吡喹酮混悬注射液的质量标准研究  

Study on Quality Standard of Praziquantel Suspension Injection

作　　者：杨海峰[1,2] 李勇军[1,2] 金礼琴[2] 赵杉杉[1] 孙爱荣[1] 乔新月 

机构地区：[1]江苏农牧科技职业学院,江苏泰州225300 [2]江苏倍康药业有限公司,江苏泰州225300

出　　处：《动物医学进展》2015年第6期91-95,共5页Progress In Veterinary Medicine

基　　金：江苏省高校"青蓝工程"资助项目;江苏省高等学校大学生实践创新训练计划项目(201412806004Y)

摘　　要：建立吡喹酮混悬注射液的质量标准,为其质量控制提供依据。采用紫外光谱扫描法和高效液相色谱法对吡喹酮混悬注射液进行鉴别。吡喹酮混悬注射液的粒度、分散性、装量、无菌等检查项目按照2010年版《中国兽药典》进行。采用HPLC法测定吡喹酮混悬注射液中吡喹酮含量。结果表明,吡喹酮混悬注射液的各项检查指标均符合国家相关质量要求。建立的含量测定方法简便、可靠、灵敏、重复性好,平均回收率为99.24%,RSD为0.77%,吡喹酮混悬注射液中吡喹酮含量为标示量的99.8%~100.5%。结果表明,吡喹酮混悬注射液质量可靠,质控方法可行。Study on quality standard of praziquantel suspension injection was carried out to provide the basis for its quality control. Praziquantel suspension injection was identificated by the UV absorption spectrum and HPLC method. The granularity, dispersity, volume and sterility of praziquantel suspension injection were inspected according to Chinese Veterinary Pharmacopoeia 2010 standards. HPLC method was used to determine the content of praziquantel. All examination parameters of praziquantel suspension injection were in line with national quality requiments. The determination method was simple, sensitive and accu- rate with good repeatability. The average recovery rate was 99.24% and RSD was 0.77%/00. Praziquantel content of praziquantel suspension injection （percent of the labeled amount） was 99.8%-100.5%. The re- sults showed that the quality of praziquantel suspension injection was controllable and the quality control method was feasible.

关 键 词：吡喹酮 混悬注射液 质量标准 高效液相色谱 

分 类 号：S859.795[农业科学—临床兽医学]