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
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[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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