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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.

Active Publication Date: 2010-09-22
贵州益康制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing dosage form is granule, which has been included in the liver and gallbladder sub-volume of the national standard compilation of Chinese patent medicines. Its quality standard is relatively simple, and only the quality control of Fangji in the prescription is carried out, so the effectiveness and effectiveness of its clinical use cannot be well ensured. Safety, further research is required to improve its quality control standards
According to the relevant provisions of my country's Drug Administration Law, changing the dosage form or process is regarded as a new drug research management. Jinmagantai Tablets and Jinmagantai Capsules are new drugs, and there is currently no effective quality control method

Method used

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  • Method for detecting quality of medicinal preparation for curing hepatitis
  • Method for detecting quality of medicinal preparation for curing hepatitis
  • Method for detecting quality of medicinal preparation for curing hepatitis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0117] Implement 1. The quality control method of Jinmagantai Capsules for treating hepatitis is as follows:

[0118] Properties: This product is a hard capsule, the contents are brown to tan granules and powder; fragrant, bitter;

[0119] Identification: (1) Identification of Salvia miltiorrhiza: Take 3g of the contents of Jinmagantai capsule, add 25ml of methanol, heat and reflux for 1 hour, filter, evaporate the filtrate to dryness, add 20ml of water to dissolve the residue, shake and extract 3 times with ethyl acetate, 20ml each time, combined ethyl acetate solution, evaporated to dryness, and dissolved the residue in 1ml of methanol as the test solution. Take another protocatechualdehyde reference substance, add methanol to make a solution containing 1mg per 1ml, as the reference substance solution. According to the thin-layer chromatography (Appendix VIB, Chinese Pharmacopoeia, 2005 edition), draw 0.5-1 μl of the reference substance solution and 2-5 μl of the test solu...

Embodiment 2

[0132] Implement 2. The quality control method of Jinmagantai tablets for treating hepatitis is as follows:

[0133] Properties: This product is a film-coated tablet, grayish-brown to tan after removing the film-coating; fragrant, bitter;

[0134] Identification: (1) Identification of Salvia miltiorrhiza: Take Jinmagantai tablet, remove the film coating, grind finely, take about 3g, add 25ml of methanol, heat and reflux for 1 hour, filter, evaporate the filtrate to dryness, add 20ml of water to the residue to dissolve, and use ethyl acetate Shake and extract the ester three times, 20ml each time, combine the ethyl acetate solution, evaporate to dryness, add 1ml methanol to the residue to dissolve, and use it as the test solution. Take another protocatechualdehyde reference substance, add methanol to make a solution containing 1mg per 1ml, as the reference substance solution. According to the thin-layer chromatography (Appendix VIB, Chinese Pharmacopoeia, 2005 edition), draw ...

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Abstract

The invention discloses a method for detecting the quality of a medicinal preparation for curing hepatitis. The method comprises the following steps of: detecting characters, identifying, inspecting and determining content, wherein identification means identifying astragalus, red paeony root and root of red-rooted salvia in the preparation by adopting thin layer chromatography; and content determination means determining icraiin content of the preparation through high performance liquid chromatography or simultaneously determining tetrandrine content and fangichinoline content of the preparation through the high performance liquid chromatography under the same chromatographic condition. The method has the advantages of effectively controlling and ensuring stable, controllable, high-efficient and safe quality of Jinma Gantai tablets and Jinma Gantai capsules for curing the hepatitis, ensuring clinical curative effect of the preparation and meeting medical requirements, along with scientificity, reasonability, high accuracy and high reproducibility.

Description

technical field [0001] The invention relates to a quality testing method for medicines, in particular to a quality testing method for pharmaceutical preparations for treating hepatitis, specifically a quality testing method for Jinmagantai tablets or capsules, and belongs to the technical field of medicines. Background technique [0002] Jinmagantai Tablets and Jinmagantai Capsules, the main ingredients of which are nine traditional Chinese medicinal materials such as horseshoe gold, iron-coated gold, verbena, Fangji, Patrinia, Epimedium, Astragalus, Radix Paeoniae Rubra and Salvia Miltiorrhiza, used as national medicines It has the effects of clearing heat and detoxifying, invigorating the spleen and promoting dampness, promoting blood circulation and removing blood stasis. It is mainly used for acute and chronic hepatitis caused by liver and gallbladder damp-heat, qi stagnation and blood stasis. The existing dosage form is granule, which has been included in the liver and ...

Claims

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Application Information

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IPC IPC(8): A61K36/85A61P1/16A61P31/14A61P31/20G01N30/02G01N30/36G01N30/90
Inventor 张秋生高翔
Owner 贵州益康制药有限公司
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