克霉唑阴道片和克霉唑栓的质量评价  

Quality assessment of clotrimazole vaginal tablets and the suppositories

作　　者：梁亚伟 席志芳 张伊榕 王小亮 邓玉龙 牛龙青 李芯蕊 张秉华 Liang Yawei;Xi Zhifang;Zhang Yirong;Wang Xiaoliang;Deng Yulong;Niu Longqing;Li Xinrui;Zhang Binghua(Shaanxi Institute for Food and Drug Control,Xi'an 710065)

机构地区：[1]陕西省食品药品检验研究院,西安710065

出　　处：《中国抗生素杂志》2025年第3期328-335,共8页Chinese Journal of Antibiotics

基　　金：2024国家药品抽检资助国药监药管(No.[2024]1号)。

摘　　要：目的评价国内克霉唑阴道片和克霉唑栓的整体质量现状。方法采用法定标准检验结合探索性研究,通过对产品的有关物质、体外释放度、残留溶剂、含量均匀度、头尾药物浓度分布及辅助给药工具中环氧乙烷残留量等关键质量属性的考察,综合评价其产品质量及现行质量标准对其质量的可控性。结果按法定标准检验,187批次样品合格率为100.0%。探索性研究结果表明,产品的主要问题为38%的克霉唑阴道片企业和71%的克霉唑栓企业的产品的体外释放度较低;克霉唑栓头部尾部的药物浓度比值的分布为0.89~1.21,差异显著。此外,法定标准在杂质控制方面存在不足;含量测定中平行测定结果误差偏大。结论国内上市的克霉唑阴道片和克霉唑栓总体质量一般;现行质量标准需进一步统一和提高,建议完善有关物质检测方法,增加克霉唑栓含量均匀度检查,并以其均值替代含量测定结果;建议各企业开展体外释放度试验,优化处方及工艺。Objective To evaluate the quality of clotrimazole vaginal tablets and the suppositories in China.Methods The quality of clotrimazole vaginal tablets and the suppositories was assessed,along with their current specifications,in accordance with the legal standard determination and exploratory study.This involved investigating into related substances,release characteristics in vitro,residual solvents,content uniformity,drug concentration distribution between head and tail,and ethylene oxide residue in auxiliary drug delivery tools.Results The qualified rate of 187 batches of samples was 100.0%according to the statutory quality specifications.The results of exploratory study indicated that the main problem of the products,which were of 38%of the clotrimazole vaginal tablets and 71%of the clotrimazole suppositories,were low in vitro release rate.The concentration ratio distribution of clotrimazole suppositories in the head and tail ranges from 0.89 to 1.21,and the difference is significant.In addition,the legal standards had some deficiencies in impurity control,in the content determination,the error of parallel determination is too large.Conclusion The quality of clotrimazole vaginal tablets and the suppositories in China was ordinary.The current specifications should be further unified and improved.It is suggested to improve the detection methods of relate substances.The uniformity test of clotrimazole suppository was increased,and its mean was substituted for the result of content.It is recommended that all enterprises should carry out release characteristics in vitro,optimize prescription and production process.

关 键 词：克霉唑阴道片 克霉唑栓 质量评价 有关物质 体外释放度试验 

分 类 号：R917[医药卫生—药物分析学]