天麻酸枣仁胶囊毒理学安全性研究

目的 研究天麻和酸枣仁复合胶囊毒理学特性, 为其进一步研究开发奠定基础。方法 首先进行小鼠极性经口毒性试验, 采用最大给药量实验法(maximum tolerated dose, MTD), 然后进行遗传毒性试验, 包括Ames试验、小鼠骨髓细胞微核试验(间隔24 h两次经口灌胃法)和小鼠精子畸形试验, 最后进行大鼠30 d喂养试验来评价其毒理学安全性, 剂量分别为334、500、667 mg/kg×bw, 观察大鼠体重、增重量、进食量、食物利用率、血常规等指标的变化。结果 以最大给药量(30000 mg/kg)的样品灌胃后, 未见中毒症状, 无动物死亡; Ames试验、小鼠骨髓细胞微核试验和小鼠精子畸形试验3项遗传毒性试验结果均为阴性; 30 d喂养试验发现, 与对照组相比, 各剂量组大鼠的各项指标差异没统计学意义(P>0.05)。结论 天麻酸枣仁胶囊在本实验范围内尾无毒、无遗传毒性的产品, 可进一步进行开发研究。

Toxicological safety study of gastrodiae rhizoma-semen ziziphi spinosae capsule

Objective To explore the toxicological characteristics of compound capsule of gastrodiae rhizoma and ziziphi spinosae semen, making a foundation for its further step of research and development. Methods First step, acute mouth diameter MTD maximum tolerated dose (MTD) was used to perform polar toxicity test. Then, genetic toxicity test was also carried on, including Ames test, micronucleus test of bone marrow cells in mice (24 hours twice oral gavage method) and mouse sperm malformation test. Finally, 30 days rat feeding experiment was carried out to evaluate the toxicological safety. Doses were 334, 500 and 667 mg/kg, respectively. Meanwhile, the changes of body weight, weight gain, food intake, food utilization, routine serum index were observed. Results The maximum dosage (30000 mg) of the sample after gavage. No poisoning symptoms and animal death occurred. The genetic toxicity result of Ames test, mouse bone marrow cells mi-cronucleus test and mouse sperm malformation test were negative. Through 30 days feeding test found that blood and serum indexes of each dose group had no significant difference compared with the control group (P>0.05). Results Gastrodiae rhizoma and ziziphi spinosae semen capsule was not toxic and has no genetic toxicity in the scope of this test, which can come to a further step of development and research.