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注射用广炎灵粉针剂成型工艺及质量标准的研究

Forming Technology and Quality Standard of Guang Yanling Power for Injection

【作者】 程淑云

【导师】 李永吉;

【作者基本信息】 黑龙江中医药大学 , 药剂学, 2007, 硕士

【摘要】 注射用广炎灵粉针是以木樨科丁香属植物紫丁香的干燥叶为原料,经提取精制而获得的有效部位,又经过科学方法冻干而制得的粉针剂。本文主要对广炎灵粉针冻干工艺进行了系统的研究。比较了不同种类的填充剂、不同浓度的填充剂、药液的不同浓度、液面厚度不同对冻干工艺的影响,以及在配液过程中pH值、活性炭、超滤等因素对有效成分的影响,制订了广炎灵粉针的冻干曲线,为注射用广炎灵粉针的工业化生产提供了参考。为了控制注射用广炎灵粉针的质量,确保临床用药的安全性与有效性,本课题对注射用广炎灵粉针的质量标准进行了初步研究,为制定注射用广炎灵粉针的质量标准提供了实验依据。

【Abstract】 Guang Yanling Powder for Injection is a broad-spectrum antiseptic one which is purified from the leaves of Oleacea Syringa plants syringa oblata Lindl.In this article, freezing-dry processing techniques have been systematically studied. So have the influence of different concentration of drug solution and additives, as well as different volumn of solution on freezing-dry processing techniques.In addition, in the progress of preparing drug solution ,the influence of some factors such as pH ,activated charcoal ,SF and running vapour sterilization on active principle have been studied .Meanwhile, the curve of lyophilization or freeze drying was formulated,this experiment made a foundation for the further large-scale production of Guang Yanling Powder for Injection.In order to control the quality and insure the security and efficiency of the Injection, we studied the quality standard, which will improve the quality control Guang Yanling Injection.

  • 【分类号】TQ461
  • 【被引频次】4
  • 【下载频次】305
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