磺胺噻唑鈉鹽安瓿,放置时間較長后,原来透明無色的溶液,会慢慢变成橙黃色乃至深紅棕色,繼而产生渾濁及沉淀等现象。其他磺胺制剂,亦存在着相同的問題。变色的原因,过去曾有許多推测:有認为是原料包括蒸溜水中杂質的变化;有認为由于安瓿玻璃鹼性改变了溶液的pH值,促进內容物的分解;亦有認为是灭菌不徹底所引起的。但是也有原料与操作条件完全相同,所生产的同一批号安瓿,存放同一时間后,却产生不同的变化。有一些变了顏色,顏色深淺亦不一样;有些並無变化,仍然保持了原来的透明無色。这些現象要作进一步解釋,就感到困难。至于所产生的色素与沉淀,究竟是什么东西,也是很难回答的問題。去年全国制剂技术交流会上,对这个問題曾提出来討論过,由于缺乏实驗数据,仍然沒有作出結論。 Sulfathiazole sodium salt ampoule, place a longer time, the original transparent colorless solution, will gradually turn into orange and even dark reddish brown, and then produce the phenomenon of turbidity and precipitation. Other sulfa preparations, there are also the same problem. The reason for the discoloration has been speculated in the past to be that there is a change in the raw materials, including impurities in the distilled water, that the pH of the solution is changed due to the basicity of the ampoule glass, and the decomposition of the contents is promoted, Not caused by bacteria completely. But there are also the same raw materials and operating conditions, the same batch of ampoules produced, stored at the same time, but produce different changes. Some have changed color, color depth is not the same; some did not change, still maintain the original transparent colorless. It is difficult to explain these phenomena for further explanation. As for the resulting pigment and precipitation, what exactly is also difficult to answer the question. Last year at the National Technical Conference on Formulation, this issue was discussed and discussed. Due to the lack of experimental data, no conclusion has been reached yet.