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題名 | 小型注射劑產品之發熱性物質檢驗=Pyrogenic Contamination Testing for Small Volume Parenteral Pharmaceuticals |
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作者姓名(中文) | 連淑華; 邱進益; 林嘉伯; | 書刊名 | 藥物食品檢驗局調查研究年報 |
卷期 | 24 民95.12 |
頁次 | 頁79-96 |
分類號 | 412.36 |
關鍵詞 | 小型注射劑; 發熱性物質; 熱原試驗; 細菌內毒素試驗; Small volume parenteral; Pyrogenic contamination; Pyrogen test; Bacterial endotoxin test; |
語文 | 中文(Chinese) |
中文摘要 | 小型注射劑產品其注射途徑可直接靜脈或肌肉注射於人體,或加入大型輸注液中靜脈點滴注射於人體血管中,故產品品質須達到無菌及無發熱性物質之製造要求,若注射劑產品受到發熱性物質污染,病患經注射後會引發一連串生理反應,如發燒、畏寒、低血壓、休克及器官代謝異常,嚴重時甚至可造成病患之死亡。而發熱性物質主要成分為內毒素,約90%以上由受污染水質中革蘭氏陰性菌細胞壁內之脂多醣體而來。因此為確保民眾用藥安全並提升醫藥品質,本計畫對於大型輸注液中維生素製劑及非新藥安全監視期間之學名藥製劑進行品質監測。本監測計畫,係採市售與源頭抽樣併行方式,協調各縣市衛生局至轄區醫院、診所、藥局或製藥廠,共抽取檢體324件,包括國產290件佔89.5%,輸入34件佔10.5%,分別來自國內藥廠34家,輸入藥廠18家。本計畫發熱性物質檢驗方法,係依據美國藥典第29版、中華藥典第五版及抽驗產品之檢驗規格,分別選用體內試驗方法,即「熱原試驗方法」,使用兔子經耳靜脈注射檢體測量肛溫之方式進行檢驗;或體外試驗方法,即「細菌內毒素試驗方法」,以內毒素凝膠方式,進行檢體內毒素含量之檢驗。檢驗結果顯示27件以兔子熱原試驗及297件以細菌內毒素檢驗之檢體,皆符合藥典試驗方法中發熱性物質檢查之規定。 |
英文摘要 | Small Volume Parenteral (SVP) can be injected intravenously, into human muscle, or used as vena injection in human blood vessel with the addition of Large Volume Parenteral (LVP). Therefore the quality of the parenteral pharmaceutical must be aseptic or free from pyrogenic contamination. If the SVP was contaminated or pyrogenic, patient will have a serial physical reaction after injection, such as fever, coldness, hypotension, shock, abnormal organ metabolism, or even death in more serious cases. Pyrogenic contamination is mainly composed of endotoxin, about 90% of which is lipopolysaccharide (LPS) from gram-negative bacteria. The purpose of this study is to monitor the SVP in vitamin products and existing generic pharmaceuticals. Total of 324 samples were collected by the local health authorities from hospitals, clinics, pharmacies and manufacturers from 21 counties in Taiwan. 290 samples (89.5%) were produced by local manufacturers (30 factories) and 34 (10.5%) were imported (17 factories). The pyrogenic contamination test method was based on the Chinese Pharmacopoeia V, including the in vivo Progen Test, using rabbit ear injection to measure rectal temperature, and the in vitro Bacterial Endotoxin Test, using Limulus Amebocyte Lysate Gel-Clot method (LAL test) for testing endotoxin contamination. The resut showed 27 rabbit pyrogen tests and 297 Gel-Clot LAL tests met the pyrogenic contamination guidelines. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。