网站大量收购独家精品文档,联系QQ:2885784924

地西泮的质量研究-药物分析学专业论文.docx

  1. 1、本文档共105页,可阅读全部内容。
  2. 2、原创力文档(book118)网站文档一经付费(服务费),不意味着购买了该文档的版权,仅供个人/单位学习、研究之用,不得用于商业用途,未经授权,严禁复制、发行、汇编、翻译或者网络传播等,侵权必究。
  3. 3、本站所有内容均由合作方或网友上传,本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺!文档内容仅供研究参考,付费前请自行鉴别。如您付费,意味着您自己接受本站规则且自行承担风险,本站不退款、不进行额外附加服务;查看《如何避免下载的几个坑》。如果您已付费下载过本站文档,您可以点击 这里二次下载
  4. 4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等,请点击“版权申诉”(推荐),也可以打举报电话:400-050-0827(电话支持时间:9:00-18:30)。
查看更多
地西泮的质量研究-药物分析学专业论文

华中科技大学硕士学位论文 华 中 科 技 大 学 硕 士 学 位 论 文 PAGE 2 PAGE 2 Studies On Quality For Diazepam Candidate:Jiang Ying Supervisor:Jiang Ming Jiang Hong Abstract The paper systematically studied on quality for Diazepam and its preparations.The method for the test of related substances in diazepam was developed and validated.Structures of three related substances were determined.This paper also did a series of work in the key link of quality control of the solid and liquid preparations .The whole work provided reference for the reinforcement of the National Drug Standard,as well as for the quality-evaluation and the quality-control in the processing of diazepam. The paper consisted of three parts: First, study on the main methods for quality control of API(Active Pharmaceutical Ingredient),as well as the reference substances of the impurities.Established an RP-HPLC method for the analysis of related substances in diazepam.The validation result showed that this method was convenient,sensitive,and had a good specificity.Subsequently,we analyzed the crude products and decomposable compounds of diazepam by LC-MS,determined three related substances,prepared them by rational synthesis and determined their molecular structures by UV,IR,MS,NMR.Then,the purities of these related substances were calculated and the response factors were also determined for the selection of the quantative methods of these related substances. Second,study on the dissolution property of diazepam tablets. Developed a new method for dissolution test,carried out the tests in four mediums with different pH values,and evaluated the dissolution properties of the tablets produced by different factories by f2 factor. The results indicated that a small variation existed in the dissolution properties of these tablets,but also showed that the method in Ch.p could not reflect the dissolution differences.The study provided suggestion and reference for the dissolution method revision and evaluation for the dissolution of sol

您可能关注的文档

文档评论(0)

peili2018 + 关注
实名认证
内容提供者

该用户很懒,什么也没介绍

1亿VIP精品文档

相关文档