畜牧兽医学报 ›› 2016, Vol. 47 ›› Issue (10): 2115-2125.doi: 10.11843/j.issn.0366-6964.2016.10.021

• 基础兽医 • 上一篇    下一篇

五氯柳胺口服混悬剂的制备及其含量测定

张吉丽,李冰,司鸿飞,郭肖,朱阵,尚晓飞,周绪正,张继瑜*   

  1. (中国农业科学院兰州畜牧与兽药研究所,农业部兽药创制重点实验室,兰州 730050)
  • 收稿日期:2016-02-01 出版日期:2016-10-23 发布日期:2016-10-23
  • 通讯作者: 张继瑜(1967-),E-mail: infzjy@sina.com
  • 作者简介:张吉丽(1992-),女,黑龙江大庆人,硕士生,主要从事动物抗寄生虫药研究,E-mail:zhangjlzjl@sina.com
  • 基金资助:

    国家科技支撑计划项目(2015BAD1101);国家现代农业产业技术体系专项(CAR-38)

Preparation and Content Measurement of Oxyclozanide Oral Suspension

ZHANG Ji-li,LI Bing,SI Hong-fei,GUO Xiao,ZHU Zhen,SHANG Xiao-fei,ZHOU Xu-zheng,ZHANG Ji-yu*   

  1. (Key Laboratory of Veterinary Pharmaceutical Development of Ministry of Agriculture,Lanzhou Institute of Husbandry and Pharmaceutical Sciences,Chinese Academy of Agricultural Sciences,Lanzhou 730050,China)
  • Received:2016-02-01 Online:2016-10-23 Published:2016-10-23

摘要:

研究的目的是制备五氯柳胺混悬剂,研究其理化性质并建立含量测定方法。通过单因素筛选及二次回归正交旋转设计,以沉降体积比和再分散性为考察因素,优化处方制备五氯柳胺混悬剂,用透射电子显微镜、激光粒度测定仪对其形态和粒径进行测定,考察制剂的稳定性,建立测定含量的高效液相色谱方法。五氯柳胺混悬剂每100 mL中含五氯柳胺 3.2 g,卡波姆974p 0.2 g,十二烷基硫酸钠 0.3 g,对羟基苯甲酸甲酯0.02 g,焦亚硫酸钠0.4 g。混悬剂沉降体积比为0.999,再分散性良好。五氯柳胺在18~100 μg•mL-1的质量浓度范围内与峰面积呈良好的线性关系。制备的五氯柳胺混悬剂工艺简单,物理性状良好,稳定性和分散性好,质量可控。

Abstract:

The study aimed to prepare oxyclozanide oral suspension and evaluate its physical and chemical properties,and establish an HPLC method for the determination of oxyclozanide.The sedimentation volume ratio and redispersibility were used as variable factors,the single factor experiment and the quadratic regression orthogonal rotational combination design were carried out to optimize the prescription.Then,the shape,size of oxyclozanide suspension was measured by transmission electron microscopylaser and particle size analyzer,and the content of oxyclozanide in suspension was determined by HPLC.The result showed that the suspension (100 mL) was consisted of 3.2 g oxyclozanide,0.2 g carbomer 974p,0.3 g sodium dodecyl sulfate sodium salt,0.02 g methyl 4-hydroxybenzoate and 0.4 g sodium pyrosulfite.With good redispersibility,the sedimentation volume ratio of oxyclozanide suspension was 0.999.Excellent line relationship was obtained in the range of 18-100 μg•mL-1 (r2=0.999 3).The oxyclozanide suspension was successfully prepared with simple preparation process,good stability and well quality-controlled product.

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