汉莲牌红曲灵芝丹参胶囊的动物毒理学 安全性评价研究

目的对汉莲牌红曲灵芝丹参胶囊的服用安全性开展毒理学研究。方法按照国家标准要求和相关规定,首先进行小鼠急性毒性试验,采用最大给药量实验法(maximum tolerated dose,MTD),然后进行遗传性毒性试验,包括Ames试验、小鼠骨髓细胞微核试验和小鼠精子畸形试验,最后进行大鼠30 d喂养实验来评价其毒理学安全性,以2670.0、2002.5、1335.0 mg/kg·bw三个剂量,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。结果给最大给药量(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无统计学意义(P0.05)。结论本品在本实验范围内无毒,无遗传性产品,可以作为降血脂保健食品用于人体。

The toxicological safety evaluation and research of Hanlian brand Monas-cus Ganoderma Salvia capsule

Objective Tostudy the taking toxicoligical safety of Hanlian brand Monascus Ganoderma Salvia capsule. Methods According to the national standard requirements and relevant provisions, at first, acute mouth daimeter MTD maximum tolerated dose (MTD) was used to perform polar toxicity test. Then, genetic toxicity test was also carried on, including Ames test, micrinucleus test of bone marrow cells in mice and mouse sperm malformation test. Finally, 30 days rat feeding expermient was carried out to evaluate the toxicoligical safety. The dose were 2670.0, 2002.5, 1335.0 mg/kg?bw respectively. Meanwhile the change of body weight, weight gain, food intake, food utilization, routine serum index were observed. Results The maximum dosage of the sample after gavage, no poisoning symptoms and animal death occurred. The genetic toxicity result of Ames test, mouse bone marrow cells micronucleus test and mouse sperm maformation test were negative. Blood and serum indexes of each dose group had no significant difference compared with the control group after 30 days feeding test (P>0.05). Conclusion This product is a non-toxic, no genetic toxicity and non-toxic product in the scope of this experiment, and can be used as a kind of new hypolipidemic health food.