五氯柳胺阿苯达唑复方混悬液的制备及其含量测定

Preparation and content measurement of oxyclozanide and albendazole compound suspension

为制备五氯柳胺阿苯达唑复方混悬液,对其质量评价并建立含量测定方法。通过辅料相容性、单因素筛选及回归正交设计,以沉降体积比、再分散性等为考察因素,优化处方制备五氯柳胺阿苯达唑复方混悬液,用激光粒度测定仪、透射电子显微镜,对其粒径和形态进行测定,考察制剂的稳定性,建立测定五氯柳胺阿苯达唑复方混悬液含量的高效液相色谱方法。结果显示,五氯柳胺阿苯达唑复方混悬液每100mL中含五氯柳胺4.00g,阿苯达唑4.00g,黄蓍树胶0.25g,十二烷基硫酸钠0.20g,甘油3.00mL,柠檬酸钠1.20g,苯甲酸0.15g。混悬液沉降体积比为0.99,再分散性良好。1~100mg/L的五氯柳胺、阿苯达唑与峰面积呈良好的线性关系(R^2=0.9999,R2=0.9997),平均回收率为101.15%和100.89%,RSD为0.13%和0.10%(n=9)。结果表明,制备的五氯柳胺阿苯达唑复方混悬液工艺简单,性状良好,稳定性和分散性好,质量可控。所建立的高效液相色谱法快速简便、准确可靠,可用于复方混悬液中五氯柳胺、阿苯达唑含量的测定。

To prepare oxyclozanide and albendazole compound suspension and evaluate its physical and chemical properties,and establish an HPLC method for the determination of oxyclozanide and albendazole.The prescription of oxyclozanide and albendazole compound suspension was optimized in terms of the sedimentation volume ratio and redispersibility by the excipient compatibility,single factor experiment and the regression orthogonal design.Subsequently,the shape and size of oxyclozanide and albendazole compound suspension was observed and measured by transmission electron microscope(TEM)and laser particle size analyzer(LPSA),respectively.A HPLC method was established to determine the content of oxyclozanide and albendazole in the compound suspension.The results showed that the prescription of oxyclozanide and albendazole compound suspension(100mL)was determined as follows:4.00g oxyclozanide,4.00g albendazole,0.25g gum tragacanth,0.20g carboxymethylcellulose sodium,3.00mL glycerine,1.20g sodium citrate,0.15g benzoic acid,and the sedimentation volume ratio of 0.99showed a good redispersibility.The good linear relationships for oxyclozanide and albendazole were obtained in the range of 1-100mg/L with R^2≥0.999.The average recovery for oxyclozanide and albendazole were 101.15%(RSD was 0.35%)and 100.89%(RSD was 0.21%),respectively.The oxyclozanide and albendazole compound suspension was successfully prepared with simple preparation process,good stability and well quality-controlled product.The validation results showed that the HPLC method was rapid,simple,accurate and can be used to the content determination of oxyclozanide and albendazole compound suspension.