经典名方地黄饮子片的制备工艺

Study on the Preparation Technology of DihuangYinziTablets

目的:研究地黄饮子片剂的制备工艺。方法:以颗粒的合格率为指标,研究颗粒制备中润湿剂的选择、辅料种类、辅料用量、粒干燥温度等对制备工艺的影响;考察润滑剂硬脂酸镁的用量;以崩解度、重量差异和脆碎度考察片剂质量。结果:制备颗粒时选择乳糖作为稀释剂,干膏粉与稀释剂的比例为1∶1;硬脂酸镁用量为0.8%。制粒工艺:将准备好的干膏粉与乳糖按1∶1的比例混合,加入适量水制软材,使用摇摆颗粒机制粒,放入50~60℃的鼓风干燥箱干燥,干燥后整粒。压片加入0.8%的硬脂酸镁,增加颗粒流动性。结论:最终制备出的地黄饮子片脆碎度、重量差异、崩解时限均符合要求,片剂口感较好、外观光洁、制剂工艺合理可行。

Objective: The preparation technology of DihuangYinzi tablet was studied. Methods: Taking the qualified rate of granules as the index, the influence of the selection of wetting agent, type of auxiliary materials, quantity of auxiliary materials and drying temperature of granules on the preparation process was studied. The dosage of magnesium stearate in lubricant was investigated. The quality of tablets was examined by disintegrating degree, weight difference and brittleness. Results: lactose was selected as the diluent, and the ratio of dry paste powder to diluent was 1 ∶ 1. Magnesium stearate was used in 0.8%. Granulating process: will only prepared dry paste powder mixed with 1 ∶ 1 according to the proportion of lactose, adding suitable amount of water is made of soft material, used to sway, particle mechanism size in 50 ~ 60 ℃ drum wind drying oven drying, dry granulation. By adding 0.8% magnesium stearate into the tablet, the particle fluidity was increased. Conclusion: The final DihuangYinzi tablets have good taste, bright appearance and reasonable preparation technology.