other gets Radix Angelicae Sinensis control medicinal material 0.5 gram, 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 5 microlitre of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, be developing solvent with normal hexane-ethyl acetate (9: 1), launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, with control medicinal material chromatograph relevant position on, show the fluorescence speckle of same color.
The present invention relates to the Radix Aconiti Kusnezoffii that capsule contains is the tuber of ranunculaceae plant Aconitum kusnezoffii Reichb Aconitumkusnezoffii Reichb., contains aconitine (aconitine) and atisine alkali toxic alkaloids such as (atisine).All contain multiple alkaloid in the Radix Aconiti Kusnezoffii, its mesaconitine toxicity maximum.Its toxicity performance is as follows:
1. vascular system: uncomfortable in chest, cardiopalmus, blood pressure drops (even can not surveying) and various types of arrhythmia, comprise that sinus tachycardia, Dou Xingting are rich, atrial fibrillation, polyphyly ventricular premature contraction, the ventricular premature contraction that takes place frequently are premature ventricular beat, premature ventricular beat, ventricular tachycardia, chamber quiver, room conduction block, left bundle branch block, and it is can cause shock, even dead.
2. nervous system: teleneuron and central nervous system are all had excited earlier back inhibitory action.Show as dispute, extremity and total numbness, oral cavity or whole body burn feeling, dizzy, pale complexion are perspired, extreme cold of the limbs, dysphoria, tic of the limbs is tetanic then, and is drowsiness, delirium, obnubilation.Quadriplegia appears in indivedual cases.
3. digestive system: sialorrhea, dysphagia, nausea and vomiting, even spit out white foams, or vomiting coffee sample gastric content, separate the black loose stool; Stomachache, diarrhoea, tenesmus, the performance of similar dysentery.There is report to cause toxic hepatitis secondary cirrhotic ascites.
4. respiratory system: breathe hard, dyspnea, cyanosis etc. finally can be dead because of respiratory paralysis.
5. urinary system: oliguria, dysuria, urine retention, even acute renal failure.
Thereby the aconitine content in the control finished capsule product is extremely important.The quality standard of at present existing capsules for curing waist pain is only controlled its quality with the microscopical identification method, reason at aspects such as experimental check or processing, sometimes the microscopic features of indivedual medical material tissues can't be seen, be difficult to its down fixed against regulation judgement, because Radix Aconiti Kusnezoffii is hypertoxic medicine, the index components aconitine does not have suitable detection method in the finished capsule product, and does not have detection method qualitatively in the quality standard yet; This all is the deficiency in the current standard.
Originally have only qualitative method in the quality standard of capsules for curing waist pain, do not have quantitative analytical method, this also is a deficiency that exists at present.
[summary of the invention]
The object of the present invention is to provide control capsules for curing waist pain mesaconitine qualitative method and and the quantitative method of quality control of peoniflorin.
Method of quality control particularly of the present invention is: get capsules for curing waist pain content 6.0 grams, put in 500 milliliters of tool plug conical flasks, add 60 milliliters of strong ammonia solutions, make moistening, add diethyl ether 200 milliliters, supersound process 40 minutes is put coldly, divides and to get ether solution, volatilize, residue adds dehydrated alcohol to be made dissolving and is settled to 2 milliliters, and as need testing solution, it is an amount of that precision takes by weighing the aconitine reference substance in addition, add dehydrated alcohol and make per 1 milliliter of solution that contains 1 milligram, product solution according to the test of an appendix VIB of Chinese Pharmacopoeia version in 2005 thin layer chromatography, is drawn each 5 microlitre of above-mentioned need testing solution and reference substance solution in contrast, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with ethyl acetate-acetone-strong ammonia solution (40: 2: 0.3) is developing solvent, launches, and takes out, dry, spray is with rare bismuth potassium iodide test solution, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on the speckle that occurs should be less than the speckle of reference substance.
