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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

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【作者】 李肖玲孙黎沈金芳陆伦根曹爱萍曹惠明

【Author】 LI Xiaoling,SUN Li,SHEN Jinfang,CAO Huiming(Dept.of Pharmacy,Affiliated Renji Hospital of Shanghai Second Medical University,Shanghai200001,China) LU Lungeng,CAO Aiping(Shanghai Institute of Digestive Diseases,Shanghai200001,China)

【机构】 上海第二医科大学附属仁济医院药剂科上海市消化疾病研究所上海第二医科大学附属仁济医院药剂科 上海市200001上海市200001

【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。

【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 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.

  • 【分类号】R96
  • 【被引频次】22
  • 【下载频次】266
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