痔得好口服液的制备及急性毒性实验

Preparation and acute lexicological test of Zhidehao liquid

目的 介绍了自制制剂——痔得好口服液的制备及其质量标准的拟定。方法 在制备上汲取民间经验——对活体昆虫动物药直接采用高梁酒醉死再浸泡,以保证原方疗效。结果 经反复试验,摸索出了经济、可行的质量内控方法;急性毒性实验表明,痔得好口服液经小白鼠口服灌胃观察,未见毒性反应,测得小白鼠1日灌胃的最大耐受量相当于原生药684g/kg,为拟用临床剂量的1200倍。结论 实验提示痔得好口服液耐受性很大,临床治疗口服剂量是安全的。

Objective To introduce a method of preparation of Zhidehao liquid and to work out a qualified standard.Methods The liquid was prepared by assimilating the traditional experience as immersing the live insect, paratenodera sinensis saussure in Gaoliang spirit and mixed it with several herb extraction. The supernatant liquid was used as the final Zhidehao liquid to test the maximal dose tolerance in mice by gastric instillation of the liquid.Results The maximal tolerable dose in mice was 684g/kg, equivalent to the orignal drug, 1200 times higher than the expected clinical dosage. Conclusion The results suggest that Zhidehao liquid is an excellent, tolerable and safe liquid in treating hemorrhoids.