重组人生长激素体内生物活性测定中美药典方法对比研究  

A Comparative Study on Chinese Pharmacopeia and U.S.Pharmacopeia Methods for rhGH in Vivo Bioactivity Determination

作　　者：梁誉龄 高学军 李湛军[1] 梁成罡[1] Liang Yuling;Gao Xuejun;Li Zhanjun;Liang Chenggang(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2020年第6期658-663,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:对重组人生长激素(rhGH)中国药典与美国药典的体内生物活性测定方法进行试验比较与梳理分析。方法:按照《中国药典》2015年版四部通则1219和《美国药典》40版通则126的rhGH去垂体大鼠体内生物测定法,分别测定3批rhGH生物活性。结果与结论:应用二种方法测定3批rhGH原料生物效价的结果相近。通过分析比较两种测定方法的结果及各个环节,可以得出结论,中国药典与美国药典的rhGH体内生物活性测定方法基本相同。Objective: To compare and analyze the Chinese Pharmacopeia(ChP) and U. S. Pharmacopeia(USP) methods for recombinant human growth hormone(rhGH) in vivo bioactivity determination. Methods: Three batches of rhGH were tested in hypophysectomized rats according to the in vivo bioassays in general rule 1219 of part Ⅳ of ChP 2015 edition and general rule 126 of USP 40 edition, respectively. Results and Conclusion: The bioactivity results of the three batches of rhGH are almost equivalent by the two methods. The ChP and USP methods for rhGH in vivo bioactivity determination are almost the same, both having advantages and disadvantages based on analyzing and comparing the results of the two methods and each element.

关 键 词：重组人生长激素 体内生物测定 去垂体大鼠 中国药典2015年版 美国药典40版 比较研究 

分 类 号：R95[医药卫生—药学]