Study Of The The Matrine Microemulsion Preparation And Quality Standards

Purpose:With the help of modern scientific methods,mateine was preparationed to microemulsions which was extracted from Sophora flavescens Ait..The pseudo-ternary phase diagram was utilized to select proper matrine microemulsions formulas.Study the effect of components and their proportion on the formation of matrine microemulsion and to screen out the prescription of matrine microemulsion and investigate its characteristics.Developed matrine microemulsion and the initial stability of quality standards for research. Material and method:1 Material:Matrine API was purchased in Boji City Fang Sheng Biological Development Company,the batch number:091126.Matrine reference substance was purchased in the Chinese pharmaceutical testing of biology products,the batch number:110805-200306.2 Method:(1)The pseudo-ternary phase diagram was utilized to select proper matrine microemulsions formulas.The influence,which was brought by different factors,was also studied and determin the best preparation;(2)Matrine microemulsion by measuring the viscosity,conductivity,Zeta electric potential,particle size,transmission electron microscopy matrine droplets from microemulsion method,evaluated the quality of the preparation;(3)Preparations by high performance liquid chromatography to determine the content and quality standards setablished;(4)By the influential factors experiment and stability,we study initial stability of matrine microemulsion.Results:1 Cremophor EL,Cremophor RH-40,Tween-80 and OP^-10 were used as surfactant,ethanol,1,2-propanediol,glycerin and butanol were investigated as co-surfactants and IPM,oleic acid and ethyl oleate were choose as oil.Pseudo-ternary phase diagrams had been constructed for microemulsion systems comprising of water-surfactants-oil at 25℃.Based on the section size of microemulsion and the content of matrin,screen out the appropriate prescription of matrin microemulsion.Finally,matrin microemulsion was composed of Cremophor EL,ethanol,ethyl oleate and distilled water.The prime prescription of blank microemulsion was ethyl oleate 4.50 %,Cremophor EL 19.13 %,ethanol 6.37 % and distilled water 70.00 %.The prime prescription of matrine microemulsion was mareine 4.0 %,ethyl oleate 3.0 %,Cremophor EL 19.5 %, ethanol 6.5 % and distilled water 67.0 %.2 It can define the best technology of preparation by studying the order of mixture and strength of dispersedness in the course of making matrine microemulsion.3 The relevant parameters of matrine microemulsion:(1)To differentiate the type of matrine microemulsion with the method of dilution,stain and conductivity.O/W matrine microemulsio-ns were successfully prepared;(2)The relevant parameters of blank microemulsion were as fo-llows:viscosity was 0.015 mPa·s,conductivity was 185.2μS·cm^-1,pH was 8.14,average diame-ter was 60.9 nm,zeta electric potential was about 0 mV.The relevant parameters of matrine microemulsion were as follows:viscosity was 0.022 mPa·s,conductivity was 183.7μS·cm^-1,pH was 8.23,average diameter was 61.3 nm,zeta electric potential was also about 0 mV.4 It determines a rational high quality control method to enforce the quality of the drugs and establish quality standard of matrine microemulsion.5 We study initial stability of matrine microemulsion.By the influential factors experiment and stability,we take samples on time and observe their appearance,pH and the change of content of medicines.Results indicat that matrine microemulsion would be conserved in the conditiion of low temperature,without air and without sunshine.Conclusion:With the help of modern scientific methods,mateine was preparationed to microemulsion.The matrin microemulsion is stable,safe and effective,according to the standards of microemulsion and drug delivery.We establish quality standard of matrine microemulsion.This subject research provides the basical experimental material for the new drug development.