CN102645505A - Method for determining content and content homogeneity degree of chlorpheniramine maleate in antitussive and expectorant particles - Google Patents
Method for determining content and content homogeneity degree of chlorpheniramine maleate in antitussive and expectorant particles Download PDFInfo
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- CN102645505A CN102645505A CN2012101548029A CN201210154802A CN102645505A CN 102645505 A CN102645505 A CN 102645505A CN 2012101548029 A CN2012101548029 A CN 2012101548029A CN 201210154802 A CN201210154802 A CN 201210154802A CN 102645505 A CN102645505 A CN 102645505A
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Abstract
The invention discloses a method for determining the content and the content homogeneity degree of chlorpheniramine maleate in antitussive and expectorant particles, comprising the following four steps of: preparing a comparison product solution, preparing a solution of a sample to be tested under a content determination item, preparing a solution of the sample to be tested under a homogeneity degree determination item, and utilizing a high performance liquid chromatography to determine. The method has the advantages that the specially-prepared solution of the sample to be tested is combined with the high performance liquid chromatography so that the method with good stability and repeatability for determining the content and the content homogeneity degree of the chlorpheniramine maleate in the antitussive and expectorant particles is provided for detecting the content and the content homogeneity degree of the chlorpheniramine maleate in the antitussive and expectorant particles; and therefore, the quality detection index of the antitussive and expectorant particles is more comprehensive and the product quality can be better controlled.
Description
Technical field
The present invention relates to a kind of drug ingredient Determination on content method, the assay method of chlorphenamine maleate content and uniformity of dosage units in particularly a kind of pleasant particle that reduces phlegm.
Background technology
The proterties of the pleasant particle that reduces phlegm be light brown to brown particle, sweet, little hardship of distinguishing the flavor of, function cures mainly: relieving cough and asthma, pleasant reducing phlegm.Be used to treat sense, acute and chronic tracheitis, cough ant phlegm, disease such as out of breath uncomfortable in chest.Drug ingedient is fruit of negundo, the pinecone, Asiatic plantain, Radix Glycyrrhizae four flavor Chinese medicines and aminophylline, the chemical medicine of chlorphenamine maleate two flavors.Above Six-element, fruit of negundo, the pinecone, Asiatic plantain, Radix Glycyrrhizae four flavor Chinese medicines, the boiling secondary, each 3 hours, collecting decoction staticly settled, and filtered, and getting supernatant concentration to relative density is the clear cream of 1.24 (80 ℃); Aminophylline, chlorphenamine maleate mix with above-mentioned clear cream and dextrin, sucrose with facing-up method elder generation and dextrin mixing again, process particle, and drying promptly gets the pleasant particle that reduces phlegm.
The composition of the above-mentioned pleasant particle that reduces phlegm is differentiated: these article 2g is got in (1), and porphyrize adds methyl alcohol 30ml, and sonicated 20 minutes filters, and filtrating is concentrated into about 2ml, as need testing solution; Other gets theophylline and chlorphenamine maleate reference substance, adds methyl alcohol and processes the solution that every 1ml contains 2mg and 0.2mg respectively, as reference substance solution.According to the thin-layered chromatography test, draw each 5 μ l of above-mentioned three kinds of solution, put in same silica G F respectively
254On the thin layer plate, with chloroform-methanol-acetone-strong ammonia solution (volume ratio 9: 1.5: 1: 0.05) be developping agent, launch; Take out, dry, put under the ultraviolet lamp (254nm) and inspect; In the test sample chromatogram, with the corresponding position of theophylline reference substance chromatogram on, show the spot of same color.Spray again with rare bismuth potassium iodide test solution, inspect under the daylight, in the test sample chromatogram, with the corresponding position of chlorphenamine maleate reference substance chromatogram on, show the spot of same color.(2) get fruit of negundo control medicinal material 1g, add water 100ml, decocted 30 minutes, put coldly, filter, filtrating is concentrated into the thick paste shape, adds methyl alcohol 20ml, and sonicated 20 minutes filters, and filtrating is concentrated into about 1ml, as control medicinal material solution.According to the thin-layered chromatography test, draw need testing solution and each 5 μ l of above-mentioned control medicinal material solution in aforementioned (1), put respectively on same silica gel g thin-layer plate; Upper solution with butyl acetate-methanol-water (volume ratio 3: 1: 1) is a developping agent, launches, and takes out; Dry, put under the ultraviolet lamp (365nm) and inspect, in the test sample chromatogram; With the corresponding position of control medicinal material chromatogram on, show a fluorescence principal spot of same color.
