[关键词]
[摘要]
目的 比较国产烟酰胺片在4种不同pH溶出介质中的溶出行为的差异,比较不同厂家药品的内在品质,为药品质量控制与仿制药质量一致性评价提供参考。方法 通过体外溶出度试验,测定3家企业生产的9批次烟酰胺片在4种不同pH溶出介质中的溶出度。结果 试验涉及到3家企业的9批样品,上海信谊委托上海黄河制药生产的3批样品在4种介质中的溶出行为差别不明显,且批间溶出行为差异较为一致;天津力生制药股份有限公司、广州康和药业有限公司生产的各3批样品,在4种溶出介质中的溶出行为有一定的差异;且批间溶出行为有较大差异;用新建立的溶出度检查法测定不同来源的73批样品,结果仍有19批样品溶出量低于75%。结论 目前国内该品种生产处方工艺差异较大,不同厂家、同一厂家不同批号样品溶出行为存在差异。生产企业应加强处方工艺的筛选、优化,提高改进生产工艺。建立的溶出度测定方法可作为药品内在质量控制的有效手段之一。
[Key word]
[Abstract]
Objective By comparing the difference of dissolution behavior of domestic nicotinamide tablets in four different pH dissolution media and comparing the intrinsic quality of different manufacturers'drugs,it provides a reference for drug quality control and generic drug quality consistency evaluation.Method The dissolution profiles of 9 batches of nicotinamide tablets produced from 3 pharmaceutical factories was determined in 4 different pH dissolution media by an in vitro dissolution test.Result The test involved 9 batches of samples from 3 companies.The dissolution behavior of the three batches of samples produced by Shanghai Huanghe entrusted by Shanghai Xinyi pharmaceutical factory was not obvious,and the difference in dissolution behavior between batches was consistent.The dissolution behaviors of the 3 batches of samples produced by Tianjin Lisheng pharmaceutical factory and Guangzhou Kanghe pharmaceutical factory were different in the 4 dissolution media;and the dissolution behavior between batches was quite different.When 73 batches of samples from different sources were determined using the newly established dissolution test,the results showed that there were still 19 batches of samples with a dissolution of less than 75%.Conclusion At present,there are significant differences in the processes for producing prescriptions of this medicine in China,which is reflected in the difference in dissolution rate of samples from different manufacturers or samples of different batches of the same manufacturer.Production enterprises should strengthen the screening and optimization of prescription processes and improve the production process.Establishing dissolution measurement method can be used as one of the effective means for internal quality control of drugs.
[中图分类号]
[基金项目]