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目的:评价国产吲哚美辛栓的质量现状和问题。方法:按照2010年度国家评价性抽验计划,采用法定检验方法结合探索性研究进行样品检验。结果:本文采用英国药典32版和2005年版中国药典方法,通过专属性实验和各厂家样品杂质含量结果的比较,证实2005年中国药典方法更为简便,而2个主要杂质经质谱分析,证明为工艺杂质,来源于原料。采用美国药典32版溶出度方法检查样品的溶出情况,发现国内产品采用脂溶性基质,国外产品采用水溶性基质,两者溶出情况不一致。结论:目前吲哚美辛栓的产品质量能符合现行标准的要求;探索性研究提示可以以提高吲哚美辛原料质量的方式,提高制剂质量。
Objective: To evaluate the quality status and problems of domestic indometacin suppository. Methods: In accordance with the 2010 National Assessment of sampling plan, the use of statutory test methods combined with exploratory research sample test. Results: The comparison of the results of the proprietary experiments with the results of the impurity content of the samples from various manufacturers showed that the method of Chinese Pharmacopoeia 2005 was more simple and convenient, and the two major impurities were confirmed by mass spectrometry Process impurities, from raw materials. Using the United States Pharmacopoeia 32 dissolution method to check the dissolution of the sample, found that domestic products using fat-soluble matrix, foreign products using water-soluble matrix, dissolution of the two inconsistent. Conclusion: At present, the product quality of indometacin suppository meets the requirements of current standards. Exploratory studies suggest that the quality of the preparation can be improved by improving the quality of indomethacin raw materials.