复合益生菌制剂"海生元"长期毒性试验研究

目的：观察及评价复合益生菌制剂“海生元”(HSP)的长期用药安全性。方法：以正常健康Wistar大鼠为受试对象，HSY及其核心成分M9、T9菌株为受试物，改良TPY和生理盐水(NS)为对照物，用M9、T9、HSY三种受试物的最大耐受剂量(分别为成人每日用量的125倍、200倍、500倍)口服给药4个月，给药前后及恢复期满(3周后)分别测定受试大鼠的体重、血液学及血生化指标、脏器系数并做病理学检查。结果：长期口服M9、T9及HSY，大鼠的外观、活动、食欲、大便、毛发等无明显异常变化。在给药的4个月内，除极少数指标外，三种受试物对大鼠的体重增长、外周血象、血液生化学指标、脏器系数及各组织器官的病理形态均未见有显著影响，与对照组基本一致。结论：HSY及其核心成分M9和T9菌株毒性极低，经口服长期应用是十分安全的。

PRELIMINARY STUDY OF LONG-TERM TOXICITY TEST FOR COMPLEX-PROBIOTIC-PREPARATION "HAI SHENG YUAN"

Objective:To observe and evaluate the safety of a complex-probiotic-preparation during the long-term oral administration on the healthy wistar rats. Methods:The healthy wistar rats were oral administered by the treating subjects (M 9?T 9 and HSY) and the placebo(modified TPY and normal saline)with the maximal talerance dose for 4 months. The rats'body weight,hematological and biochemical index and organ coefficient were separately determined and the pathological examination of the rats was also performed before and after the administration and at the restoration stage(3 weeks after the administration). Results:The outward appearance,activity,appetite,stool and pili of the rats have not been obviously abnormal during the long-term oral administration of the three treating subjects(M 9?T 9 and HSY) along with the control subjects(modified TPY and normal saline). In the 4 month's administration,the three treating subjects hadn't the signifieant influence on the rats'body weight,perilheral-hematological and biochemical metabolism,tissue and organs' state compared with the control subjects except a few index.Conclusion:HSY and its core component(M 9 and T 9) showed very much low toxicity in the long-term toxicity test by oral administration of rats,which suggested the subjects have fully safety for long-term oral using.