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目的 保证新药某健胎中药 (PAKRQAB)的临床用药安全 ,评价其毒理学和分子生物学效应。方法 设 3个剂量组 :6 0、12和 2 4g (kg·d) ,最高剂量相当于临床拟用量的 80倍 ,另设溶剂对照组和阳性对照组。于孕期 6～ 15d经口给予受试物 ,第 2 0天检查对孕鼠和胎鼠的毒性和致畸性 ,并用WesternBlot方法测定孕鼠和胎鼠肝组织HSP70水平。结果 3个健胎液剂量组均未诱发畸形 ,但高剂量组妊娠率下降 ,与阴性对照组比较差异有显著性 (P <0 0 5 )。孕鼠各剂量组HSP70表达与阴性对照组比较有不同程度的降低 ,对胎鼠HSP70表达影响不明显 ,孕鼠表达量较胎鼠高。结论 该健胎中药无致畸性 ,无母体毒性及发育毒性 ,但对高剂量组孕鼠妊娠率可能产生一定的影响
Objective To ensure the safety of clinical drug use of a new drug Jiantai Chinese medicine (PAKRQAB) and to evaluate its toxicological and molecular biological effects. Methods Three dose groups were set up: 60, 12 and 24 g (kg·d). The highest dose was equivalent to 80 times the clinical dosage. A solvent control group and a positive control group were set up. On the 6th to 15th day of pregnancy, the subjects were given orally, and the toxicity and teratogenicity of pregnant rats and fetal rats were examined on the 20th day. HSP70 levels in liver tissues of pregnant rats and fetal rats were determined by Western Blot. Results The three fetal fluid dose groups did not induce deformity, but the high-dose group pregnancy rate decreased, compared with the negative control group, the difference was significant (P <0 05). The expression of HSP70 in each dose group of pregnant rats decreased to some extent compared with the negative control group, and had no significant effect on the expression of HSP70 in the fetus. The expression of HSP70 in pregnant mice was higher than that in the fetus. Conclusion The fetus without teratogenicity has no maternal toxicity and no developmental toxicity, but it may have a certain effect on the pregnancy rate of high-dose pregnant mice.