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HERBAL MEDICINE

Phase I Safety and Pharmacokinetic Study of Magnesium Isoglycyrrhizinate After Single and Multiple Intravenous Doses in Chinese Healthy Volunteers

Li Sun, BS, Jinfang Shen, BS, Xiaoyun Pang, MS, Lungen Lu, MD, Yimin Mao, MS and Minde Zeng, MD

From Department of Clinical Pharmacology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai (Ms Sun, Ms Shen, Ms Pang), and the Department of Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai (Dr Lu, Dr Mao, Dr Zeng).

The safety and pharmacokinetics of magnesium isoglycyrrhizinate were assessed in healthy Chinese volunteers. In the single-dose format of this pharmacokinetic study, 100-, 200-, and 300-mg doses of magnesium isoglycyrrhizinate were given by intravenous infusion. The results indicated that the plasma levels were directly proportional to the administered dose, with the mean Cmax and AUC0-72 ranging from approximately 28.79 to 99.28 mg·L–1 and 448.68 to 1688.42 mg·h·L–1 over the dose range. In the multiple-dose format of this pharmacokinetic study, 100 mg magnesium isoglycyrrhizinate was administrated once daily for 9 days. Moderate drug accumulation was noted, which was attributable to the drug's long terminal half-life of 19 to 31 hours. The distribution and elimination rate of magnesium isoglycyrrhizinate had no changes. It had a favorable pharmacokinetics and safety profile that enables the drug to be explored in future clinical studies that target patients with hepatic impairment.

Key Words: Safety • pharmacokinetics • magnesium isoglycyrrhizinate • single dose • multiple dose

Address for reprints: Jinfang Shen, BS, Department of Clinical Pharmacology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle Shan-dong Road, Shanghai, 200001 China.


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