The component content of the above-mentioned pleasant particle that reduces phlegm is measured: according to high effective liquid chromatography for measuring.(1) chromatographic condition and system suitability test: using octadecylsilane chemically bonded silica to be filling agent, is moving phase with methanol-water (volume ratio 25: 75), and the detection wavelength is 275nm.Number of theoretical plate calculates by the theophylline peak should be not less than 5000.(2) preparation of reference substance solution: it is an amount of to get the theophylline reference substance, and accurate the title decides, and processes the solution that every 1ml contains 10 μ g with moving phase, promptly gets.(3) preparation of need testing solution: get the content under these article content uniformity item, porphyrize is got 1g, and accurate the title decides; Put in the 100ml measuring bottle, it is an amount of to add moving phase, and sonicated 30 minutes is put cold; Add moving phase and be diluted to scale, shake up, filter, precision is measured subsequent filtrate 2ml; Put in the 25ml measuring bottle, be diluted to scale, shake up, promptly get with moving phase.(4) determination method: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject liquid chromatograph, measure, promptly get.Every bag of 6g of these article contains aminophylline with theophylline anhydrous (C
7H
8N
4O
2) meter, should be 54.7mg～82.1mg.
By above visible; The quality testing of the pleasant particle that reduces phlegm at present; In existing index, had the discriminating of aminophylline, chlorphenamine maleate, fruit of negundo, the assay of aminophylline has been arranged, but do not had the mensuration of less content for Chlorphenamine Maleate of content and uniformity of dosage units; This just can not know that whether the content of chlorphenamine maleate in the pleasant particle that reduces phlegm is accurate, even, can not control product quality better.
Summary of the invention
Goal of the invention: to the problems referred to above, the purpose of this invention is to provide the assay method of chlorphenamine maleate content and uniformity of dosage units in a kind of pleasant particle that reduces phlegm, to control the pleasant grain products quality of reducing phlegm better.
Technical scheme: chlorphenamine maleate content and cloud test method thereof in a kind of pleasant particle that reduces phlegm may further comprise the steps:
(1) preparation of reference substance solution: it is an amount of to get the chlorphenamine maleate reference substance, and accurate the title decides, and adds methyl alcohol and processes the solution that every 1ml contains 20 μ g approximately, promptly gets;
(2) preparation of need testing solution under the assay item: get the pleasant particle that reduces phlegm, porphyrize is got the about 1g of powder, and accurate the title decides; Put in the 25ml volumetric flask, it is moistening to add 1mol/l sodium hydroxide solution 2.5ml, adds about 18ml methyl alcohol, sonicated 30 minutes again; Put coldly, add methyl alcohol and be diluted to scale, shake up; Filter, get subsequent filtrate, promptly get;
(3) preparation of need testing solution under the Determination of Content Uniformity item: get pleasant 1 bag of the particle of reducing phlegm, put in the mortar, add 1mol/l sodium hydroxide solution 10ml moistening after, porphyrize; With the about 70ml of methyl alcohol, be transferred in the 100ml measuring bottle sonicated 30 minutes; Put coldly, add methyl alcohol and be diluted to scale, shake up; Filter, get subsequent filtrate, promptly get;
(4) use high-performance liquid chromatogram determination:
A. using octadecylsilane chemically bonded silica to be filling agent, is that phosphate buffer-methyl alcohol of 70: 30 is moving phase with volume ratio, and the detection wavelength is 264nm, and number of theoretical plate calculates by the chlorphenamine peak and is not less than 4000;
B. each 20 μ l of need testing solution under need testing solution, the Determination of Content Uniformity item inject liquid chromatograph under accurate respectively absorption reference substance solution, the assay item, measure, and calculate, and promptly get chlorphenamine maleate content;
C. go out the pleasant every bag of relative content that is 100 with labelled amount 3.0mg of particle that reduces phlegm by external standard method with the chlorphenamine calculated by peak area, promptly get the chlorphenamine maleate content uniformity coefficient.
