市售胃腸用口服膠漿及懸液微生物限度調查

使用胃腸用口服膠漿及懸液之對象多為罹患腹瀉、消化不良、胃酸過多、胃痛、胃灼熱、胃脹氣、胃潰瘍及十二指腸潰瘍等症狀之急者，此二類產品雖未被要求必須完全無菌，但在製程中仍須嚴格管制其微生物數量及種類，以避免造成二次傷害。因此行政院衛生署於民國七十一年即公告胃腸用口服膠漿及懸液之微生物限度，以確保國人用藥安全。而本局八十三年度市售胃腸用口服膠漿及懸液之微生物限度調查發現其合格率僅72.5%。有鑑於此，本局特委請台灣省各縣市衛生局及北、高二市政府衛生局於民國八十九年三月至六月底，至轄區內藥局或西藥房抽購販售之胃腸用口服膠漿37件及懸液62件，共計99件包裝完整之有效檢體進行微生物限度試驗。試驗結果顯示抽購之99件檢體中不合格者有3件（佔3.0%），與八十三年度調查結果相比（不合格佔27.5%）可知此二類產品品質已有顯著改善，然而此二次調查結果不合格者皆屬國產製品，顯示國內製藥廠在生產原料、製程管制及環境衛生各方面，仍須注意改善。本次調查結果不合格之3件產品皆為國產之“成大”美佳胃懸濁液，其不合格項目皆為生菌數過高且遭受綠膿桿菌污染，而此3件不合格檢體已發函原送驗衛生局查明處辦中。本次調查雖顯示國內市售胃腸用口服膠漿及懸液品質已較八十三年度調查時明顯改善，但仍檢出少量不合格產品，故建議衛生行政單位就製藥廠微生物污染控管方面持續查核輔導，以使國產藥品能符合國際品質，並維護國人用藥安全，確保消費者權益。本調查係本局之比較檢驗，曾於八十九年八月三十一日發佈新聞在案。

關鍵字

胃腸用口服懸液；膠漿；生菌數；大腸桿菌；綠膿桿菌

並列摘要

Oral-gastrointestinal gels and suspensions are used for the relief of peptic ulcer, gastritis, peptic esophagitis, gastric hyperacidity, sour stomach, acid indigestion, and hiatal hernia. These drugs are not demanded to be manufactured under aseptic process, therefore, their microbial counts are required to be limited. The Department of Health of Executive Yuan had announced the microbial limit for the oral-gastrointestinal gels and suspensions to protect user's safety. It regulates that the total aerobic microbial count to be no more than 100 CFU per gram/ML in gel or suspension, and that both gel and suspension must not be contaminated with Escherichia coil and Pseudomonas aeruginosa. In order to ensure the quality of domestic marketed oral-gastrointestinal gels and suspensions, 62 samples of oral suspensions and 37 samples of oral gels were purchased from 23 cities/counties at Taiwan area during March to June 2000. The total 99 samples were proceeded with the microbial limit tests included the total microbial count and the assay for Escherichia coil and Pseudomonas aeruginosa. The results showed that all 37 oral gel samples met the regulations. There were three out of the 62 suspension samples that were contaminated with Pseudomonas aeruginosa and the results of the total aerobic microbial counts were higher than the national criterion. The results indicated that here were total 3% of the samples with microbial counts exceeded the limit. This result was lower than the 27.5% in 1994. We found that the disqualified samples were from the same pharmaceutical manufacturer. This revealed that the entire microbial quality control should be improved. Generally speaking, the microbial-limit quality of domestic marketed oral-gastrointestinal gels and suspensions has reached a certain degree in Taiwan.

並列關鍵字

oral-gastrointestinal gels ； suspensions ； total aerobic count ； Escherichia coli ； Pseudomonas aeruginosa

國際替代計量

市售胃腸用口服膠漿及懸液微生物限度調查

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