- 期刊
市售大型輸注液生理食鹽水之熱原調查
Pyrogen Testing of Large Commercial Packages of Normal Saline
摘要
The purpose of this project was to survey for the presence of pyrogen in the products of normal saline in large commercial packages. Samples were collected from commercial drug stores in several towns and cities in northern Taiwan. In all 36 samples were collected and represented products manufactured by 7 companies in Taiwan. Four different packaging materials were used for containers. These included glass, plastic bottles and soft bags of 500mL and plastic bottles of 1000mL. The method of pyrogen testing was adapted from the Chinese Pharmacopoeia, 4th edition, using rabbits as the laboratory recipients. The results show that the average rise in body temperature was low (＜3(C) indicating that all products tested ware pyrogen free. We conclude that the products of normal saline in large packaging produced by local manufactures all meet the testing standards of pyrogen free status.
並列摘要
The purpose of this project was to survey for the presence of pyrogen in the products of normal saline in large commercial packages. Samples were collected from commercial drug stores in several towns and cities in northern Taiwan. In all 36 samples were collected and represented products manufactured by 7 companies in Taiwan. Four different packaging materials were used for containers. These included glass, plastic bottles and soft bags of 500mL and plastic bottles of 1000mL. The method of pyrogen testing was adapted from the Chinese Pharmacopoeia, 4th edition, using rabbits as the laboratory recipients. The results show that the average rise in body temperature was low (＜3(C) indicating that all products tested ware pyrogen free. We conclude that the products of normal saline in large packaging produced by local manufactures all meet the testing standards of pyrogen free status.