
浏览全部资源
扫码关注微信
北京中医药大学 中药信息学系,中药生产过程控制与质量评价北京市重点实验室, 教育部中药制药与新药开发关键技术工程研究中心,北京 102400
唐正馨,在读硕士,从事中药粉体研究,E-mail:Tangzx1@163.com
* 徐冰,博士,副教授,从事中药质量和先进工艺控制研究,Tel:010-53912118,E-mail:xubing@bucm.edu.cn; *
乔延江,博士,教授,从事中药信息学研究,Tel:010-53912117,E-mail:yjqiao@bucm.edu.cn
收稿日期:2021-01-05,
网络出版日期:2021-03-11,
纸质出版日期:2021-09-20
移动端阅览
唐正馨,李婉婷,曹君杰等.颗粒粒径对中药二元混合粉体密度的影响[J].中国实验方剂学杂志,2021,27(18):113-120.
TANG Zheng-xin,LI Wan-ting,CAO Jun-jie,et al.Impact of Particle Size on Density of Binary Powder Mixture of Chinese Medicine[J].Chinese Journal of Experimental Traditional Medical Formulae,2021,27(18):113-120.
唐正馨,李婉婷,曹君杰等.颗粒粒径对中药二元混合粉体密度的影响[J].中国实验方剂学杂志,2021,27(18):113-120. DOI: 10.13422/j.cnki.syfjx.20211147.
TANG Zheng-xin,LI Wan-ting,CAO Jun-jie,et al.Impact of Particle Size on Density of Binary Powder Mixture of Chinese Medicine[J].Chinese Journal of Experimental Traditional Medical Formulae,2021,27(18):113-120. DOI: 10.13422/j.cnki.syfjx.20211147.
目的
2
研究颗粒粒径对中药二元混合粉体密度的影响,为中药制剂处方设计提供参考。
方法
2
构建3组具有不同粒径比(
α
)的中药二元混合体系,即木蝴蝶-微晶纤维素PH102(MCC PH102)(
α
=0.071 7),银柴胡-MCC PH200(
α
=0.158 7)和当归-MCC KG802(
α
=0.840 6)。每组按9个质量配比(90∶10,80∶20,70∶30,60∶40,50∶50,40∶60,30∶70,20∶80和10∶90)制备混合粉体,共得到27种含中药的二元混合粉体。对6种单一粉体和27种二元混合粉体的粒径分布、密度等参数进行表征。基于堆积理论和多变量分析阐释粒径相关参数对中药二元混合粉体的填充结构和密度的影响。
结果
2
当归-MCC KG802二元混合体系的
α
大于替换置换率(
α
r
=0.741 0),其密度与质量配比之间具有良好的线性关系,符合替换机制。木蝴蝶-MCC PH102二元混合体系的
α
小于临界比率(
α
c
=0.154 0),其密度随组分质量比呈非线性变化,符合填隙机制。银柴胡-MCC PH200二元混合体系的
α
介于
α
c
和
α
r
之间,其密度受填隙机制和替换机制的双重影响。基于偏最小二乘法(PLS)模型的变量投影重要性(VIP)分析结果进一步证明混合质量配比(VIP值=1.62),
α
(VIP值=1.13)和
D
10
(粒径分布累积至10%时对应的粒径,VIP值=1.06)是影响二元混合粉体密度的关键因素。
结论
2
在中药二元混合粉体中,2种粉体的粒径差异越小,混合粉体密度和组分质量配比之间的关系越接近于线性。
Objective
2
To investigate the influence of particle size on density of binary powder mixture of traditional Chinese medicine (TCM), and to provide reference for formulation design of TCM preparations.
Method
2
Three groups of binary powder mixtures with different particle size ratio (
α
) were constructed, namely Oroxyli Semen-microcrystalline cellulose PH102 (MCC PH102) (
α
=0.071 7), Stellariae Radix-MCC PH200 (
α
=0.158 7) and Angelicae Sinensis Radix-MCC KG802 (
α
=0.840 6). Binary powder mixtures with nine mass ratios (90∶10, 80∶20, 70∶30, 60∶40, 50∶50, 40∶60, 30∶70, 20∶80 and 10∶90) were prepared for each group, and 27 binary powder mixtures containing TCM were obtained. The particle size distribution, density and other parameters of six single materials and 27 binary powder mixtures were characterized. Based on the packing theory and multivariate analysis, the effects of particle size related parameters on the filling structure and density of the binary powder mixtures were elucidated.
