Passl W J
J Pharm Pharmacol. 1979 Nov;31(11):721-5. doi: 10.1111/j.2042-7158.1979.tb13644.x.
Concern about limited surface durability has been the main reasons for recommendations by advisory committees and government health authorities, not to reu-use sulphur-treated soda-lime glass (type II) bottles for intravenous solutions. In order to contribute specific data, the interactions of slightly acid and neutral parenteral solutions with ammonium sulphate-treated type II glass bottles have been investigated. It was established that the amounts of silica, sodium and calcium released into the solution are not greater than the potential background contamination from the raw materials. The number of particles in the solution was well below the limits set by the British Pharmacopoieia and not much higher than the lowest background count practically achievable. On an average, bottle surfaces released less material after the first time of use. Bottle-to-bottle variations revealed by scanning electron microscopy point at problems in achieving smooth, evenly surface-treated bottle surfaces during bottle manufacture.
对表面耐久性有限的担忧一直是咨询委员会和政府卫生当局建议不要重复使用经硫磺处理的钠钙玻璃(II型)瓶来盛装静脉注射液的主要原因。为了提供具体数据,研究了微酸性和中性肠胃外溶液与经硫酸铵处理的II型玻璃瓶之间的相互作用。结果表明,释放到溶液中的二氧化硅、钠和钙的量不大于原材料潜在的背景污染量。溶液中的颗粒数量远低于英国药典规定的限度,且仅略高于实际可达到的最低背景计数。平均而言,瓶子表面在首次使用后释放的物质较少。扫描电子显微镜揭示的瓶与瓶之间的差异表明,在瓶子制造过程中,要实现表面光滑、均匀处理的瓶子表面存在问题。