异甘草酸镁注射液正常人体耐受性试验

目的:评价异甘草酸镁注射液在健康志愿者中的安全性和耐受性,为临床制订安全、有效的给药方案提供参考。方法:36名健康志愿者随机分为4组,分别参加单次静脉滴注异甘草酸镁注射液100mg、200mg、300mg组以及每次200mg,qd,持续7d的连续给药组。观察临床症状、生命体征、心电图、血尿常规、肝肾功能等指标变化。结果:单次给药后即刻、1h、8h、24h受试者的生命体征和实验室指标与给药前比较均未发现异常变化;连续给药组给药后第4d、第8d受试者生命体征和实验室指标与给药前比较均在正常值范围内。结论:正常人体对异甘草酸镁注射液具有良好的耐受性,推荐每日剂量为100mg~200mg。

Investigation on Tolerance of Magnesium Isoglycyrrhizinate Injection in Healthy Volunteers

OBJECTIVE:To evaluate the safety and tolerance of magnesium isoglycyrrhizinate(MgIG)injection in Chinese healthy volunteers,and provide safe and utility dosage scheme.METHODS:36healthy volunteers were randomly divided into4groups,each group administered respectively with single-dose intravenous infusion of100,200,300mg of MgIG and mulˉti-dose intravenous infusion of200mg of MgIG,qd for7consecutive days.Clinical symptoms,vital signs,electrocardiograms,routine blood and urine tests,as well as hepatic and renal function were observed before and after IV infusion of MgIG.RESULTS:In single-dose IV infusion of MgIG groups,the vital signs and laboratory indices did not change in the subjects immediately after or at1h,8h,24h after administration,as compared with before,while in multi-dose constant intravenous infusion group,the vital signs and laboratory indices at4days and8days after administration were in the normal range,as compared with before.CONCLUSION:Tolerance of healthy subjects to MgIG is good,and daily dosage of100mg to200mg is recommended for clinical use.