グリチルリチン注射剤「ミノフィット^[○!R]」(プレフィルドシリンジ製剤)の有用性について

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We evaluated the usefulness of "Minofit^[○!R]" glycyrrhizin injection, a prefilled syringe (PFS) product, as regards speed and ease of dispensing, β-glycyrrhizic acid (β-GZ) content, impurities, and clinical effects when administered intravenously. Compared with ampules, the PFS shortened the dispensing time to about 1/2 for 20 mL of the drug and to about 2/5 for 40 mL of the drug. Upon measuring the contents of β-GZ, α-glycyrrhizic acid (α-GZ), glycyrrhetic acid (GA), and glycyrrhetic acid monoglucuronide (MGGR) by HPLC, we found that the β-GZ content was 1.940 mg/mL for Minofit^[○!R] and 1.833 mg/mL for the Stronger neo-minophagen-C^[○!R] (SNMC) product. The α-GZ form accounted for less than 5% of the β-GZ content and GA and MGGR each accounted for less than 0.15% of the glycyrrhizic acid content. The contents of major impurities were similar for both Minofit^[○!R] and SNMC. To evaluate the clinical effects in 28 patients with hepatitis C (excluding HCC) who were continuously treated using SNMC for 6 months and using Minofit^[○!R] for the next 6 months or longer, the ALT and AST values immediately before the change to Minofit^[○!R] were compared with those 6 months after the change. The mean ALT value was 54.8±25.9 IU/L be-fore the change and 46.8±26.0 IU/L afterwards indicating that the clinical effects of Minofit^[○!R] and SNMC were similar. In conclusion, having a β-GZ content and clinical effects similar to those of SNMC, Minofit^[○!R] should demonstrate a high degree of usefuness as a glycyrrhizin injection product.
日本医療薬学会の論文
2007-05-10

グリチルリチン注射剤「ミノフィット^[○!R]」(プレフィルドシリンジ製剤)の有用性について

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