臺北地區市售“非無菌性要求藥品”之微生物污染情形調查

Studies on the Microbial Contamination of Nonsterility-Required Drug Preparations Purchased in Taipei Area

10.6946/ASRNL.198509.0024

李志恒(Jih-Heng Li)；游祥榮(Shiang-Rong Yu)

非無菌性要求藥品 ； 微生物限度試驗 ； Nonsterility-required drug preparations ； microbial limit tests

藥物食品檢驗局調查研究年報

3號（1985 / 09 / 01）

24 - 28

繁體中文

於民國72年6月在臺北地區抽購市售「非無菌性要求藥品」共251件（包括中藥丸劑57件、維生素錠劑59件、維生素膠囊劑21件、胃乳液43件、硬空膠囊24件及膣劑47件），依據中華藥典第三版並參照美國藥典第廿版的方法，進行微生物限度試驗。各種製劑並分別依據或參照如下公定書的標準加以判定：中華藥典第三版（硬空膠囊）、行政院衛生署公告（胃乳液）、WHO一般製劑微生物容許量基準（維生素錠劑及膠囊劑、中藥丸劑、膣劑）。檢驗結果發現，與規定標準不符比率以中藥丸劑的86.0% (49/57)為最高，以下依次為胃乳液20.9% (9/43)、維生素錠劑8.5% (5/59)、硬空膠囊8.3% (2/24)，維生素膠囊劑及膣劑則均在標準範圍內。顯見部分藥品遭微生物污染之比率偏高，有加強管理之必要。

251 cases of nonsterility-required drug preparations, including herb drug pill 57 cases, vitamin tablet 59 cases, vitamin capsule 21 cases, aluminum hydroxide gel 43 cases, empty hard capsule 24 cases and vaginal suppository & tablet 47 cases, were purchased in Taipei area on June, 1983. Microbial limit tests were performed with the methods described in Ch.P Ⅲ and U.S.P.XX. The standards for each drug preparations are as follows, Ch.P Ⅲ (for empty hard capsules), Bulletin of Department of Health (for aluminum hydroxide gels) and WHO standards for general drug preparations (for vitamin tablets & capsules, herb drug pills, vaginal suppositories & tablets), respectively. Herb drug pills showed high ratios of contamination: 86.0% (49/57), and seriatim in a decreasing order were aluminum hydroxide gels 20.9% (9/43), vitamin tablets 8.5% (5/59), empty hard capsules 8.3% (2/24), while both vitamin capsules and vaginal preparations met the standards. That some of the drug preparations were severely contaminated by microorganisms was shown in this study, and this fact reflects the necessity of reinforcing drug-production control.