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目的:制备木蝴蝶含片。方法:以木蝴蝶提取物为主药,采用湿法制粒压片法,在单因素考察基础上,以含片外观、口感、崩解时限、硬度为指标,通过正交设计试验对处方进行优化筛选,确定含片的制备处方。以平均重量差异和平均崩解时间为指标,对按照优化的处方工艺制备的3批含片进行质量检查。结果:优选的处方为:甘露醇50%,甜味剂为蔗糖-甜菊糖苷(100∶1)5%,清凉剂为天然薄荷油5%,粘合剂为聚维酮-K30(PVP-K30)-85%乙醇(6∶10)35%。以筛选的处方工艺制备的3批含片平均重量差异为(1.83±0.29)%,平均崩解时间为(14.7±0.6)min,均符合药典质控要求。结论:木蝴蝶含片制备工艺稳定,重复性良好。
Objective: Preparation of wood butterfly pieces. Methods: Wood butterfly extract was used as the main drug. The wet granulation method was adopted. Based on the single factor study, the prescription was optimized by orthogonal design with the appearance, taste, disintegration time and hardness as the indexes Screening to determine the tablet preparation preparation. Based on the average weight difference and average disintegration time, three batches of tablets prepared according to the optimized formulation process were inspected for quality. Results: The preferred prescriptions were mannitol 50%, sweetener 5% sucrose-steviol glycoside 100%, refreshing agent 5% natural peppermint oil, binder Povidone-K30 (PVP-K30 ) -85% ethanol (6:10) 35%. The average weight difference of the three batches prepared by the screening prescription was (1.83 ± 0.29)% and the average disintegration time was (14.7 ± 0.6) min, all of which met the quality control requirements of pharmacopoeia. Conclusion: The preparation process of wood butterfly lozenge is stable and reproducible.