市售大型輸注液異物微粒子品質調查

Investigation on the Particulate Matters Contamination in Commercial Large Volume Parenteral Solutions (LVPs)

鄒玫君(Meir-Chyun Tzou) ； 陳玉盆(Yuh-Pun Chen) ； 徐廷光(Ting-Guang Shyu) ； 莊清堯(Ching-Yao Chuang)

《藥物食品檢驗局調查研究年報》 6號 (1988/09) Pp. 29-42

https://doi.org/10.6946/ASRNL.198809.0029

摘要

為了解市售大型輸注液異物微粒子污染情形，於74年9月至75年1月間分赴台灣地區各醫院、診所及藥局、藥房抽購該項檢體共550件，其中國產品519件，輸入品31件，依英國藥典1980版1收載之電阻檢驗法及規定予以檢驗，檢驗結果共88件不合該規定（占16.0%），其中國產品74件，輸入品14件。國產品不合該規定者主要以氯化鈉注射液較葡萄糖類（包括葡萄糖、葡萄糖電解質、葡萄糖醛內酯－葡萄糖）注射液者為多。輸入品中胺基酸注射液不合該規定之比率達43.5%。

關鍵字

大型輸注液 ； 異物微粒子 ； 電阻檢驗法

並列摘要

In order to survey the contamination of particulate matters in commercial large volume parenteral solutions, we purchased 550 samples randomly from hospitals and drugstores in Taiwan area from Sep., 1985. to Jan., 1986. All samples were analyzed by the electrical resistance method described in the B. P. 1980 using a particle size analyzer (Coulter counter (superscript ®)). The results showed that a total of 88 cases (i. e., 16.0%), including 74 domestic and 14 imported products, did not meet the requirements of ”Limit Test for Particulate Matters” in B. P. 1980. Among the domestic disqualified samples, the contaminations of particulate matters for both sodium chloride and Ringer's solutions were more serious than that of the glucose-containing solutions (pure glucose, electrolyte-glucose and glucurolactone-glucose were all included).
About 43.5% of imported amino acid solutions can't meet the requirements specified in the B. P. 1980.