Method of quality control particularly of the present invention is: get capsules for curing waist pain content 6.0 grams, put in 500 milliliters of tool plug conical flasks, add 60 milliliters of strong ammonia solutions, make moistening, add diethyl ether 200 milliliters, supersound process 40 minutes, put coldly, divide and to get ether solution, volatilize, residue adds dehydrated alcohol to be made dissolving and is settled to 2 milliliters, as need testing solution, it is an amount of that precision takes by weighing the aconitine reference substance in addition, adds dehydrated alcohol and make per 1 milliliter of solution that contains 1 milligram, product solution in contrast, according to an appendix VIB of Chinese Pharmacopoeia version in 2005 thin layer chromatography test, draw each 5 microlitre of above-mentioned need testing solution and reference substance solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, be made into developing solvent with ethyl acetate-acetone-strong ammonia solution according to 40: 2: 0.3 ratio, launch, take out, dry, spray does not occur speckle with rare bismuth potassium iodide test solution on the corresponding position of chromatograph.
Above-mentioned method of quality control also adopts following method:
Every of the capsules for curing waist pain that the present invention relates to contains Radix Paeoniae Rubra with peoniflorin (C
23H
28O
11) meter be no less than 0.3 milligram.
Above-mentioned method of quality control preferably adopts following method:
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler, acetonitrile-0.05% phosphate aqueous solution (14: 86) is a mobile phase, detects wavelength 230nm, flow velocity: 1.0 ml/min, number of theoretical plate is pressed the peoniflorin peak and is calculated, and should be not less than 3000.
The preparation of reference substance solution: it is an amount of to the peoniflorin reference substance of constant weight to get drying under reduced pressure, and accurate the title decides, and adds 50% methanol and makes per 1 milliliter of solution that contains 60 micrograms, promptly.
The preparation of need testing solution: the content of getting under the capsules for curing waist pain content uniformity item is an amount of, and porphyrize is got about 3 grams, and accurate the title decides, and puts in the tool plug conical flask.Precision adds 50 milliliters of 50% methanol, and close plug claims to decide weight.Ultrasonic (power 200W, frequency 26.5KHz) handled 30 minutes, put coldly, claimed decide weight, added 50% methanol and supplied and subtract weight loss, shake up, and filtration, promptly.
Algoscopy: accurate respectively reference substance solution and each 10 microlitre of need testing solution drawn, inject chromatograph of liquid, measure, promptly.
Method of quality control of the present invention provides the qualitative checking method of the relevant aconitine of capsules for curing waist pain, be this rheumatic arthritis that is widely used in, the hypertrophy spondylitis of lumbar vertebra, hypertrophy thoracic vertebra inflammation, cervical spondylitis, sciatica, the medicine of lumbar muscle strain provides authentication method more safely and effectively, for medicine actual production, field of circulation quality monitoring and clinical practice provide effective guarantee.
In addition, method of quality control of the present invention also provides the quantitative detecting method of capsules for curing waist pain first, be this rheumatic arthritis that is widely used in, the hypertrophy spondylitis of lumbar vertebra, hypertrophy thoracic vertebra inflammation, cervical spondylitis, sciatica, the medicine of lumbar muscle strain provides authentication method more safely and effectively, for medicine actual production, field of circulation quality monitoring and clinical practice provide effective guarantee.
[specific embodiment]
Experimental example 1
The capsules for curing waist pain of 5 lot numbers of random choose (lot number is: 20070712-1,20070824-1,20070911-1,20071015-1,20071112-1).
Get the capsular content 6.0g of above 5 lot numbers, put in 500 milliliters of tool plug conical flasks, add 60 milliliters of strong ammonia solutions, make moistening, add diethyl ether 200 milliliters, supersound process 40 minutes is put coldly, divides and to get ether solution, volatilize, residue adds dehydrated alcohol to be made dissolving and is settled to 2 milliliters, as need testing solution.It is an amount of that precision takes by weighing the aconitine reference substance in addition, adds dehydrated alcohol and make per 1 milliliter of solution that contains 1 milligram, product solution in contrast.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw each 5 microlitre of above-mentioned need testing solution and reference substance solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with ethyl acetate-acetone-strong ammonia solution (40: 2: 0.3) is developing solvent, launch, take out, dry, spray is with rare bismuth potassium iodide test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on the speckle that occurs should or speckle appear less than the speckle of reference substance.Concrete experimental result sees the following form 1.
