羟氯扎胺盐酸左旋咪唑复方混悬液溶出度的考察  

Study on dissolution of compound suspension of oxyclozanide and levamisole hydrochloride

作　　者：陈玲玲 张东辉 张欣欣 高馨儿 张继瑜[1] 周绪正[1] CHEN Ling-ling;ZHANG Dong-hui;ZHANG Xin-xin;GAO Xin-er;ZHANG Ji-yu;ZHOU Xu-zheng(Key Laboratory of Veterinary Pharmaceutical Development,Ministry of Agriculture and Rural Affairs,Key Laboratory of New Animal Drug Project of Gansu Province,Lanzhou Institute of Husbandry and Pharmaceutical Sciences,Chinese Academy of Agricultural Sceiences,Lanzhou 730050,China)

机构地区：[1]中国农业科学院兰州畜牧与兽药研究所、农业农村部兽用药物创制重点实验室、甘肃省新兽药工程重点实验室,甘肃兰州730050

出　　处：《中国兽医科学》2023年第3期373-380,共8页Chinese Veterinary Science

基　　金：国家肉牛牦牛产业技术体系项目(CARS-37);甘肃省科技计划项目(20JR10RA023)。

摘　　要：为了建立具有区分度的羟氯扎胺盐酸左旋咪唑复方混悬液中羟氯扎胺和盐酸左旋咪唑的溶出度方法。本研究采用Agilent XDB-C18(150 mm×4.6 mm,3.5μm)色谱柱,以含0.1%磷酸的10 mmol/L磷酸二氢铵水溶液为A相,甲醇为B相,进行梯度洗脱。试验条件为检测波长230 nm,流速0.8 m L/min,柱温35℃,进样量5μL。通过筛选不同pH的缓冲液及含不同浓度表面活性剂的溶出介质,测定混悬液中羟氯扎胺和盐酸左旋咪唑的体外溶出曲线,溶出方法为桨法,转速为50 r/min。结果显示,羟氯扎胺和盐酸左旋咪唑的浓度分别在5~100μg/m L和2.5~50μg/m L范围内与峰面积呈现良好的线性关系,其平均回收率分别为98.98%和98.66%。以含0.5%十二烷基硫酸钠的pH7.4的磷酸盐缓冲液为溶出介质时,能获得具有适当区分度的溶出曲线,且羟氯扎胺和盐酸左旋咪唑在45 min内均能达到80%以上的溶出度。上述结果表明,该方法简便、准确、专属性强,可用于羟氯扎胺盐酸左旋咪唑复方混悬液的溶出度测定。In order to establish a method to differentiate the dissolution rate of oxyclozanide and levamisole hydrochloride in a compound suspension of oxyclozanide and levamisole hydrochloride.The chromatographic column(Agilent XDB-C18(150 mm)was usedX4.6 mm,3.5μm)was gradient eluted with 10 mmol/L aqueous solution of ammonium dihydrogen phosphate containing 0.1% phosphoric acid as phase A and methanol as phase B.The detection wavelength was 230 nm,the flow rate was 0.8 mL/min,the column temperature was 35℃,and the injection volume was 5μL.The in vitro dissolution curves of oxyclozanide and levamisole hydrochloride in this product were determined by screening the different pH buffers and dissolution media containing different concentrations of surfactants,and the dissolution method was a paddle method with a speed of 50 r/min.The results showed that the concentrations of oxyclozanide and levamisole hydrochloride were 5—100μg/mL and 2.5—50μg/mL,and their mean recovery rates were 98.98% and 98.66% respectively.This test demonstrated that dissolution profiles with appropriate differentiation were obtained for and oxyclozanide levamisole hydrochloride when a phosphate buffer at pH7.4 containing 0.5% sodium dodecyl sulfate were used as dissolution media,the oxyclozanide and levamisole hydrochloride can reach more than 80% within 45 min,which meets the requirements.The method is simple,accurate and specific.It can be used to determine the dissolution of compound suspension of oxyclozanide and levamisole hydrochloride.

关 键 词：羟氯扎胺 盐酸左旋咪唑 含量测定 HPLC 溶出度 

分 类 号：S852.795[农业科学—基础兽医学]