發(fā)布時間：2018-01-31 10:29

  本文關(guān)鍵詞： 卡馬西平 固體分散體 紫外分光光度法　出處：《中國新藥雜志》2017年03期 　論文類型：期刊論文

【摘要】：目的:采用固體分散技術(shù)改善卡馬西平片的體外溶出度。方法:采用紫外分光光度法測定藥物含量,以體外溶出為指標(biāo),對固體分散體的載體、制備方法及比例進(jìn)行優(yōu)化。通過濕法制粒壓片法制備卡馬西平固體分散體片劑,根據(jù)日本橙皮書的要求對片劑的體外溶出進(jìn)行考察,并采用相似因子f2法與參比制劑(得理多)進(jìn)行比較。結(jié)果:載體采用泊洛沙姆188,與藥物質(zhì)量比為1∶1,通過溶劑-熔融法制備的固體分散體體外溶出效果較好,且制成的片劑在4種介質(zhì)(pH 1.2鹽酸溶液、pH 4.0醋酸鹽緩沖液、pH 6.8磷酸鹽緩沖液和水)中的溶出曲線與參比制劑相似。結(jié)論:固體分散技術(shù)可顯著改善卡馬西平的體外溶出,所制備的卡馬西平固體分散體片劑能滿足日本橙皮書的要求。
[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.
【作者單位】： 南京理工大學(xué)泰州科技學(xué)院化工學(xué)院;
【基金】：天津市天大天發(fā)科技有限公司特別支持
【分類號】：R943
【正文快照】： 卡馬西平(carbamazepine,CBZ)臨床上用于治療癲癇、外周神經(jīng)痛、神經(jīng)源性尿崩癥、躁狂抑郁癥和心律失常等疾病,是癲癇單純及部分性發(fā)作的首選藥[1],最早由諾華公司于1968年以Tegretol湟片劑上市[2]。國內(nèi)生產(chǎn)該藥的廠家眾多,到目前為止,我國已相繼頒發(fā)了138個卡馬西平片的生產(chǎn)

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