Result
2
The
α
of Angelicae Sinensis Radix-MCC KG802 binary mixture system was larger than the replacement rate (
α
r
=0.741 0), and its density had a good linear relationship with the mass ratio, which conformed to the replacement mechanism. The
α
of Oroxyli Semen-MCC PH102 binary mixture system was smaller than the critical ratio (
α
c
=0.154 0), and its density was nonlinear with the mass ratio of components, which conformed to the filling mechanism. The
α
of Stellariae Radix-MCC PH200 binary mixture system was between
α
c
and
α
r
, its density was affected by both of replacement mechanism and filling mechanism. Based on the partial least squares (PLS) model, the variable importance in the projection (VIP) analysis further proved that the mixing mass ratio (VIP value=1.62),
α
(VIP value=1.13) and
D
10
(the corresponding particle size when the particle size distribution accumulated to 10%, VIP value=1.06) were the key factors affecting the density of binary powder mixtures of TCM.
Conclusion
2
In the binary powder mixtures of TCM, the linearity relationship between density and mass ratio is largely depended on particle size difference of components.
陈程 . 口服固体制剂车间智能化的实施探讨和新趋势分析 [J]. 化工与医药工程 , 2020 , 41 ( 2 ): 16 - 18 .
国家药典委员会 . 中华人民共和国药典:一部 [M]. 北京 : 中国医药科技出版社 , 2020 .
王洁 , 赵国巍 , 廖正根 , 等 . 肿节风混合粉的粉体学基本性质与吸湿性的相关性研究 [J]. 中草药 , 2014 , 45 ( 2 ): 188 - 193 .
蒋且英 , 赵国巍 , 张守德 , 等 . 超微粉碎对血竭-红花混合粉体稳定性的影响 [J]. 江西中医药大学学报 , 2017 , 29 ( 5 ): 65 - 69 .
张前亮 , 罗铮 , 邓雯 , 等 . 丹参破壁饮片物理属性的质量评价 [J]. 中国实验方剂学杂志 , 2020 , 26 ( 23 ): 145 - 152 .
张毅 , 徐冰 , 孙飞 , 等 . 中药提取物粉末物理指纹谱研究及应用 [J]. 中国中药杂志 , 2016 , 41 ( 12 ): 2221 - 2227 .
SANDLER N , WILSON D . Prediction of granule packing and flow behavior based on particle size and shape analysis [J]. J Pharm Sci , 2010 , 99 ( 2 ): 958 - 968 .
欧阳鸿武 , 何世文 , 陈海林 , 等 . 粉体混合技术的研究进展 [J]. 粉末冶金技术 , 2004 , 22 ( 2 ): 104 - 108 .
CHANG S Y , WANG C G , SUN C Q . Relationship between hydrate stability and accuracy of true density measured by helium pycnometry [J]. Int J Pharm , 2019 , 567 : 118444 .
STRANZINGER S , MARKL D , KHINAST J G , et al . Review of sensing technologies for measuring powder density variations during pharmaceutical solid dosage form manufacturing [J]. Trac-Trends Anal Chem , 2020 , 135 : 116147 .
ALI U , MAHMOODKHANI Y , SHAHABAD S I , et al . On the measurement of relative powder-bed compaction density in powder-bed additive manufacturing processes [J]. Mater Des , 2018 , 155 : 495 - 501 .
GRASSMANN P . Physical principles of chemical engineering [J]. J Fluid Mech , 1971 , 18 ( 6 ): 1281 .
SCHOLTZ J C , STEENEKAMP J H , HAMMAN J H , et al . The SeDeM expert diagram system:its performance and predictability in direct compressible formulations containing novel excipients and different types of active ingredients [J]. Powder Technol , 2017 , 312 : 222 - 236 .
ZHANG Y , XU B , WANG X , et al . Optimal selection of incoming materials from the inventory for achieving the target drug release profile of high drug load sustained-release matrix tablet [J]. AAPS PharmSciTech , 2019 , 20 ( 2 ): 76 .
DAI S Y , XU B , ZHANG Z Q , et al . A compression behavior classification system of pharmaceutical powders for accelerating direct compression tablet formulation design [J]. Int J Pharm , 2019 , 572 : 118742 .
BUSIGNIES V , MAZEL V , DIARRA H , et al . Prediction of the compressibility of complex mixtures of pharmaceutical powders [J]. Int J Pharm , 2012 , 436 ( 1/2 ): 862 - 868 .
