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摘要：该实验是在标准操作规程的指导下对化合物A的HPLC分析方法进行全面验证以用于混悬液制剂中化合物A的浓度测定，对混悬型化合物A制剂（制剂浓度范围：0.2 mg/mL 到200 mg/mL）的均一性和稳定性进行评价，以支持临床前药物安全性评价工作，所有适用的实验参数和相关联的验收标准是按照美国FDA及全球GLP规范预先定义的。在我们国家甚至与全世界范围内，所有的新药在上市之前,所必须进行的新药审批一定要经过非临床与临床研究,而这其中其安全性评价又是重中之重。新药的非临床安全性研究的最终目的就是为了降低临床研究安全性方面的风险性,只有当GLP标准表明该药有充分的安全性和有效性[1],才可以进入到临床研究阶段。由于我国医药行业存在诸多问题,多数新药临床前安全性评价不符合GLP标准,不得上市造福人类,药企也面临着无法生存的难题。因此,必须坚持和落实科学发展观,确保新药安全性评价以及GLP的有效实施。本实验就是在严格的，符合全世界最高的实验室规范标准下所进行的小分子制剂分析。本实验最终结果为：成功完成化合物A的HPLC分析方法全面验证及其混悬型制剂均一性和稳定性的评价。23269
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毕业论文关键词：高效液相色谱法；制剂分析；均一性；稳定性；药物安全性评价；GLP
HPLC analytical method validation and preparation of compound A homogeneity and stability assessment
Abstract:This test under the direction of the HPLC analysis of compound A complete validation of a suspension formulation for use in measuring the concentration of compound A with SOP, compound A of the suspension type formulation (Formulation concentration range: 0.2 mg / mL to 200 mg / mL) of homogeneity and stability were evaluated to support preclinical safety evaluation of drugs,
All applicable experimental parameters and associated acceptance criteria are pre-defined with FDA and global GLP formulation analysis method. Now,in order to value the lives,new drugs must pass those two stages,which are non-clinical and clinical studies be-fore they are put on the market.The most important one is the safety study.The ultimate goal of the non-clinical drug safety study is to reduce the risks of testing the new drugs in the clinical study.And only if the GlP standards show the efficiency and safety of the dugs can they finally be allowed to use in the clinical studies.There are still many problems in China’s pharmaceutical industry,and most of the pre-clinical drug safety evaluation is not up to the GLP standard.Thus,these new drugs can not benefit mankind,and the marketing of them will also cause the problems in the pharmaceutical enterprises.Therefore,we must implement the scientific concept of develop-ment to ensure the safety evaluation of new drugs,as well as the effective enforcement of the GLP. The experiment was strictly in line with the highest standards worldwide under laboratory practice conducted the analysis of small molecules preparations .Finally, experimental results show that: HPLC analysis of compound A successful completion of a comprehensive evaluation and validation, and stability of the suspension type formulation uniformity.
Key words: HPLC，Formulation Analysis，homogeneity and stability，drug safety evaluation，glp
1.目录
化合物A的HPLC分析方法验证及其制剂均一性和稳定性评价 1
HPLC analytical method validation and preparation of compound A homogeneity and stability assessment 2
2.绪论 5
2.1实验目的 6
2.2实验意义 7
2.3高效液相色谱法法简介 7
2.31 高效液相色谱法在药物分析中的应用 8
2.32 高效液相色谱法应用于药物分析中的发展趋势 9
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