复方栀子油软胶囊长期毒性实验探究.docVIP

复方栀子油软胶囊长期毒性实验探究[摘要] 目的 了解复方栀子油软胶囊是否具有长期毒性作用，为临床应用提供参考依据。 方法 通过灌胃方式给大鼠连续给药90、120 d，停药后并持续观察14 d后，检测大鼠血常规、肝肾功能等血生化指标和重要脏器系数及组织切片。 结果 连续注射给药90、120 d后，大鼠未出现明显外观、血常规、肝肾功能等血生化及13种脏器组织的毒性变化。 结论 该药无明显毒副作用，具有临床用药的安全性。 [关键词] 复方栀子油软胶囊；长期毒性实验；研究 [中图分类号] R285.5 [文献标识码] A [文章编号] 1673-7210（2012）07（c）-0005-03 Experimental study on chronic toxicity of Compound Gardenia Oil Soft Capsule CHEN Yahui1 ZHU Mei2 LI Baoli1 ZHU Jianwen2 ZHANG Zhengxiang1 CHENG Yanping1 1.Department of Physiology, Yan′an University of Medical College, Shaanxi Province, Yan′an 716000, China; 2.Guangxi Mountain Cloud Biochemical Technology Company, Guangxi Zhuang Autonomous Region, Liuzhou 545600, China [Abstract] Objective To test whether Compound Gardenia Oil Soft Capsule had long term toxicity so as to provide information for clinical application. Methods After the rats were given Compound Gardenia Oil Soft Capsule for 90 days, 120 days and they were given the observation for 14 days continuously in order to test the drug′s toxicity; the biochemical index of routine blood test, liver and kidney function, and vital organs, tissue slices were detected in rats. Results After 90 days and 120 days, no abnormal changes was appeared, blood biochemical reaction routine such as routine blood test, function of liver and kidney, and pathological examination of 13 kinds of visceras tissue. Conclusion Compound Gardenia Oil Soft Capsule has no evident toxic and side effect, so it is safe to be used in clinic. [Key words] Compound Gardenia Oil Soft Capsule; Chronic toxicant experiment; Study 酸枣仁油、栀子油配伍柏子油制成复方栀子油软胶囊，有学者已对其最佳组方、主要药效学、制剂工艺学进行了研究，该复方具有安神、益智、耐缺氧、改善体能等作用[1-3]，并由药食同源原料组成，既安全又符合中药组方理论。本研究为了对复方油栀子油软胶囊的安全性评价作进一步的研究，观察长期服用该胶囊的毒性作用，通过大鼠连续灌胃给药90、120 d，并于停药14 d后，观察大鼠外观、血常规、肝肾功能等改变和脏器组织的毒性变化，以便为临床用药提供参考，现报道如下： 1 材料与方法 1.1 实验动物 SD大鼠[SCXK（军）2002-005]，二级合格动物。 1.2 实验药品及试剂 1.2.1 药品 酸枣仁油购自陕西旭煌植物科技发展有限公司（批号：XHS-080107）；柏子油由广西山云生化科技有限公司提供（批号：081012）；栀子油由广西山云生化科技有限公司生产（批号：080501）。酸柏栀油软胶囊是将酸枣仁油、柏子仁油、栀子油