Study On The Promotion Of The Quality Standard Of Jinhoujian Spray

Objective∶ Jinhoujian spray is one of breed which one hundred and fifty-four national drug standards rising national standards.The statutory standards of jinhoujian spray only control the content of borneol and menthol,lacking of safety, effective, stable, controllable quality standard system.To protect clinical drug safety,enhance quality standards of jinhoujian spray comprehensively.Methods∶ This research subject will according to relevant requirements of Chinese Pharmacopoeia,2010.Establish a method of TLC for the identification of the oil about Cinnamomum migao, Borneol from the oil of Blumea balsamifera DC, Menthol and Glycyrrhizic acid ammonium salt and the method validations of TLC were completed.The content of ethanol was been determinated in the preparation.A method had been established by GC on the determination of the 1,8- cineole which is the effective ingredients in the oil of Cinnamomum migao and the method validations of GC were completed.The HPLC method of Glycyrrhizic acid ammonium salt also been estabilished and the method validations of HPLC were completed.The methodological study pattern of quantitative analysis of multi-components by single marker(QAMS) had been established and examing its feasibility and technical applicability in the quality control of compound preparation of traditional Chinese medicine- jinhoujian sprays.This research subject use GC method to establish fingerprint of the volatile components in jinhoujian spray. Similarity calculation according to National Pharmacopoeia Committe fingerprint similarity evaluation software and analysis fingerprint using SPSS software. Results∶ This research subject adds method of the 1,8- cineole which is the effective ingredients in the oil of Cinnamomum migao for TLC and GC. The TLC method for Borneol from the oil of Blumea balsamifera DC and Menthol.The method of Glycyrrhizic acid ammonium salt for TLC and GC. 10 bathes of jinhoujian spray samples were used to establish the fingerprint.Conclusion∶ This research subject improve jinhoujian sprays existing gold standard and establish an effective means of monitoring for active ingredients of prescription.While for the complex characteristics of Chinese medicine, QAMS had been established to study Chinese medicine of quality control mode.The fingerprin were established to control quality standards fully.