摘要
目的采用视频跟踪技术考察酒石酸美托洛尔片的溶出行为,为仿制药的质量评价提供新的技术参考。方法以酒石酸美托洛尔片为模型药物,pH1.2的氯化钠盐酸溶液为溶出介质,采用摄像头视频跟踪直观考察溶出行为;同时测定酒石酸美托洛尔片的溶出曲线并计算相似因子(f_(2)),并对处方组成、比例及其制剂工艺进行剖析。结果各时间点的视频图显示各企业样品均为溶蚀性崩解,与原研一致;企业A的样品与原研溶出行为最为接近,B、G和J的25 mg规格样品以及企业E、I和J的50 mg规格样品与原研溶出行为存在较大的差异,与溶出曲线获得的结果一致。溶出视频记录的溶散速率和崩解的颗粒大小、形态更直观反映出处方工艺的差异。结论视频跟踪技术清晰客观地反映了酒石酸美托洛尔片的溶出行为,为溶出质量评价提供新思路新方法。
Objective The video tracking technology was used in investigating the dissolution behavior of metoprolol tartrate tablets in order to provide a new technical reference for the quality evaluation of generic drugs.Methods With metoprolol tartrate tablets as model drug and pH 1.2 sodium chloride hydrochloric acid solution as dissolution medium,the dissolution behavior was directly investigated by camera video tracking.At the same time,the dissolution curve of metoprolol tartrate tablets was determined and the similarity factor(f_(2))was calculated.At last,the composition,proportion and preparation procedureof metoprolol tartrate tablets were analyzed.Results The video images at each time point showed that the tablets of each enterprise were eroding disintegrated.The dissolution behaviors of samples with 25 mg specifications from Company B,G and J and with 50 mg specifications from Company E,I and J were not similar to that of the reference preparations,which was consistent with the results obtained from the dissolution curve.The disintegrating rate and the size and shape of disintegrated particles recorded in the dissolving video reflect the difference of prescription process more directly.Conclusion The video tracking technology clearly and objectively reflected the dissolution behavior of metoprolol tartrate tablets,and provided a new idea and method for the quality evaluation of dissolution.
作者
李耕
严菲
曹玲
夏颖
陈民辉
LI Geng;YAN Fei;CAO Ling(Jiangsu Institute for Food and Drug Control,Nanjing 210019,China)
出处
《中国处方药》
2022年第2期21-23,共3页
Journal of China Prescription Drug
基金
药品监管科学科研计划(202022)。
关键词
酒石酸美托洛尔片
溶出视频
溶出曲线
相似因子
处方工艺
一致性评价
Metoprolol tartrate tablets
Video of dissolution
Dissolution curve
Similarity factor
Prescription process
Consistency evaluation
