健脾祛湿颗粒成型工艺及其急性毒性试验

目的：研究健脾祛湿颗粒的成型工艺及用药后的急性毒性。方法成型工艺中进行辅料的确定，采用效应面试验确定糊精用量和乙醇浓度；制备样品后进行健脾祛湿颗粒小鼠急性毒性试验，观察给予健脾祛湿颗粒后小鼠的死亡情况，以确定药物的急性毒性。结果制备的健脾祛湿颗粒为黄色，大小均匀，辅料糊精的用量为17%，乙醇浓度90%；急毒实验结果是小鼠单次给药的最大给药量为120 g · kg-1。结论用17%糊精，乙醇浓度90%制备的健脾祛湿颗粒，工艺可靠，安全低毒，适合临床应用。

The forming process and acute toxicity test of Jianpi Qushi Granules

Objective To research the forming process of Jianpi Qushi Granules and its acute toxicity after administra-tion.Methods Adjuvants were definited in forming process,the amount of dextrin and the concentration of ethanol were definited by response surface methodology.After preparation of the samples,the acute toxicity test of Jianpi Qushi Granules in mice were carried out,and definited the acute toxicity according to the death of mice.Results The preparation of Jianpi Qushi Granules was yellow,uniform size,the amounts of excipients were 17% dextrin,90% ethanol.The acute toxicity results was that:the largest dosage was 120 g·kg-1 for single dose in mice.Conclusion The preparation process of Jianpi Qushi Granules with 17% dextrin,90% ethanol was reliable,safe and low toxicity,and suitable for clinical application.