中文摘要在我国，仿制药占据着极大部分，是我国生产及使用药品的主体。提高仿制药质量以及疗效，提升我国制药行业的整体水平，改善药品企业良莠不齐、仿制药与原研在工艺处方上的差异，提高我国产药物的竞争力，最终造福于人民。77004

本课题，即是在一致性评价如火如荼的潮流之下，依国家食品药品管理总局的要求，开展的企业的一致性评价中的基础步骤。本次实验，需经过大量文献查阅和市场调研等，为实验操作本身找出理论依据。通过对国外的原研产品以及对国内已经批准上市的仿制制剂的溶出曲线的测定和对比性的研究，对企业的一致性评价工作奠定基础。经过实验数据的分析，可以作为指导或建议企业的处方工艺的改进与变更的基本依据。

盐酸赛庚啶，已被列入2018年底前需完成的一致性评价项目。目前，在国内上市销售的盐酸相关批准文号有24个之多，该药品的一致性评价是必须严格执行的，而且是紧急且繁重的。

本实验，通过对参比制剂溶出方法和溶出曲线测定方法的建立，用该方法研究参比制剂和上市的某厂家三个批次不同效期的仿制制剂在四个溶出介质中的溶出曲线，并将两者进行对比性的研究。建议在今后的实验中，对其方法学进行完整性的研究，验证该方法的准确及稳定可行性。最后，对于溶出曲线比较所得的结论，为厂家提出制剂工艺方面的改进和建议。

通过对比及f2和f1的计算发现，该厂家的多批次盐酸赛庚啶片，溶出度的批间差异不大，但与原研产品还存在少量的差异，效期内的批次溶出行为比较一致。

毕业论文关键词：溶出；仿制药；一致性评价；盐酸赛庚啶

二  英文摘要

Generic medicines are the subject of production and use of drugs in China, which occupy most of pharmaceutical market of our country 。Improving the quality and efficacy of generic drugs , promoting the overall level of China's pharmaceutical industry , improving the good and bad of pharmaceutical enterprises and differences between generic and original pharmaceutical formulations , improving the competitiveness of Chinese Medicine which brings benefit to our people finally 。

In accordance with the requirements of the State Food and Drug Administration , this topic is a basic step in the evaluation of corporate coherence under the current trend of consistent evaluation 。 This experiment needs a lot of literature review and market research to find the theoretical basis for the experimental operation itself 。The dissolution curves of foreign original products and the generic preparations approved in China have been determined and compared ,it lays a foundation for the consistency evaluation of enterprises 。 The analysis of experimental data can serve as a basis for guiding or suggesting improvements and changes in the formulation process of an enterprise 。

Pethidine hydrochloride has been included in the conformity assessment project to be completed by the end of 2018 。 At present, the number of relevant approval documents for the sale of hydrochloric acid in the domestic market is as large as 24 , and the evaluation of the consistency of the drug must be strictly enforced and urgent and burdensome。

In this experiment, based on the reference preparation method for dissolution and dissolution determination curve, using the method of different than a manufacturer and agents listed three batches of valid generic preparations in four dissolution medium, and the research of comparison。It is suggested that the integrity of methodology should be studied in future experiments to verify the accuracy and stability of the method。Finally, the conclusions of the dissolution curve were compared, and some suggestions were made for the improvement of the preparation process。