Study On Preparation And Quality Control For Feilin Gel

Objective Vaginitis is a common disease in gynecology inflammation,Vaginitis is a common disease in gynecology inflammation, which is a inflammation because vaginal mucosa and submucosal connective tissue infection of pathogenic microorganisms(fungi,trichomonas vaginalis, candida etc.), it is hard to heal and easy to recur.We do research on a clinical prescription at the ailment. ① To analyse every Chinese herbal medicine in the recipe, to reduce the dose, confirm the preparation which is based on holding the active ingredient. ②To establish the quality standard.Methods ① Preformulation study It is to confirm extraction technology,by the acti ve substance of herbal medical from documentation. ② Formulation and process research The contents of gentiopicroside and peoniflorin that are determined by H PLC is taken for the trial index of OED. It is optimized for the water extraction p arts of Chinese herbal medicine in the recipe. According to the route of administra tion, to determine the best dosage form. According to optimize content and species of gel matrix, and confirm the preparation technics by the trial index of characters,viscous, drug loading, p H. ③ Quality standard research According to the related r ule of Chinese Pharmacopoeia 2010, it is established to the quality standard, whi-c h include character, TLC in every herbal medicines,determination of gentiopicroside and peoniflorin by HPLC.Results ①Preformulation study The optimized extraction technics is established a s follow: added 10 times water into the Gentiana scabra Bge, Stemona sessilifolia(Miq.),Radix Paeoniae Rubra(crush to piece),Cortex Fraxini,Cortex Dictamni,Radix et Rhizoma Gl-ycyrrhizae in the recipe and extracted for 3 times, 1h per time.The filtrate is condensed to paste(ρ=1.15~1.20, 60℃), add alcohol to make the c ontent of alcohol up to 70%,standing for 24 hours, the supernatant, after recycling the ethnol, is condensed to thick paste(ρ=1.30~1.35,60℃).②Formulation and process research The optimized preparation technics is established as follow:Com bine carbopol 941 with xanthan gum to make a gel base, which is dispersed by propanediol and glycerol, apply water to the gel base till it fully expanded, add t he paste into it,to stir completely,then put potassium sorbate and triethanolamine,to stir completely,then get the Feil gel after filling. ③Quality standard research T he content determination method of Gentiopicroside and Peoniflorin was establishe d.Conclusions By studying on Feilin gel,it is demonstrated that the preparation technics is feasible, the quality of products is stable and controllable. The procedure is easy, sensitive with a good result and repeatability. It can be used control the quality of Feilin gel.