复方竹节参胶囊的毒理学试验  

Toxicological Research of Panax Japonicus C.A.Mey Complex

作　　者：樊柏林[1,2] 刘春霞[2] 杨文祥[2] 田辉[2] 孙凡中[2] 马弋[2] 向继洲[1] 

机构地区：[1]华中科技大学同济医学院,湖北武汉430030 [2]湖北省疾病预防控制中心,湖北武汉430079

出　　处：《癌变．畸变．突变》2008年第6期483-486,共4页Carcinogenesis,Teratogenesis & Mutagenesis

摘　　要：背景与目的:检测复方竹节参胶囊的毒性。材料与方法:按照常规方法进行小鼠经口急性毒性、小鼠骨髓微核试验、小鼠精子畸形试验、Ames实验以及大鼠30d喂养试验。小鼠骨髓微核试验、精子畸形试验均同时设阴性对照组(蒸馏水)和阳性对照组(环磷酰胺),大鼠30d喂养试验设阴性对照组给予蒸馏水。结果:复方竹节参胶囊对雌、雄性SPF级昆明种小鼠在灌胃量达20g/kg时,两周内动物未见明显中毒症状。微核试验、精子畸形试验和Ames实验结果均为阴性。30d喂养试验结果表明:给药剂量达6g/kg复方竹节参胶囊对Wistar大鼠的行为表现、血液学、生化学、脏器重量和系数以及病理组织学等指标均未见毒性作用。结论:在本实验条件下,复方竹节参胶囊可以通过急性毒性、微核试验、精子畸形试验、Ames实验和30d喂养试验的毒理学安全性评价,未见明显毒性。BACKGROUND AND AIM： To test the safety of Panax japonicus C.A.Mey complex formulation. MATERIALS AND METHODS： Acute toxicity test,bone marrow cell micronucleus test,mice sperm abnormality test,Ames test and 30 d feeding test were used to study the toxicity. Negative control and positive control groups were set up with administration of water and cyclophosphamide in bone marrow cell micronucleus test and mice sperm abnormality test, respectively. Negative control group animals received water in 30 d feeding test. RESULTS： In acute toxicity test, male and female KM mice were fed with 20 g/ kg dose of Panax japonicus C.A.Mey complex, no toxic symptoms were observed. The results of bone marrow cell micronucleus test, mice sperm abnormality test and Ames test were negative. In the 30 d feeding test, no obvious toxic effects in clinical, blood examination and biochemical index examinations, organism weight and pathological studies were detected in rats with the dose of 6 g/kg, which is 200 times the clinical prescribed dose. CONCLUSION： Panax japonicus C.A.Mey complex formulation could pass the toxicological assessment using the tests mentioned above.

关 键 词：复方竹节参 急性毒性 微核 精子畸形 AMES实验 30 d喂养实验 

分 类 号：R994.1[医药卫生—毒理学]