ABSTRACT
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 1 200 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.