The testing result of table 1 capsules for curing waist pain mesaconitine
Method of quality control of the present invention provides the qualitative checking method of the relevant aconitine of capsules for curing waist pain, be this rheumatic arthritis that is widely used in, the hypertrophy spondylitis of lumbar vertebra, hypertrophy thoracic vertebra inflammation, cervical spondylitis, sciatica, the medicine of lumbar muscle strain provides authentication method more safely and effectively, for medicine actual production, field of circulation quality monitoring and clinical practice provide effective guarantee.
Experimental example 2
The capsules for curing waist pain of 5 lot numbers of random choose (lot number is: 20070712-1,20070824-1,20070911-1,20071015-1,20071112-1).
Measure according to high performance liquid chromatography (Chinese Pharmacopoeia version appendix in 2005 VID).
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica, acetonitrile-0.05% phosphate aqueous solution (14: 86) is a mobile phase, detects wavelength 230nm, flow velocity: 1.0 ml/min, number of theoretical plate is pressed the peoniflorin peak and is calculated, and should be not less than 3000.
It is an amount of to the peoniflorin reference substance of constant weight that drying under reduced pressure is got in the preparation of reference substance solution, and accurate the title decides, and adds 50% methanol and makes per 1 milliliter of solution that contains 60 micrograms, promptly.
The content that the preparation of need testing solution is got under the capsules for curing waist pain content uniformity item is an amount of, and porphyrize is got about 3g, and accurate the title decides, and puts in the tool plug conical flask.Precision adds 50 milliliters of 50% methanol, and close plug claims to decide weight.Ultrasonic (power 200W, frequency 26.5KHz) handled 30 minutes, put coldly, claimed decide weight, added 50% methanol and supplied and subtract weight loss, shake up, and filtration, promptly.
Accurate respectively reference substance solution and each 10 microlitre of need testing solution drawn of algoscopy inject chromatograph of liquid, measure, promptly.Concrete experimental data sees the following form 2.
The testing result of peoniflorin in table 2 capsules for curing waist pain
Method of quality control of the present invention provides the quantitative detecting method of capsules for curing waist pain first, be this rheumatic arthritis that is widely used in, the hypertrophy spondylitis of lumbar vertebra, hypertrophy thoracic vertebra inflammation, cervical spondylitis, sciatica, the medicine of lumbar muscle strain provides authentication method more safely and effectively, for medicine actual production, field of circulation quality monitoring and clinical practice provide effective guarantee.
Claims (5)
1. the method for quality control of a capsules for curing waist pain, it is characterized in that adopting following method: get capsules for curing waist pain content 6.0 grams, put in 500 milliliters of tool plug conical flasks, add 60 milliliters of strong ammonia solutions, make moistening, add diethyl ether 200 milliliters, supersound process 40 minutes is put cold, divide and get ether solution, volatilize, residue adds dehydrated alcohol to be made dissolving and is settled to 2 milliliters, as need testing solution, it is an amount of that precision takes by weighing the aconitine reference substance in addition, add dehydrated alcohol and make per 1 milliliter of solution that contains 1 milligram, product solution is tested according to an appendix VIB of Chinese Pharmacopoeia version in 2005 thin layer chromatography in contrast, draw each 5 microlitre of above-mentioned need testing solution and reference substance solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, be made into developing solvent with ethyl acetate-acetone-strong ammonia solution according to 40: 2: 0.3 ratio, launch, take out, dry, spray is with rare bismuth potassium iodide test solution, and the speckle that occurs on the corresponding position of chromatograph is less than the speckle of reference substance.
