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

比較切開玻璃和塑膠安瓿裝甘草酸苷注射液後之微粒污染狀況

Katsuhiro Yorioka ； Shigeharu Oie ； Akira Kamiya

《藥物食品分析》 17卷3期 (2009/06) Pp. 225-228

摘要

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.

關鍵字

微粒污染 ； 甘草酸苷注射液 ； 玻璃安瓿 ； 塑膠安瓿 ； 玻璃碎片

並列摘要

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.

並列關鍵字

particulate contamination ； glycyrrhizin injection ； glass ampoule ； plastic ampoule ； glass fragment