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复合益生菌制剂“海生元”急性毒性试验研究 被引量:5

PRELIMINARY STUDY OF ACUTE TOXICITY TEST FOR COMPLEX-PROBIOTIC-PREPARATION "HAI SHENG YUAN"
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摘要 目的:观察复合益生菌制剂"海生元"(HSY)及其核心成分-益生菌(M9、T9)经两种途径给药的急性毒性反应,评价其安全性.方法:以健康小鼠为对象,将HSY、M9、T9三种受试物按i.p(腹腔注射)和p.o(口服灌胃)两种给药方式进行急毒试验.每种给药方法分5个剂量组.i.p小鼠用Bliss法测得受试物的LD50和95%可信限,p.o小鼠用安全限度试验测得受试物的最大耐受量.结果:1)i.p法测得各受试物LD50和95%可信限:M9为898.31 mg/ml(770.18~925.79);T9为1 856.95 mg/ml(1 521.48~2 010.36);HSY为7 605.23 mg/ml(6 980.52~8 304.11).2)p.o法测得各受试物最大耐受量及耐受倍数:健康小鼠最大耐受量分别为M9>4 000 mg/ml,T9>6 000 mg/ml,HSY>15 000 mg/ml;最大耐受量倍数(即耐受成人每日用量的倍数)分别为133倍、200倍和500倍.结论: HSY、M9、T9口服给药均非常安全.三种受试物比较,又以HSY安全程度最高. Objective:To observe the acute toxicity reaction of the healthy mice to a complex-probiotic-preparation(Hai Sheng Yuan,HSY)and its two core components M 9 and T 9 (Two probiotic strains),and evaluate the safety of those subjects.Methods:The subjects(HSY,M 9,T 9)were administrated to the healthy mice by two ways:the peritoneal injection and the gastric perfusion by mouth. Fine doses of each subject were performed successively during the acute toxicity test. LD 50 and 95% confidence limit of the three subjects were determined by Bliss'method in the periloneal injection,and maximal tolerance dose and tolerant multiple were determined by safety limit test in the gastric perfusion. Results:(1)LD 50 and 95% confidence limit:M 9 was 893.31(770.48~925.79)mg/ml,T 9 was 1 856.95(1 521.48~2 010.36)mg/ml,and HSY was 7 605.23(6 980.52~8 304.11)mg/ml. (2)Maximal tolerance dose and tolerant multiple:M 9 were 4 000mg/ml and 133 times(more than that of the adult daily intake),T 9 were 6 000 mg/ml and 200 times,HSY were 15 000 mg/ml and 500 times. Conclusion:According to the test,all of HSY,M 9 and T 9 are very safety in the oral administration and HSY has the highest safety extent in the three subjects.
出处 《中国微生态学杂志》 CAS CSCD 2003年第4期202-203,207,共3页 Chinese Journal of Microecology
关键词 复合益生菌制剂 “海生元” 急性毒性试验 腹腔注射 灌胃给药 Complex-probiotic-preparation Acute toxicity test Peritoneal injection Gastric perfusion
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