グリチルリチン注射剤市販品の物性および成分含量の比較検討

概要

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We evaluated the quality of parenteral injections (22 products) containing monoammonium glycyrrhizinate, the main extract from the Glycyrrhizae radix. The pH and osmolarity ratio of each product were within the range stated in the package insert. The glycyrrhizic acid, glycine, and L-cysteine concentrations in the injection products were 2.07-2.51 mg/mL, 16.0-21.4 mg/mL, and 1.04-1.30 mg/mL, respectively. The concentrations of glycyrrhetinic acid and glycyrrhetic acid-3-O-glucuronide, impurities that cause pseudo-aldosteronism, were 0.173-2.24μg/mL and 0.777-8.29μg/mL, respectively, showing that there was a wide variation in the concentrations of these 2 substances among the products. Further, the results of discriminant analysis on impurity proportions suggested that it is possible to distinguish bulk powders from each other based on impurity contents. In conclusion, it is important to determine the proportions of impurities in glycyrrhizic acid products and their bulk powders in order to assess their quality.
日本医療薬学会の論文
2008-06-10