中草药提取物胶囊壳破损原因分析

Analysis of the Causes of Capsule Shell Damage in Traditional Chinese Herbal Extract Capsules

摘要

以中草药提取物为主要内容物的明胶胶囊制剂为研究对象，针对行业普遍存在的胶囊壳破损问题，通过水分迁移验证、不同水分梯度内容物脆碎度测试、植物胶囊适配性评价及热收缩炉影响考察等系列实验，系统探究胶囊壳破损的关键影响因素并提出改善方案。结果表明：胶囊内容物与明胶囊壳间的水分迁移是导致胶囊脆碎破损的核心诱因；内容物颗粒的最适水分控制范围为4.5%~5.3%；生产过程中的瓶装品特殊情况下重复通过热收缩膜的热收缩炉工序对胶囊破损无显著影响。本研究可为中草药提取物胶囊制剂的质量稳定性提升提供实验依据与技术参考。

Abstract

This study focuses on gelatin capsules containing herbal extracts as the primary active ingredient, addressing the prevalent issue of capsule shell breakage in the industry. Through a series of experiments—including moisture migration validation, fragility testing under varying moisture gradients, compatibility evaluation of plant-based capsules, and analysis of thermal shrinkage oven effects— we systematically identified key contributing factors to capsule rupture and proposed improvement strategies. The results demonstrate that moisture transfer between the capsule contents and the gelatin shell is the primary cause of fragility and breakage; the optimal moisture content range for capsule particles is 4.5%-5.3%; and repeated exposure of bottled products to the thermal shrinkage oven process involving heat-shrink film does not significantly affect capsule integrity under specific manufacturing conditions. These findings provide experimental evidence and technical guidance for enhancing the quality stability of herbal extract capsule formulations.

关键词

中草药提取物 / 明胶胶囊 / 胶囊破损 / 水分迁移 / 脆碎度

Key words

chinese herbal medicine extracts / gelatin capsules / capsule rupture / water migration / fragility

参考文献

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