• 评价技术与方法 • 下一篇
邵纯君
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摘要: 肌氨肽苷注射液的现行的质量标准中,按照次黄嘌呤含量测定的色谱条件实验,系统适用性很难达到标准要求,严重影响检验结果的准确性。本文为药品检验人员提供了三种操作方式以达到系统适用性的要求,供药品检验人员参考。并根据实验中出现的问题对现行标准提出了修改建议,以便更好地控制肌氨肽苷注射液的药品质量。
Abstract: When analyzing the hypoxanthine for Jiantaigan injection, it is quite difficult to make the system suitability to meet the requirement of Chinese Pharmacopoeia, if follows the chromatographic condition according to the current criterion completely. In which condition, the result of analysis is not accurate frequently. We provide three ways to solve the problem in order to assist the people who meet the same situation. What is more, we also offer some proposals about the criterion in order to preferably control the quality of Jiantaigan injection.
邵纯君. 关于肌氨肽苷注射液次黄嘌呤含量测定的讨论[J]. .
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http://www.zgywpj.cn/CN/Y2015/V32/I3/0