卡培他滨片的处方研究

论文总字数：18655字

摘 要

本文通过查阅了卡培他滨相关的文献资料，进行了大量的处方前基础性研究实验，对于原料药性质做了引湿性和流动性实验，采用了溶出度对比与有关物质测定等验证方法，为进一步来的处方和工艺研究做了前期的基础性准备。

在制备的过程中，参考原研产品的基础上，结合处方前原料药性质的考察，主药以流动性和溶出为指标，对不同的辅料用量进行筛选，确定初步处方。以市售同种制剂希罗达为参比制剂，以2010版中国药典本品的质量标准为验证依据，对自制和参比制剂进行了质量对比研究，并从片剂的外观、性状、溶出度、有关物质等项目与市售希罗达参比制剂进行了比较研究，结果表明并无明显差异，溶出行为相似。有关物质的也与希罗达杂质图谱基本一致。

关键词：卡培他滨；处方筛选；溶出曲线；有关物质

Abstract

In this paper, a review of the capecitabine-related literature, a great deal of basic research experiments before prescribing, for bulk drugs do hygroscopic nature and liquidity test, using a dissolution contrast and related substances determination and so authentication methods, for prescription and technology research further to make a fundamental pre-preparation.

 In the process of preparation, reference is based on the original research products, combined with study of prescription drugs before the raw nature, the main drug in liquidity and dissolution as an indicator of the amount of different materials were screened to determine the initial prescription. Xeloda same kinds of preparations marketed as the reference formulation, quality standards Chinese Pharmacopoeia 2010 for the verification of the product based on preparations made and the reference quality comparative studies and from the tablet"s appearance, character, dissolution degree, and commercial projects related substances Xeloda reference preparation were compared, the results show no significant difference in dissolution behavior similar. It is basically the same impurity related substance with Xeloda map.

Keywords: capecitabine; prescription screening; dissolution curve; related substances

目录

摘要.........................................................................I

Abstract....................................................................II

第一章　引　　言.............................................................1

　　1.1 本课题的研究背景与意义...............................................1

1.2 卡培他滨片的基本情况.................................................1

1. 　正　　文.............................................................3

　　2.1 处方初步开发.........................................................3

　　　2.1.1 参比制剂产品信息.................................................3

　　　　2.1.1.1 参比制剂的处方信息...........................................3

　　　　2.1.1.2 用于质量特征研究的参比制剂...................................3

　　　2.1.2处方筛选过程研究.................................................4

　　　　2.1.2.1 卡培他滨原料药引湿性的研究...................................4

　　　　2.1.2.2 制备工艺选择依据—卡培他滨原料药流动性的研究.................5

　　2.1.2.3 辅料种类选择依据—原辅料相容性实验...........................5

　　　　2.1.2.4 辅料用量选择依据.............................................9

　　2.2 处方和工艺确定......................................................13

　　　2.2.1 处方组成.......................................................13

　　　2.2.2 制备工艺.......................................................13

　　2.3制剂相关特性.........................................................14

　　　2.3.1 自制样品与参照药品不同溶出介质中的溶出行为对比. .................14

　　　2.3.2 自制样品与参照药品有关物质比较. .................................26

1. 　结　　语............................................................29　

　　3.1 小结与讨论..........................................................29

　　3.2 不足与展望..........................................................29

致谢........................................................................30

参考文献....................................................................31

附录........................................................................32

1. 引言

1.1 本课题的研究背景与意义

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