各種塩酸バンコマイシン注射製剤の品質比較

概要

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Two lots (3 samples each) of 4 companies' (Shionogi & Co., Ltd., Meiji Seika Kaisha, Ltd., Nichi-iko Pharmaceutical Co., Ltd. and Merck Pharmaceutical Co., Ltd.) vancomycin hydrochloride injection products (referred to hereafter as VCM injections) were dissolved in normal saline 100mL. The solubility of each product was investigated for 3 different dissolution times (5 seconds, 10 seconds, 30 seconds) using a bioassay method employing Bacillus subtilis ATCC 6633 and a fluorescence polarization immunoassay.The dissolution rate of the Shionogi product increased from 83.9±2.8% at 5 seconds to 99.0±0.7% at 30 seconds which was in proportion to the increase in dissolution time. Further, the dissolution rates for the Meiji Seika Kaisha and Nichi-Iko Pharmaceutical products were 90% or more for a dissolution time of 30 seconds. On the other hand the dissolution rate of the Merck Pharmaceutical product, which was 81.7±2.6% for a dissolution time of 10 seconds, was only 83.1±2.8% for a dissolution time of 30 seconds. These results show that in order to obtain dissolution rates exceeding 90%, at least 30 seconds of dissolution time is required even for the VCM injection products manufactured by Shionogi, Meiji Seika Kaisha and Nichi-Iko Pharmaceutical. Moreover, as there were differences in the solubility of preparations, this should be taken into account when selecting the product.
2008-09-10