Pharmaceutical Research Of Bi Tong-ning Cataplasm

Bi Tong-ning Cataplasm is the preparation consists of Gentianae macrophyllae Radix, Sinomenii caulis, Paeoniae radix albe, Angelicae sinensis Radix, Radix et rhizoma tripterygii wilfordii. It has the function of Qufeng desiccant, Huoxue analgesic effect, to relieve rheumatoid arthritis caused by joint swelling, pain.This paper selected clinical Chinese medicine prescription, with the guidance of Traditional Chinese Medicine and technology of modern pharmacy, the cataplasm was stedied pri-clinical pharmaceutical qualities.Based on the demand of clinical use and characteristics of the herbs, the form of the drug was chosen to be cataplasm.Pharmacodynamic screening resulrs to determine the route of Angelica essential oil was extracted, and the rest of the prescription was chosen to use ethanol. This study determined the process parameters after optimization. Angelica sifted through a10mesh sieve, plus10times the amount of water, soak3h,steam distillation method distillation8h, collection of volatile oil and extract spare; the remaining four drugs soaked1h, the first time add9-fold amount of50%ethanol, and the second and the third times add8-fold amount, and extracted3times, lh each time, recovering ethanol until no alcohol flavor extract concentrated, with the volatile oils from the mother liquor after merge to a relative density of1.25to1.30(500) of the extract, then joined volatile oil, stir, total extract.The molding process of the preparation, screening matrix formulation and optimized using the Box-Behnken design, obtained the best prescription ratio, transdermal experimental screening2%borneol penetration enhancers. Final preparation process established:Weighing the prescribed amount of sodium polyacrylate, glycerin dispersed evenly adding the right amount of water, swelling uniform as the A-phase; carbomer add appropriate amount of water swelling and the total extract mixed, then added castor oil is dispersed evenly glycine aluminum,stir, as the B-phase; borneol small study as C-phase; citric acid solution as the D-phase; mixed B and C phase evenly, then add the A-phase mixing uniformity, the last mixing D-phase, refining under the conditions of600,100r/min and20min, adjust the coating thickness of2.5mm, applied to the non-woven fabric,60(?) drying, cut into7cm×10cm size.In the research of preparation’s quality criteria,TLC was used to identify all the herbs in the preseription. HPLC was used to determine content of Gentiopicroside which is the active component of Gentianae macrophyllae Radix, and systematic methodological study was established. The experimental results met the requirements, so they were brought into the text. According to the result of there batches of samples, individual provision stardards was made with the content of Gentiopicroside.In the stability research, accelerated test and long-term test for six month of there batches of samples had been conducted. The results showed that no change in appearance and performance, TLC identification of a positive reaction, the amount of gypsum, forming, adhesion, and content are qualified.