复方氨基酸(15)双肽(2)注射液异常毒性及降压物质方法学研究  

Methodology Research on the Abnormal Toxicity Test and Depressor Substance Test of Compound Amino Acids(15)and Dipeptides(2)Injection

作　　者：肖佳音 李庆忠 田冰 XIAO Jiayin;LI Qingzhong;TIAN Bing(Heilongjiang Institute for Drug Control,Haerbin Heilongjiang 150088,China)

机构地区：[1]黑龙江省药品检验研究中心,哈尔滨150088

出　　处：《药品评价》2020年第13期26-28,32,共4页Drug Evaluation

摘　　要：目的:建立复方氨基酸(15)双肽(2)注射液异常毒性及降压物质检查项,以确保该品种的临床用药安全。方法:通过试验计算本品LD50及其95%可信限,并以此确定其异常毒性检查法的限值。比较注射本品与组胺标准品后所引起的麻醉猫血压下降程度,确定其降压物质检查法的限值。结果:在原有质量标准中拟增加异常毒性及降压物质检查项,异常毒性检查项的限值定为“取本品加氯化钠注射液制备成7倍的稀释液”,降压物质检查项的限值定为按猫体重每1 kg静脉注射0.5 mL,按此限值检查结果符合规定。结论:为保证其临床应用的安全,减少不良反应的发生,应在其原有质量标准中增加异常毒性及降压物质检查项。Objective:To establish the abnormal toxicity and depressor substance method for the Compound Amino Acids(15)and Dipeptides(2)Injection,to ensure the clinical safety of this variety.Methods:Through calculating the LD50 and its 95%confidence limits,determine the limit of abnormal toxicity test.And through comparing of the degree in blood pressure drop between CAADI and histamine diphosphate standard substance,determine the limit of depressor substance test.Results:Abnormal toxicity test and depressor substance test should be increased in the original quality standard.We suggested the abnormal toxicity test limit determining as 7 times of dilution with sodium chloride injection,depressor substance test limit determining 0.5 mL/kg·BW intravenous injection to the cat,and according to this limit,the inspection results are in accordance with the regulations.Conclusion:In order to ensure the safety of clinical application,reduce the occurrence of adverse reactions,We should increase the abnormal toxicity and blood pressure method in the original quality standards.

关 键 词：复方氨基酸(15)双肽(2)注射液 异常毒性 降压物质 限值 

分 类 号：R927[医药卫生—药学]