摘要
目的:建立流池法测定氨糖美辛肠溶片的溶出度检查方法,并考察不同企业产品溶出行为,为科学评价药品质量提供参考。方法:采用流通池的开环系统,流速为8 mL·min^(-1),经0.1 mol·L^(-1)盐酸溶液中释放2 h后,再在pH6.8磷酸盐缓冲液中释放2 h,对7家生产企业市售的氨糖美辛肠溶片进行体外溶出试验,在规定时间点取样后采用HPLC法测定氨糖美辛肠溶片中吲哚美辛的溶出量。以Weibull方程拟合溶出曲线,并提取溶出参数进行统计分析,评价体外溶出行为。结果:7家生产企业的氨糖美辛肠溶片体外溶出曲线的部分溶出参数有统计学差异,部分生产企业的氨糖美辛肠溶片溶出均一性较差。结论:该方法可为氨糖美辛肠溶片的质量一致性评价提供参考。
Objective:To establish a flow-through cell method for the dissolution test of Glucosamine Indomethacin Entric-coated Tablets(GIETs),and compare the in vitro dissolution behavior of products from different manufacturers,in order to provide reference for the evaluation of quality consistency.Methods:The dissolution profiles of seven manufacturers were determined using the open loop system with flow-through cell and the flow rate was 8 mL·min^(-1).After being released for 2 hours in 0.1 mol·L^(-1)hydrochloric acid solution,the dissolution medium was changed to pH6.8 phosphate buffer solution for another 2 hours.The dissolution amount of indomethacin at prescribed time points was determined by HPLC.The release rate curve in vitro was fitted by Weibull function and dissolution parameters were extracted for statistical analysis to evaluate the differences in dissolution behavior in vitro.Results:Statistically significant differences in parts of dissolution parameters were observed among the dissolution curve of GIETs from senen manufacturers.The quality homogeneity of partial preparation were poor.Conclusion:This method can provide reference for quality consistency evaluation of GIETs.
作者
甘加明
邹瑜
黄丹
陈冬华
严全鸿
GAN Jia-ming;ZOU Yu;HUANG Dan;CHEN Dong-hua;YAN Quan-hong(Guangdong Institute for Drug Control,NMPA Key Laboratory for Rapid Testing Technology of Drugs,Guangdong Guangzhou 510663,China)
出处
《中国药物评价》
2023年第6期480-484,共5页
Chinese Journal of Drug Evaluation
基金
广东省医学科学技术研究基金项目(课题名称:流通池法在肠溶制剂体外溶出中的应用,项目编号:B202298)
广东省医学科学技术研究基金项目(课题名称:流通池法在复杂口服缓释制剂中体外释放评价的应用研究,项目编号:B2023313)。
关键词
氨糖美辛肠溶片
流池法
溶出曲线
Weibull方程
Glucosamine Indomethacin Entric-coated tablets
Flow-through cell method
Dissolution curve
Weibull equation
