目的对革皮氏海参总皂苷的使用安全性进行评价,阐明其毒性及潜在的危险。方法将健康ICR小鼠随机分为正常组和革皮氏海参总皂苷不同剂量组,每组5只。根据预实验的结果灌胃剂量分别为0.464、1、2.15和4.64 g.kg-1bw,一次性灌胃后连续观察14 d,记录各组的死亡数;另取健康ICR小鼠50只,随机分为正常对照组、阳性对照组和革皮氏海参总皂苷低、中、高剂量组,每组10只,♀♂各半,取股骨骨髓细胞涂片观察骨髓嗜多染红细胞微核率的变化;大鼠30 d喂养实验中,将Wistar大鼠随机分为4组,每组♀♂各10只,给大鼠灌胃不同浓度(分别为20、50和100mg.kg-1)的革皮氏海参总皂苷30 d后,进行体重、外周血象、血糖、血脂、肝脏功能、心肌损伤、肾脏功能等指标检测,取肝、肾、睾丸、卵巢、胃、心、肺进行了组织病理学观察。结果革皮氏海参总皂苷对♂小鼠的LD50为1.08 g.kg-1,♀小鼠LD50为1.10 g.kg-1,属低毒级;骨髓细胞微核实验结果为阴性;30 d喂养实验中,不同剂量组大鼠各项检测指标与正常组相比较差异均无显著性(P〉0.05),组织病理观察发现革皮氏海参总皂苷对大鼠睾丸有轻微毒性作用。结论革皮氏海参总皂苷的急性毒性级别为低毒,未发现遗传毒性,存在一定的亚急性毒性。
Aim To evaluate the safety of the use of saponins of pearsonothuria graeffei(saponins of P.graeffei) and to explore its toxicity and potential hazard.Methods The healthy ICR mice were randomly divided into normal group and saponins of P.graeffei groups of different dosages(n=5).According to the result of previous trials,dosages were 0.464,1,2.15 and 4.64 g·kg-1 bw respectively.The representation of mice was observed 14 d after administered by oral gavage once and the death number was recorded and LD50 was calculated.Another 50 healthy ICR mice were randomly divided into normal group,positive group and saponins of P.graeffei groups((bisexual each half,n=10) by gavage once a day for suceessive two days.The mice were sacrificed six hours after the last gavage,then the bone marrow slides were made,and the alleosis rate of mieronueleu(MN) from polychromosome erythrocytes(PCE) was observed.In the thirty-day feeding test,the Wistar rats were randomly divided into 4 groups and there were 10 rats in each group.The saponins of P.graeffei doses were 25,50 and 100 mg·kg-1 bw in the treatment groups for 30 days,indices including body weight,peripheral hemogram,blood glucose and lipids,liver function,myocardial damage,renal function and histopathological examination on liver,kidney,testis,ovary,stomach,heart,lung.Results The LD50 of saponins of P.graeffei was 1.08 g·kg-1 in male mice and 1.10g·kg-1 in female mice,being involved in low toxic grade.Bone marrow polychromatic erythrocyte micronucleus test showed negative result.The results of the thirty-day feeding test indicated that no obvious difference in each index was observed compared with the normal group(P0.05)and slight toxicity changes were found in liver.Conclusion Saponins of P.graeffei have low toxicity,subacute toxicity and no genetic toxicity.