A Study On Xiao'er Qingre Zhike Koufuye

Objective:The ingredients of Xiao'er Qingre Zhike Koufuye is listed in the Volumeâ… of "Pharmacopoeia of People's Republic of China".It is primarily applied to affection by exopathogen of infants,cough and yellow-phlegm et al.Its curative effects are reliable and its application is abroad.In this study,using this ingredients as the groundwork,the process of extraction was optimized;the process of clarifying method was choused;the quality standard was improved;the stability of preparation was studied;and the pharmacodynamics was compared with the preparation in the market.Methods:(1)The quantity of water was taken shape by using the mono factor design which took the differences of the extraction rate,the contents of ephedrine and baicalin treated by those different water quantity and not treated as indices.(2)To refine the extraction,three methods which were ultracentrifugation,clarifying agent and alcohol-precipitation were adopted.And the most stable,the most executable and could be used by industrialization from these three methods would be choused at last.(3)The quality standard was established.TLC method was used to identify the four kinds of main Chinese traditional medicine:Herba Ephedrae,Radix Scutellariae,Radix Isstidis and Rhizoma Menispermi.HPLC was used to assay Ephedrine and Baicalin fast and exactly. (4)The pharmacodynamics effects of removing heat,relieving cough and having anti-inflammatory effect were appraised by animal models of cough,inflammation and fever.Then compared with the preparation in the market statistically.(5)According to the golden ruler of stability experiment in the addenda of "Pharmacopoeia of People's Republic of China",we progressed stress testing,accelerated testing and long-term testing. In these testings we seeing about the stability of our preparation through the requirements followed the quality standard.Results:(1)The quantity of water was confirmed as 12 times than the quantity of drugs in the first time and 10 times in the second time.(2)The optimized refining technology contained 1:1 water extracts,60%alcohol and refrigerated for 24 hours.(3) The established quality standard can be used to control the quality of the preparation.(4) The pharmacodynamics experiments of inhibition of cough,inflammation and fever were done.The results show that Xiao'er Qingre Zhike Koufuye produced by ourselves could remove heat,relieve cough and have anti-inflammatory effect obviously.There was no statistics difference between the preparation and that in the market.Conclusions:(1)The optimized extraction and refining technologies are stable, practical and suitable to industrialization.(2)The established quality standard is practical and the quality of the preparation is controllable.(3)Xiao'er Qingre Zhike Koufuye was stable under different test conditions for 9 months.(4)There was no statistics difference between Xiao'er Qingre Zhike Koufuye we produced and that in the market.So we could consider them have similar pharmacodynamics.