Through said determination method gained, chlorphenamine maleate content was every bag and contains 2.4mg～3.6mg during the said pleasant particle 6g that reduces phlegm adorned every bag, and the chlorphenamine maleate content uniformity coefficient is A+1.8S＜20.0 in the said pleasant particle that reduces phlegm.
Being prepared as of phosphate buffer described in the step (4) adds phosphoric acid 1ml after ammonium dihydrogen phosphate (ADP) 11.5g is dissolved in water, and thin up is to 1000ml again.
Ultrasonic power described in step (2), the step (3) is that 250W, frequency are 40kHz.
Beneficial effect: compared with prior art; Advantage of the present invention is the need testing solution combination high performance liquid chromatography through special preparation; Chlorphenamine maleate content and uniformity of dosage units in the pleasant particle that reduces phlegm are measured; The assay method of chlorphenamine maleate content and uniformity of dosage units in the pleasant particle that reduces phlegm of a kind of stability, good reproducibility is provided, has made the quality detecting index of the pleasant particle that reduces phlegm more comprehensive, to control product quality better.
Embodiment
Below in conjunction with specific embodiment; Further illustrate the present invention; Should understand these embodiment only be used to the present invention is described and be not used in the restriction scope of the present invention; After having read the present invention, those skilled in the art all fall within the application's accompanying claims institute restricted portion to the modification of the various equivalent form of values of the present invention.
Chlorphenamine maleate content and cloud test method thereof in a kind of pleasant particle that reduces phlegm may further comprise the steps:
(1) preparation of reference substance solution: it is an amount of to get the chlorphenamine maleate reference substance, and accurate the title decides, and adds methyl alcohol and processes the solution that every 1ml contains 20 μ g chlorphenamine maleates approximately, promptly gets.
(2) preparation of need testing solution under the assay item: get the pleasant particle that reduces phlegm, porphyrize is got the about 1g of powder, and accurate the title decides; Put in the 25ml volumetric flask, it is moistening to add 1mol/l sodium hydroxide solution 2.5ml, adds about 18ml methyl alcohol again, is that 250W, frequency are the sonicated 30 minutes of 40kHz through power; Put coldly, add methyl alcohol and be diluted to scale, shake up; Filter, get subsequent filtrate, promptly get.
(3) preparation of need testing solution under the Determination of Content Uniformity item: get pleasant 1 bag of the particle of reducing phlegm, put in the mortar, add 1mol/l sodium hydroxide solution 10ml moistening after, porphyrize; With the about 70ml of methyl alcohol, be transferred in the 100ml measuring bottle, be that 250W, frequency are the sonicated 30 minutes of 40kHz through power; Put coldly, add methyl alcohol and be diluted to scale, shake up; Filter, get subsequent filtrate, promptly get.
(4) use high-performance liquid chromatogram determination:
A. using octadecylsilane chemically bonded silica to be filling agent, is that phosphate buffer-methyl alcohol of 70: 30 is moving phase with volume ratio, and the detection wavelength is 264nm, and number of theoretical plate calculates by the chlorphenamine peak and is not less than 4000; Being prepared as of phosphate buffer adds phosphoric acid 1ml after ammonium dihydrogen phosphate (ADP) 11.5g is dissolved in water, and thin up is to 1000ml again
B. each 20 μ l of need testing solution under need testing solution, the Determination of Content Uniformity item inject liquid chromatograph under accurate respectively absorption reference substance solution, the assay item, measure, and calculate, and promptly get chlorphenamine maleate content; Record the pleasant particle 6g that reduces phlegm adorn every bag in chlorphenamine maleate content be every bag and contain 2.4mg～3.6mg;
C. go out the pleasant every bag of relative content that is 100 with labelled amount 3.0mg of particle that reduces phlegm by external standard method with the chlorphenamine calculated by peak area, promptly get the chlorphenamine maleate content uniformity coefficient; Record that the chlorphenamine maleate content uniformity coefficient is A+1.8S＜20.0 in the pleasant particle that reduces phlegm.
