酵素製剤・漢方製剤の微生物汚染

概要

論文の詳細を見る
The quality control of drugs was evaluated from the direction of microbial contamination which was determined by sterility test, total aerobic microbial counts and the detection of coliform bacteria. 19 pharmaceutical products showing serious microbial contamination in our previous tests and 41 additional pharmaceutical products newly developed from natural substances (Chinese medicines) were selected for the present study. The total aerobic microbial counts exceeding 10^3/g were observed in 5 of the 19 Products, which showed the same incidence as that in the previous test. The results of the sterility test and microbial counts were correlated well. Coliform bacteria were detected in 3 products, compared with 2 products in the previous test. In case of the newly tested 41 products, the total aerobic microbial counts over 10^3/g were observed in 6 products, whereas coliform bacteria were detected in 1. Although the microbial contamination at high degrees was still observed especially in products consisting of natural substances, it is concluded that the recent microbial quality control of the pharmaceutical products has generally been improved.
日本医療薬学会の論文
1982-06-20