Cooley R L, Lubow R M
Oral Surg Oral Med Oral Pathol. 1981 May;51(5):481-3. doi: 10.1016/0030-4220(81)90005-0.
Particulate contamination was found in one particular lot number of local anesthetic, lidocaine with 1:100,000 epinephrine. The contaminants were noticed in several cartridges of each container and varied in size from minute to several millimeters. Analysis of the foreign matter revealed the particles to be of a way or puttylike consistency; however, the sterility of the solution was not altered and the pH was still within acceptable limits. The contaminant was most likely wax or a combination of wax, silicone, and glycerin, which are constituents of the rubber stopper and its associated lubricants. This problem was most likely due to temperature changes during storage and shipment, but it was also possibly due to manufacturing discrepancies.
在一批特定批号的局部麻醉药（含1:100,000肾上腺素的利多卡因）中发现了微粒污染。在每个容器的几个药筒中都发现了污染物，其大小从微小到几毫米不等。对异物的分析表明，这些颗粒具有蜡状或油灰状的稠度；然而，溶液的无菌性未改变，pH值仍在可接受范围内。污染物很可能是蜡，或者是蜡、硅酮和甘油的混合物，它们是橡胶塞及其相关润滑剂的成分。这个问题很可能是由于储存和运输过程中的温度变化，但也可能是由于生产差异。
