盐肤木总酚酸微丸胶囊质量标准的研究  

Quality standard for Rhus chinensis Mill. total phenolic acid pellet capsules

作　　者：王晓颖[1] 叶淼 许文[1] 褚克丹[1] 卢晓艺 连红 徐伟[1] WANG Xiao-ying;YE Miao;XU Wen;CHU Ke-dan;LU Xiao-yi;LIAN Hong;XU Wei(College of Pharmacy,Fujian University of Traditional Chinese Medicine,Fuzhou Fujian 350122,China;Fuzhou HaiWang Jinxiang Traditional Chinese Medicine Co.,Ltd,Fuzhou Fujian 350014,China)

机构地区：[1]福建中医药大学,福建福州350122 [2]福州海王金象中药制药有限公司,福建福州350014

出　　处：《时珍国医国药》2020年第4期863-867,共5页Lishizhen Medicine and Materia Medica Research

基　　金：国家自然科学基金(81803678);福建省卫生计生中青年骨干人才培养项目(2017-ZQN-65)。

摘　　要：目的建立盐肤木总酚酸微丸胶囊的质量标准。方法从外观对该微丸胶囊进行观察,采用薄层色谱法(TLC)定性鉴别制剂中的没食子酸和没食子酸乙酯成分,根据《中国药典》2015版第四部进行胶囊剂的相关检查,采用高效液相色谱法(HPLC)测定盐肤木总酚酸微丸胶囊中没食子酸、苔黑酚葡萄糖苷、没食子酸乙酯和五没食子酰葡萄糖的含量。结果胶囊外观整洁,无异臭,内容物微丸外观圆整光滑、粒径均一,薄层色谱斑点清晰、专属性强;胶囊剂的相关检查均符合2015版《中国药典》规定;没食子酸质量浓度在3.94~78.75μg/mL(r=0.9998),苔黑酚葡萄糖苷质量浓度在13.21~264.25μg/mL (r=0.9998),没食子酸乙酯质量浓度在6.59~131.75μg/mL (r=0.9998),五没食子酰葡萄糖质量浓度在19.58~391.50μg/mL (r=0.9996)范围内,均与峰面积线性关系良好;平均加样回收率没食子酸为100.71%(RSD=2.91%),苔黑酚葡萄糖苷101.06%(RSD=1.25%),没食子酸乙酯为102.07%(RSD=2.29%),五没食子酰葡萄糖为101.29%(RSD=2.96%)。结论该质量标准专属性强,方法简便、快速准确、重复性好,可用于盐肤木总酚酸微丸胶囊的质量控制。Objective To establish the quality standard for the Rhus chinensis Mill. total phenolic acid pellet capsules.Methods The appearance of capsules were observed. The gallic acid and ethyl gallate were qualitatively identified by thin-layer chromatography(TLC). The related examinations of the capsules were checked based on the fourth part of the Chinese Pharmacopoeia 2015 Edition. And the content of gallic acid, orcinol glucoside, ethyl gallate and penta-O-galloyl-β-D-glucose in Rhus chinensis Mill. total phenolic acid pellet capsules were determined by high performance liquid chromatography(HPLC). Results The appearance of capsules is neat and odorless. The appearance of the pellets is round and smooth, and the particle size is uniform. The established TLC identification method was specific and the spots were clear. The related examinations of capsules were in accordance with the provisions of Chinese Pharmacopoeia 2015 edition. The gallic acid, orcinol glucoside, ethyl gallate and penta-O-galloyl-β-D-glucose showed a good linear relationship with peak area in the ranges of 3.94~78.75 μg/mL( r = 0.9998), 13.21~264.25 μg/mL( r = 0.9998), 6.59~131.75 μg/mL( r = 0.9998) and 19.58~391.50 μg/mL( r = 0.9996), respectively.The average recovery rates of gallic acid, orcinol glucoside, ethyl gallate and penta-O-galloyl-β-D-glucose were 100.71%(RSD=2.91%), 101.06%(RSD=1.25%),102.07%(RSD=2.29%)and 101.29%(RSD=2.96%),respectively. Conclusion The quality standard has strong specificity, and the method is simple, rapid, accurate and reproducible. It can be used for the quality control of Rhus chinensis Mill. total phenolic acid pellet capsules.

关 键 词：盐肤木总酚酸 微丸胶囊 质量标准 薄层色谱 高效液相色谱 

分 类 号：R284.1[医药卫生—中药学] R283[医药卫生—中医学]