Investigation on Tolerance of Magnesium Isoglycyrrhizinate Injection in Healthy Volunteers
- VernacularTitle:异甘草酸镁注射液正常人体耐受性试验
- Author:
Xiaoling LI
;
Li SUN
;
Jinfang SHEN
;
Huiming CAO
- Publication Type:Journal Article
- Keywords:
Magnesium isoglycyrrhizinate;
Tolerance trial;
Healthy volunteers
- From:
China Pharmacy
1991;0(04):-
- CountryChina
- Language:Chinese
-
Abstract:
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 mul?ti-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.
