复方咪康唑洗剂长期稳定性考察  

Long-term stability of compound miconazole lotion

作　　者：林丽 曾维国 李添朋 何隽灵 李嘉良 莫国栋 LIN Li;ZENG Wei-guo;LI Tian-peng(Zhongshan Second People's Hospital,Zhongshan 528447,China)

机构地区：[1]广东省中山市第二人民医院,528447

出　　处：《中国实用医药》2025年第5期177-180,共4页China Practical Medicine

基　　金：2023年度中山市医学科研项目(项目编号:20231A020084)。

摘　　要：目的考察复方咪康唑洗剂的长期稳定性。方法采用高效液相色谱法(HPLC)测定制剂中硝酸咪康唑的含量并考察长期稳定性中制剂在室温避光条件下贮存,以制剂的性状、含量、pH值,再分散性、微生物限度为评价指标,于第0、3、6、9、12个月末取样测定。结果硝酸咪康唑在0~2.0189 mg/ml浓度范围内与峰面积(RSD)呈良好的线性关系(r=0.9996);平均回收率为98.64%,RSD=0.64%(n=9)。三批制剂的含量分别为98.6%、99.3%、98.9%。长期稳定性考察,三批留样制剂在室温贮存条件下性状、含量、pH值,再分散性、微生物限度均未发生明显变化。结论硝酸咪康唑洗剂的HPLC含量测定方法准确性、重复性好,适用于该制剂的含量测定。在规定贮存条件下制剂各指标的稳定性良好,可拟定有效期为1年。Objective To investigate the long-term stablility of compound miconazole lotion.Methods The content of miconazole nitrate in the preparation was determined by high performance liquid chromatography(HPLC)and the long-term stability of the preparation was investigated.Samples were kept in cool dry place away from direct sunlight at room tepretature.The properties,content,pH value,re-dispersability and microbial limit of the preparation were taken as evaluation indexes and determined at the end of the 0th,3rd,6th,9th,and 12th month.Results Miconazole nitrate showed good linearity(r=0.9996)with relative standard derivation(RSD)over the concentration range of 0-2.0189 mg/ml;the average recovery was 98.64%with RSD=0.64%(n=9).The contents of the three batches of preparations were 98.6%,99.3%and 98.9%,respectively.According to the observation on long-term stability,no signification change was found in properties,content,pH value,re-dispersibility and microbial limit test of three batches of preparations.Conclusion HPLC method for the determination of miconazole nitrate lotion is accurate,reproducible and suitable for the determination of the content of this preparation.The preparation is stable for at least one year under regulated storage conditions.

关 键 词：高效液相色谱法 硝酸咪康唑 含量测定 长期稳定性 

分 类 号：R28[医药卫生—中药学]