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目的:研究生地黄汤口崩片的制备工艺,筛选出最佳工艺参数。方法:采用正交实验法,以崩解时间、硬度、脆碎度、片重差异为评价指标,考察载药量、辅料配比、润滑剂用量等因素对口崩片制备工艺的影响。结果:最佳制备工艺为药粉40%,MCC∶PVPP(4∶1)59%,硬脂酸镁1.0%。采用粉末直接压片法,崩解时间为27 s,硬度为2.69 kg,脆碎度0.28%,片重差异为1.32%,均符合要求。结论:生地黄汤口崩片的制备工艺合理可行,压出的药片质量稳定。
Objective: To study the preparation process of Dihuang Tang orally disintegrating tablets and screen out the best process parameters. Methods: The orthogonal experiment was used to evaluate the influence of disintegration time, hardness, friability and weight difference on the preparation of Orally disintegrating tablets. Results: The best preparation process was 40% of drug powder, 59% of MCC: PVP (4:1) and 1.0% of magnesium stearate. The powder direct compression method, the disintegration time of 27 s, hardness of 2.69 kg, friability 0.28%, weight difference of 1.32%, are in line with requirements. Conclusion: The preparation process of rehmanniae decoction piece is reasonable and feasible, and the quality of the extruded tablets is stable.