摘要
目的:考察注射用硫普罗宁与不同输液溶媒配伍的稳定性。方法:检测注射用硫普罗宁用专用溶媒(5%碳酸氢钠溶液,pH7.5～8.5)溶解后,分别与5%葡萄糖注射液、0.9%氯化钠注射液配伍,于20℃放置12h内的外观、不溶性微粒、pH值的变化情况,并应用高效液相色谱法测定各输液溶媒中硫普罗宁在各时间点的含量。结果:在20℃、12h内,注射用硫普罗宁采用专用溶媒配制后扩容,其外观和不溶性微粒数均无明显变化,pH值逐渐增大,含量显著下降。结论:注射用硫普罗宁用专用溶媒配制后应尽早使用,以确保其质量的稳定。
OBJECTIVE： To study the stability of Tiopronin for injection in different infusion solvents. METHODS： After dissolved in special solvent （5% sodium bicarbonate, pH 7.5-8.5） , the changes in appearance, insoluble particles and pH of Tiopronin for injection in 5% Glucose injection and 0.9% sodium chloride injection at 20 ℃ for 12 h were observed or tested; the contents of tiopronin in infusion solvents were measured by HPLC at various test time. RESULTS： Tiopronin for injection prepared according to the instruction after the expansion, its appearance and the number of insoluble particles had no significant changes, pH value was gradually increased while their contents were significantly decreased in 12 h at 20 ℃. CONCLUSIONS： Tiopronin for injection prepared by special solvents should be used up as soon as possible for the stability of quality.
出处
《中国药房》
CAS
CSCD
2013年第22期2073-2075,共3页
China Pharmacy
