グリチルリチン注射剤「ミノフィット」(プレフィルドシリンジ製剤)の有用性について
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概要
- 論文の詳細を見る
We evaluated the usefulness of"Minofit®"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 20mL of the drug and to about 2/5 for 40mL 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 1.940mg/mL for Minofit® and 1.833mg/mL for the Stronger neo-minophagen-C® (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® 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® for the next 6 months or longer,the ALT and AST values immediately before the change to Minofit® were compared with those 6 months after the change.The mean ALT value was 54.8±25.9 IU/L before the change and 46.8±26.0 IU/L afterwards indicating that the clinical effects of Minofit® and SNMC were similar.In conclusion,having a β-GZ content and clinical effects similar to those of SNMC,Minofit® should demonstrate a high degree of usefuness as a glycyrrhizin injection product.
- 日本医療薬学会の論文
日本医療薬学会 | 論文
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