目的 對(duì)黃芩莖葉水浸液進(jìn)行系統(tǒng)的安全性評(píng)價(jià)，以期為黃芩藥材的綜合利用提供安全性依據(jù)。方法 稱取黃芩莖葉，經(jīng)2次90℃的水浸泡30 min，將2次濾液合并蒸發(fā)濃縮至所需濃度作為受試物。急性毒性實(shí)驗(yàn)：設(shè)置對(duì)照組和受試物（15 g/kg）組，一次性給藥，觀察并記錄給藥后14 d內(nèi)的毒性反應(yīng)、死亡情況和體質(zhì)量變化。遺傳毒性實(shí)驗(yàn)：分別進(jìn)行了Ames試驗(yàn)、小鼠骨髓微核試驗(yàn)和小鼠精子畸形試驗(yàn)。長(zhǎng)期毒性實(shí)驗(yàn)：設(shè)置受試物低、中、高劑量（0.417、4.167、8.333 g/kg）組和對(duì)照組，給藥90 d，檢測(cè)指標(biāo)包括動(dòng)物體質(zhì)量、攝食量、血液學(xué)指標(biāo)、血清生化、臟器質(zhì)量及系數(shù)和病理組織學(xué)檢查。致畸試驗(yàn)：將雌、雄大鼠1：1放置使其受孕，設(shè)置受試物低、中、高劑量（0.417、4.167、8.333 g/kg）組、對(duì)照組和陽(yáng)性對(duì)照（維生素A醋酸酯，1 g/kg）組，在受孕的第7~16天，每天ig給藥，于第20天斷頭處死，記錄子宮質(zhì)量，吸收胎、早死胎、晚死胎及活胎數(shù)，逐一記錄胎仔性別、體質(zhì)量、體長(zhǎng)、檢查胎鼠外觀有無(wú)異常，并進(jìn)行骨骼檢查。結(jié)果 小鼠急性毒性最大耐受量（MTD）為15 g/kg，按急性毒性分級(jí)，屬無(wú)毒級(jí)。3項(xiàng)遺傳毒性試驗(yàn)結(jié)果均為陰性，未見受試物有致突變作用。90 d喂養(yǎng)試驗(yàn)未見動(dòng)物中毒性損傷改變。致畸試驗(yàn)表明，未見母體毒性，無(wú)致畸作用。結(jié)論 黃芩莖葉水浸液對(duì)受試動(dòng)物無(wú)明顯毒性。

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