异甘草酸镁注射液正常人体耐受性试验  

Investigation on Tolerance of Magnesium Isoglycyrrhizinate Injection in Healthy Volunteers

作　　者：李肖玲[1] 孙黎[1] 沈金芳[1] 陆伦根[2] 曹爱萍[2] 曹惠明[1] 

机构地区：[1]上海第二医科大学附属仁济医院药剂科,上海市200001 [2]上海市消化疾病研究所,上海市200001

出　　处：《中国药房》2006年第4期279-282,共4页China Pharmacy

摘　　要：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。OBJECTIVE： To evaluate the safety and tolerance of magnesium isoglycyrrhizinate（MglG） injection in Chinese healthy volunteers,and provide safe and utility dosage scheme. METHODS： 36 healthy volunteers were randomly divided into 4 groups, each group administered respectively with single dose intravenous infusion of 100,200,300mg of MglG and multi -dose intravenous infusion of 200mg of MglG, qd for 7 consecutive 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 MglG. RESULTS： In single- dose Ⅳ infusion of MglG groups, the vital signs and laboratory indices did not change in the subjects immediately after or at lh, 8h, 24h after administration, as compared with before, while in multi- dose constant intravenous infusion group, the vital signs and laboratory indices at 4 days and 8 days after administration were in the normal range, as compared with before. CONCLUSION ： Tolerance of healthy subjects to MglG is good, and daily dosage of 100mg to 200mg is recommended for clinical use.

关 键 词：异甘草酸镁 耐受性试验 健康志愿者 

分 类 号：R965.3[医药卫生—药理学]