糖醇类辅料的粉体学性质及直接压片工艺考察

曹韩韩; 赵燕龙; 刘鸿越; 白桦

doi:10.13422/j.cnki.syfjx.2018050025

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糖醇类辅料的粉体学性质及直接压片工艺考察

药剂与炮制 | 更新时间：2024-01-04

- 糖醇类辅料的粉体学性质及直接压片工艺考察
- Investigation of Powder Properties and Direct Compression Process of Sugar Alcohols
- 中国实验方剂学杂志 2018年24卷第5期页码：25-30
- 作者机构：
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.2018050025
  中图分类号： R283.6
- 纸质出版日期：2018
- 稿件说明：
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曹韩韩, 赵燕龙, 刘鸿越, 等. 糖醇类辅料的粉体学性质及直接压片工艺考察[J]. 中国实验方剂学杂志, 2018,24(5):25-30.

CAO Han-han, ZHAO Yan-long, LIU Hong-yue, et al. Investigation of Powder Properties and Direct Compression Process of Sugar Alcohols[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(5): 25-30.
曹韩韩, 赵燕龙, 刘鸿越, 等. 糖醇类辅料的粉体学性质及直接压片工艺考察[J]. 中国实验方剂学杂志, 2018,24(5):25-30. DOI： 10.13422/j.cnki.syfjx.2018050025.

CAO Han-han, ZHAO Yan-long, LIU Hong-yue, et al. Investigation of Powder Properties and Direct Compression Process of Sugar Alcohols[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(5): 25-30. DOI： 10.13422/j.cnki.syfjx.2018050025.

摘要

目的：研究糖醇类辅料的粉体学性质、可压缩性和成型性，为糖醇类辅料在固体制剂过程中的应用提供参考。方法：选择5种常用的糖醇类辅料（赤藓糖醇、山梨糖醇、木糖醇、麦芽糖醇、甘露糖醇），测定其粉体学性质，如含水量、粒径及粒径分布、休止角、流速、松密度和振实密度等，使用XP1型感应压片机压片，采用片重差异、出片力、崩解时限、脆碎度、抗张强度等参数及其变化规律来评价糖醇类辅料的可压性和成型性。结果：5种糖醇的含水量均<0.3%，赤藓糖醇的粒径最大、分布最均匀，麦芽糖醇的粒径最小、分布最不均匀。木糖醇的卡尔指数为15.68%，其他4种辅料的卡尔指数都在5%~15%，说明5种糖醇的流动性均较好。5种糖醇的片重差异都在规定的范围内。对于出片力，山梨糖醇完全可以满足生产的需求，甘露糖醇和赤藓糖醇也基本可以满足生产的需求。在5种糖醇中山梨糖醇的抗张强度最大，说明其成型性较好。不同压力下所有糖醇的崩解时限均<650 s。山梨糖醇在各个压力下所制得片剂的脆碎度均<1%，符合2015年版《中国药典》的要求，其他4种糖醇的脆碎度均不符合2015年版《中国药典》的要求。结论：得到了糖醇在不同压力下可压性和成型性的变化规律，在直接压片过程中不同糖醇表现出不同的优势，可为糖醇类辅料在固体制剂中的应用提供理论依据。

Abstract

Objective:To study on the powder properties

compressibility and moldability of sugar alcohols

and to provide reference for the application of sugar alcohols in solid preparation. Method:Five kinds of sugar alcohols were chosen

after determining the powder properties

such as water content

particle size and particle size distribution

angle of repose

flowability

bulk density and tap density

the powder was tableted at the same filling height

and the compressibility and moldability were evaluated by the tablet weight difference

ejection force

disintegration time

friability

tensile strength and their change rules as indexes. Result:The water contents of 5 kinds of sugar alcohols were below 0.3%

particle size of erythritol was maximum and particle size distribution was the most uniform

particle size of maltose alcohol was minimum and particle size distribution was the most nonuniform.The Carr index of xylitol was 15.68%

and the others were between 5%-15%

indicating that the 5 kinds of sugar alcohols had good flowability.Tablet weight variation of the 5 kinds of sugar alcohols within the prescribed limits.For the ejection force

sorbitol could meet the needs of production

mannitol and erythritol could basically meet the needs of production.Among 5 kinds of sugar alcohols

the tensile strength of sorbitol was the largest

which showed its moldability was good.The disintegration times of all sugar alcohols under different pressures were within 650 s.The friability of sorbitol at various pressures was <1%

it met the requirements of the 2015 edition of Chinese Pharmacopoeia

but friabilities of the other 4 kinds of sugar alcohols were not in accordance with the requirements of the 2015 edition of Chinese Pharmacopoeia. Conclusion:The regularity of compressibility and moldability of sugar alcohols under different pressures is obtained.Different kinds of sugar alcohols have different advantages in direct compression process

this study can provide a theoretical basis for the application of sugar alcohols in solid preparations.

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