木香动力胶囊的耐受性

Tolerance of Muxiangdongli capsule

目的观察木香动力胶囊（胃动力中药方剂）对人体的耐受性及安全性。方法按不同性别，24名（单次给药）和12名（多次给药）健康受试者，分别分配到5个剂量（0．25，0．5，1．0，1．5，2．0g）组和2个剂量（1．5，2．0g）组，分别进行多次给药的耐受性试验。观察给药后的临床症状、生命体征等。结果单次给药组用药后，出现6例受试者血常规、部分活化凝血酶原时间、肌肝超出正常值范围；多次给药组用药后，出现7例受试者血常规、血浆纤维蛋白原、血浆凝血酶时间。超出正常值范围；但均无临床意义。结论健康志愿者单次口服木香动力胶囊0．25～2．00g及多次口服其1．5，2．0g是安全的。

Objective To observe and evaluate the tolerance and safety of Muxiangdongli capsule in Chinese volunteers. Methods Twenty four, twelve healthy subjects, seperated to 5 different dose （0.25, 0.5 1.0, 1.5, 2.0 g） and 2 difference dose （ 1.5, 2.0 g） respectively. Singledose （ n = 24 ） and multipl dose （ n = 12 ） groups according to different gender randomly gender randomly. The clinical symptoms, signs of life, etc were observed. Results The result of routine blood tests, APTT and Cr beyond the normal range occurred in 6 persons in the single dose group. The result of routine blood tests, FIB and TT beyond the normal range were founded in 7 cases in the multiple dose groups. There was no clinical significance for the changes after combing with other indicators. Conclusion Healthy volunteers can tolerate single oral dose of 0. 25 - 2. 00 g· d^-1 each day and multiple dose 1.5 or 2. 0 g · d^-1.