It below is contrast test report to the invention described above assay method.
1, instrument and reagent
Instrument: high performance liquid chromatograph.
Reagent: methyl alcohol is chromatographically pure reagent, and water is purified water, and other reagent are pure for analyzing.
Reference substance: chlorphenamine maleate (lot number: 100047-200606 supplies assay to use), Nat'l Pharmaceutical & Biological Products Control Institute provides.
Test sample: (lot number: 100801), specification: every packed 6g is provided by our company the pleasant particle that reduces phlegm.
2, chromatographic condition
Using octadecylsilane chemically bonded silica to be filling agent, is that phosphate buffer-methyl alcohol of 70: 30 is moving phase with volume ratio, and the detection wavelength is 264nm, and number of theoretical plate calculates by the chlorphenamine peak and is not less than 4000.
3, the selection of wavelength
Getting 20 μ g/ml chlorphenamine maleate reference substance solution, is blank with methyl alcohol, in 250～350nm wavelength coverage, scans.Characteristic absorption is the most obvious at the 264nm place to show the chlorphenamine maleate reference substance, and this test and Selection 264nm is for detecting wavelength.
4, the pre-treatment of test sample
This test sample is a compound Chinese medicinal preparation, and through evidence, undressed test sample ingredient is more, so need it is carried out pre-treatment.At first analyzed contained principal ingredient in each item physicochemical property and the test sample of chlorphenamine maleate,, confirmed that its basic processing process is that alkali treatment, alcohol dissolve, constant volume after consult a large amount of documents.Because of chlorphenamine maleate is that chlorphenamine adds sour salify, soluble in water, ethanol or methenyl choloride are slightly soluble in ether; So list of references; It is alkalescent that test design adopts the NaOH regulator solution, in be free alkali with maleic acid reduction chlorphenamine after, use the methyl alcohol ultrasonic Extraction.The result shows that alkalization back ultrasonic method is simple.
5, the selection of moving phase
The chlorphenamine maleate content assay method is generally selected the phosphate-buffered salt system.In test; Acetonitrile is changed to methyl alcohol; Can get rid of the interference of other composition in the test sample, make chlorphenamine maleate retention time and peak type all suitable, selecting volume ratio at last is phosphate buffer-methyl alcohol of 70: 30; Being prepared as of phosphate buffer adds phosphoric acid 1ml after ammonium dihydrogen phosphate (ADP) 11.5g is dissolved in water, and thin up is to 1000ml again.
6, stability test
Get need testing solution under the assay item, respectively at 0,1,2,4,8 hour sample introduction, measure the chlorphenamine peak area, RSD is 1.15% (n=5) as a result.
7, precision test
Get 20 μ g/ml chlorphenamine maleate reference substance solution, repeat sample introduction 5 times, measure the chlorphenamine peak area, RSD is 0.78% (n=5) as a result.
8, replica test
Get parallel 6 parts of test sample, measure the content of every part of test sample according to method under the assay item, average every bag to contain chlorphenamine maleate be 99.8% of labelled amount, and RSD is 0.94% (n=6).
9, average recovery test
It is an amount of that precision takes by weighing test sample, and totally 9 parts, add the chlorphenamine maleate reference substance solution of different volumes respectively, handle according to method under the assay item, measure calculate recovery rate.Average recovery rate is 99.23%, and RSD is 0.98% (n=9) as a result.
10, test sample assay
Respectively accurate the absorption by each 20 μ l of need testing solution under the reference substance solution of the inventive method preparation and the assay item injected liquid chromatograph, measures, and with the chlorphenamine calculated by peak area, getting this batch, to contain chlorphenamine maleate be the 2.83mg/ bag by external standard method.
