甲砜霉素肠溶片释放离散性的影响因素分析  

Analysis of the Influencing Factors in the Release Variance of Thiamphenicol Enteric-coated Tablets

作　　者：朱富根 Zhu Fugen(Guangdong P.D. Pharmaceutical Co. Ltd. ,Guangdong Kaiping 529331 ,China)

机构地区：[1]广东彼迪药业有限公司,广东开平529331

出　　处：《中国药师》2019年第5期939-942,共4页China Pharmacist

摘　　要：目的:凭借回顾性验证信息,分析在线控制的工艺参数的合理性,探讨甲砜霉素肠溶片体外释放度的影响因素。方法:对不同时期及不同工艺控制条件下所生产的中间产品或最终产品进行释放度的检查,并绘制释放曲线,找出影响释放离散性的工艺因素。结果:依照现行的生产工艺组织生产,制粒阶段对释放度影响相对较小,但片芯进行肠溶薄膜包衣时的工艺参数能大大影响成品的释放曲线。结论:完善薄膜包衣工艺,补充关键工艺参数,可以减小批内与批间产品释放性能的差异,使释放曲线趋于一致。对成品质量有重要影响的工艺参数应当通过控制措施来解决。Objective:To study the influencing factors in the drug release of thiamphenicol enteric-coated tablets in vitro by using retrospective validation information and analyze the rationality of the parameters in the process control.Methods:The drug release of the intermediate or finished product produced under conditions with different time and different process control was tested,and the release profile was drawn to find how the process factors affecting the release variance.Results:According to the current manufacturing process,the granulation stage had little influence on the release of thiamphenicol enteric-coated tablets,while the release amount of drug in the finished product could be greatly affected by the parameters of film-coating process for the tablet core.Conclusion:Optimizing the film-coating process and supplementing the key process parameters,the differences in the release performance within-batch and batch-to-batch can be reduced,and the release profile tends to be consistent.Those process parameters important to the final product quality should be addressed by the control strategy.

关 键 词：甲砜霉素肠溶片 片剂 制剂工艺 药物释放度 

分 类 号：R944.4[医药卫生—药剂学]