| 中文摘要 |
口服液劑便於服用且接受度高，常用於嬰幼兒、老年人及癌症患者等提高其服藥順從性，然因其為水溶液，且如糖漿劑經矯味後富含糖類，若製造流程、運送或儲存條件不慎，將導致微生物生長，故其微生物控管相對重要，為避免患者服用遭致病原菌或過量微生物污染的藥品危害健康，有必要監控口服液劑之微生物品質。目前國內除胃腸用口服膠漿及懸液外，尚未對其他口服液劑藥品訂定微生物品質規範，因此有必要了解並建立該類非無菌製劑品質之背景資料。有鑑於此，本計畫先針對國內核准製造及輸入口服液劑類藥品，委由地方政府衛生局採分區分階段方式至轄區診所、藥局及製造廠（含代理商）等地點進行隨機及源頭抽樣，依中華藥典第八版之微生物計數法及特定微生物檢驗法進行「好氧性微生物總數」、「酵母菌與黴菌總數」、「大腸桿菌」、「綠膿桿菌」及「金黃色葡萄球菌」之檢驗，以建立口服液劑之微生物品質背景資料。本次調查建立124件口服液劑之微生物背景資料，將供主管單位及中華藥典制定相關規範之參考，以保障國人健康與用藥安全。
Due to the ease to intake and high acceptance, oral liquid medicines are widely used among infants/ children, elders, and cancer patients to improve medication compliance. However, since oral liquid medicines are aqueous solutions rich in sugar after flavored, if the manufacturing, transporting, or storing condition is inadvertent, microorganisms could easily grow; thus, the microbiological control is especially important for oral liquid medicines. To prevent the contamination of oral liquid medicine from pathogens or excessive microorganisms, the purpose of this investigation is to monitor the microbiological quality of oral liquid medicines. Currently, standards for microbiological quality have not been established for all oral liquid medicines, except for the mucilage and suspensions used for gastrointestinal issues. Hence, it is necessary to identify the background information for all non-sterile products. To address this problem, local health bureau collected samples of oral liquid medicine that have been approved for manufacture and import with phase approach. One hundred and twenty-four samples from the clinics, pharmacies, manufactories as well as agents were collected. The total aerobic microbial count, total combined yeasts/ molds count, and the detection of Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus were conducted according to the Chinese Pharmacopeia Edition VIII. The collected results could be used as important references for further policy development to ensure the safety of medicines in public health. |
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