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目的:筛选青蒿琥酯干混悬剂的最佳处方,并对其质量进行考察。方法:以沉降体积比、再分散性以及干燥失重等为考察指标,分别采用单因素和正交试验考察填充剂、助悬剂、黏合剂和崩解剂的种类和用量,优选出最佳处方。采用HPLC法测定制剂中主药的含量,考察不同转速及溶出介质对其溶出行为的影响,并考察制剂在温度为(30±2)℃、相对湿度为(75±5)%条件下放置4个月的稳定性。结果:青蒿琥酯干混悬剂的最佳处方为:以蔗糖作为填充剂,15%微晶纤维素为崩解剂,8%黄原胶和12%羧甲基纤维素钠为助悬剂,浓度为6%的聚乙烯吡咯烷酮K30醇溶液(50%乙醇)为粘合剂。采用优化的处方制备4批样品,其标示含量均大于95%,沉降体积比均高于0.9,20 min时的溶出度均在80%以上,样品放置4个月后各项检测指标均符合要求,且无显著性变化。结论:所筛选的青蒿琥酯干混悬剂处方工艺简单、重复性好、稳定可控。
Objective: To screen the best formulation of artesunate dry suspension and investigate its quality. Methods: Taking sedimentation volume ratio, redispersibility and weight loss as indexes, the types and contents of filler, suspending agent, binder and disintegrant were investigated by single factor and orthogonal experiment respectively, and the best prescription . The content of the main drug in the preparation was determined by HPLC. The effects of different rotation speed and dissolution medium on its dissolution behavior were investigated. The preparation was placed under the temperature of (30 ± 2) ℃ and the relative humidity of (75 ± 5)% for 4 Month’s stability. Results: The optimum prescription of artesunate suspension was sucrose as filler, 15% microcrystalline cellulose as disintegrator, 8% xanthan gum and 12% sodium carboxymethyl cellulose as suspending aid Agent, polyvinylpyrrolidone K30 alcohol solution (50% ethanol) at a concentration of 6% is a binder. Four batches of samples were prepared with the optimized prescription, the content of which was more than 95%, the volume of sedimentation volume was higher than 0.9, the dissolution rate was more than 80% at 20 minutes. After the samples were placed for 4 months, the detection indexes were in accordance with the requirements , And no significant changes. Conclusion: The selected artesunate dry suspension formulation process is simple, reproducible, stable and controllable.