苦碟子注射液致小鼠模型呼吸系统不良反应症状分析

Analysis of adverse drug reaction in mice model respiratory system induced by kudiezi injection

目的:通过观察不同制剂工艺及剂量的苦碟子注射液致敏的小鼠模型的症状,探索其导致呼吸系统不良反应的主要症状。方法:将60只豚鼠随机分为10组,每组6只,雌雄各半。即卵白蛋白阳性对照组、生理盐水阴性对照组和苦碟子注射液121℃45min灭菌后组、过滤加炭前组、1万超滤稀配后组、3万超滤稀配后组、121℃45min灭菌后5倍组、过滤加炭前5倍组、1万超滤稀配后5倍组、3万超滤稀配后5倍组。每组动物给予腹腔注射被试药物0.5ml/只·次,隔日1次,共4次.14天后,腹腔注射2倍剂量(1ml/只)相应药物激发。观察小鼠症状30min。结果:苦碟子注射液各实验药物组均出现呼吸系统症状,多数为搔鼻和(或)呼吸急促。结论:制剂工艺为发生不良反应的重要因素,超剂量使用易导致或加重不良反应的发生。

Objective：By observing the symptoms of the mice model with variant Kudiezi Injections of different doses and different preparation methods,, the main symptoms of the respiratory system adverse reaction were explored.Methods：60mices were randomly divided into 10 groups with 6 in each group, and half male and half female. Namely positive control group （ treated with egg albumin injection）, negative control group （treated with saline injection）, Kudiezi 1 Injection group（treated with Kudiezi Injection sterilized under 121 C for 45 min）, Kudiezi 2 Injection group （ treated with Kudiezi Injection with filtration adding carbon front）, Kudiezi 3 Injection group （treated with Kudiezi Injection with 10 thousand ultrafiltration dilution method）, Kudiezi 4 Injection group （treated with Kudiezi Injection with 30 thousand ultrafiltration dilution）, Kudiezi 5 Injection group （ treated with Kudiezi Injection of 5 times the normal dose and sterilized under 121 C for 45min）, Kudiezi 6 Injection group （treated with Kudiezi Injection of 5 times the normal dose and filtrated adding carbon front）, Kudiezi 7 Injection group （treated with Kudiezi Injection of 5 times the normal dose andl0 thousand ultrafiltration dilution）, and Kudiezi 8 Injection （ treated with Kudiezi Injection of 5 times the normal dose and 30 thousand ultrafiltration dilution） group. Each animal was treated with 0.5ml corresponding reagent once every other day by intraperitoneal injection, 4 times in total. 14 days later, lml reagent was given by intraperitoneal injection to each animal. Mice were observed 30 min.Results：Kudiezi Injection experimental drug group were respiratory symptoms, mostly scratching nose and shortness of breath. Conclusion：Preparation process is an important factor in the occurrence of adverse reactions, the use of high doses of easy to cause or aggravate the occurrence of adverse reactions.