一种易崩解且卵磷脂含量高的蛋黄卵磷脂片的成型工艺研究

Study on Forming Technology of Egg Yolk Lecithin Tablets with Easy Disintegration and High Lecithin Content

梁俊晖 ¹陈亮 ¹曾荣华 ¹梁晶晶 ¹刘春芳 ¹韩亚明 ¹许文东¹

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作者信息

1. 广州白云山汉方现代药业有限公司,中药制药过程技术与新药创制国家工程研究中心,广东省药用脂质重点实验室,广东广州 510240
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摘要

目的:研究一种易崩解且卵磷脂含量高的蛋黄卵磷脂片的成型工艺.方法:以蛋黄卵磷脂为原料,以片剂成型评价为指标,采用湿法制粒压片工艺,通过单因素试验和正交试验,确定蛋黄卵磷脂片的最佳配方及工艺.结果:蛋黄卵磷脂片的最佳配方为以蛋黄卵磷脂片质量为基准,麦芽糊精添加量10%,山梨糖醇添加量29%～59%,硬脂酸镁添加量1%,粘合剂为 5%羟丙基甲基纤维素溶液,在此条件下制得的蛋黄卵磷脂片表面光滑,硬度适中,口感适宜,片重差异限度、脆碎度以及崩解时限均符合《中国药典》(2020年版)要求.结论:该产品成型工艺稳定可行,适合产业化大规模生产.

Abstract

Objective:To study the forming process of egg yolk lecithin tablet which is easy to disintegrate and has high phospholipid content.Methods:Using yolk lecithin as raw material and tablet forming evaluation as index,the best formula and technology of yolk lecithin tablet were determined by single factor test and orthogonal test.Results:The optimal formula of yolk lecithin tablets is based on the quality of yolk lecithin tablets,the addition of maltodextrin 10%,sorbitol 29%～59%,magnesium stearate 1%,and the adhesive is 5%hydroxypropyl methyl cellulose solution.Under these conditions,the yolk lecithin tablets are prepared with smooth surface,moderate hardness and suitable taste.The difference limit of tablet weight,brittleness and disintegration time limit meet the requirements of Chinese Pharmacopoeia(2020 edition).Conclusion:The forming process of yolk lecithin tablet is stable and feasible,which is suitable for industrial large-scale production.

关键词

蛋黄卵磷脂/片剂/易崩解/成型工艺/单因素试验法/正交试验法

Key words

egg yolk lecithin/tablet/easy to disintegrate/tablet formability/single factor test method/orthogonal test method

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出版年

2024

广东化工

广东省石油化工研究院

广东化工

影响因子：0.288

ISSN：1007-1865

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