Preparation And Quality Standards Of The Sinomenine Enteric-coated Sustained-release Tablets

Clinical immune rheumatic disease involving many disciplines and fields, and greatly harm to human health, which contain RA, RHA, AS, It cause the pain and give the sufferer trouble and inconvenience.Sinomenine originated from the Chinese Caulis Sinomenii ,it is one kind of alkaloids extracted from leaves. has strong effect anti-inflammatory, anti-immunization, analgesia, sedation, and so on, for patients who encounter immune disease,it can release the rheumatic joint pain, inflammation, and exudation, However, it has a short half-life,just 2hs. stimulus effect to the stomach, it should be prepared in the way of enteric-coated and sustained-release.To patient, it is simple to take, little side effects.This topic has been on the basis of the finished studies, inspected the release of sustained-release tablets, available .To determine the prescription and preparation technology of the enteric-coated sustained-release tablets and to study its quality standards. Laid the foundation for further clinical research and application .The main topics as following:1. Studied the release laws of the sustained-release tablets on the market (zheng Qing feng tong ning) it meet Higuchi equation, can delay release every well. But did not consider the dissolution in the stomach, and there may be decomposed.2. Prepared enteric-coated sustained-release tablets different from the tablets available. Formulate the appropriate indicators to the finished product, to choose the best materials from the EC, stearic acid, and octadecanol, then inspected the preparation process. Finally determine the best prescription as fallow: hydrochloride sinomenine: EC: MCC: dextrin: magnesium stearate = 60:300:90:40:10. Then coating for the tablets. Through the selection of different coating materials, as well as weight gain of different proportion。At last, determined the coating solution as 12% Opadry Sureteric, weight increase of 3% -4%.3. form the quality standard of hydrochloride sinomenine enteric-coated sustained-release tablets, By UV, TLC, HPLC, and so on. Get the qualitative identification, and studied its release law.Results: The initial establishment the quality standards of hydrochloride sinomenine enteric-coated and sustained-release tablets, it has stabilized methodology, high accuracy, good reproducibility, can control the drug's quality Easily.