Medicine composition and detection method of preparations of medicine composition

A detection method and composition technology, which is applied in the direction of drug combinations, pharmaceutical formulations, active ingredients of hydroxyl compounds, etc., can solve the problems of lack of quantitative detection methods and the inability to fully guarantee the quality of prescription products

Active Publication Date: 2011-05-18
哈尔滨蒲公英药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The above two qualitative detection methods cannot fully guarantee the quality of the prescription product, and the lack of a quant...

Method used

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  • Medicine composition and detection method of preparations of medicine composition
  • Medicine composition and detection method of preparations of medicine composition
  • Medicine composition and detection method of preparations of medicine composition

Examples

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Comparison scheme
Effect test

preparation example Construction

[0310] Preparation of the test solution: take 1 / 4 of the daily dosage of the preparation of the present invention, pulverize it, add 1 g of diatomaceous earth, grind it evenly, add 20 ml of ethanol, heat and reflux for 1 hour, filter, and the filtrate is used as the test solution;

[0311] Preparation of the reference substance solution: take another reference substance of cholic acid and hyodeoxycholic acid, add ethanol to make a mixed solution containing 1mg per 1ml, and use it as the reference substance solution;

[0312] According to the test of thin-layer chromatography (Appendix VIB of the Chinese Pharmacopoeia in 2005), draw 2 μl of each of the above two solutions, and spot them on the same silica gel G thin-layer plate with carboxymethylcellulose sodium as the binder. Alkane-ethyl acetate-glacial acetic acid is 15:7:5 as the developer, develop, take out, dry in the air, spray with 10% sulfuric acid ethanol solution (ie: a mixture of 10ml sulfuric acid and 100ml ethanol)...

Embodiment 1

[0383] Embodiment 1: the detection method of pharmaceutical composition powder of the present invention

[0384] Raw material composition 1, take the raw material, add conventional excipients, make a powder according to the conventional process, and take 6g per day.

[0385] The detection method is: a combination of identification methods A, B, C, D, and content determination methods A, B, C, and D.

Embodiment 2

[0386] Embodiment 2: the detection method of pharmaceutical composition powder of the present invention

[0387] API composition 2;

[0388] The process steps are: Steps A3, B2, C1, and D2 in process 1, mixing the powders of intermediates I, II, and III with medicinal powder, adding conventional auxiliary materials to make powder according to conventional processes, and taking 6g per day.

[0389] The detection method is: a combination of identification methods A and B, and content determination methods A and B.

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Abstract

The invention discloses a traditional Chinese medicine Annao pill and a detection method of preparations prepared from the raw materials in the formula of the Annao pill. The detection method disclosed by the invention comprises identifying and/or content measuring methods, wherein the identifying methods are one or more of methods for identifying cholic acid and hyodeoxycholic acid, identifying rhizoma coptidis, identifying geniposide and identifying baicalein; and the content measuring methods are one or more of methods for measuring contents of geniposide, baicalein, rhizoma coptidis, menthol and borneol. The detection method disclosed by the invention has good linear relation, precision, stability, repeatability and recovery and is of great importance for strictly controlling the quality of the Annao pill and the preparations of the Annao pill.

Description

technical field [0001] The invention relates to a detection method of a pharmaceutical composition, in particular to a detection method of An Nao Pill and its preparation. Background technique [0002] Annao Pills is a traditional Chinese medicine prescription recorded on page 77 of the thirteenth volume of the Ministry of Health's drug standards for traditional Chinese medicine preparations. The standard number is WS3-B-2517-97. The prescriptions of Annao Pills recorded in the standard include: Gall powder, cinnabar, borneol, concentrated buffalo horn powder, pearl, baicalin, coptis, gardenia, realgar, turmeric, gypsum, ochre, mother of pearl and menthol; patent application No. 93100258.3 discloses the prescription dosage of Annao Pill Proportion relationship, and its conventional preparation process; the existing information discloses that Annao Wan has the effects of clearing heat and detoxifying, refreshing the brain, calming the nerves, eliminating phlegm, resuscitating...

Claims

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Application Information

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IPC IPC(8): A61K36/9066A61P29/00A61P25/00G01N30/02G01N30/90A61K35/56A61K35/413A61K35/32A61K33/36A61K33/28A61K33/26A61K33/06A61K31/045A61K35/618
Inventor 刘丽颖郑松涛
Owner 哈尔滨蒲公英药业有限公司
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