炔诺酮片国际药典标准的制定

发布时间：2018-05-13 00:19

本文选题：炔诺酮片 + 国际药典　；参考：《中国药学杂志》2017年02期

【摘要】：目的制定炔诺酮片的国际药典质量标准。方法参照国内外已有的炔诺酮及炔诺酮片的质量标准和文献,按照国际药典标准的制定要求,选择合适的方法并进行验证。结果薄层鉴别系统适用性试验中炔诺酮和炔雌醇可有效分离;有关物质检测色谱条件可有效分离9种已知杂质和其他未知杂质,液质联用试验证明主峰相对保留时间1.1倍处的杂质为炔雌醇;炔诺酮片在含0.09%的SDS的0.1 mol·L~(-1)的盐酸中30 min均能溶出90%以上,溶出曲线达到平台;按照含量测定的色谱条件实验,炔诺酮在0.746~29.840μg·m L~(-1)内与峰面积呈良好线性关系(r=0.999 9),炔诺酮和炔雌醇的分离度大于4.0。结论制定的质量标准简便、准确,充分考虑了方法的可行性、试剂可及性,可有效控制产品质量。
[Abstract]:Objective to establish the quality standard of norethisterone tablets in international pharmacopoeia. Methods referring to the quality standards and literatures of norethisterone and norethisterone tablets at home and abroad, according to the requirements of international pharmacopoeia standards, the appropriate method was selected and verified. Results in the applicability test of TLC identification system, norethisterone and ethylestradiol could be effectively separated, and the chromatographic conditions for the detection of related substances could effectively separate 9 kinds of known impurities and other unknown impurities. The results of liquid-mass spectrometry showed that the impurity at 1.1 times the relative retention time of the main peak was ethylestradiol, and that norethisterone tablets could be dissolved more than 90% in 30 min of hydrochloric acid containing 0.09% SDS, and the dissolution curve reached a plateau. Norethisterone showed a good linear relationship with the peak area in the range of 0.746 ~ 29.840 渭 g / L ~ (-1). The separation of norethisterone and ethylestradiol was greater than 4.0. Conclusion the established quality standard is simple and accurate. The feasibility of the method and the reachability of the reagent are fully considered, and the quality of the product can be effectively controlled.
【作者单位】：湖北省食品药品监督检验研究院;
【分类号】：R927

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