Qingwen Mixture Preparation Process And Quality Standards Study

Objective:"Qingwen mixture" is from clinical experience, which is a modified prescription of "qingwen baidu yin".It contains Scutellaria baicalensis Georgi,Gardenia jasm inoides Ellis,Rhubarb,Red Paeony Root,Fructus aurantii,Amomum tsao-ko,Perilla Frutescens Seeds,Perilla frutescens and Nepeta cataria L. With the function of clearing and detoxifying through the evil by the effect of desease, it can be used for the treatment of patients with clinical acute bacterial wilt. In this study, by selecting the appropriate preparation, the prescription is made into mixture, and a preparation of quality standards has been established.Methods:(1) Study on process technology:By using single factor and orthogonal experimental design, methods on the volatile oil and the water boiling process were screened separately. Then the optimum extraction conditions were established.Meanwhile, according to the optimization of molding conditions the type of additives and amount of preservatives were formulated, so the praeparatum technology was established.(2) The study on quality specification and initial stability:By using TLC qualitative analysis on Gardenia jasm inoides Ellis,Paeonia Lactiflora Pall,Scutellaria baicalensis Georgi,Rhubarb,Fructus aurantii has been done; By using HPLC quantitative analysis on Geniposide,baicalin has been made; In accordance with the provisions of the draft quality standards and methods of the project, the initial stability has been done.Results:(1) Determined the optimum and stable extraction process of Fructus aurantii,Amomum tsao-ko,Perilla Frutescens Seeds,Perilla frutescens and Nepeta cataria L w as extracted with 10-fold water decoction for 12 hours. (2) The optimum extraction process of Geniposide and baicalin was 10-fold water,2 times for extraction(the first time for 2 hours and second time for 1 hour). (3)When the amount of polysorbate-80 is as 3 times as volatile oil,volatile oil is dissolved completely; When the amount of potassium sorbate was 0.2%,preservative effect can achieved. (4) We have established a stable and reliable quality specification,which can be used as quality control of qingwen mixtureConclusion:The effective materials of Chinese empirical prescription were extracted and made into mixture. The quality standard of the preparation was established. It provides GA patients with a valuable medicine whose curative effect was confirmed and quality was controllable for the clinical. Meanwhile, this study established a solid pharmaceutical basis for future research.