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Quality control method of tables for treating asthma

A quality control method and asthma technology, applied in medical preparations containing active ingredients, measuring devices, pharmaceutical formulations, etc., can solve the problems of difficult separation of ingredients, large prescriptions, insufficient control of finished product quality, etc., to improve specificity and quality. Effectiveness

Active Publication Date: 2009-02-11
GUANGZHOU BAIYUNSHAN ZHONGYI PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because there are no reference substances for some medicinal materials, or due to the large prescription, the ingredients are difficult to separate, the original quality control standard of the preparation is relatively simple, only the trait inspection items, no drug identification and content determination method, which is not enough to control the quality of the finished product, thus affecting its clinical practice Efficacy and use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] A kind of quality control method of Chuanchuanning tablet in the present embodiment, comprises:

[0019] Identification:

[0020] (1) Take 15 finished Chuan Chuan Ning tablets, grind them finely, add 20 drops of concentrated ammonia test solution, add 10 ml of chloroform, heat and reflux for 1 hour, filter, evaporate the filtrate to dryness, add 1 ml of methanol to the residue to dissolve, and use as test In addition, get ephedrine hydrochloride reference substance, add methanol to make a solution containing 1mg per 1ml, as reference substance solution; according to the thin-layer chromatography test recorded in an appendix VIB of the Chinese Pharmacopoeia version in 2005, draw each of the above two solutions 5μl, respectively spot on the same silica gel G thin-layer plate, in a developing cylinder pre-saturated with concentrated ammonia test, use 5:20:2 toluene-chloroform-methanol as developing agent, develop, take out, dry in the air, spray with Ninhydrin test soluti...

Embodiment 2

[0028] Embodiment 2: the quality control method of Chuanchuanning tablet can comprise:

[0029] Identification:

[0030] (1), take 15 finished products of Chuanchuanning Tablets, grind them finely, add 20ml of chloroform, heat and reflux for 30 minutes, filter, evaporate the filtrate to dryness, add 1ml of chloroform to the residue to dissolve, and use it as the test solution; The method is made into contrast medicinal material solution; Get Schisandrin A reference substance again, add chloroform and make the solution that every 1ml contains 1mg, as reference substance solution; 5 μl of each solution, respectively spot on the same silica gel GF 254 Use 9:1 toluene-ethyl acetate as the developing agent on the thin-layer plate, develop, take out, dry, and inspect under a 254nm ultraviolet lamp; At the position, spots of the same color are displayed;

[0031] (2) Take 20 tablets of this product, grind finely, add 30ml of 10% hydrochloric acid absolute ethanol solution, heat an...

Embodiment 3

[0037] Embodiment 3: the quality control method of Chuanchuanning tablet can comprise:

[0038] Identification:

[0039] Take 15 finished Chuanchuanning tablets, grind them finely, add 20ml of chloroform, heat and reflux for 30 minutes, filter, evaporate the filtrate to dryness, add 1ml of chloroform to the residue, and use it as the test solution; Solution; get Schizandrin reference substance again, add chloroform and make every 1ml contain 1mg solution, as reference substance solution; According to the thin-layer chromatography test that Chinese Pharmacopoeia 2005 edition one appendix VIB records, draw each 5 μ l of above-mentioned three kinds of solutions , respectively point on the same silica gel GF 254 Use 9:1 toluene-ethyl acetate as the developing agent on the thin-layer plate, develop, take out, dry, and inspect under a 254nm ultraviolet lamp; At the position, spots of the same color are displayed;

[0040] Content determination:

[0041] Take the finished product...

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PUM

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Abstract

The invention discloses a quality control method for Xiaochuanning Pian (a tablet for treating asthma), to which drug identification and content determination are added. The method can identify the active compositions of Chinese ephedra, fructus schisandrae chinensis and radix polygalae and determine the content of Chinese ephedra to improve the exclusiveness and effectiveness of the quality control, thus being beneficial for the effective quality control of the finished Xiaochuanning Pian.

Description

technical field [0001] The invention relates to a quality control method for Chuanchuanning tablets. Background technique [0002] Chuanchuanning Tablets is a traditional Chinese medicine used to treat bronchial asthma, chronic cough, and shortness of breath. This product is included in the Ministry of Health of the People's Republic of China. 75g, Dajinhua 50g, Schisandra 400g, Polygala (manufactured) 150g, Radix Pseudostellariae 400g, Ephedra (honey-roasted) 200g and other eight-flavored medicinal materials. Because there are no reference substances for some medicinal materials, or due to the large prescription, the ingredients are difficult to separate, the original quality control standard of the preparation is relatively simple, only the trait inspection items, no drug identification and content determination method, which is not enough to control the quality of the finished product, thus affecting its clinical practice curative effect and use. Contents of the invent...

Claims

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Application Information

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IPC IPC(8): A61K36/8884A61P11/06G01N30/02G01N30/36G01N30/90A61K33/06
Inventor 庾燕珍
Owner GUANGZHOU BAIYUNSHAN ZHONGYI PHARMA COMPANY
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