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市販醫藥品의 微生物汚染에 關한 調査硏究

A Study on Microbial Contamination of Currently-sold Drugs

공중보건잡지 1974년 11권 1호 p.69 ~ 79
정문식, 金營一, 李容旭,
소속 상세정보
정문식 (  ) - 서울대학교 보건대학원
金營一 (  ) - 서울대학교 보건대학원
李容旭 (  ) - 서울대학교 보건대학원

Abstract


An investigation was carried out on a basis of the microbiological examination with a view to detecting the degree of microbial contamination for the 117 samples collected from the locally-sold drugs which are composed of 82 Oral liquid preparations, 10 O-phthalmic solutions, 4 Ophthalmic ointments, 2 Ear & Nasal preparations, and 19 Topical ointments.
The test period was 47 days from August 15 to September 30, 1973. Specially, the study has put emphasis on the total viable bacteria count and the identification of E. coli, Staph. aureus, Pseudomonas aerginosa and mold & yeast species from samples.
The results obtained are summarized as follows:
1. Total Viable Bacteria (TVB) per ml or gm in each test sample shows as follows.
a. Oral liquid; Min.; 0 Max.; ??
b. Ear & Nasal preparations; Min.; 0 Max.; ??
c. Ophthalmic ointments; All samples showed 0.
d. Topical ointments; All samples are less than 10.
Among the test samples, Ear & Nasal preparations have shown the highest bacterial contamination rate.
In the Liquids, 2 items of Herb medicines have shown comparatively high bacterial contamination degree.
2. Except Ophthalmic solutions, the samples that showed unsuitable to the specification of TVB are proved 10 items (9.3%) among total 107 items: 9 items of Oral liquid and 1 item of Ear & Nasal preparations. Generally, the bacterial contamination of unsuitable products is demonstrated relatively high.3. In the Oral liquid, 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 tems) this fact suggests that the more than 50% decreasing tendency has come from the technical preventive efforts on bacterial contamination.
4. In the 10 Ophthalmic solutions, the results of sterility test are demonstrated as 1 unsuitable item (10%), and Pseudomonas aeruginosa could not be detected.
5. E. coli, Staph. aureus, and Pseudomonas aeruginosa could not he detected with the 84 items of Oral liquid, Ear & Nasal preparations, and the number of confirmable mycotic contamination in the test samples has been revealed as 19 items (22.6%).
6. In the Oral liquid and Ear & Nasal preparations, the number of approved items for TVB has proved to be 74 items, of which the number of mycotic contamination items is 13 (17.6%).
7. Chiefly, the causative organisms of the contamination are proved to be bacilli and fungi broadly distributed in nature.
8. In the Oral liquid, 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%)
6.0∼7.0 〃 4/9 (44.4%)
4.0∼6.0 〃 5/45 (11.1%)
< 4.0 〃 0/24 (0.0%)
9. In the Oral liquid, the viability of general bacteria has shown a rather decreasing tendency in time.

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