王松涛;张静;林晓;沈岚;冯怡;
WANG Song-tao;ZHANG Jing;LIN Xiao;SHEN Lan;FENG Yi;School of Pharmacy,Shanghai University of Traditional Chinese Medicine;Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine of Ministry of Education,Shanghai University of Traditional Chinese Medicine;The Second Hospital of Jilin University;

• 1:上海中医药大学中药学院
• 2:上海中医药大学中药现代制剂技术教育部工程研究中心
• 3:吉林大学第二医院药学部

摘要(Abstract)：

通过喷雾干燥技术分别制备乳糖-糊化淀粉、乳糖-不糊化淀粉共处理辅料,比较共处理辅料与物理混合物及喷雾干燥乳糖之间在粉体学性质和所形成片剂性质上的差异,并以栀子提取物和垂盆草提取物为模型药物,考察共处理辅料在中药直接压片中应用的可行性。结果表明,将淀粉预糊化后再与乳糖共喷雾干燥可提升淀粉作为黏合剂的性能与效率,制备所得共处理辅料的物理机械性质得到显著改善。在中药粉体直接压片中,该共处理辅料表现出比自制和市售喷雾干燥乳糖更好的可压性和更大的载药量。综上所述,乳糖-糊化淀粉共处理辅料具有优良的物理机械性质,有望成为一种新型的直压共处理辅料。
Co-processed excipients with gelatinized or non-gelatinized starch were prepared by spray drying. Powder and tablet properties of co-processed excipients prepared were compared with those of physical mixtures and spray-dried lactose. Their applicability in traditional Chinese medicine( TCM) powder tableting was tested on two TCM extracts,i. e.,the gardenia extract and the Herba Sedi extract. It was shown that gelatinizing starch before co-spray drying with lactose could improve the performance and efficiency of starch as a binder,resulting in remarkable improvement in physicomechanical properties of co-processed excipients prepared. Compared to self-made and commercially available spray-dried lactose,co-processed excipients achieved better compactability and higher drug loading for TCM extracts. In conclusion,the lactose-gelatinized starch co-processed excipient,with excellent physicomechanical properties,is promising to be explored as a new excipient for direct tableting.

关键词(KeyWords)： 共处理辅料;喷雾干燥;乳糖;糊化淀粉;压片
co-processed excipient;spray drying;lactose;gelatinized starch;tableting

Abstract:

Keywords:

基金项目(Foundation): 上海市教育委员会科研创新项目(13ZZ098)

作者(Author): 王松涛;张静;林晓;沈岚;冯怡;
WANG Song-tao;ZHANG Jing;LIN Xiao;SHEN Lan;FENG Yi;School of Pharmacy,Shanghai University of Traditional Chinese Medicine;Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine of Ministry of Education,Shanghai University of Traditional Chinese Medicine;The Second Hospital of Jilin University;

Email:

DOI:

参考文献(References)：

• [1]Marwaha M,Sandhu D,Marwaha R K.Coprocessing of excipients:a review on excipient development for improved tabletting performance[J].Int J Appl Pharm,2010,2(3):41.
• [2]Meeus L.Direct compression versus granulation[J].Pharm Tech Eur,2011,23:21.
• [3]Katdare A,Chaubal M V.Excipient development for pharmaceutical,biotechnology and drug delivery systems[M].New York:CRC Pr I Llc,2006:51.
• [4]Patel R P,Bhavsar M.Directly compressible materials via co-processing[J].Int J Pharm Tech Res,2009,1(3):745.
• [5]Schoneker D.The IPEC excipient composition guide[EB].2009:3.
• [6]王松涛,林晓,冯怡.共处理制备直接压片辅料的研究现况[J].中国实验方剂学杂志,2014,20(4):201.
• [7]Cole E T,Rees J E,Hersey J A.Relations between compaction data for some crystalline pharmaceutical materials[J].Pharm Acta Helv,1975;50(1/2):28.
• [8]Lin X,Chyi C W,Ruan K F,et al.Development of potential novel cushioning agents for the compaction of coated multi-particulates by co-processing micronized lactose with polymers[J].Eur J Pharm Biopharm,2011,79:406.
• [9]杜焰,冯怡,徐德生,等.药物粉体压缩与结合特性研究进展[J].中国现代应用药学,2012,29(1):24.