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复方葛丹胶囊的安全毒理学评价
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| 篇名： | 复方葛丹胶囊的安全毒理学评价 |
| TITLE： | |
| 摘要： | 目的：对复方葛丹胶囊的安全毒理学进行评价。方法：根据最大耐受量（MTD）试验经口累计染毒20 g/kg，连续观察14 d，进行急性毒性实验。设置污染物致突变性实验（Ames实验）、小鼠骨髓嗜多染红细胞（PCE）微核实验、小鼠精子畸变实验，考察复方葛丹胶囊的遗传毒性。Ames实验采用鼠伤寒沙门氏菌组氨酸营养缺陷型TA97、TA98、TA100、TA102进行，采用平板掺入法，设复方葛丹胶囊剂量为8、40、200、1 000、5 000 μg/皿，在加与不加S-9混合液条件下，统计各组回变菌落数；小鼠骨髓PCE微核实验取50只小鼠分为阴性对照组（蒸馏水）、阳性对照组（环磷酰胺 40 mg/kg）和复方葛丹胶囊低、中、高剂量组（2.5、5.0、10.0 g/kg），每组10只，ig给药，末次给药6 h后计算微核细胞率及PCE与正染红细胞数比值；精子畸变实验取25只小鼠分组给药剂量同上，每天ig给药1次，连续5 d，35 d后统计精子畸变率。30 d喂养实验取80只大鼠随机分成阴性对照组和复方葛丹胶囊低、中、高剂量组（0.67、1.33、2.67 g/kg），ig给药，连续30 d，观察大鼠体质量增量、进食量、食物利用率、血常规等指标的变化。结果：雌雄两组小鼠经口MTD均大于20 g/kg；3项遗传毒性试验结果均为阴性；30 d喂养实验结果显示，喂养期间各组大鼠均未出现中毒症状，血液学、血液生化和病理组织学检查等各项指标均处于正常范围内，未有异常变化。结论：复方葛丹胶囊属于无毒级，不具有遗传毒性，大鼠30 d喂养后未见明显毒性反应。 |
| ABSTRACT： | OBJECTIVE： To evaluate the toxicological security of Compound gedan capsule. METHODS： According to maximal tolerance dose （MTD） test， mice were orally treated with Compound gedan capsule at the dose of 20 g/kg for 14 days in the acute toxicity test. Ames test， marrow polychromatic erythrocytes （PCE） micronucleus test and mice sperm abnormality test were set up to investigate the inherent toxicity of Compound gedan capsule. In Ames test， the number of revertant colonies was recorded after Bacillus breslaviensis histidine auxotrophy TA97， TA98， TA100 and TA102 were treated with Compound gedan capsule at 8，40，200，1 000，5 000 μg/plate combined with or without S-9 suspension. In marrow PCE micronucleus test， 50 mice were divided into negative control group （distilled water）， positive control group （cyclophosphamide 40 mg/kg） and Compound gedan capsule low-dose， medium-dose and high-dose groups （2.5， 5.0， 10.0 g/kg） with 10 mice in each group； they were given relevant medicine intragastrically； the rate of micronucleus cell， the ratio of PCE to normochromatic erythrocyte were calculated 6 h after last administration. In mice sperm abnormality test， 25 mice were grouped and treated with relevant medicine （same dose as above） intragastrically once a day， for consecutive 5 d； the rate of sperm abnormality was calculated 35 days later. In thirty-days feeding study， 80 rats were randomly divided into negative control group and Compound gedan capsule low- dose， medium-dose and high-dose groups （0.67， 1.33， 2.67 g/kg）； they were given relevant medicine intragastrically for consecutive 30 d. The changes of body weight， weight gain， food intake， food utilization and blood routine index were observed in rats. RESULTS： The oral MTD in both male and female mice were more than 20 g/kg. The results of three genetic toxicity tests were all negative. The thirty-days feeding study of rats demonstrated that no toxicity symptom was found， and the index of blood test， blood biochemical index test and histopathological examination were all within normal range； no abnormal change was found. CONCLUSIONS： Compound gedan capsule is atoxic and doesn’t show genetic toxicity. No obvious toxic reaction is found in thirty-days feeding study of rats. |
| 期刊： | 2016年第27卷第28期 |
| 作者： | 丁文宇，王志斌，丁丽娜，张宪党 |
| AUTHORS： | DING Wenyu，WANG Zhibin，DING Lina，ZHANG Xiandang |
| 关键字： | 复方葛丹胶囊；急性毒性；遗传毒性；30 d喂养实验；小鼠；大鼠 |
| KEYWORDS： | Compound gedan capsule； Acute toxicity； Genetic toxicity； Thirty-days feeding study； Mice； Rats |
| 阅读数： | 315 次 |
| 本月下载数： | 4 次 |
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