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作 者:李金枝 罗毓 阮洪生[1] 崔明超[1] 董珂[1] 潘萍 林晓[2,3] LI Jin-zhi;LUO Yu;RUAN Hong-sheng;CUI Ming-Chao;DONG Ke;PAN Ping;LIN Xiao(College of Chinese Materia Medica,Zhejiang Pharmaceutical College,Ningbo 315100,China;College of Chinese Materia Medica,Shanghai Unitersily of Traditional Chinese Medicine,Shanghai 201203,China;Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine of Ministry of Education,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
机构地区:[1]浙江医药高等专科学校中药学院,浙江宁波315100 [2]上海中医药大学中药学院,上海201203 [3]上海中医药大学中药现代制剂技术教育部工程研究中心,上海201203
出 处:《中国中药杂志》2020年第22期5518-5524,共7页China Journal of Chinese Materia Medica
基 金:浙江省食品药品监督管理系统科技计划项目(2019014)。
摘 要:目前限制中药片剂开发与生产的难点较多,该研究旨在通过中药提取物与致孔剂碳酸氢铵喷雾共处理改善中药片剂溶出困难及服用剂量大的问题。以金荞麦提取物和碳酸氢铵组合为研究对象,通过喷雾干燥方法制备金荞麦多孔粉体并进行压片,考察共处理前后粉体学和片剂性质变化,同时以金荞麦市售片和原料药片作为对照药物,考察其可压性和溶出性能的改善程度。结果表明,金荞麦提取物与碳酸氢铵共处理后的粉体具有较高的孔隙率、较大的比表面积、粒子形态近球形并呈中空状态。以该粉体制备的多孔片剂,溶出速率和压缩成形性均得到显著提高,在片剂生产中可通过减少辅料用量的方式提高载药量,进而降低服用剂量。At present, there are many difficulties in the development and production of traditional Chinese medicine(TCM) tablets. This work aimed to explore the feasibility of improving dissolution difficulty and large dosage of TCM tablets by co-spray drying TCM extract with a small amount of pore-foaming agent ammonium bicarbonate. A series of porous Fagopyri Dibotryis Rhizoma powders were prepared by co-spray drying Fagopyri Dibotryis Rhizoma with different amounts of ammonium bicarbonate, and their powder pro-perties and tablet properties were comparatively investigated. At the same time, Fagopyri Dibotryis Rhizoma commercial tablets and raw material tablets were used as control drugs, the improvement degree of its compressibility and dissolution rate was investigated. The results showed that there were higher porosity, specific surface area and hollow spheroidal particles structure of powders via co-spray drying Fagopyri Dibotryis Rhizoma with NH4HCO3. Compared to parent and commercial Fagopyri Dibotryis Rhizoma tablets, the dissolution rates and compressibility of porous Fagopyri Dibotryis Rhizoma tablets were significantly increasing. High compressibility could increase drug loading by reducing excipients in manufacturing of tablets and lower the dose of Fagopyri Dibotryis Rhizoma tablets.
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