菌克软膏质控标准的研究  

Study on quality control of Junke cream

作　　者：瞿发林[1] 陆健[1] 章杰兵[2] 

机构地区：[1]解放军第102医院,江苏常州213003 [2]南京军区联勤部药品检验所,江苏南京210003

出　　处：《中国现代应用药学》2005年第6期505-506,共2页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的制定菌克软膏的质量控制标准.方法定性及定量均采用高效液相色谱法,HYPERSIL-CN色谱柱(5μm,4.6mm×200mm),流动相0.05 mol·L-1硼砂溶液(用磷酸调节pH至6.0)-甲醇(85:15),流速1.0 mL·min-1;检测波长214nm;进样量10μL.结果盐酸林可霉素和硝酸咪康唑的峰能完全分开且样品中其他成分对鉴别和测定没有干扰.盐酸林可霉素在0.4～3.2 mg·mL-1内均呈良好的线性关系,r=0.999 9(n=6),硝酸咪康唑在0.4～2.4 mg·mL-1内呈良好的线性关系,r=0.9998(n=5).盐酸林可霉素的平均回收率为101.23%,RSD为0.93%,硝酸咪康唑的平均回收率为99.82%,RSD为0.57%.结论方法简便,结果稳定可靠,可用于菌克软膏的质量控制.OBJECTIVE To study quality control of Junke cream. METHODS An HPLC method with chromatographic conditions including HYPERSIL-CN column （5 0μm ,4.6mm × 200mm） and the mobile phase consisted of 0.05 mol·L^ -1 lsodium borste （ adjust with phosphoric acid to a pH of 6.0）-methanol（ 85：15 ） was used. The detection wavelength was 214 nm, the flow rate was 1.0mL·min^-1 , the injection volume was 10μL. RESULTS The peaks of lincomycin hydrochloride and miconazole nitrate could be separated completely and the assay could avoid being influenced by other peaks. Lincomycin hydrochloride had a good linearity（ r =0. 9999） in the range of 0.4～3.2 mg ·mL^- 1, its average recovery was 101.2% （ RSD = 0.93%, n = 5 ）. Minconazole nitrate had a good line- arity （ r = 0.9993 ） in the range of 0.4～1.6 mg· mL^- 1, its average recovery was 99.8% （ RSD = 0.57%, n = 5 ）. CONCLUTION The method is simple, sensitive and reliable, which can be applied to quality control of Junke cream.

关 键 词：高效液相色谱法 菌克软膏 盐酸林可霉素 硝酸咪康唑 

分 类 号：R926.23[医药卫生—药学]