摘要
目的优选术连理气颗粒制备工艺及建立指标成分HPLC含量测定方法。方法选取君药黄连中盐酸小檗碱、盐酸巴马汀,臣药枳壳、佐药陈皮中柚皮苷、新橙皮苷、橙皮苷作为关键评价指标,运用L9(34)正交试验法,系统地对不同条件下的水提效果进行评估,筛选最适配术连理气颗粒的水提工艺。以颗粒制粒情况、成型率为考察指标,优选最佳成型工艺。结果最佳水提工艺为加10倍量水提取两次,每次1 h,辅料种类为糊精,药辅比为2∶1,润湿剂为乙醇;柚皮苷、新橙皮苷、橙皮苷、盐酸巴马汀、盐酸小檗碱在线性范围内线性关系良好,精密度、稳定性、重复性等方法学结果的RSD值均<2%,平均加样回收率分别为100.55%、101.53%、98.09%、99.15%、99.09%,RSD值分别为1.82%、1.86%、1.15%、1.13%、2.30%。结论所建立的制备工艺稳定、可靠,含量测定简单可行,重复性良好,可为术连理气颗粒工业化生产提供依据,为其新药开发提供参考。
Objective To optimize the preparation process of Zhulianliqi Granules and establish an HPLC-based method for the determination of the content of index components.Methods Berberine hydrochloride and palmatine hydrochloride from the primary drug Coptidis Rhizoma,naringin,neohesperidin,and hesperidin from the secondary drug Aurantii Fructus and the adjuvant drug Citrts Reticul Pericarp were selected as the key evaluation indicators,the L9(34)orthogonal test method was used to systematically evaluate the water extraction effect under different conditions and screen the water extraction process that was most suitable for the Zhulianliqi Granules of the technique.Taking the granulation condition of granules and the molding rate as the investigation indicators,the best molding process was selected.Results The optimal water extraction protocol entailed two rounds of extraction,each lasting one hour with 10-fold water volume.The type of excipient was dextrin,the ratio of drug to excipient was 2∶1,and the wetting agent was ethanol.Naringin,neohesperidin,hesperidin,palmatine hydrochloride,and berberine hydrochloride,excellent linear relationships were manifested within the linear ranges.The results of precision,stability,and repeatability tests demonstrated RSD values<2%.The average recoveries were 100.55%,101.53%,98.09%,99.15%,and 99.09%respectively,and the corresponding RSD values were 1.82%,1.86%,1.15%,1.13%,and 2.30%respectively.Conclusion The established preparation process is stable and reliable,and the content determination method is simple,feasible and features good repeatability.It can provide a basis for the industrial production of Zhulianliqi Granules and serve as a reference for the development of new drugs.
作者
周德勇
龚韬
严文利
宋京美
杨薇
王夏
胡银燕
李蜀平
ZHOU Deyong;GONG Tao;YAN Wenli;SONG Jingmei;YANG Wei;WANG Xia;HU Yinyan;LI Shuping(Beijing Institute of Traditional Chinese Medicine,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China)
出处
《中国医药导报》
2025年第14期46-49,共4页
China Medical Herald
基金
北京市中医药研究所市财政专项项目(YJS-2024-23)。
关键词
术连理气颗粒
水提取工艺
正交试验
成型工艺
质量评价
Zhulianliqi Granules
Water extraction technology
Orthogonal test
Molding technology
Quality evaluation
