Method for detecting quality of medicinal preparation for curing hepatitis
A quality inspection method and technology for pharmaceutical preparations, which are used in pharmaceutical combinations, pharmaceutical formulations, and medical preparations containing active ingredients, etc., can solve the problems of lack of quality control methods and the inability to ensure the effectiveness and safety of clinical medication.
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[0117] Implementation 1. The quality control methods of Jinma Gantai Capsules for treating hepatitis are as follows:
[0118] Properties: This product is a hard capsule, the content is brown to brown granules and powder; smell and bitter;
[0119] Identification: (1) Identification of Danshen: Take 3g of Jinmagantai capsule content, add 25ml of methanol, heat to reflux for 1 hour, filter, evaporate the filtrate, add 20ml of water to dissolve the residue, shake and extract 3 times with ethyl acetate, each 20ml each time, combine the ethyl acetate solution, evaporate to dryness, add 1ml methanol to the residue to dissolve, as the test solution. Take another reference substance of protocatechualdehyde and add methanol to make a solution containing 1mg per 1ml as the reference substance solution. According to thin layer chromatography (Chinese Pharmacopoeia 2005 edition one appendix VIB) test, draw 0.5-1μl of the reference solution and 2-5μl of the test solution and place them on the...
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[0132] Implementation 2. The quality control methods of Jinma Gantai tablets for hepatitis are as follows:
[0133] Properties: This product is a film-coated tablet, which is gray-brown to brown after removing the film-coating; it smells and tastes bitter;
[0134] Identification: (1) Danshen identification: take Jinma Gantai tablets, remove the film coating, grind into fine pieces, take about 3g, add 25ml methanol, heat to reflux for 1 hour, filter, evaporate the filtrate to dryness, add 20ml water to the residue to dissolve it, use ethyl acetate The ester was shaken and extracted 3 times, 20 ml each time, the ethyl acetate solution was combined, evaporated to dryness, and the residue was dissolved by adding 1 ml of methanol, and used as the test solution. Take another reference substance of protocatechualdehyde, add methanol to make a solution containing 1mg per 1ml, as the reference substance solution. According to thin layer chromatography (Chinese Pharmacopoeia 2005 edition ...
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