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)

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%。

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 ®). 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.