大型輸注液（葡萄糖溶液）之熱原試驗   全文下載

The Quality Investigation of Large Volume Parenteral (Glucose Injection Solution) with Pyrogen Testing

大型輸注液（Large Volume Parenteral, LVP）是指以點滴方式，直接注射100毫升以上之各種電解質、代用血漿、胺基酸、維他命等注射液於體質虛弱、手術後復原之病人，若被污染或具發熱性物質存在，則影響病人健康甚鉅。本計畫之目的係調查台灣省21個縣市地區各醫院、診所及藥局所販賣之大型輸注用葡萄糖注射液，是否含有發熱性物質以確定其安全性，檢體來源係函請台灣省21個縣市地區地方衛生單位至各縣市醫院、診所及藥局抽取檢體30件，包括南光、信東、台裕、永豐、濟生、安星及壽元等7家藥廠。檢體容量分別為500mL及250mL，檢體容器材質有3種，包括玻璃瓶、塑膠瓶及塑膠軟袋。熱原試驗方法係依據美國藥典第23版及中華藥典第四版，使用兔子作為實驗動物，其檢驗結果顯示所有兔子體溫上升範圍皆在藥典規定內，表示受試檢體皆不含熱原，其合格率為百分之百。"

Large Volume Parenteral (LVP) means to inject large volume of IV solution including electolytes, substitute plasma, amino acids, vitamins etc. into weak patients recovering from surgery. If it was contaminated or pyrogen found, it would be a great threat to the health of patients.The purpose of this project was to make a survey of the quality of LVP (Glucose injection solution) with pyrogen test in order to keep the safety of the commercial products in Taiwan.Thirty samples were collected from hospitals, clinics and pharmacis in twenty one counties in Taiwan. These samples were manufactured by 7 manufacturers including Nang Kuang, Sintong, Tai Yu, Yung Fang, Chi Sheng, Astar and Siu Guan. The volume of the samples was 500mL or 250mL, and the containers were glass bottles, plastic bottles or soft bags.The method of pyrogen test was adopted from the US Pharmacopoeia XXIII and the Chinese Pharmacopoeia IV, using rabbits as the laboratory recipients. The results showed that the average rise value of rabbit's body temperature met the Pharmacopoeia standards, indicating that all tested samples were pyrogen free.