若干药物的大鼠皮肤类过敏试验  

Application of rat skin anaphylactoid test to several drugs

作　　者：康黎静 谢家骏[1] 易娟娟[1] 赵琳[1] 

机构地区：[1]上海中医药大学药物安全评价研究中心,上海201203

出　　处：《中成药》2014年第10期2033-2036,共4页Chinese Traditional Patent Medicine

基　　金：国家"十二五"科技重大专项课题(2011ZX09301-009)

摘　　要：目的考察和评价10种造影剂、中药注射剂和化学合成药的大鼠皮肤类过敏试验方法的适用性。方法大鼠皮内注射受试药物后立即尾静脉注射0.5%伊文思蓝染液,15 min后处死,测量蓝斑直径。设定蓝斑直径>0.5 cm为类过敏反应阳性。结果临床剂量下,碘海醇、复方泛影葡胺注射液、双黄连、生脉、脉络宁和喜炎平注射液出现类过敏反应阳性,而碘普罗胺注射液、清开灵和金纳多注射液呈类过敏反应阴性;高于临床剂量时,上述受试药物除清开灵外,均为类过敏反应阳性。盐酸川芎嗪在临床剂量和临床2倍剂量下类过敏反应均为阴性。结论蓝斑直径与给药剂量有关,大鼠皮肤类过敏试验方法可作为初步评价注射类药物临床前类过敏性的一种简便、快速的检测方法。AIM To investigate and evaluate the applicability of rat skin anaphylactoid test to ten different contrast media, herb injections and synthetic drugs. METHODS Rats receiving intracutaneous injection of test drugs were instantly injected 0.5% Evans blue by caudal vein and then killed in fifteen minutes. Diameters of blue spots in those rats were assayed. Any sample with a blue spot diameter more than 0. 5 cm was designated as the positive reaction. RESULTS When tested at clinical concentrations, Iohexol, Compound Meglumine Diatrizoate Injection, Shuanghuanglian, Shengmai, Mailuoning and Xiyanping Injection showed positive results, but Iopro- mide Injection, Qingkailing, Ginkgo biloba Extract Injection presented negative results. When tested at above clin- ical concentration level, all tested drugs mentioned above except for Qingkailing showed positive. Ligustrazine hydrochloride presented negative results when tested with either at clinical concentration or up to two times of the clinical concentration. CONCLUSION The experiments suggest that the blue spot diameter has a direct relation- ship with the concentration of tested drugs. Rat skin anaphylactoid test can be used as a preliminary, simple and rapid detection method for pre-clinical evaluation.

关 键 词：大鼠皮肤类过敏试验 造影剂 中药注射剂 化学合成药 

分 类 号：R285.5[医药卫生—中药学]