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我国胰岛素质量标准及其制剂的发展进程 被引量:2

Development Process of Quality Standards and Preparations of Insulin in China
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摘要 目的为提高我国胰岛素质量标准提供参考。方法概括了我国胰岛素发展状况;依据《中国药典》1953年版~2010年版,对我国胰岛素质量标准及其制剂的发展进程进行综述,并指出存在的问题。结果与结论从《中国药典》1953年版收载胰岛素至今,我国胰岛素质量不断提高,标准不断完善,我国第三代胰岛素正快速发展,逐步缩短与国外差距,但目前《中国药典》收载的胰岛素品种和制剂还很少,《中国药典》2015年版将面临新的挑战。 Objective To provide a reference for improving the insulin quality standard in China. Methods The development of insulin in China was summarized. And by referring to Chinese Pharmacopoeia of 1953-2010 versions, the development process of insulin quality standards and its preparations was reviewed. The problems concerning this issue were also discussed. Results and Conclusion Insulin quality has been improved and its standards have been perfected in China since Chinese Pharmacopoeia (1953 version) embodied insulin. At present, the third generation of insulin is developing rapidly in China, and the gap with foreign countries is gradually shortened. However, the current Chinese Pharmacopoeia has not contained all insulin varieties and preparations yet. In this view, the Chinese Pharmacopoeia of 2015 edition will face new challenges.
作者 王亚敏
出处 《中国药事》 CAS 2012年第9期1006-1010,共5页 Chinese Pharmaceutical Affairs
关键词 胰岛素 制剂 质量标准 中国药典 insulin preparation quality standards Chinese Pharmacopoeia
作者简介 王亚敏,Email:wangyamin27@yahoo.cn
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