氯甲硫洗剂质量控制的制定  

Formulation of Quality Control of Lvjialiu Lotion

作　　者：区杰彬[1] 余晓霞[1] 刘春霞[1] 

机构地区：[1]中山大学孙逸仙纪念医院药学部,广州510120

出　　处：《海峡药学》2014年第10期66-69,共4页Strait Pharmaceutical Journal

摘　　要：目的建立氯甲硫洗剂的质量控制方法。方法参照《中国药典》2010年版相关鉴别方法对氯甲硫洗剂中主要成分进行鉴别，采用紫外．分光光度法测定甲硝唑的含量。结果氯甲硫洗剂中的主要成分升华硫、甲硝唑、氯霉素的鉴别反应均呈阳性。甲硝唑含量测定线性范围为4．52-22．60μg·mL～，回归方程为Y：0．0480x-0．0052（r=O．9996），平均加样回收率为100．0％，RSD=0．80％（n=9）。结论 该方法简单、灵敏，准确度高，可用于氯甲硫洗剂的质量控制。OBJECTIVE To establish a method for quality control of lvjialiu lotion. METHODS The main components were identified according to the methods in Chinese Pharmacopoeia 2010. The concentration of metron- idazole was detected by UV-visible spectrophotometry. RESULTS The identification reactions were positive of all main components Determination of metronidazole yielded a linear range of 4. 520 -22. 600μg · mL-1. The regression equation of y = 0. 0480x - 0. 0052 （ r = 0. 9996）, with the average recovery of 100. 03 % and RSD of 0. 802% （ n = 9 ） · CONCLUSION The identify and determination methods are convenient, sensitive and accurate, and can be used for the quality control of lvjialiu lotion.

关 键 词：氯甲硫洗剂 升华硫 甲硝唑 氯霉素 质量控制 

分 类 号：R969.4[医药卫生—药理学] R282.71[医药卫生—药学]