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基于粉体改性的山药配方颗粒溶出度改善技术与原理

[Technology and principle of improving solubility of Dioscoreae Rhizoma formula granules based on powder modification].

作者信息

Liao Wei, Zhang Ding-Kun, Guo Zhi-Ping, Liu Yu-Hua, Ge Chun-Li, Song Yi-Chen, Liao Jia-Bao, Han Li

机构信息

State Key Laboratory of Southwestern Chinese Medicine Resources,School of Pharmacy,Chengdu University of Traditional Chinese Medicine Chengdu 611137,China.

Sichuan Houde Pharmaceutical Technology Co.Ltd. Chengdu 610041,China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2023 Apr;48(8):2138-2145. doi: 10.19540/j.cnki.cjcmm.20230112.302.

DOI:10.19540/j.cnki.cjcmm.20230112.302
PMID:37282902
Abstract

The powder modification technology was used to improve the powder properties and microstructure of Dioscoreae Rhizoma extract powder, thereby solving the problem of poor solubility of Dioscoreae Rhizoma formula granules. The influence of modifier dosage and grinding time on the solubility of Dioscoreae Rhizoma extract powder was investigated with the solubility as the evaluation index, and the optimal modification process was selected. The particle size, fluidity, specific surface area, and other powder properties of Dioscoreae Rhizoma extract powder before and after modification were compared. At the same time, the changes in the microstructure before and after modification was observed by scanning electron microscope, and the modification principle was explored by combining with multi-light scatterer. The results showed that after adding lactose for powder modification, the solubility of Dioscoreae Rhizoma extract powder was significantly improved. The volume of insoluble substance in the liquid of modified Dioscoreae Rhizoma extract powder obtained by the optimal modification process was reduced from 3.8 mL to 0 mL, and the particles obtained by dry granulation of the modified powder could be completely dissolved within 2 min after being exposed to water, without affecting the content of its indicator components adenosine and allantoin. After modification, the particle size of Dioscoreae Rhizoma extract powder decreased significantly, d_(0.9) decreased from(77.55±4.57) μm to(37.91±0.42) μm, the specific surface area and porosity increased, and the hydrophilicity improved. The main mechanism of improving the solubility of Dioscoreae Rhizoma formula granules was the destruction of the "coating membrane" structure on the surface of starch granules and the dispersion of water-soluble excipients. This study introduced powder modification technology to solve the solubility problem of Dioscoreae Rhizoma formula granules, which provided data support for the improvement of product quality and technical references for the improvement of solubility of other similar varieties.

摘要

采用粉体改性技术改善山药提取物粉末的粉体性质和微观结构,从而解决山药配方颗粒溶出度差的问题。以溶出度为评价指标,考察改性剂用量和研磨时间对山药提取物粉末溶出度的影响,筛选出最佳改性工艺。比较改性前后山药提取物粉末的粒度、流动性、比表面积等粉体性质。同时,通过扫描电子显微镜观察改性前后微观结构的变化,并结合多角度激光散射仪探讨改性机理。结果表明,添加乳糖进行粉体改性后,山药提取物粉末的溶出度显著提高。采用最佳改性工艺得到的改性山药提取物粉末液体中不溶物体积从3.8 mL降至0 mL,改性粉末干法制粒得到的颗粒遇水后2 min内可完全溶解,且不影响其指标成分腺苷和尿囊素的含量。改性后,山药提取物粉末的粒度显著减小,d_(0.9)从(77.55±4.57)μm降至(37.91±0.42)μm,比表面积和孔隙率增大,亲水性提高。改善山药配方颗粒溶出度的主要机制是破坏淀粉颗粒表面的“包膜”结构以及水溶性辅料的分散作用。本研究引入粉体改性技术解决山药配方颗粒的溶出度问题,为产品质量提升提供了数据支持,也为其他同类品种溶出度改善提供了技术参考。

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