盐酸苯环壬酯控释片半透膜包衣工艺优化  

Optimization of Coating Technology for the Semipermeable Membrane of Phencynonate Hydrochloride Controlled-release Tablets

作　　者：王彦辰 曾媛[1] 刘辉[1] 赵静[1,2] 陶志强 WANG Yanchen;ZENG Yuan;LIU Hui;ZHAO Jing;TAO Zhiqiang(Dept. of Pharmacy, Wuhan General Hospital of Guangzhou Military Region, Wuhan 430070;College of Pharmacy, Hubei Universily of Chinese Medicine, Wuhan 430065)

机构地区：[1]中国人民解放军广州军区武汉总医院药剂科,湖北武汉430070 [2]湖北中医药大学药学院,湖北武汉430065

出　　处：《中国医药工业杂志》2018年第4期485-490,共6页Chinese Journal of Pharmaceuticals

基　　金：国家"十二五"重大新药创制科技重大专项经费资助课题(2013ZX09J13109-05C)

摘　　要：采用中试级高效包衣机和正交试验方法,以包衣外观合格率作为评价指标,进行盐酸苯环壬酯渗透泵控释片半透膜包衣工艺优化。所得优化包衣工艺参数如下:喷液量13.0 ml/min;物料温度16℃;雾化压力0.035 MPa。测定了优化后盐酸苯环壬酯控释片的体外释放度,并采用扫描电镜观察合格片释放试验前后及不合格片半透膜的微观结构。结果表明,本工艺所得盐酸苯环壬酯控释片的半透膜包衣外观透亮、均匀;微观结构清晰、致密;体外释放度符合质量标准;可适用于盐酸苯环壬酯控释片半透膜包衣的中试级放大。The coating process of the semipermeable membrane of phencynonate hydrochloride controlled- release osmotic pump tablets prepared by pilot coating machine was optimized by orthogonal test with the quality of coating appearance as the assessment index. The optimal parameters were as follows： spray amount was 13.0 ml/min; material temperature was 16 -C; spray pressure was 0.035 MPa. The in vitro release behaviors of three batches of the optimal coating tablets of phencynonate hydrochloride were investigated. Moreover, the microstructure characteristics of the coating films of the optimal tablets before and after release as well as the unqualified tablets were observed by scanning electron microscopy （magnification ranging from 30× to 500×）. The results showed that the appearance of the semipermeable membrane of phencynonate hydrochloride controlled-release tablets was transparent, uniform and pyknotic, and in vitro release behavior met the quality standard. From the above, the parameters of this coating process were applicable to the pilot scale test of the semipermeable membrane coating of the phencynonate hydrochloridc controlled-release tablets, and this process had been proved to be stable, efficient and easy to control, regardless of the macroscopic appearance of the product or the microstructure characteristics of the product and the in vitro release of the product.

关 键 词：盐酸苯环壬酯 渗透泵控释片 包衣工艺 释放度 微观结构 

分 类 号：R944.4[医药卫生—药剂学]