目的 对黄芩茎叶水浸液进行系统的安全性评价，以期为黄芩药材的综合利用提供安全性依据。方法 称取黄芩茎叶，经2次90℃的水浸泡30 min，将2次滤液合并蒸发浓缩至所需浓度作为受试物。急性毒性实验：设置对照组和受试物（15 g/kg）组，一次性给药，观察并记录给药后14 d内的毒性反应、死亡情况和体质量变化。遗传毒性实验：分别进行了Ames试验、小鼠骨髓微核试验和小鼠精子畸形试验。长期毒性实验：设置受试物低、中、高剂量（0.417、4.167、8.333 g/kg）组和对照组，给药90 d，检测指标包括动物体质量、摄食量、血液学指标、血清生化、脏器质量及系数和病理组织学检查。致畸试验：将雌、雄大鼠1：1放置使其受孕，设置受试物低、中、高剂量（0.417、4.167、8.333 g/kg）组、对照组和阳性对照（维生素A醋酸酯，1 g/kg）组，在受孕的第7~16天，每天ig给药，于第20天断头处死，记录子宫质量，吸收胎、早死胎、晚死胎及活胎数，逐一记录胎仔性别、体质量、体长、检查胎鼠外观有无异常，并进行骨骼检查。结果 小鼠急性毒性最大耐受量（MTD）为15 g/kg，按急性毒性分级，属无毒级。3项遗传毒性试验结果均为阴性，未见受试物有致突变作用。90 d喂养试验未见动物中毒性损伤改变。致畸试验表明，未见母体毒性，无致畸作用。结论 黄芩茎叶水浸液对受试动物无明显毒性。

Objective To systematically evaluate the safety and toxicology of Scutellaria baicalensis stem-leaf aqueous extract (SBSLAE), in order to provide safety evidence for the comprehensive utilization. Methods SBSL were soaked in water at 90℃ for 30 min for two times. The filtrate was evaporated and concentrated to the required concentration as the test substance. Acute toxicity experiment:set up a control group and a drug administration group, observe and record the situation of toxicity, death and weight within 14 days after drug administration. Long-term toxicity experiment:set three dosage groups (0.417, 4.167, 8.333 g/kg) of SBSLAE and solvent control group. Rats in three dosage groups are given SBSLAE for 13 weeks. The test indicators include the status of animal weight, food intake, hematology index, blood biochemistry, organ weight and coefficient, and histopathological examination. Genotoxicity tests:Ames test, skeletal cell micronucleus test and mouse sperm deformity test were conducted. Teratogenicity test:set up a drug administration group, a negative control group and a positive control group. Male and female rats are placed at the ratio of 1:1 to conceive, and then administer the drug for 10 days. The rats are killed on the 20th day, and record the weight of the uterus. The number of absorbed fetuses, early fetuses, late fetuses and live fetuses are recorded. Recording the sex, weight, and body length of the fetus respectively and inspection of whether the appearance of the fetus is abnormal and perform a bone examination. Results The MTD values of acute oral toxicity test in mice were 15.0 g/kg. The results of the three genotoxicity tests were all negative, and test substance has no mutagenic effect. In the ninety-day feeding test, the high-dose group of the test substance did not cause any changes in animal toxic damage. Teratogenic test showed no maternal toxicity and no teratogenic effect. SBSLAE may promote the growth and development of embryos. Conclusion SBSLAE had no obvious toxicity to the tested animals.

R965.3