CSカプセルの保存によるCSの力価の安定性に関する研究

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It has been reported that the activity of cycloserine was lost under various storage conditions such as high humidity. The author made a study on the activity of cycloserine after storage under different conditions. Cycloserine capsules sealed in aluminium foil were stored under the room temperature and 37°C with and without high humidity. The method to determine the drug activity was as follows: a capsule containing 250 m g cycloserine was taken out from the sheet and the content was removed into sterile test tube. Cycloserine powder was suspended in sterile distilled water, and then diluted to 1 mg/ml by sterile distilled water. The activity of the solution was examined by the vertical diffusion method.1 ml of 1 mg/ml solution was poured into the flat-based test tube containing 1% Ogawas egg medium which was inoculated with 0.1 mg of H37Rv on the previous day. The length of the inhibitory zone was examined after 10 days incubation in vertical position. The assessment of the drug activity was made at 1, 3 and 6 mo n ths after the storage. Two media were used for each sample and 5 samples were tested for each assessment. The length of the inhibitory zone was demonstrated by the average of 5 samples. The results were shown in the table. Samples produced by the c ompanies A and B showed good stability of activity after 6 months storage under 37°C with high humidity, while two samples produced by the company X lost its activity after 3 months storage under the same condition. The author concluded that the improvement of the sealing method should be required for certain product of cycloserine to obtain the good stability during the storage.
日本結核病学会の論文

著者

大里敏雄
結核予防会結核研究所

CSカプセルの保存によるCSの力価の安定性に関する研究

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