시판의약품(市販醫藥品)의 미생물(微生物) 오염도(汚染度) 조사(調査) (제2보)(第2報) - 시판내복액제(市販內服液劑)의 세균오염도(細菌汚染度) -

A Survey on Microbial Contamination of Currently-Sold Drugs( II ) - Bacterial contamination of marketed liquid -

An investigation was carried out on a basis of the examination with a view to detecting the degree of microbial contamination for the 82 samples collected from the locally-sold liquid preparations. The results obtained are summarized as follows ; 1. Total viable Bacteria(TVB) per ml. in test sample shows min. 0 and Max. $8.0{\times}10^5$. Among the test samples, 2 items of Herb medicines have shown the highest bacterial contamination degree. 2. The number of unsuitable products are 9(11.0%) of the 82 items tested. Comparing with the study of 1971 (18 or 23.4% of 77 items), this fact suggests that the more than 50% decreasing tendency has come from the technical preventive efforts on bacterial contamination. 3. E. coli, Staph. aureus, and Pseudomonas aeruginosa could not be detected with the test sample. 4. The number of confirmable mycotic contamination in the test samples has been revealed as 17 items (20.7%). 5. Chiefly, the causative organisms of the contamination are proved to be bacilli and fungi broadly distributed in nature. 6. Generally, the neutrality of the pH had greatly increased the number of products unsuitable on the specification of TVB. pH >7.0 No. of unsuitable items 0/4 (0.0%) pH 6.0-7.0 No. of unsuitable items 4/9 (44.4%) pH 4.0-6.0 No. of unsuitable items 5/45(11.1%) pH <4.0 No. of unsuitable items 0/24(0.0%) 7. The viability of general bacteria has shown a rather decreasing tendency in time.