人工淚液眼用藥品之無菌試驗品質監測調查   全文下載

Sterility Surveillance of Artificial Tears in Taiwan

人工淚液眼用藥品可維持眼睛濕潤，可緩解眼睛乾澀不適感，如使用受污染之人工淚液將導致嚴重感染進而造成身體損傷，112年初美國疾病管制與預防中心公佈一起由印度藥廠生產之人工淚液因污染導致細菌群聚感染事件，造成民眾死亡或永久性失明。有鑑於此，為瞭解現階段市場品質現況，確保國人使用安全，旋即針對適應症為暫時緩解因眼睛乾澀所引起灼熱感與刺激感等人工淚液產品進行無菌品質調查。列入本抽樣計畫之有效許可證共35張（含國產15張及輸入20張），並依藥廠或代理商所在地委請衛生局逕至源頭抽樣，共抽得27件檢體，再由本署依據中華藥典第九版進行無菌試驗，該27件檢體之無菌試驗結果均符合中華藥典第九版無菌試驗法規範，確保國民用藥安全。

Artificial tears are used to provide moisture and relieve symptoms of eye dryness. Using artificial tears contaminated with bacteria increases risk of severe infections that could lead to blindness and even death. In 2023, the U.S. Centers for Disease Control and Prevention (CDC) issued an outbreak notice regarding a cluster infection related to contaminated artificial tears. In order to ensure the medication safety, this study aimed to investigate the sterility of artificial tears. Twenty-seven randomly selected samples were collected by local health authorities from factories and distributors in 2023. The sterility test was conducted according to the membrane filtration method as described in the ninth edition of Taiwan Pharmacopeia. The results showed that all of the samples were qualified for the sterility test and this meets the criteria for public health and medication safety.