Quality control method for quick-acting antidiarrheal capsule
A detection method and capsule technology, which are applied in the directions of capsule delivery, medical preparations containing active ingredients, measuring devices, etc., can solve problems such as inability to effectively control product quality, lack of identification and measurement methods, etc., to ensure safety and process control. strictly reasonable effect
Active Publication Date: 2010-11-10
贵州省科晖制药有限公司
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Problems solved by technology
The Suxiao Zhixie Capsules described in the drug standards of the Ministry of Health of the People's Republic of China only provides a qualitative detection method for berberine hydrochloride, lacking identification and determination methods for other major flavors of the drug, and cannot effectively control product quality
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The invention discloses a quality control method of Suxiaozhixie Capsule, which comprises the following steps: identifying the capsule, detecting content according to high performance liquid chromatography: A chromatographic condition and system qualification test, B preparing contrast solution, C preparing testing solution for assay, and D precisely sucking 10 mu l contrast solution and testing solution for assay respectively, injecting into liquid chromatograph, detecting, wherein, labelled amount of berberine hydrochloride in the product is 90-110%.The invention can better control the quality of the capsule, guarantee safety for administration, guide production with rational and strict process control.
Description
Detection method of Suxiao Zhixie Capsules technical field The invention belongs to the field of quality control of traditional Chinese medicine preparations, in particular to a detection method for quick-acting antidiarrheal capsules. Background technique Suxiao Zhixie Capsules are composed of berberine hydrochloride and boxing ginseng, which have the functions of clearing heat and dampness, astringent and antidiarrheal; it is used for red dysentery, heat diarrhea, enteritis, etc. The Suxiao Zhixie Capsules described in the drug standards of the Ministry of Health of the People's Republic of China only provides a qualitative detection method for berberine hydrochloride, and lacks the identification and determination methods of other main medicinal flavors of the drug, which cannot effectively control the product quality. Contents of the invention The purpose of the present invention is to overcome the above-mentioned shortcoming and provide a kind of detection method t...
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IPC IPC(8): G01N30/02G01N30/90A61K36/704A61K9/48A61P1/12A61K31/4375
Inventor 霍昕杨迺嘉刘文炜刘建华
Owner 贵州省科晖制药有限公司
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