微生物油脂PUFAs微囊粉胶囊剂的安全性观察

Toxicological Assessment of Microbe Lipid PUFAs Capsules

目的:观察微生物油脂PUFAs微囊粉胶囊剂经动物试验的安全性。方法:将该制剂经灌胃和喂养,检测其急性毒性、遗传学毒性、生理生化反应和病理学指标。结果:SPF级昆明小鼠2次灌胃量达13.2 g/kg后2周,未见中毒症状和死亡;SPF级昆明小鼠骨髓嗜多染红细胞微核试验,小鼠精子畸形试验结果均为阴性;PUFAs喂养30 d对Wistar大鼠的一般反应、血液生化指标、脏器重量和系数以及病理学指标无明显影响;未发现对该受试动物有明显的毒性作用。结论:含有微生物油脂PUFAs的10%γ-亚麻酸和20%亚油酸的制剂是无突变和安全的。

Objective： To evaluate the virulence of polyunsaturated fatty acids （PUFAs） which were produced by Moritorella isabellina strain AS3. 3410 fermentation. Methods. Genetic toxicity test, acute toxicity test and thirty days feeding tests were performed, and effects of PUFAs on biochemical and pathological changes were observed. Results： All mice survived for two weeks after administrated via stomach at the dose of 13.2 g/kg. No genetics toxicity had been found in genetic toxicity test. After thirty days of administration, no obvious toxicity had been found in Wistar rats. Conclusion. PUFAs produced by Moritorella isabellina strain As3. 3410 fermentation were safe for the experimental animals.