國產非無菌藥品之微生物品質調查研究   全文下載

Microbial Quality Investigation of Non-sterile Pharmaceutical Products in Taiwan

非無菌藥品依給藥途徑包含口服及其他經由直腸、口腔黏膜、牙齦、皮膚、鼻、耳、陰道、經皮吸收貼片及吸入等非口服方式，若產品遭微生物污染，則可能導致藥品療效減少甚至失去功效，且使患者增加感染機會。目前國外如歐洲藥典（European Pharmacopoeia, EP 9.0）、美國藥典（United States Pharmacopoeia, USP 40）及日本藥典（Japanese Pharmacopoeia, JP XVII）等均已針對各類非無菌藥品制定微生物品質建議規格，食藥署106年已進行口服液劑藥品之微生物品質調查研究，107年再針對其他非無菌藥品進行微生物品質調查研究。為了解國內製造廠非無菌藥品之微生物品質現況，故針對國內核准製造之非無菌藥品進行抽樣。檢驗結果顯示206件檢體中，203件檢體（98.5％）符合國際藥典建議規格，3件檢體（1.5％）好氧性微生物總數不符合建議規格，不符合國際藥典建議規格之產品已進行後續處辦或要求製造廠改善。彙整分析106－107年之非無菌產品微生物品質調查結果，抽得國產產品共318件（106年國產件數為112件，107年國產件數為206件），僅有5件（1.6％）產品之好氧性微生物總數（均含天然物質成分）不符合國際藥典建議規格，雖然國內大部分藥廠製程品質皆具有相當水準，但仍可再更加精進，故可將非無菌藥品微生物品質之國際藥典建議規格納入中華藥典中，以增進國人用藥之安全。

Non-sterile pharmaceutical products can be divided into oral, rectal, oromucosal, gingival, cutaneous, nasal, auricular, vaginal, transdermal patches and inhalation uses according to the routes of administration. Micro-organisms contamination in non-sterile pharmaceutical products could diminish the therapeutic effect and cause infection. European Pharmacopoeia (EP 9.0), United States Pharmacopeia (USP 40) and Japanese Pharmacopoeia (JP XVII) have established the recommended acceptance criteria of microbiological quality for non-sterile pharmaceutical products. We have investigated the quality and microbial limits of the oral liquid medicine in 2017. This study was thus aimed to investigate and monitor the quality and microbial limits of other dosage forms of non-sterile pharmaceutical products made in Taiwan in 2018. 203 out of 206 samples met the recommended acceptance criteria, except 3 samples were noncompliance. We notified local health authorities of these noncompliant results and requested the manufacturers to take corrective and preventive action. In summary, a total of 318 samples were tested (112 and 206 samples in 2017 and 2018, respectively). The result showed that the total aerobic microbial counts of 5 samples (1.6%), all of which contained raw material from natural origin, were noncompliant with the recommend acceptance criteria. In conclusion, most of the production quality of pharmaceutical manufacturers in Taiwan met the recommended acceptance criteria. To ensure the safety of medicines for public health, the recommended acceptance criteria of microbial quality of non-sterile pharmaceutical products should be adopted in Chinese Pharmacopeia.