克痒舒洗液质量标准的研究  

Improvement of Quality Standard of Keyangshu Lotion

作　　者：刘志宏[1] 宋华硕 陈旭[1] 李蔚[2] 吴新安[2] 宋洪涛[1] 

机构地区：[1]南京军区福州总医院药学科,福建福州350025 [2]解放军105医院药剂科,安徽合肥230031

出　　处：《解放军药学学报》2016年第3期263-265,268,共4页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：军队医疗机构制剂标准提高科研专项课题重点项目;No.14ZJZ17

摘　　要：目的提高克痒舒洗液的质量标准。方法采用HPLC法测定制剂中苦参碱、氧化苦参碱及度米芬的含量。结果苦参碱、氧化苦参碱、度米芬在36.5~365.0μg·ml^(-1)(r=0.9998)、31.5~315.0μg·ml^(-1)(r=0.9997)、0.112~1.12mg·ml^(-1)范围内线性关系良好,平均加样回收率分别为99.0%、98.6%、100.6%,RSD分别为1.39%、1.94%、1.81%(n=6)。结论本研究建立的方法结果准确,稳定性好,专属性强,提高后的质量标准可用于克痒舒洗液的质量控制。Objective To improve the quality standard of Keyangshu lotion. Methods The contents of matrine, oxymatrine and domiphen bromide were determined by HPLC. Results The spots in the ehromatogram ob- tained with the test solution corresponded in position and colour to those obtained with the reference drug solution and the reference solution in the TLC test. Matrine and oxymatrine showed a good linear relationship within the range of 36.5 -365.0 μg .ml-1 （ r =0. 9998） ,and 31.5 - 315.0 μg .ml-1 （ r =0. 9997） respecctively,with an average recovery of 99.0% （ RSD = 1.39%, n = 6） ,98.6% （RSD = 1.94%, n = 6）. Domiphen bromide showed a good linear relationship within the range of 0.112 - 1.12 mg .ml-1（ r = 0. 9999）, with an average recovery of 100.6% （RSD = 1.81%, n =6）. Conclusion This method is simple,accurate and stable in results with good spe- cificity. The improved quality standard is applicable to quality control of Keyangshu lotion.

关 键 词：克痒舒洗液 质量标准 苦参碱 氧化苦参碱 度米芬 

分 类 号：R927.1[医药卫生—药学]