JONAT S , HASENZAHL S , DRECHSLER M , et al . Investigation of compacted hydrophilic and hydrophobic colloidal silicon dioxides as glidants for pharmaceutical excipients [J]. Powder Technol , 2004 , 141 ( 1/2 ): 31 - 43 .
陈关凤 , 侯晓杰 , 李玮 . 木蝴蝶质量标准及药理作用研究进展 [J]. 农技服务 , 2019 , 36 ( 5 ): 46 - 48,51 .
王秀芬 , 李静 , 方光明 . 中药银柴胡质量评价研究进展 [J]. 宁夏农林科技 , 2020 , 61 ( 3 ): 28 - 31 .
马玲芳 , 张亮 , 叶旭波 , 等 . 银柴胡不同种源抗旱性及主要药效成分比较研究 [J]. 中国野生植物资源 , 2020 , 39 ( 4 ): 23 - 31 .
杨蕊菁 , 赵磊 , 夏鹏飞 , 等 . 不同产地当归药材9种成分的含量测定及主成分分析 [J]. 中药新药与临床药理 , 2020 , 31 ( 4 ): 473 - 477 .
国家药典委员会 . 中华人民共和国药典:四部 [M]. 北京 : 中国医药科技出版社 , 2020 : 151 - 153 .
YU A B , STANDISH N . An analytical-parametric theory of the random packing of particles [J]. Powder Technol , 1988 , 55 ( 3 ): 171 - 186 .
STOVALL T , DE-LARRARD F , BUIL M . Linear packing density model of grain mixtures [J]. Powder Technol , 1986 , 48 ( 1 ): 1 - 12 .
BOSCHINI F , DELAVAL V , TRAINA K , et al . Linking flowability and granulometry of lactose powders [J]. Int J Pharm , 2015 , 494 ( 1 ): 312 - 320 .
YU A B , STANDISH N . Estimation of the porosity of particle mixtures by a linear-mixture packing model [J]. Ind Eng Chem Res , 1991 , 30 ( 6 ): 1372 - 1385 .
FATHOLLAHI S , FAULHAMMER E , GLASSER B J , et al . Impact of powder composition on processing-relevant properties of pharmaceutical materials:an experimental study [J]. Adv Powder Technol , 2020 , 31 ( 7 ): 2991 - 3003 .
GALDÓN E , CASAS M , GAYANGO M , et al . First study of the evolution of the SeDeM expert system parameters based on percolation theory:monitoring of their critical behavior [J]. Eur J Pharm Biopharm , 2016 , 109 : 158 - 164 .
PILLITTERI S , LUMAY G , OPSOMER E , et al . From jamming to fast compaction dynamics in granular binary mixtures [J]. Sci Rep , 2019 , 9 ( 1 ): 7281 .
YU W L , MUTEKI K , ZHANG L , et al . Prediction of bulk powder flow performance using comprehensive particle size and particle shape distributions [J]. J Pharm Sci , 2011 , 100 ( 1 ): 284 - 293 .
WANG Y , KOYNOV S , GLASSER B J , et al . A method to analyze shear cell data of powders measured under different initial consolidation stresses [J]. Powder Technol , 2016 , 294 : 105 - 112 .
MUTEKI K , MACGREGOR J F , UEDA T . Mixture designs and models for the simultaneous selection of ingredients and their ratios [J]. Chemometrics Intell Lab Syst , 2008 , 86 ( 1 ): 17 - 25 .
JALLO L J , GHOROI C , GURUMURTHY L , et al . Improvement of flow and bulk density of pharmaceutical powders using surface modification [J]. Int J Pharm , 2012 , 423 ( 2 ): 213 - 225 .
LEANE M , PITT K , REYNOLDS G , et al . A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms [J]. Pharm Dev Technol , 2015 , 20 ( 1 ): 12 - 21 .
DENG X L , DAVÉ R N . Dynamic simulation of particle packing influenced by size,aspect ratio and surface energy [J]. Granul Matter , 2013 , 15 ( 4 ): 401 - 415 .
KALLUS Y . The random packing density of nearly spherical particles [J]. Soft Matter , 2016 , 12 ( 18 ): 4123 - 4128 .
KUNNATH K , CHEN L , ZHENG K , et al . Assessing predictability of packing porosity and bulk density enhancements after dry coating of pharmaceutical powders [J]. Powder Technol , 2021 , 377 : 709 - 722 .
0
浏览量
24
下载量
2
CSCD
关联资源
相关文章
相关作者
相关机构
京公网安备11010802024621