市售腸胃用口服膠漿及懸浮液微生物限度調查   全文下載

MICROBIAL LIMIT TESTS OF GASTROINTESTINAL DRUG

為瞭解國內市售腸胃用口服膠漿及懸浮液受微生物污染之情形，故對全省此類產品分北中南東進行抽購工作，共抽得檢品40件。依據美國藥典第二十二版之方法進行微生物限度試驗，並依據美國藥典第二十二版之規格及衛生署71年9月29日公告胃腸用口服膠漿及懸浮液之微生物限度：應需氧微生物總數每mL不得超過100個且不能有綠膿桿菌及大腸桿菌來加以判定。結果發現不符合規定者高達11件，佔總檢體數之27.5%。此不符合規定之11件中，需氧微生物總數皆超過衛生署公告之標準，且其中有2件受到綠膿桿菌污染，2件受到大腸桿菌之污染。

In order to determine the quality of marketed gastrointestinal drugs (gel & suspension), 40 commercial samples were purchased from different cities in Taiwan during 1994. The specimens were subjected to microbial limits test including total aerobic microbial count, for Pseudomonas aeruginosa and Escherichia coli: The results showed that 11 of products (27.5%) were contaminated with total aerobic microbial counts higher than 100/mL Furthermore, 2 samples were found to be contaminated with Pseudomonas aeruginosa and 2 samples contaminated with Escherichia coli.