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

시장의약품(市販醫藥品)의 미생물(微生物) 오염도(汚染度) 조사(調査) (제1보)(第1報) -시판내복액제(市販內服液劑)의 세균오염도(細菌汚染度)-

An investigation was carried out on a basis of the bacteriological examination with a view to detecting the degree of bacterial contamination for the 77 samples collected from the locally-sold liquid specialties. It's test period was 50 days from July 10 to August 30, 1971. Specially, the survey has put emphasis on the population of general bacteria and the identification of coli-form group, staphylococcus species, streptococcus species, bacillus species, fungi, and yeast species from liquid samples. The results obtained are summarized as follows; (1) For the 77 samples tested, the contamination of general bacteria was found out as minimun 0, i,e., maximum, $12{\times}10^4$ and the total average $45{\times}10^2$ per milliliter. (2) Although streptococcus species could not be detected with the samples, the contamination of the coli-form and staphylococcus species means the strong suggestion of the possibility of pathogenic bacterial contamination. (3) Specially, the products which stay in the neutral pH range and use suspending agents need to care for the microbial contamination in the manufacturing crocess. (4) It is thought necessary to perform the microbiological quality control in the liquid preparations only at least. (5) As the microbial contamination degree in the liquid decreases according to the elapse of time, the microbiological quality control will have to be carried out immediately after the completion of the manufacturing process in order to know the accurate degree. (6) The author thinks that the main reason of the microbial contamination in the liquid is the contamination during the manufacturing process. (7) For the purpose of prevention of the microbial contamination in liquid, therefore, it is more important to make efforts for the rationalization of manufacturing process, the improvement of equipment and environment, the specific training of workers for hygienic knowledges, etc. rather than the use of preservatives for the preparations.