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山药配方颗粒溶化性差的原因分析与解决策略 被引量:6

Cause Analysis and Solution Strategy of Poor Solubility of Dioscoreae Rhizoma Formula Granules
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摘要 山药配方颗粒由山药饮片经水煎煮提取、分离、浓缩、干燥、制粒而成,具有调剂简单、使用方便、免煎易服等优势。然而,因山药富含淀粉与黏液质类成分,其提取物粉末与配方颗粒溶化性差,在5 min内难以完全溶化或分散,不溶物即使在水中静置24 h也难以完全溶散,影响了配方颗粒的质量评价与患者的服药心理。因此,通过研究山药提取物及其配方颗粒的溶化过程与机制,发现山药特殊的化学组成、高温提取过程中淀粉的变性及其与蛋白质等物质的复合、喷雾干燥过程中“衣膜”的收缩形成等因素综合叠加,最终形成“衣膜”包覆淀粉粒的特殊微观结构,是山药配方颗粒溶化性差的根本原因。基于课题组前期对粉体结构-性质-功能的研究,笔者提出采用粉体改性工艺改善山药配方颗粒溶化性的技术策略,并通过实验证明改性处理后的山药配方颗粒能在2 min内实现全部溶散,解决了该技术难题,可为其他类似品种的溶化性改善提供借鉴,推动中药配方颗粒产业的高质量发展。 Dioscoreae Rhizoma formula granules are made from decoction pieces by decocting,extracting,separating,concentrating,drying and granulating,which have the advantages of simple dispensing,convenient use and easy to take without decoction.However,because Dioscoreae Rhizoma is rich in starch and mucus components,its extract powder and formula granules are poorly soluble and difficult to dissolve or disperse completely within 5 min,and the insoluble material is difficult to dissolve completely even after 24 h in water,which affects the quality evaluation of the formula granules and medication psychology of patients.Therefore,by studying the dissolution process and mechanism of Dioscoreae Rhizoma extract and its formula granules,it was found that the special chemical composition of Dioscoreae Rhizoma,the denaturation of starch and its compounding with protein and other substances during the high temperature extraction process,and the contraction of coating membrane during the spray drying process were combined to form the special microstructure of coating membrane covering starch granules,and it is the root cause of poor solubility of Dioscoreae Rhizoma formula granules.Based on the research on the structure,property and function of the powder,this paper proposed a technical strategy to improve the solubility of Dioscoreae Rhizoma formula granules by powder modification process,and experimentally demonstrated that the modified Dioscoreae Rhizoma formula granules could completely dissolve within 2 min,which solved the technical problem and could provide reference for the improvement of solubility of other similar varieties,and promote the high-quality development of traditional Chinese medicine formula granule industry.
作者 廖维 张定堃 郭治平 阮世发 葛春丽 廖嘉宝 韩丽 LIAO Wei;ZHANG Dingkun;GUO Zhiping;RUAN Shifa;GE Chunli;LIAO Jiabao;HAN Li(School of Pharmacy,State Key Laboratory of Southwestern Chinese Medicine Resources,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China;Sichuan Houde Pharmaceutical Technology Co.Ltd.,Chengdu 610041,China;China Resources Sanjiu Modern Chinese Medicine Pharmaceutical Co.Ltd.,Shenzhen 518110,China)
出处 《中国实验方剂学杂志》 CAS CSCD 北大核心 2023年第7期193-198,共6页 Chinese Journal of Experimental Traditional Medical Formulae
基金 华润三九现代中药制药有限公司-成都中医药大学企业委托横向课题(3010210586)。
关键词 山药 中药配方颗粒 溶化性 微观结构 喷雾干燥 粉体改性技术 淀粉 Dioscoreae Rhizoma traditional Chinese medicine formula granules solubility microstructure spray drying powder modification technology starch
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