摘要
目的评价多潘立酮片的产品质量。方法按国家评价性抽验计划总体要求,采用法定检验方法结合探索性研究对11个厂家的239批样品进行检验,分析检验结果 ,并评价多潘立酮片的质量现状。结果多潘立酮片检验合格率为100.00%;实时溶出曲线在4种不同溶出介质中存在明显差异,且各厂家产品的实时溶出度在批内、批与批之间的均匀度有差异;建立了用于快速鉴别的近红外一致性检验模型,可用于"一厂一品一规一模"的快速鉴别。结论该品种现行标准基本可行,质量控制较好,但存在产品均一性问题。建议对多潘立酮片深入开展体外生物利用度再评价,制订更加严格的溶出度试验,以提高其生产工艺水平。
Objective To evaluate the quality of Domperidone Tablets. Methods According to the general requirements of national evaluative selective acceptance test project,239 batches of samples from 11 manufacturers were detected by using statutory test methods combined with the exploratory research. The detection results were analyzed and the quality status quo of Domperidone Tablets was evaluated. Results The qualification rate of Domperidone Tablets was 100%; significant differences of the real- time dissolution curves of Domperidone Tablets were observed in 4 kinds of different dissolution medium,moreover the uniformity of the real time dissolution from the products by different manufacturers had the intra- batch and inter- batch differences; the near- infrared consistency test model was established for the rapid identification of ＂a factory a product and a regulation a model＂. Conclusion The existing standard of Domperidone Tablets is basically feasible with better quality control. But the product homogeneity problem exists. It is suggested that the in vitro bioavailability re- evaluation of Domperidone Tablet should be deeply carried out and the more strict dissolution test should be formulated for increasing the production technological level.
出处
《中国药业》
CAS
2015年第14期79-81,共3页
China Pharmaceuticals
关键词
多潘立酮片
评价性抽验
质量评价
Domperidone Tablets
evaluative selective acceptance test
quality evaluation
