卡马西平固体分散体及其片剂的制备

发布时间：2018-01-31 10:29

本文关键词： 卡马西平固体分散体紫外分光光度法　出处：《中国新药杂志》2017年03期 　论文类型：期刊论文

【摘要】：目的:采用固体分散技术改善卡马西平片的体外溶出度。方法:采用紫外分光光度法测定药物含量,以体外溶出为指标,对固体分散体的载体、制备方法及比例进行优化。通过湿法制粒压片法制备卡马西平固体分散体片剂,根据日本橙皮书的要求对片剂的体外溶出进行考察,并采用相似因子f2法与参比制剂(得理多)进行比较。结果:载体采用泊洛沙姆188,与药物质量比为1∶1,通过溶剂-熔融法制备的固体分散体体外溶出效果较好,且制成的片剂在4种介质(pH 1.2盐酸溶液、pH 4.0醋酸盐缓冲液、pH 6.8磷酸盐缓冲液和水)中的溶出曲线与参比制剂相似。结论:固体分散技术可显著改善卡马西平的体外溶出,所制备的卡马西平固体分散体片剂能满足日本橙皮书的要求。
[Abstract]:Objective: to improve the dissolution of carbamazepine tablets in vitro by solid dispersion. Methods: UV spectrophotometry was used to determine the content of the drug. The preparation method and proportion were optimized. Carbamazepine solid dispersible tablets were prepared by wet granulation and pressing method. The dissolution of tablets in vitro was investigated according to the requirements of Japanese orange peel book. The similarity factor f2 method was used to compare with the reference preparation. Results: the carrier was Poloxamer 188 with a mass ratio of 1: 1. The solid dispersion prepared by solvent-melting method had good dissolution effect in vitro, and the tablets were prepared in four kinds of medium pH 1.2 hydrochloric acid solution and pH 4.0 acetate buffer. The dissolution curve in pH 6.8 phosphate buffer and water was similar to that in reference preparation. Conclusion: solid dispersion technique can significantly improve the dissolution of carbamazepine in vitro. The prepared carbamazepine solid dispersible tablets can meet the requirements of Japanese orange peel.
【作者单位】：南京理工大学泰州科技学院化工学院;
【基金】：天津市天大天发科技有限公司特别支持
【分类号】：R943
【正文快照】： 卡马西平(carbamazepine,CBZ)临床上用于治疗癫痫、外周神经痛、神经源性尿崩症、躁狂抑郁症和心律失常等疾病,是癫痫单纯及部分性发作的首选药[1],最早由诺华公司于1968年以Tegretol湟片剂上市[2]。国内生产该药的厂家众多,到目前为止,我国已相继颁发了138个卡马西平片的生产

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