壳聚糖的安全性研究

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２４ｈ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２０倍、１０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４９８０ｍｇ／ｋｇ ｂ．ｗ．，是临床用量的１２４．５倍。一次性最大腹腔注射量为１６６０ｍｇ／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

A STUDY ON SAFETY IN ANIMAL OF CHITOSAN

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.