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目的:优选穿心莲内酯混悬剂的处方工艺。方法:采用分散法制备穿心莲内酯混悬剂,以沉降体积比、再分散性和溶出度的综合评分为指标,采用正交试验优选处方。结果:最佳处方工艺为每1 mL混悬剂含穿心莲内酯100 mg,羧甲基纤维素钠5 mg(0.5%),甘油5 mg(0.5%)。制得穿心莲内酯混悬剂的沉降体积比0.99,再分散性良好,1 h溶出度99.59%。结论:优选的处方工艺稳定可行,制剂的物理稳定性良好,符合混悬剂的质量要求。
Objective: To optimize the formulation of andrographolide suspension. Methods: The andrographolide suspension was prepared by the dispersive method. The orthogonal test was used to optimize the prescription with the comprehensive score of sedimentation volume ratio, redispersibility and dissolution as indexes. Results: The optimal prescription was 100 mg of andrographolide, 5 mg of sodium carboxymethylcellulose and 0.5 mg of glycerol per 1 mL of suspension. The prepared volume of andrographolide suspension volume ratio of 0.99, good redispersibility, 1 h dissolution 99.59%. Conclusion: The preferred prescription process is stable and feasible, and the physical stability of the preparation is good, which meets the quality requirements of the suspension.