胃腸用口服膠漿及懸液之微生物品質監測

Microbiological Survey of Oral-Gastrointestinal Gels and Suspensions

胃腸用口服膠漿及懸液屬非無菌性藥品，多用於腸胃道發炎、潰瘍或黏膜有傷口之患者。過去監測結果發現仍有少數市售產品之微生物品質需改善，故本年度持續進行微生物品質監測。檢驗方法係依據中華藥典第八版微生物計數法檢驗，檢驗規格依前行政院衛生署71.09.29衛署藥字398194號公告規定不得檢出大腸桿菌及綠膿桿菌，且好氧性微生物總數不得超過100CFU／mL（g）進行判定。本計畫經函請地方政府衛生局配合至轄區內藥局、診所、製造廠及代理商等進行抽查，共計抽得43件產品（胃腸用膠漿7件，胃腸用懸液36件），共26張許可證（胃腸用膠漿3張，胃腸用懸液23張）。結果顯示抽查之4件產品（1張許可證）好氧性微生物總數不合格（不合格率9.3％），另有1件產品（1張許可證）申請商名稱及地址標示與許可證登記不符（不符合率2.3％）；上述不符合之檢體已函送各轄區衛生局進行處辦及啟動下架程序，並進行後續追蹤處置，以保障國人之健康及醫療品質。 Oral-gastrointestinal gels and suspensions are non-sterile products. They are used in the treatment of peptic ulcer, inflammation and other stomach and gastrointestinal discomforts. In order to ensure the safety of medication, this study aimed to investigate the microbiological quality of these products in 2017. A total of 43 samples (7 oral-gastrointestinal gels and 36 oral-gastrointestinal suspensions) were collected from hospitals, pharmacies, and manufactories. The microbiological quality of non-sterile products were conducted according to Chinese Pharmacopoeia Edition VIII published in 2016 and announcement No. 398194 of the Department of Health of Taiwan. Based on the regulation, the total aerobic microbial count of gels and suspensions should not be more than 100 CFU per mL (gram) and must not be contaminated with Escherichia coli and Pseudomonas aeruginosa. The results showed that total aerobic microbial counts of the 4 non-compliant samples exceeded the specification limit (non-compliant rate was 9.3%), and 1 sample (2.3%) failed to comply with their labeling requirements. To protect public health and medical quality, these results have been forwarded to the local health authorities. Moreover, the suppliers were requested to recall their products and correct labeling mistakes.