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本文在综述他汀类药物（一类对羟甲戊二酰辅酶A还原酶抑制剂）的药理作用和临床应用，以及其中一个重要成员洛伐他汀的药理研究进展、生产现状等的基础上，认为洛伐他汀的市场需求量还很大，甚至前景将更好。 但技术发展使社会对医药产品质量要求越来越高，美国药典要求洛伐他汀产品中杂质总含量不超过1.0%，单杂质含量不超过0.2%，除非能有充分的药理数据证明杂质成分的药理作用与主成分一致，而且不具有其他的毒理作用。我国是洛伐他汀原料药的主要生产国，为了适应各国药典对洛伐他汀药品的新要求，有必要对洛伐他汀产品中的杂质进行深入研究。首先得到单体化合物，鉴定它们的结构，明确它们的性质，然后阐明这些杂质成分是在生产的哪一环节产生的，如何减少它们的产生，在纯化过程中如何除去它们；同时累积足够的杂质单体化合物，进行药理和毒理研究。 本文的主要研究内容就是对洛伐他汀发酵产物的杂质成分进行了分离纯化，并鉴定它们的结构。本文以洛伐他汀提取纯化最后步骤的结晶母液为原料，反复应用硅胶柱色谱、硅胶制备TLC、反相硅胶柱色谱、半制备HPLC等方法，从中分离得到6个杂质单体化合物；综合运用波谱学方法，如FT-IR、1H-NMR、13C-NMR、1H-1H COSY、HSQC、HMBC和MS等，鉴定了它们的结构。这些化合物分别是： |
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蓝天306(金币+1, 翻译EPI+1): 呵呵，帮忙翻译下？ 2011-04-07 11:23:00
ringzhu(翻译EPI-1): …… 2011-04-07 11:24:01
ringzhu(翻译EPI-1): …… 2011-04-07 11:24:01
哇！~好诱人啊！~ |
2楼2011-04-07 11:15:58
3楼2011-04-07 11:24:49
5楼2011-04-07 11:54:27
福！ 6楼2011-04-07 12:07:46
7楼2011-04-07 12:08:30
8楼2011-04-07 12:30:11
9楼2011-04-07 12:31:36
10楼2011-04-07 12:32:38
蓝天306(金币+149, 翻译EPI+1): 非常感谢！！！！ 2011-04-07 12:56:19
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This article is a review on the pharmacological effects and clinical applications of statins (reductase inhibitors of hydroxymethyl coenzyme A ). based on the pharmacology and production status of lovastatin-one of the important member of statins, there is a great market demand, and even better prospects. The development of technology put a higher standard on the pharmaceutical products. USP has the requirement that unless there are enough evidences to prove that the impurity has the same pharmacological effects as the principal component, and still the impurity has no toxicological effects, the total content of impurities in the product should be less than 1.0%. Single impurity content should be less than 0.2%. China is the major producer of raw materials of lovastatin. In order to meet the new national pharmacopoeia requirements of lovastatin, there is a need to conduct in-depth study of impurities in lovastatin. First of all, compounds are obtained and their structures should be identified, and their properties are studied. And then make clear in reaction steps these impurities are generated. Another problem is how to reduce the production of the impurities,and how to remove them. At the same time, get enough monomer impurity in the compounds to conduct pharmacological and toxicological studies. The main idea of this paper is purification of the impurity in the fermentation products of lovastatin and identification of their structure. In this study the raw materials is the crystal liquor of lovastatin in the final step of extraction and purification. And then take measures like silica gel column chromatography, silica gel prepared by TLC, RP-silica gel column chromatography, semi-preparative HPLC and other methods to get 6 isolated compounds. And Comprehensive usage of spectrum study methods, such as FT-IR, 1H-NMR, 13C-NMR, 1H-1H COSY, HSQC, HMBC and MS can be taken to identify their structures. These compounds are: [ Last edited by ringzhu on 2011-4-7 at 12:49 ] |
11楼2011-04-07 12:41:05
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Mally894楼
2011-04-07 11:28
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