摘要
目的:分析评价国产吲哚美辛胶囊和缓释胶囊有关物质情况及存在问题,为质量标准的提高、完善提供依据。方法:采用高效液相色谱(HPLC)法,对本次抽验的106批次吲哚美辛胶囊、34批次吲哚美辛缓释胶囊及吲哚美辛原料进行有关物质测定,通过ADMET性质预测软件预测各杂质毒性,结合统计分析结果对国产吲哚美辛胶囊、缓释胶囊有关物质结果进行分析评价。结果:建立了HPLC法测定吲哚美辛胶囊和缓释胶囊有关物质的方法,ADMET性质预测软件预测结果提示,吲哚美辛各杂质毒副作用较大,分析评价结果提示国产吲哚美辛胶囊和缓释胶囊现行标准的有关物质方法有待提高。结论:新建方法可以更好地分析测定吲哚美辛胶囊和缓释胶囊的有关物质项目。吲哚美辛胶囊和缓释胶囊有关物质的风险比较大,考虑本品的不良反应较多及各杂质的毒性预测结果,各生产企业应高度重视与产品质量密切相关的各个环节,确保产品质量的稳定,保障用药安全。
Objective:To analyze and evaluate the related substances and existing problems of domestic indomethacin capsules and sustained-release capsules,so as to provide basis for improving quality standards.Methods:The related substances of 106 batches of indomethacin capsules,34 batches of indomethacin sustainedrelease capsules and the raw material of indomethacin were determined by HPLC.The toxicity of impurities was predicted by ADMET property prediction software.The results of related substances in domestic indomethacin capsules and sustained-release capsules were analyzed and evaluated by statistical analysis.Results:An HPLC method for determination of the related substances in indomethacin capsules and sustained-release capsules was established.The ADMET software predicted the toxicity and side effects of various impurities of indomethacin.The analysis and evaluation results indicated that the current standard methods for detection of related substances in domestic indomethacin capsules and sustained-release capsules needed to be improved.Conclusion:The new method can better analyze and determine the related substances of indomethacin capsules and sustained-release capsules.The risk of related substances in indomethacin capsules and sustained-release capsules is relatively high.Considering the adverse reactions and toxicity prediction results of impurities,the manufacturers should attach great importance to all links closely related to product quality to ensure the stability of product quality and medication safety.
作者
黄春青
唐永强
黄翰林
曹桂红
王璐
许波
HUANG Chun-qing;TANG Yong-qiang;HUANG Han-lin;CAO Gui-hong;WANG Lu;XU Bo(Guizhou Institute for Food and Drug Control,Guiyang 550004,China;Sinopharm Group Tongjitang(Guizhou)Pharmaceutical Co.,Ltd.,Guiyang 550004,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2019年第18期2285-2290,共6页
Chinese Journal of New Drugs
