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Quality control method of tables for treating asthma

A technology for asthma Ning tablets and analysis method, applied in the field of quality control of asthma Ning tablets, can solve the problems of difficult separation of components, influence on clinical efficacy and use, no drug identification and content determination methods, etc., so as to improve specificity and effectiveness Effect

Active Publication Date: 2011-10-05
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 the reference medicinal material solution; then get the Schizandrin reference substance, add chloroform to make a solution containing 1mg per 1ml, as the reference substance solution; according to the TLC test of the Chinese Pharmacopoeia 2005 edition one appendix VI B record, absorb the above-mentioned 5 μl of each of the three solutions were spotted 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...

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 solution containing 1mg, as reference substance solution; 5μl, 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;

[0040] Content determination:

[0041] Take the finished product of Huachuanning Tablets under the weight difference item, grind it finely, take 1.0g, accurately weigh it, put it in a 50ml conical flask with a stopper, add 1ml of con...

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