注射用凯西莱与专用溶剂配伍合理性的实验研究

目的:通过实验,考察注射用凯西莱与专用溶剂配伍合理性,以供临床用药参考.方法:将注射用凯西莱分成两组,配伍组按说明书方法配制；实验组则直接分别溶解在5％葡萄糖注射液、10％葡萄糖注射液及氯化钠注射液中,在同一温度条件下放置,在各检测时间点观察其外观、不溶性微粒、pH值的变化情况,并通过HPLC法测定配伍液中凯西莱的含量.结果:在同一温度条件下,各检测时间点的配伍液其外观、不溶性微粒数均无明显变化,pH值则均逐渐增大,含量显著下降；而实验组则无明显变化.结论:注射用凯西莱配制不必使用碱性专用溶剂,以免影响其注射液质量的稳定.

Experimental research of injectable tiopronin and the rationality of special solvent compatibility

Objective: To observe the injectable tiopronin and the rationality of special solvent compatibility through experiments so as to provide reference to clinical drug use.Methods: Injectable tiopronin were divided into 2 groups.The compatibility group was prepared in terms of the instruction method,while the experimental group was directly dissolved in 5% glucose injection,and in 10% glucose injection and 10% sodium chloride injection respectively.They were stored under the same temperature.The appearance and insoluble particles and the changes of pH values were observed in different detection time points.Also the tiopronin concentration in the compatible special solvent was determined by HPLC method.Results: Under the same temperature,the appearance and insoluble particle nubers in the compatibility group did not change significantly,but the pH values of all solutions increased gradually and the concentration decreased greatly.whereas these did not change obviously in the experimental group.Conclusion: The preparation of the injectable tiopronin does not need any alkaline special solvent in case it will affect the steadiness of the quality of the injections.