Studies of the Preparation and Quality Standard on Fuailing Patch
|School||Heilongjiang University of Traditional Chinese Medicine|
|Keywords||Strychnos Total ginsenoside Patch Anti-tumor effect Release|
Efficacy group of Fuailing patch are Strychni extracts and ginsenosides. As a traditional Chinese medicine, Strychnine is common Chinese herbal medicine having toxicity.According to research literature through more years Strychni can be used in treating diseases for various types of cancer.Its chemical composition is mainly alkaloids. Strychnine has a certain anti-cancer alkaloids and a similar role of non-steroidal anti-inflammatory drugs, features and a strong analgesic effect, and no addiction. Analgesic effects last longer, persistent pain on better treatment.Ginseng as a traditional tonic modern medical research shows that ginseng saponin also has high anti-tumor activity.Although Semen Strychni and its complex were used very well in clinic, the application was restricted seriously by its narrow curative window. Therefore it is very important to study and develop a safe, efficient, accurate, and persistent TTS dosage form of Semen Strychni. In this thesis, some researches were studied.①The best extraction and purification technology of Strychnine active ingredients was determined by orthogonal test. Determine the extraction process Strychni 10 times of 70% ethanol and extracted three times, each time 2 hours.②The forming process of patch was studied. The type of patch was adhesive dispersion type TTS. Penetration enhancers were selected with modified Franz diffusion cell. Azone as 5% was selected as the best concentration of transdermal enhancers.③The quality standard was determined, including characters、ointment content、adhesiveness、weight variation of patch, and the test of content determination、in vitro release、stability and skin toxicity. Determination of in vitro release method using modified Franz diffusion cell. Strychnine and the patch to determination of HPLC analysis of the same liquid on the receiver were determined Strychnine. Proved that the patch release in vitro was increased with time for the process, meet Hughchi equation, regression equation (y=277.22t1/2+595.46 r=0.9942) shows that the skeleton of controlled release formulations are TDD systems.On the basis of rules of SFDA, the stability and quality control of the Semen Strychni patch was studied. It had proved that the Fuailing patch was stable and controllable. It has good prospects for clinical application.