双柏散糊剂的制备工艺及质量控制  

Preparation technique and quality control of Shuangbai Powder Paste

作　　者：覃滢颖 陈海辉 蓝鲜艳 QIN Ying-ying;CHEN Hai-hui;LAN Xian-yan(Guangxi University of Chinese Medicine,Nanning 530200,China;Third Affiliated Hospital of Guangxi Uni-versity of Chinese Medicine,Liuzhou 545001,China)

机构地区：[1]广西中医药大学,广西南宁530200 [2]广西中医药大学第三附属医院,广西柳州545001

出　　处：《时珍国医国药》2025年第4期666-676,共11页Lishizhen Medicine and Materia Medica Research

基　　金：国家自然科学基金地区科学基金项目(82260504);广西自然科学基金项目(2020GXNSFBA297112);柳州市科技局资助项目(2019DH10604)。

摘　　要：目的研究双柏散糊剂的制备工艺及质量控制,为该药品保存及临床应用提供参考依据。方法制备不同赋形剂(水、姜汁、蜂蜜水、糖水、醋水)、不同光照(避光、不避光)、不同温度(低温、常温)下双柏散糊剂,观测其性状,建立HPLC法测定双柏散糊剂中异槲皮苷、小檗碱、木犀草素、大黄素的含量。结果当双柏散与赋形剂比例为5∶11时糊剂成形,湿润度适中。双柏散糊剂在常温下仅能保存3天,低温冷藏可保存7天。随着保存时间的延长,糊剂中有效成分异槲皮苷、小檗碱、木犀草素含量均有不同程度减少,大黄素含量增加,不避光保存可保留较多有效成分,冷藏条件下可减缓有效成分含量变化速度。双柏散以醋水作赋形剂时,保存过程中整体有效成分含量相对较高。结论建议临床调制双柏散糊剂时用醋水做赋形剂,在冷藏条件下保存使用。Objective To investigate the preparation technique and quality control of Shuangbai Powder(SBP)paste,providing a refer⁃ence for the preservation and clinical application of this medicine.Methods SBP paste was prepared with different excipients(water,ginger juice,honey water,sugar water,vinegar water),under different light conditions(protected from light or not),and at different temperatures(low temperature and room temperature).The properties of the paste were observed,and the contents of isoquercitrin,ber⁃berine,luteolin,and emodin in SBP paste were determined by High performance liquid chromatography(HPLC).Results When the ra⁃tio of SBP to excipient was 5:11,the paste was formed with moderate humidity.The paste could be stored for only 3 days at room temper⁃ature,and 7 days at low temperature.With prolonged storage,the contents of isoquercitrin,berberine and luteolin in the paste were de⁃creased to varying degrees,while the content of emodin was increased.More active ingredients could be retained without avoiding light preservation,and cold storage slowed down the rate of change in active ingredients.When SBP used vinegar water as excipient,the over⁃all content of active ingredients was relatively higher remained during storage.Conclusion It is recommended that vinegar water be used as excipient in the clinical preparation of SBP paste and be stored under the refrigerated conditions.

关 键 词：双柏散 糊剂 制备工艺 质量控制 高效液相色谱 

分 类 号：R283[医药卫生—中药学]