中药粉体物性周期表的建立及应用
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摘要
目的:提出建立中药口服固体制剂常用物料的物理性质周期表并将其用于处方设计,以筛选最佳辅料并确定其用量,为处方选择合适的工艺路线提供帮助。方法:选择77批辅料、53批中药提取物以及5批化药为研究对象,测定135批物料的物理指纹图谱,根据性质计算粉体五大类指标(堆积性、均一性、流动性、可压缩性、稳定性),并且计算综合评价指标。结果:分别以6个指标中的任意两个指标作为周期表的横轴和纵轴,每一种物料在周期表中的位置,代表了粉体在6个方面的性质。结论:中药粉体物性周期表是对中药粉体性质的高度概括,为中药制剂处方设计的辅料筛选提供依据并且为合适的工艺路线选择提供建议。
Objective: To establish a physical periodic table for commonly used materials for oral solid dosage of Chinese materia medica. Then, the physical periodic table can be used to screen the best excipients in prescription design, and furthermore to help select the appropriate process route for the prescription. Methods: Seventy-seven batches of excipients, 53 batches of spray-dried power of Chinese materia medica extracts and 5 batches of chemical were selected as research objects.Determine the physical fingerprints of 135 batches of materials, calculate five indices of the powders based on the properties, and calculate the comprehensive evaluation index. Results: Every two indices of the six indices were used as horizontal and vertical axes of the physical periodic table. The position of each material in the physical periodic table represented the properties of the powder in six aspects. Conclusion: The physical periodic table for Chinese materia medica powder is a high-level generalization of the properties of Chinese materia medica powder, which provides a basis for the selection of excipients designed for Chinese medicine prescriptions and provides suggestions for the selection of appropriate process routes.
Objective: To establish a physical periodic table for commonly used materials for oral solid dosage of Chinese materia medica. Then, the physical periodic table can be used to screen the best excipients in prescription design, and furthermore to help select the appropriate process route for the prescription. Methods: Seventy-seven batches of excipients, 53 batches of spray-dried power of Chinese materia medica extracts and 5 batches of chemical were selected as research objects.Determine the physical fingerprints of 135 batches of materials, calculate five indices of the powders based on the properties, and calculate the comprehensive evaluation index. Results: Every two indices of the six indices were used as horizontal and vertical axes of the physical periodic table. The position of each material in the physical periodic table represented the properties of the powder in six aspects. Conclusion: The physical periodic table for Chinese materia medica powder is a high-level generalization of the properties of Chinese materia medica powder, which provides a basis for the selection of excipients designed for Chinese medicine prescriptions and provides suggestions for the selection of appropriate process routes.
引文
[1]国家药典委员会.中华人民共和国药典.一部.北京:中国医药科技出版社,2015
[2]徐冰,崔向龙,杨婵,等.质量源于设计在银杏叶片制粒工艺中的应用(Ⅱ):颗粒关键质量属性辨识.中国中药杂志,2017,42(6):1043-1047
[3]Zhang Y,Xu B,Wang X,et al.Setting up multivariate specifications on critical raw material attributes to ensure consistent drug dissolution from high drug load sustained-release matrix tablet.Drug Development and Industrial Pharmacy,2018,44(11):1733-1743
[4]杨志欣,王祺茹,张文君,等.半夏泻心汤胃内滞留片的处方及体外释药机制研究.中华中医药杂志,2017,32(1):270-274
[5]Van Snick B,Dhondt J,Pandelaere K,et al.A multivariate raw material property database to facilitate drug product development and enable in-silico design of pharmaceutical dry powder processes.International Journal of Pharmaceutics,2018,549(1-2):415-435
[6]张毅,徐冰,孙飞,等.中药提取物粉末物理指纹谱研究及应用.中国中药杂志,2016,41(12):2221-2227
[7]Raymond C R,Paul J S,Marian E Q.Handbook of pharmaceutical excipients.Sixth edition.London:The Pharmaceutical Press,2009
[8]European Pharmacopeia.9th ed.vol.7.2,Council of Europe.Strasbourg(France),2017
[9]Leane M,Pitt K,Reynolds G.A proposal for a drug product Manufacturing Classification System(MCS)for oral solid dosage forms.Pharmaceutical Development and Technology,2015,20(1):12-21
[2]徐冰,崔向龙,杨婵,等.质量源于设计在银杏叶片制粒工艺中的应用(Ⅱ):颗粒关键质量属性辨识.中国中药杂志,2017,42(6):1043-1047
[3]Zhang Y,Xu B,Wang X,et al.Setting up multivariate specifications on critical raw material attributes to ensure consistent drug dissolution from high drug load sustained-release matrix tablet.Drug Development and Industrial Pharmacy,2018,44(11):1733-1743
[4]杨志欣,王祺茹,张文君,等.半夏泻心汤胃内滞留片的处方及体外释药机制研究.中华中医药杂志,2017,32(1):270-274
[5]Van Snick B,Dhondt J,Pandelaere K,et al.A multivariate raw material property database to facilitate drug product development and enable in-silico design of pharmaceutical dry powder processes.International Journal of Pharmaceutics,2018,549(1-2):415-435
[6]张毅,徐冰,孙飞,等.中药提取物粉末物理指纹谱研究及应用.中国中药杂志,2016,41(12):2221-2227
[7]Raymond C R,Paul J S,Marian E Q.Handbook of pharmaceutical excipients.Sixth edition.London:The Pharmaceutical Press,2009
[8]European Pharmacopeia.9th ed.vol.7.2,Council of Europe.Strasbourg(France),2017
[9]Leane M,Pitt K,Reynolds G.A proposal for a drug product Manufacturing Classification System(MCS)for oral solid dosage forms.Pharmaceutical Development and Technology,2015,20(1):12-21