原托品生物碱在罂粟家族中广泛分布,具有广泛的药理作用。MPTA是从Macleayacordata(Willd。)R.Br。以前,我们报道了MPTA良好的抗炎活性以及大鼠口服急性和亚慢性毒性研究。为了对MPTA进行系统的毒理学安全性评估,口服急性毒性,遗传毒性(骨髓细胞染色体畸变试验,精子异常试验,骨髓细胞微核试验,和大鼠致畸试验),在这项研究中对小鼠进行了慢性毒性。在口服急性毒性试验中,ICR小鼠的LD50为481.99mg/kg,95%的置信区间为404.27至574.70mg/kg。在60.25-241.00mg/kg的范围内,所有三个诱变测试均为阴性。大鼠致畸试验结果显示,仅7.53mg/kg无生殖或胚胎发育毒性,这可以被认为是一个没有观察到的效应水平(NOEL)的致畸试验。因此,MPTA在测试剂量下使用是安全的,但应注意妊娠动物的潜在风险,并进一步研究目标动物的安全性评估和毒性机制。
The protopine alkaloids are widely distributed within the opium poppy family and have a wide range of pharmacological effects. MPTA is a product of the protopine total alkaloids extracted from the Macleaya cordata (Willd.) R. Br. Previously, we reported good anti-inflammatory activity of MPTA as well as oral acute and sub-chronic toxicity studies in rats. In order to perform a systematic toxicological safety assessment of MPTA, oral acute toxicity, genotoxicity (bone marrow cell chromosome aberration test, sperm abnormality test, bone marrow cell micronucleus test, and rat teratogenicity test), and chronic toxicity in mice were performed in this study. In the oral acute toxicity test, the LD50 in ICR mice was 481.99 mg/kg, with 95% confidence limits ranging from 404.27 to 574.70 mg/kg. All three mutagenicity tests tested negative in the range of 60.25-241.00 mg/kg. The results of the teratogenicity test in rats showed no reproductive or embryonic developmental toxicity at only 7.53 mg/kg, which can be considered as a no observed effect level (NOEL) for the teratogenicity test. Therefore, MPTA is safe for use at the doses tested, but attention should be paid to the potential risk to pregnant animals and the safety evaluation and toxicity mechanisms in target animals should be further investigated.