熊茜, 王小平, 张定堃, 任桂林, 郭治平, 杨明, 谭庆刍, 韩丽. 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J. 药学学报, 2017,52(10): 1611-1620. doi: 10.16438/j.0513-4870.2017-0495
引用本文: 熊茜, 王小平, 张定堃, 任桂林, 郭治平, 杨明, 谭庆刍, 韩丽. 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J. 药学学报, 2017,52(10): 1611-1620. doi: 10.16438/j.0513-4870.2017-0495
XIONG Xi, WANG Xiao-ping, ZHANG Ding-kun, REN Gui-lin, GUO Zhi-ping, YANG Ming, TAN Qing-chu, HAN Li. Optimization and evaluation of intermediate uniformity in Chinese medicine pill powders based on particle design principle:exemplifying by Xiaojin PillsJ. Acta Pharmaceutica Sinica, 2017,52(10): 1611-1620. doi: 10.16438/j.0513-4870.2017-0495
Citation: XIONG Xi, WANG Xiao-ping, ZHANG Ding-kun, REN Gui-lin, GUO Zhi-ping, YANG Ming, TAN Qing-chu, HAN Li. Optimization and evaluation of intermediate uniformity in Chinese medicine pill powders based on particle design principle:exemplifying by Xiaojin PillsJ. Acta Pharmaceutica Sinica, 2017,52(10): 1611-1620. doi: 10.16438/j.0513-4870.2017-0495

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

  • 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100 μm,RSD值达26.07%;药典法制备粉体粒径差超过50 μm,RSD近15%;粒子设计粉体粒径变化范围在4 μm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。

     

    Abstract: 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 medicine powder.

     

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