基于粒子设计原理的中药制丸粉末中间体均一性优化与评价：以小金丸为例  

Optimization and evaluation of intermediate uniformity in Chinese medicine pill powders based on particle design principle:exemplifying by Xiaojin Pills

作　　者：熊茜[1] 王小平 张定堃[1] 任桂林[1,3] 郭治平 杨明 谭庆刍[1] 韩丽 XIONG Xi WANG Xiao-ping ZHANG Ding-kun REN Gui-lin GUO Zhi-ping YANG Ming TAN Qing-chu HAN Li(Key Laboratory Breeding Base of Systematic Research and Utilization on Chinese Material Medical Resources Co-founded by Sichuan Province and Ministry of Science and Technology, Pharmacy College, Chengdu University of Traditional Chinese Medicine, Chengdu 611137, China Zhangzhou Health Vocational College, Zhangzhou 363000, China Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou 646000, China Sichuan Houde Medical Technology Co., Ltd., Chengdu 610041, China Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China)

机构地区：[1]成都中医药大学药学院,中药资源系统研究与开发利用省部共建国家重点实验室培育基地,四川成都611137 [2]漳州卫生职业学院,福建漳州363000 [3]西南医科大学附属中医医院,四川泸州646000 [4]四川厚德医药科技有限公司,四川成都610041 [5]江西中医药大学,江西南昌330004

出　　处：《药学学报》2017年第10期1611-1620,共10页Acta Pharmaceutica Sinica

基　　金：国家自然科学基金资助项目(81403115);国家基础科学人才培养基金资助项目(J13100340-19)

摘　　要：基于粒子设计原理,制备小金丸粒子设计粉体,采用粉体学表征技术与含量均匀度等方法,对其质量均一性进行考察。通过研究分类物料的混合粉碎规律,结合中药粉体粒子设计原理,制备小金丸粒子设计粉体,同时制备核壳粒子人工混合粉体及药典法制备粉体,以粒径分布及色差检查分别对3种粉体的混合均一性进行粉体学评价,并分别建立GC-MS、LC-MS/MS方法对其含量均一性进行对比研究。结果得出粒子设计小金丸粉体最佳制备工艺为:易粉碎物料置振动式超微粉碎机(-15℃)中粉碎50 min,再加入难粉碎物料,粉碎复合3 min即得。其中核壳粒子人工混合粉体粒径变化范围最大,粒径差超过100μm,RSD值达26.07%;药典法制备粉体粒径差超过50μm,RSD近15%;粒子设计粉体粒径变化范围在4μm左右,RSD值3.18%。色差检查结果表明,药典法制备粉体综合色差(dE~*)值变化范围最大,RSD为84.56%;其次为核壳粒子人工混合粉体和粒子设计粉体,RSD分别为53.83%和32.83%。粒子设计粉体麝香酮含量的RSD值约为核壳粒子人工混合粉体和药典法制备粉体的1/2,LC-MS/MS测定粉体中10种成分的含量,粒子设计粉体各化学成分含量的RSD值大多明显小于混合粉体和药典法制备粉体。结果表明,粒子设计粉体均一性明显优于核壳粒子人工混合粉体与药典法制备粉体,中药粒子设计技术能有效改善中药粉体的均一性。Based on the principle of particle design, the powder of Xiaojin Pills was prepared, and the quality uniformity was investigated by means of powder characterizations and content uniformity. By studying the mixed crushing rules of the classified materials and the design principle of the powder particles of Chinese medicine, the powder of the Xiaojin Pills was prepared. At the same time, the manmade mixed powder and the control powder prepared by pharmacopoeia were prepared. The mixed homogeneity of the three powders was evaluated by particle size distribution and color difference. The GC-MS and LC-MS/MS were used to study the homogeneity of their contents. The best preparation process of particle design powder is： materials easily crushed are smashed for 50 min in the vibrating ultrafine mill with-15 ℃, then add the materials difficultly crushed into the mill and let them crushed together for 3 min. The particle size range of manmade mixed powder was the largest with the particle size difference being more than 100 microns, the RSD value being 26.07%. The particle size range was more than 50 microns in the powder prepared by pharmacopoeia, and the RSD was nearly 15%. The difference in particle size was only around 4 μm and the RSD value was 3.18%. The color difference test showed that the composite chromatism（dE^＊） value of the powder prepared by pharmacopoeia was the largest for the RSD was 84.56%. The RSD of manmade mixed powder and the powder prepared by Pharmacopeia were 53.83% and 32.83%, respectively. The RSD value of the particle designed powder＇s muscone content is about 50% of the other two kinds of powders. The contents of 10 components in powders were determined by LC-MS/MS. The RSD values of the particle designed powder were much smaller than other two kinds of powders. Results indicate that the uniformity of the particle designed powder is better than other two kinds of powders. Chinese medicine particle design technology can effectively improve the uniformity of traditional Chinese medic

关 键 词：小金丸 粒子设计 粉体学 LC-MS/MS GC 均一性评价 

分 类 号：R944[医药卫生—药剂学]