Studys On The Preparation And Quality Standards Of Fuyuanhuoxuetang Decoction Agent

Fuyuanhuoxuetang from Li Dongyuan’s "Medical Inventions",composed of eight kinds of Chinese herbal medicine rhubarb,bupleurum,angelica,safflower,pangolin,trichosanthes root,peach kernel,licorice,known as "the first choice",with blood stasis,dredging shuluo efficacy,treatment of various diseases caused by congestion guide,for the treatment of bone disease,pain,and the original foundation still has wide application in modern clinic.In this subject the theory of traditional Chinese medicine by reading a lot of literature,and combining the actual application of drugs,drugs and technical requirements,this research made decoction,on the preparation process,quality standard,stability and other aspects of the study.Study on the preparation process:according to the physicochemical properties,pharmacological action and clinical application of each medicinal herb in the prescription,the result of the extraction of the original Decoction and reflux extraction method was compared,and a reasonable process route was worked out.Through the single factor test,absorption of medicinal materials were investigated,the optimum soaking time;through L9(34)orthogonal test,the extraction solvent dosage,extraction times,extraction time were investigated,the optimum extraction conditions;by concentrating test of concentration,temperature,pressure and the relative density were investigated,to determine the appropriate conditions and the degree of concentration;molding process research on different correctant after discussion and study,and selecting the appropriate amount of accessories.Sterilization test,the sterilization method of decocted ointment.The preparation type is packaged in a brown molded bottle on a package and taken directly or by water.The test of forming process has been carried out,and the pilot test has been carried out.The whole process is smooth,scientific,reasonable and stable.Quality standard:to ensure the ointment is stable and controllable in quality,the use of modern methods and precision instruments,the quality standard of Fuyuanhuoxue Decoction agent were studied by thin layer chromatography(TLC)of three medicinal materials in the preparation of rhubarb,safflower,bupleurum established TLC identification;HPLC(HPLC)drug in Rheum emodin and Chrysophanol in determination of each other,and made the methodological study,established the quality control system of Fuyuanhuoxue Decoction agent.Preliminary study on stability of the preparation:according to the requirements of "drug registration management measures" in technology,the stability of the initial 6 month trial of ointment,respectively,in the 0 month,1 months,2 months,3 months and 6 months regularly "Chinese Pharmacopoeia" 2015 edition four ointment(rules 0813)under examination are examined,results showed that there was no significant difference in the indexes are in line with the provisions of.