吲哚美辛栓质量分析

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 of domestic dosage form of indometacin suppositories. Methods: According to the general requirements of national assessment programs in 2010 use statutory testing methods and combine with the exploratory research to examine sample,evaluate the quality status of domestic dosage form of indometacin suppositories. Results: In this paper, we proved that the HPLC method of ChP is simple, by comparing the investigation of specificity and results of related substance between BP and ChP. We confirm that the two major impurities come from synthetic process of material. We find that domestic dosage form and import dosage form are different through the dissolution test of USA, because the domestic dosage form is fat-solubility suppository and the import dosage form is water-solubility suppository. Conclusions: At present the products quality of indometacin suppositories can meet the current standards. The exploratory research suggests that we can control the impurities of material to increase the quality of dosage.

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