2. the method for quality control of a capsules for curing waist pain, it is characterized in that adopting following method: get capsules for curing waist pain content 6.0 grams, put in 500 milliliters of tool plug conical flasks, add 60 milliliters of strong ammonia solutions, make moistening, add diethyl ether 200 milliliters, supersound process 40 minutes is put cold, divide and get ether solution, volatilize, residue adds dehydrated alcohol to be made dissolving and is settled to 2 milliliters, as need testing solution, it is an amount of that precision takes by weighing the aconitine reference substance in addition, add dehydrated alcohol and make per 1 milliliter of solution that contains 1 milligram, product solution is tested according to an appendix VIB of Chinese Pharmacopoeia version in 2005 thin layer chromatography in contrast, draw each 5 microlitre of above-mentioned need testing solution and reference substance solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, be made into developing solvent with ethyl acetate-acetone-strong ammonia solution according to 40: 2: 0.3 ratio, launch, take out, dry, spray does not occur speckle with rare bismuth potassium iodide test solution on the corresponding position of chromatograph.
3. according to claim 1 or 2 arbitrary described method of quality control, it is characterized in that peoniflorin is no less than 0.3 milligram in the every capsules of described capsules for curing waist pain.
4. method of quality control according to claim 3 is characterized in that described peoniflorin adopts high effective liquid chromatography for measuring.
5. method of quality control according to claim 4 is characterized in that the method for described high performance liquid chromatography is:
With octadecylsilane chemically bonded silica is filler, and acetonitrile-0.05% phosphate aqueous solution is made into mobile phase according to 14: 86 ratio, detects wavelength 230nm, flow velocity: 1.0 ml/min, number of theoretical plate are pressed the peoniflorin peak and are calculated, and should be not less than 3000;
The preparation of reference substance solution, it is an amount of to the peoniflorin reference substance of constant weight to get drying under reduced pressure, and accurate the title, decide, and adds 50% methanol and make per 1 milliliter of solution that contains 60 micrograms;
The preparation of need testing solution, the content of getting under the capsules for curing waist pain content uniformity item is an amount of, and porphyrize is got about 3 grams, and accurate the title, decide, and puts in the tool plug conical flask; Precision adds 50 milliliters of 50% methanol, and close plug claims to decide weight; Supersound process 30 minutes is put coldly, claims decide weight, adds 50% methanol and supplies and subtract weight loss, shakes up filtration;
Algoscopy, accurate respectively reference substance solution and each 10 microlitre of need testing solution drawn inject chromatograph of liquid, measure.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105079240A (en) * | 2014-05-13 | 2015-11-25 | 成都百草和济科技有限公司 | Medicine composition for treating hyperostosis |
| CN105079239A (en) * | 2014-05-13 | 2015-11-25 | 成都百草和济科技有限公司 | Granules for treating hyperostosis |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1813953A (en) * | 2005-12-02 | 2006-08-09 | 王衡新 | Chinese medicine formulation for promoting blood circulation to arrest pain, and its preparing method and quality control method |
| CN101199677B (en) * | 2007-11-20 | 2012-05-09 | 广西万寿堂药业有限公司 | Chinese medicine agent for treating injuries from falls, rheumatoid arthritis and preparing method thereof |
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2008
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105079240A (en) * | 2014-05-13 | 2015-11-25 | 成都百草和济科技有限公司 | Medicine composition for treating hyperostosis |
| CN105079239A (en) * | 2014-05-13 | 2015-11-25 | 成都百草和济科技有限公司 | Granules for treating hyperostosis |
| CN105079239B (en) * | 2014-05-13 | 2018-10-16 | 成都百草和济科技有限公司 | A kind of granule for treating osteoproliferation |
| CN105079240B (en) * | 2014-05-13 | 2018-10-16 | 成都百草和济科技有限公司 | A kind of pharmaceutical composition for treating osteoproliferation |
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