氯新酮乳膏质量标准的研究  

Study on the Quality Control Standard of Lvxintong

作　　者：刘彬果 王晓丽 叶盛英 Rugao LIU Binguo;WANG Xiaoli;YE Shengying(No.983 Hospital,the Joint Service Support Force of PLA,Tianjin 300142,China)

机构地区：[1]解放军联勤保障部队第九八三医院,天津300142

出　　处：《药学实践与服务》2023年第8期496-500,共5页Journal of Pharmaceutical Practice and Service

摘　　要：目的建立氯新酮乳膏的质量控制方法。方法采用TLC法对氯新酮乳膏中的新霉素、酮康唑和哈西奈德进行定性鉴别;采用HPLC法对氯新酮乳膏中的酮康唑和哈西奈德进行含量测定;色谱条件为:ZORBAX SB-C18(4.6 mm×150 mm,5μm)色谱柱;以甲醇-磷酸盐缓冲液(pH=7.40)75∶25为流动相,检测波长235 nm,流速1.0 ml/min;采用旋光法对氯新酮乳膏中的硫酸新霉素进行含量测定。结果鉴别和含量测定方法均有较好的专属性。酮康唑在1.999~39.98μg的范围内呈良好的线性关系(r=0.9999),平均回收率为97.75%,RSD为0.77%;哈西奈德在0.4008~8.016μg范围内呈良好的线性关系,平均回收率为97.57%,RSD为0.84%。硫酸新霉素的含量测定中,线性范围为130.4~2608单位/ml,r=0.9996(n=6),平均回收率为98.8%,RSD为2.6%。结论该法可用于氯新酮乳膏的质量控制。Objective To establish a quality control method for Lvxintong Rugao.Methods Ketoconazole,Halcinonide and Neomycin sulfate were identified by TLC.The content of Ketoconazole and Halcinonide were determined by HPLC.The chromatographic column of Agilent ZORBAX SB-C18(4.6 mm×150 mm,5μm)column was used.Methanol-phosphate buffer(pH=7.40,75:25)was applied as the mobile phase.The detection wavelength was 235 nm.The flow rate was 1.0 ml/min and the column temperature was set at room temperature.Neomycin Sulfate was determined by polarimetric analysis.Results The identification and determination methods showed good specificity.Ketoconazole and Halcinonide displayed good linearity within the range of 1.999~39.98μg(r=0.9999)and 0.4008~8.016μg(r=0.9999),respectively.The average recoveries were 97.75%(RSD 0.77%)and 97.57%(RSD 0.84%),respectively.For the determination of Neomycin Sulfate,r=0.9996(n=6)in the range of 130.4~2608 U/ml(n=6).The precision and repeatability of RSD were 1.1%and 1.6%,respectively.The solutions were stable in 6 h and the average recovery was 98.8%(RSD 2.6%).Conclusion The method could be used as the quality control method for Lvxintong Rugao.

关 键 词：氯新酮乳膏 酮康唑 硫酸新霉素 高效液相色谱法 旋光法 

分 类 号：R927.2[医药卫生—药学]