离体豚鼠回肠法应用于骨肽类注射剂中组胺类物质检测  

Application of Isolated Guinea Pig Ileum Method for Detection of Histamine Substances in Osteopeptide Injections

作　　者：吴畅 李晓洁 吴殷囡 王瑶 汪玉馨 宗卫峰 孟长虹 陆益红 WU Chang;LI Xiaojie;WU Yinnan;WANG Yao;WANG Yuxin;ZONG Weifeng;MENG Changhong;LU Yihong(Department of Pharmaceutical Analysis,Xuzhou Medical University,Xuzhou 221004,China;Jiangsu Institute for Food and Drug Control,Nanjing 210019,China)

机构地区：[1]徐州医科大学药物分析教研室,徐州221004 [2]江苏省食品药品监督检验研究院,南京210019

出　　处：《实验动物与比较医学》2022年第2期159-165,共7页Laboratory Animal and Comparative Medicine

基　　金：江苏省实验动物协会2021年实验动物研究课题:药品中组胺类物质测定用动物模型比较研究(DWXH202108)。

摘　　要：目的评价离体豚鼠回肠法检测骨肽类注射剂中组胺类物质的效果,以及代替猫降压物质检查法的可行性。方法按照《中国药典》2020版中组胺类物质检查法(即离体豚鼠回肠法),对5家企业共7批骨肽类注射剂进行组胺类物质检查,同时利用猫降压物质检查法对其结果进行确证和比较。结果用离体豚鼠回肠法进行组胺类物质检查发现有3批制剂结果呈阴性,与猫降压物质检查法的检查结果一致;另外4批制剂结果可疑,对照猫降压物质检查结果是3批制剂可疑,1批制剂呈阳性。离体豚鼠回肠法检查结果与猫降压物质检查法对于可疑结果的检出较为一致,总体结果一致率为85.7%(6/7)。结论离体豚鼠回肠法与猫降压物质检查法的结果基本一致,可用于骨肽类制剂中组胺类物质筛查及研究;同时,骨肽类制剂标准中建议增订降压物质或组胺类物质检查项。Objective To evaluate the detection of the histamine substances in osteopeptide injections by the isolated guinea pig ileum method,and to explore the feasibility of replacing cat depressor substances method.Methods According to the 2020 edition of Chinese Pharmacopoeia,the histamine substances in 7 batches of osteopeptide injections were detected from 5 enterprises by isolated guinea pig ileum method.The results were compared with the test method of cat depressor substances.Results By the isolated guinea pig ileum method,the histamine substances in 3 batches of preparations were negative,which was consistent with the results of the test method of cat depressor substances.The results of the other 4 batches of preparations were suspicious;while the examination results of depressor substances in cat were 3 batches suspicious and 1 batch positive.The overall consistency rate of the two methods was 85.7%(6/7).Conclusion The results of isolated guinea pig ileum method is almost the same as the test of cat depressor substances,which can be used for the screening and study of histamines in osteopeptide injections.It is suggested to add the inspection items of the test of depressor substances or histamines in the standard of osteopeptide injections.

关 键 词：离体豚鼠回肠法 骨肽类注射剂 组胺类物质检查 猫降压物质检查 

分 类 号：Q95-33[生物学—动物学] R-332[医药卫生]