土茯苓总苷片Ⅰ期临床人体耐受性研究

Tolerance of Tufuling tablets in phase Ⅰ study

目的观察人体对土茯苓总苷片(镇痛中药)的耐受性。方法筛选健康受试者48例,分别用单次及连续给药观察该药的安全性和耐受性。结果单剂量组出现药物不良反应5例,随访后均恢复正常。连续剂量组出现药物不良反应11例。结论正常人体对土茯苓总苷片服用每人每天600mg的剂量耐受较好。

Objective To study the tolerance of Tufuling in healthy subjects. Methods Filter 48 healthy volunteers were screened in this study, Single medication and continuous medication of the capsule seperately to observe the tolerance and safty. Results The single-dose group appear 5 abnormal symptoms. In the following-up, the result all return to normal. The continuous-dose group appear 11 abnormal symptoms. Condusion Normal person have a good tolerance to the capsule of Tufuling as 600 mg per day per person.