市售塑膠注射針筒之安全性調查

Safety Assessment of Commercial Disposable Plastic Syringes and Needles

連淑華(Shu-Hwa Lian) ； 吳美娟(Mei-Chuan Wu) ； 魏秀義(Shiow-Yin Wey) ； 江建勳(Chieng-Hsun Chiang) ； 林嘉伯(Chia-Po Lin)

《藥物食品檢驗局調查研究年報》 19號 (2001/09) Pp. 79-93

https://doi.org/10.6946/ASRNL.200109.0079

摘要

塑膠注射筒與注射針為目前使用最普遍的一種醫療器材，不論在醫院、診所皆大量使用，一般藥局亦可購得。塑膠注射筒或注射針之品質必須嚴格符合無毒、無菌、無熱原等規定，方可確保病人使用之安全。本計畫係調查北、高兩市及台灣地區21個縣市各醫院、診所、藥局及醫療器材用品店所販賣之塑膠注射筒或注射針，是否安全且符合生物學檢驗之規定，檢體來源係函請北、高兩市及台灣地區21個縣市地方衛生單位抽取檢體，檢體總件數44件，其中國產檢體16件佔36.3%，輸入檢體28件佔63.7%。生物學試驗方法依下列藥典進行試驗，依美國藥典第24版進行細胞毒性試驗，中華藥典第四版進行熱原試驗、LAL試驗及無菌試驗，日本醫療用具派準解說1993年版之規格進行一般急性毒性試驗，其生物學檢驗結果顯示一般急性毒性試驗、細胞毒性試驗、熱原試驗、LAL試驗及無菌試驗均符合藥典規定。本計畫除了評估市售注射針筒之安全性外，並可比較一般急性毒性試驗與細胞毒性間以及熱原試驗與LAL間試驗方法之優缺點，以期建立準確與迅速之檢驗方法。

關鍵字

塑膠注射針筒 ； 一般急性毒性試驗 ； 細胞毒性試驗 ； 熱原試驗 ； LAL試驗 ； 無菌試驗

並列摘要

Disposable plastic syringes and needles are the most commonly used medical devices, they are largely used in hospitals, clinics and could even be bought in the general pharmacies. For the safety of the patients, the quality of disposable plastic syringes must strictly meet the specification of non-toxic, sterile and non-pyrogenic. The purpose of this project is to survey the disposable plastic syringes selling in hospitals, clinics, pharmacies and medical devices supplement store in Taipei, Kaohsiung and 21 other counties in Taiwan, whether they meet the biological test requirement.
Total of 44 samples are collected, including 16(36.3%) samples manufactured in Taiwan and 28(63.7%) samples imported. The methods for the following biological tests were adapted from US Pharmacopoeia XXIV for cytotoxicity test, the Chinese Pharmacopoeia IV for pyrogen test, LAL (Limulus Amoebocyte Lysate) test and sterility test, and Interpretation of specification requirement for medical device 1993 for acute toxicity test. The results showed that acute toxicity test, cytotoxicity test, pyrogen test, LAL test and sterility test met the pharmacopoeia testing specification. This project not only evaluates the safety of commercial syringes, but also compares the advantage and disadvantage between acute toxicity test and cytotoxicity test, pyrogen test and LAL test, and also to establish faster and accurate testing method.

並列關鍵字

Disposable plastic syringes and needles ； acute toxicity test ； cytotoxicity test ； pyrogen test ； LAL test ； sterility test