当归补血片的成型工艺研究  

Study on the molding process of Danggui Buxue Tablets

作　　者：韩建鹏 孙萍 周彩娟 冯东燕 李萌萌 刘旭海 HAN Jian-peng;SUN Ping;ZHOU Cai-juan(Jiangxi University of Traditional Chinese Medicine,Nanchang 330004,China;不详)

机构地区：[1]江西中医药大学,南昌330004 [2]江中药业股份有限公司,南昌330049

出　　处：《中国处方药》2023年第9期25-31,共7页Journal of China Prescription Drug

基　　金：江西省重大科技研发专项(20203ABC28W018)。

摘　　要：目的优选当归补血片最佳处方及成型工艺条件。方法考察不同辅料对浸膏粉吸湿性、成型性的影响,采用混料设计和综合评分法优选当归补血片成型工艺条件,考察不同种类、不同配比条件下辅料对于湿法制粒所得颗粒的吸湿性、流动性、成型性、堆积性、可压性、稳定性影响,再结合最终成片抗张强度、崩解时限等参数,优选出当归补血片的最佳辅料,其中,本研究的关键是采用扭矩流变仪(MTR-3)对不同辅料、不同种类润湿剂条件下对当归补血片湿法制粒的流变分析。结果最优工艺条件为浸膏-辅料比为42.35%:57.65%;微晶纤维素101、甘露醇和乳糖以25.4%∶11.9%∶9.35%的配比当作填充剂;10%配比的交联聚维酮(PVPP)作崩解剂;1%配比的硬脂酸镁作润滑剂;15%乙醇作润湿剂,乙醇用量为0.2 ml/g。结论该片剂所选辅料合理,成型制备工艺高效可行,本研究表明扭矩流变仪在湿法制粒过程发挥关键作用,精准确定润湿剂的用量和制粒终点,为当归补血片成型工艺条件以及最优处方的确立提供了科学的实验依据。Objective To select the best prescription and molding process conditions for Danggui Buxue Tablets.Methods The effects of different excipients on the hygroscopicity and formability of the infusion powder were investigated,and the mixing design and comprehensive scoring method were used to optimize the forming process conditions of Danggui Buxue Tablets.To investigate the effects of different excipients on the hygroscopicity and formability of the powdered extracts,and to optimize the forming conditions of Danggui Buxue Tablets by using mixing design and comprehensive scoring method.The key of this study was the rheological analysis of the wet granulation of Danggui Buxue Tablets with different excipients and different types of wetting agents by using torque rheometer(MTR-3).Results The optimal process conditions were:the ratio of extract to auxiliary material was 42.35%:57.65%;microcrystalline cellulose,mannitol and lactose in the ratio of 25.4%:11.9%:9.35%as filler;10%of cross-linked povidone as disintegrant;1%of magnesium stearate as lubricant;and 15%of ethanol as wetting agent with 0.2 ml/g of ethanol.Conclusion The selected excipients are reasonable and the molding preparation process is efficient and feasible.This study shows that the torque rheometer plays a key role in the wet granulation process to precisely determine the dosage of wetting agent and the granulation endpoint,which provide a scientific experimental basis for the establishment of the molding process conditions and the optimal prescription of Danggui Buxue Tablets.

关 键 词：当归补血片 扭矩流变仪 混料设计 湿法制粒 综合评价 

分 类 号：R283.6[医药卫生—中药学]