CHEN Jianfeng, CHEN Zhilian, MA Xinqun, ZHANG Lan, CAI Tuo, YANG Xiuhong
Objective To explore the teratogenic effect of Salvia miltiorrhiza (S. miltiorrhiza) leaf extract on Sprague-Dawley (SD) rats so as to provide toxicological data for its development and utilization. Methods Reproductively mature SPF-grade pregnant SD rats were randomly assigned to the groups of low-, medium- and high-dose S. miltiorrhiza leaf extract (1,875, 3,750 and 7,500 mg/kg·bw), a solvent control group (equal volume of distilled water) and a positive control group (cyclophosphamide). From the 6th to the 15th day post-conception, the subjects or controls were orally administered with the test substances once a day, while the positive control group received an intraperitoneal injection of 15 mg/kg·bw cyclophosphamide once on the 12th day post-conception. The rats were weighed at 0, 6, 9, 12, 15, 18 and 20 days after conception, and the pregnant rats were sacrificed by anesthesia on the 20th day of pregnancy. The mother rats’ and fetal rats’ growth and development, pregnancy rate, reproductive ability and malformation indexes like appearance, viscera and bone were observed. Results The final body weight of pregnant rats in the positive control group was lower than that in the solvent control group ((402.1±21.5) g vs. (464.0±24.0) g, t=7.545, P=0.000). The body length of fetal rats in the positive control group was shorter than that in the solvent control group ((29.00±2.69) mm vs. (39.93±1.24) mm, t=33.441, P=0.000). The rates of appearance deformity, visceral deformity and skeletal deformity were all higher in the positive control group than in the solvent control group (77.78% vs. 0.00%, 41.12% vs. 0.00%, 100.00% vs. 1.59%), showing statistically significant differences (χ2=229.865, P=0.000; χ2=57.311, P=0.000; χ2=153.327, P=0.000). Compared with the solvent control group, no effects were observed on the toxicity and fertility of maternal and fetal rats in each dose group of S. miltiorrhiza leaf extract, and no appearance, viscera and bone deformities were found, showing no statistically significant differences in the above-mentioned indexes (P>0.05). Conclusion Under the conditions of this experiment, no embryotoxicity or teratogenicity of S. miltiorrhiza leaf extract is found in the SD rats, and no adverse effect dose more than 7,500 mg/kg·bw/d is observed in the rat teratogenicity test for S. miltiorrhiza leaf extract in both maternal and fetal rats.