复方羟氯扎胺混悬液的制备及含量测定  

Preparation and determination of compound oxyclozanide suspension

作　　者：申涵露 白玉彬 张东辉 路宁宁 李冰[1] 周绪正[1] 张继瑜[1] SHEN Han-lu;BAI Yu-bin;ZHANG Dong-hui;LU Ning-ning;LI Bing;ZHOU Xu-zheng;ZHANG Ji-yu(Lanzhou Institute of Husbandry and Pharmaceutical Sciences of CAAS,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,甘肃兰州730050

出　　处：《中国兽医科学》2021年第12期1579-1587,共9页Chinese Veterinary Science

基　　金：国家现代农业产业技术体系项目(CARS-37);甘肃省科技计划项目(20JR10RA023)。

摘　　要：本研究旨在制备复方羟氯扎胺混悬液,建立含量测定方法并进行质量评价。以沉降体积比、再分散性作为评价指标,通过单因素试验及响应面法确定最佳处方,建立有效成分含量测定的高效液相色谱法,并对混悬液理化特性以及稳定性进行初步评价。结果显示,复方羟氯扎胺混悬液的最佳处方为每100 mL含羟氯扎胺6 g、盐酸左旋咪唑3 g、羧甲基纤维钠0.36 g、聚山梨酯-802.5 g、柠檬酸钠0.86 g、亚硫酸氢钠0.10 g、对羟基苯甲酸甲酯钠0.18 g和柠檬黄0.01 g;建立的含量测定方法准确度高,精密度良好,羟氯扎胺和盐酸左旋咪唑分别在5~100μg/mL和2.5~50μg/mL浓度范围内与相应峰面积线性关系良好,样品平均回收率分别为98.61%和98.43%;3批小试样品沉降体积比均大于0.9,再分散次数少,粒径小于10μm,在高温及光照条件下稳定。结果表明,本研究制备的复方羟氯扎胺混悬液性状符合要求、稳定性良好、质量可控。This study aims at preparing the compound oxyclozanide suspension,determining its content and evaluating its quality.We took the sedimentation rate and redispersibility as evaluation indexes and determined the best formula by single factor test and response surface method. Meanwhile,the HPLC method was established to determine the content of main components,and the physicochemical properties and stability of the suspension were preliminarily evaluated.The results showed the optimal formulation of the compound suspension was 6 g oxyclozanide,3 g levamisole hydrochloride,0.36 g sodium carboxymethyl cellulose,2.5 g polysorbate-80,0.86 g sodium citrate,0.10 g sodium bisulfite,0.18 g methyl 4-hydroxybenzoate sodium salt and 0.01 g tartrazine per100 mL.What’s more,the HPLC method we established had high accuracy and good precision,the good linear relationships for oxyclozanide and levamisole hydrochloride were obtained in the rage of 5-100 μg/mL and 2.5-50 μg/mL,respectively,and the average recoveries were 98.61% and 98.43%,respectively.The sedimentation rate of three batches of small-scale samples was greater than 0.9,the number of redispersion was less,and the particle size was less than 10 μm,besides,the samples were stable under high temperature and light.In summary,the compound suspension prepared in this study meets the requirements,has good stability and controllable quality.

关 键 词：羟氯扎胺 盐酸左旋咪唑 含量测定 质量评价 

分 类 号：S859.79[农业科学—临床兽医学]