11, test sample Determination of Content Uniformity
Respectively accurate the absorption by the 20 μ l respectively of need testing solution under the reference substance solution of the inventive method preparation and the Determination of Content Uniformity item; Inject liquid chromatograph; Measure; Going out every bag by external standard method with the chlorphenamine calculated by peak area is 100 relative content with labelled amount 3.0mg, in the pleasant particle that reduces phlegm the chlorphenamine maleate content uniformity coefficient be A+1.8S=16.2.
12, conclusion
In sum, adopt assay method of the present invention, make the stability and the good reproducibility of chlorphenamine maleate content and Determination of Content Uniformity in the pleasant particle that reduces phlegm, thereby can guarantee the quality of medicine better.
Claims (4)
1. chlorphenamine maleate content and cloud test method thereof in the pleasant particle that reduces phlegm is characterized in that may further comprise the steps:
(1) preparation of reference substance solution: it is an amount of to get the chlorphenamine maleate reference substance, and accurate the title decides, and adds methyl alcohol and processes the solution that every 1ml contains 20 μ g approximately, promptly gets;
(2) preparation of need testing solution under the assay item: get the pleasant particle that reduces phlegm, porphyrize is got the about 1g of powder, and accurate the title decides; Put in the 25ml volumetric flask, it is moistening to add 1mol/l sodium hydroxide solution 2.5ml, adds about 18ml methyl alcohol, sonicated 30 minutes again; Put coldly, add methyl alcohol and be diluted to scale, shake up; Filter, get subsequent filtrate, promptly get;
(3) preparation of need testing solution under the Determination of Content Uniformity item: get pleasant 1 bag of the particle of reducing phlegm, put in the mortar, add 1mol/l sodium hydroxide solution 10ml moistening after, porphyrize; With the about 70ml of methyl alcohol, be transferred in the 100ml measuring bottle sonicated 30 minutes; Put coldly, add methyl alcohol and be diluted to scale, shake up; Filter, get subsequent filtrate, promptly get;
(4) use high-performance liquid chromatogram determination:
A. using octadecylsilane chemically bonded silica to be filling agent, is that phosphate buffer-methyl alcohol of 70: 30 is moving phase with volume ratio, and the detection wavelength is 264nm, and number of theoretical plate calculates by the chlorphenamine peak and is not less than 4000;
B. each 20 μ l of need testing solution under need testing solution, the Determination of Content Uniformity item inject liquid chromatograph under accurate respectively absorption reference substance solution, the assay item, measure, and calculate, and promptly get chlorphenamine maleate content;
C. go out the pleasant every bag of relative content that is 100 with labelled amount 3.0mg of particle that reduces phlegm by external standard method with the chlorphenamine calculated by peak area, promptly get the chlorphenamine maleate content uniformity coefficient.
2. chlorphenamine maleate content and cloud test method thereof in the pleasant particle that reduces phlegm according to claim 1; It is characterized in that: chlorphenamine maleate content was every bag and contains 2.4mg～3.6mg during the said pleasant particle 6g that reduces phlegm adorned every bag, and the chlorphenamine maleate content uniformity coefficient is A+1.8S＜20.0 in the said pleasant particle that reduces phlegm.
3. chlorphenamine maleate content and cloud test method thereof in the pleasant particle that reduces phlegm according to claim 1; It is characterized in that: being prepared as of phosphate buffer described in the step (4) adds phosphoric acid 1ml after ammonium dihydrogen phosphate (ADP) 11.5g is dissolved in water, and thin up is to 1000ml again.
4. chlorphenamine maleate content and cloud test method thereof in the pleasant particle that reduces phlegm according to claim 1 is characterized in that: ultrasonic power described in step (2), the step (3) is that 250W, frequency are 40kHz.
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| CN104435388A (en) * | 2014-12-12 | 2015-03-25 | 江苏中兴药业有限公司 | Method for preparing tablet for guiding qi downward and reducing phlegm |
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Application publication date: 20120822 |