Studys On The Preparation And Quality Standards Of Ganjiangqinlianrenshen Decoction Agent

The prescription of Ganjiang Qinlian Renshen decoction agent is from Zhongjing "Treatise on the " articles of Jueyin. It congsists of Zingiber officinale Roac, Scutellaria baicalensis Georgi., Coptis chinensis Franch. and pa-nax ginseg C.A. Meyer, with a clear on the temperature, the effect of lowering pungent bitter for the symptom of stomach-heat and spleen-cold. The prescription is used for the treatment of modern clinical gastroenteritis, peptic ulcer, children with diarrhea, vomiting, dyspepsia, dysentery, cholecystitis and other diseases. The main subject of this prescription medicine declare new drugs by country select decoction agent form in preparation, quality standards and stability studies.Preparation:Through accessing relevant literature referencing to the physical and chemical properties, pharmacological effects and clinical applications of biological active ingredients of prescription drugs and the result of traditional and modern extraction technology comparative testing, formulate heating reflux extraction process path with water as solvent. Though single factor test and L9(34) orthogonal test, soak time and amount of water, extraction time, extraction times are investigated to determine the best extraction conditions; through the enrichment experiments, pressure, temperature and relative density of concentration are investigated to determine the appropriate process conditions and extract the lowest concentration relative density; through the molding process research on materials for study, optimize the proportion of suitable materials and determine the finished terminal sterilization methods of decoction agent. The whole preparation process smooth, reasonable and stable.Quality Standards:In order to guarantee the quality of pharmacy stably and controllablly, the quality standards of Ganjiang Qinlianrenshen decoction agent is set up with the help of modern pharmaceutical technology, such as TLC and HPLC.After a series of experimental studies, the most important traditional Chinese medicine herb in the prescription was controled quantitatively, and the quality standards were established.Preparation of preliminary stability test:According to the technical requirements of "Dr-ug Registra tion", in a preliminary stability test, respectively 0 months,1 month,2 months, 3 months,6 months,we review the character, identification, content.relative density and oth-er physiochemical index of decoction agent regulariy. The results showed that all the index -es stable are conformed to the standard and relevant provisions of decoction agent of 2010 version "Chinese Pharmacopoeia", good stability.