注射用双黄连(冻干)调配方法优化及其成品输液稳定性研究

Optimization of blending method of Shuanghuanglian injection and its stability study in different solvents

目的优化注射用双黄连(冻干)的调配方法,并考察其在不同溶媒(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)中的稳定性。方法采用正交试验优选注射用双黄连(冻干)的最佳溶解方法;通过测定成品输液中不溶性微粒、pH值及主要成分黄芩苷、连翘苷、绿原酸的含量变化,考察注射用双黄连(冻干)在不同溶媒中配伍的稳定性。结果注射用双黄连(冻干)最佳调配工艺为:加入5 ml灭菌注射用水,以1200 r/min振荡5 min。注射用双黄连(冻干)在4种成品输液中8 h内主要成分含量均较稳定;8 h内0.9%氯化钠输液、5%葡萄糖输液不溶性微粒符合要求,4 h内10%葡萄糖输液、6 h内葡萄糖氯化钠输液不溶性微粒符合要求;8 h内0.9%氯化钠输液pH值满足最佳配伍要求,2 h内5%葡萄糖输液pH值满足最佳配伍要求,4 h内葡萄糖氯化钠输液满足最佳配伍要求。结论本研究优化了注射用双黄连(冻干)的最佳调配方法,临床应用宜使用氯化钠注射液为溶媒配制成品输液,5%葡萄糖注射液配制的成品输液应现用现配。

Objective To optimize the blending method of Shuanghuanglian injection,and to investigate its stability in different solvents(0.9%sodium chloride injection,5%glucose injection,10%glucose injection,glucose and sodium chloride injection).Methods By using orthogonal test to optimize the best dissolution method of Shuanghuanglian injection By measuring the content change of insoluble particles,pH value and principal components(baicalin,forsythione,chlorogenic acid)in the finished products to investigatethe stability of Shuanghuanglian injection in different solvents.Results The optimal blending method of Shuanghuanglian injection was to add 5 ml sterilized water for injection into the vial and oscillate at 1200 r/min frequency for 5 min.The main constituents of Shuanghuanglian injection were stable in 8 h in the infusion of four kinds of finished products.Insoluble particles in 0.9%sodium chloride infusion and 5%glucose infusion met the requirements within 8 h,and insoluble particles in 10%glucose infusion and 6 h glucose and sodium chloride infusion met the requirements.The pH value of 0.9%sodium chloride infusion within 8 h met the optimal requirements of the best compatibility,5%glucose infusion within 2 h met the requirements,and 4 h sodium chloride infusion met the requirements of the best compatibility.Conclusion This study optimized the best preparation method of Shuanghuanglian(freeze-dried)for injection.Sodium chloride injection should be used as the solvent to prepare finished infusion in clinical application,and 5%glucose injection should be prepared just before use.