粉体改性技术提升滋阴益胃胶囊内容物均一性的应用研究  

Powder modificationfor improving content uniformity of Ziyin Yiwei Capsules

作　　者：陈志泽 杨荣平[2] 史亚军 贾晓斌 郭东艳 邹俊波 封亮 赵宗平 CHEN Zhi-ze;YANG Rong-ping;SHI Ya-jun;JIA Xiao-bin;GUO Dong-yan;ZOU Jun-bo;FENG Liang;ZHAO Zong-ping(Shaanxi Provincial Key Laboratory of Traditional Chinese Medicine and New Drug Research,College of Pharmacy,Shaanxi University of Traditional Chinese Medicine,Xianyang 112046,China;College of Pharmaceutical Sciences,Southwest University,Chongqing 400115,China;School of Traditional Chinese Pharmacy,China Pharmaceutical University,Nanjing 211198,China;Shaanxi Weixin Pharmaceutical Co.,Ltd.,Xi'an 710065,China)

机构地区：[1]陕西中医药大学药学院陕西省中药基础与新药研究重点实验室,陕西咸阳712046 [2]西南大学药学院,重庆400715 [3]中国药科大学中药学院,江苏南京211198 [4]陕西威信制药有限公司,陕西西安710065

出　　处：《中国中药杂志》2021年第23期6053-6061,共9页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划项目(2018YFC1706904);陕西省中医药管理局中药制药工程重点学科项目(2017001);陕西中医药大学学科创新团队项目(2019-YL11)。

摘　　要：基于滋阴益胃胶囊内容物的粉体学性质缺陷,筛选导致内容物粉体学性质缺陷的主要问题饮片细粉,导入粉体改性工艺改善主要问题饮片细粉粉体学性质以提升胶囊内容物制剂学性质,从而提升滋阴益胃胶囊内容物均一性,为粉体学改性技术在中药固体制剂上的应用提供示范。通过滋阴益胃胶囊内容物粉体学性质考察,明确胶囊内容物粉碎粒径与粉碎时间具有良好的相关性,根据测定粉体流动性、润湿性明确造成胶囊内容物质量缺陷为蒲公英、老龙皮饮片细粉,通过引入药用辅料硬脂酸镁与蒲公英、老龙皮饮片细粉进行超微粉碎制备"核-壳"复合粒子改善问题饮片细粉粉体学性质,通过测定复合粒子流动性、润湿性等各项粉体学表征数据,以及扫描电镜测定(scanning electron microscopy,SEM)、红外测定(infrared ray,IR)结果筛选确定最佳硬脂酸镁用量为2%、复合时间为3 min,继而将复合粒子回归滋阴益胃胶囊内容物全处方,通过对比原胶囊和改性过的复合胶囊内容物粒径、流动性、润湿性、堆密度均匀度、色差值均匀度等粉体学表征数据以及含量均匀性、体外溶出测定结果,可得制备的复合胶囊内容物粉体学性质得到一定改善,含量均匀性显著提高,且改性前后并未改变该制剂的物质基础,确定该制备工艺稳定可行。通过粉体改性技术解决了传统胶囊剂制备过程中易出现的处方制剂学缺陷,为粉体改性技术用于提升中药固体制剂品质,推动胶囊剂等中药传统剂型的二次开发与升级提供了实验依据。Based on the defects in powder properties of the contents of Ziyin Yiwei Capsules,this study screened out the main medicinal slice powders causing the poor powdery properties,and introduced the powder modification process to improve the powdery properties of these slice powders,the pharmaceutical properties of the capsule contents,and the content uniformity of Ziyin Yiwei Capsules,so as to provide a demonstration for the application of powder modification technology to the preparation of Chinese medicinal solid preparations.Through the investigation on the powder properties of the contents of Ziyin Yiwei Capsules,it was clarified that the pulverized particle size of the capsule contents had a good correlation with the pulverization time.According to the measurement results of the powder fluidity and wettability,the quality defects of the capsule contents were caused by the fine powders of Taraxaci Herba and Lungwortlike Herba."Core-shell"composite particles were prepared from medicinal excipients magnesium stearate and fine powders of Taraxaci Herba and Lungwortlike Herba slices after ultra-fine pulverization to improve the powder properties of the problematic fine powders.Powder characterization data including fluidity and wettability were measured,followed by scanning electron microscopy(SEM)and infrared ray(IR)detection.It was determined that the optimal dosage of magnesium stearate was 2%,and the compositing time was 3 min.The composite particles were then used as content components of the Ziyin Yiwei Capsules.The powder characteristics between the original capsule and the modified composite capsule including the particle size,fluidity,wettability,uniformity of bulk density,and uniformity of chromatism as well as the content uniformity and in vitro dissolution were compared.The results showed that the powder characteristics and content uniformity of the prepared composite capsule were significantly improved,while the material basis of the preparation was not changed before and after modification.The preparati

关 键 词：粉体改性 滋阴益胃胶囊 超微粉碎 粉体学性质 硬脂酸镁 复合粒子 复合胶囊 

分 类 号：R283.6[医药卫生—中药学]