Gillies I R, Thiel W J, Oppenheim R C
J Pharm Pharmacol. 1986 Feb;38(2):87-92. doi: 10.1111/j.2042-7158.1986.tb04517.x.
Theoretical predictions and computer simulations indicate that it may be impossible to achieve values of the coefficient of variation usually found in large volume parenterals (LVP) when the intrinsic particulate contamination in small volume parenterals (SVP) is investigated. Snap-opened ampoules from Australian manufacturers containing 5, 10 or 20 ml Water for Injections or Sodium Chloride Injection had a high level of particulate contamination, although within the USP XXI SVP limits. Heat-opened ampoules had much lower levels of contamination which were generally below the official LVP limits. Counts ml-1 were typically less than 10 and less than 1 for 5 and 20 micron particles, respectively. Coefficients of variation of the 5 micron data from an ampoule in any batch examined, typically ranged over 30-70%. Statistical analysis of the 5 micron data indicates significant differences between batches. Occasional ampoules had higher 5 micron counts than others in the same batch. At no time were the particulate contamination levels considered to be clinically important.
理论预测和计算机模拟表明，在研究小容量注射剂（SVP）的内在微粒污染时，可能无法达到大体积注射剂（LVP）中常见的变异系数值。来自澳大利亚制造商的装有5、10或20毫升注射用水或氯化钠注射液的易折安瓿瓶微粒污染水平较高，尽管在USP XXI SVP限度内。热开安瓿瓶的污染水平要低得多，通常低于官方LVP限度。每毫升的计数通常分别小于10，对于5微米和20微米的颗粒分别小于1。在任何一批检查的安瓿瓶中，5微米数据的变异系数通常在30%-70%范围内。对5微米数据的统计分析表明批次之间存在显著差异。同一批次中偶尔有安瓿瓶的5微米计数高于其他安瓿瓶。微粒污染水平在任何时候都不被认为具有临床重要性。
