注射用清开灵(冻干)调配方法优化及其在不同溶媒中稳定性的研究

Optimization of Dispensing Method of Qingkailing Freeze-dried Powder for Injection and Its Stability in Different Kinds of Solvent

目的优化注射用清开灵(冻干)调配技术,并考察其与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液及葡萄糖氯化钠注射液配伍的稳定性。方法采用正交试验优化注射用清开灵(冻干)的溶解方法;采用高效液相色谱法(HPLC)测定成品输液中栀子苷、黄芩苷、绿原酸的含量变化,并测定不溶性微粒及pH值变化,考察成品输液的稳定性。结果注射用清开灵(冻干)最佳调配方法为每支用5 ml灭菌注射用水,1000 r/min振荡3 min。8 h内4种成品输液中栀子苷、黄芩苷、绿原酸的含量均较稳定;6 h内0.9%氯化钠输液、10%葡萄糖输液不溶性微粒符合要求,4 h内5%葡萄糖输液、葡萄糖氯化钠输液不溶性微粒符合要求;6 h时0.9%氯化钠输液、10%葡萄糖输液pH值均小于6.0,4 h时葡萄糖氯化钠输液、5%葡萄糖输液pH值均小于6.0。结论临床使用时,注射用清开灵(冻干)采用最佳调配方法溶解后,宜使用0.9%氯化钠或10%葡萄糖注射液为溶媒,现用现配。

Objective To optimize the dispensing method of Qingkailing Freeze-dried Powder for Injection and investigate its stability in 0.9%sodium chloride injection,5%glucose injection,10%glucose injection and glucose and sodium chloride injection.Methods The orthogonal test was used to optimize the dispensing method of Qingkailing Freeze-dried Powder for Injection.The contents of gardenoside,baicalin and chlorogenic acid in finished infusion were determined by HPLC and the insoluble particles and pH values were also measured to evaluate the stability of Qingkailing Freeze-dried Powder for Injection in different solvents.Results The optimal dispensing method of Qingkailing Freeze-dried Powder for Injection was as follows:5 ml Sterile Water for Injection was added,and then was oscillated for 3 min at the frequency of 1000 r/min.The insoluble particles in 0.9%sodium chloride infusion and 10%glucose infusion within 6 h and the insoluble particles in 5%glucose infusion and glucose and sodium chloride infusion within 4 h after dispensing met the requirements.The pH values of 0.9%sodium chloride infusion and 10%glucose infusion were less than 6.0 at 6 h,and the pH values of glucose and sodium chloride infusion and 5%glucose infusion were less than 6.0 at 4 h.Conclusion In clinical use,0.9%sodium chloride injection or 10%glucose injection should be used as the solvent after dissolution of Qingkailing Freeze-dried Powder for Injection,and dispensing should be carried out right before administration.