比較切開玻璃和塑膠安瓿裝甘草酸X注射液後之微粒污染狀況   全文下載

Comparison of Particulate Contamination in Glass and Plastic Ampoules of Glycyrrhizin Injections after Ampoule Cutting

本文評估甘草酸?注射液（glycyrrhizin injection）的安瓿切開後，微粒的數目和種類。經調查生產玻璃安瓿注射液5 家公司之100 支針劑，每mL注射液平均有252.9 個粒徑1.3-5 μm 以下之微粒，粒徑5-10 μm 之平均微粒數為12.5 個/mL。而且，這5 家公司的產品間，微粒數量具有明顯的差異，每mL 注射液含粒徑1.3-5 μm 之平均微粒數為121.6-351.9 個。此外，經調查6 家生產塑膠安瓿注射液公司的120 支針劑，粒徑1.3-5 μm 平均微粒數為12.5 個/mL，粒徑5-10 μm 之平均微粒數為2.1 個/mL，此6 家公司產品間的微粒數量差異很小。存在於開封後之甘草酸?注射液塑膠安瓿中之微粒數顯著低於玻璃瓶（p < 0.0001）中。以電子顯微鏡及X 光分析證實，於開封後之玻璃安瓿注射液有玻璃碎片。甘草酸?注射液在亞洲地區的日本、台灣和中國廣泛使用。為避免玻璃碎片進入人體，建議使用塑膠製安瓿。

We evaluated the number and types of particles in glycyrrhizin injections after ampoule cutting. A total of 100 glass ampoules of 5 companies were examined. The mean number of particles with diameter of 1.3- < 5 μm was 252.9/mL, and that of particles with diameter of 5- < 10 μm was 12.5/mL. The number of particles differed among products of the 5 companies, e.g., the number of particles with a diameter of 1.3- < 5 μm varied from 351.9/mL to 121.6/mL. In addition, a total of 120 plastic ampoules from 6 companies were evaluated. The mean number of particles with a diameter of 1.3- < 5 μm was 43.0/mL, and that of particles with a diameter of 5- <10 μm was 2.1/mL. Differences among products of the 6 companies were not siqnificant. The number of particles in glycyrrhizin injections after ampoule cutting was significantly lower in plastic than for glass ampoules (p < 0.0001). Scanning electron microscopy and X-ray microanalysis identified glass fragments in glycyrrhizin injection samples after the cutting of glass ampoules but identified no particles after cutting plastic ampoules. Glycyrrhizin injections are commonly used in Asia including Japan, Taiwan, and China. The use of plastic ampoules is recommended for the prevention of the entry of glass fragments into the body.