壳聚糖的安全性研究

A STUDY ON SAFETY IN ANIMAL OF CHITOSAN

目的 :为了解壳聚糖口服安全性 ,进行小鼠最大耐受量测定及大鼠的长期毒性实验。方法 :以小鼠 2 4 h最大灌胃药量 ,以及一次性最大腹腔注射药量表示最大耐受量。大鼠按临床用药剂量的 2 0倍、1 0倍、5倍分组灌胃 3个月 ,作长期毒性实验。结果 :最大耐受量灌胃为 4980 mg/kg b.w.,是临床用量的 1 2 4 .5倍 ,一次性最大腹腔注射量为 1 660 mg/kg b.w.,两组小鼠全部存活。3组大鼠喂药 3个月 ,全部存活 ,体重和血常规、肝、肾功能、血糖、血脂等各项生化指标均正常。大体解剖 ,病理检查与正常对照组无差异性。结论 :壳聚糖长期口服 ,无明显毒副作用 ,使用安全。

Objective: Through the determination of mice'MTD and experiment on chronic toxicity on white rats, the oral administration safety of chitosan is studied. Methods:MTD is the maximum dose (ig) during 24 hours and the maximum injection dose (ip)at one time stand for mice's MTD. Rats are divided into 3 groups, each respectively with the dose of 20,10,5times as clinical dose, observing the chronic toxicity. Results: Both the two groups of rats survive, between them one with the MTD of 4980mg/Kg b.w, 124.5 times as clinical dose, and the other with the maximum injection dose (IP) of 1660mg/Kg bow. And also the three groups of rats all survive after 3 months of gastric infusion of chitosm. The biochemical criterion such as glucose and lipid are normal. After gross anatomy and pathological examination, there are no differences between the contract group and experiment group. Conclusion: With no obvious toxic and side effect after long-term oral administration, chitosan can be used safely.