甘葛护肝胶囊质量标准研究
2021-06-08彭霜陈凌云李江
彭霜 陈凌云 李江



【摘 要】 目的:建立甘葛护肝胶囊的薄层鉴别和含量测定方法,用于控制其质量。方法:采用薄层色谱法分别对甘葛护肝胶囊中的干姜、木香、砂仁、白豆蔻、陈皮、青皮、泽泻进行鉴别;并采用高效液相色谱法测定其中葛根素的含量。结果:7味药的薄层特征斑点明显,阴性无干扰,重复性良好。葛根素在0.106~1.06μg范围内,峰面积与进样量呈良好的线性关系(r=1),平均加样回收率为99.49%,RSD=1.11%。结论:建立的薄层鉴别方法斑点清晰,专属性好,含量测定方法阴性无干扰,结果准确、稳定,可用于控制该制剂标准。
【关键词】 甘葛护肝胶囊;葛根素;薄层鉴别;高效液相色谱法
Abstract:Objective Establish a thin-layer chromatography(TLC) identification and content determination method for Gange Hugan Capsules to control its quality.Methods TLC was used to identify dry Zingiberis rhizoma,Aucklandae radix,Amomum fructus,Amom fructus rotundus,Citri reticulatae pericarpium ,atae pericarpium viride and Alismatis rhizoma respectively in Gange Hugan capsule.Puerarin content was determined by HPLC.Results 7 medicines dispcayed obvious characteristic spots in TLC with non-interfering and good repeatability.In negate samples of puerarin from 0.106 to 1.06μg,the peak area has a good linear relationship with the injection volume (r=1).The average sample recollectron is 99.49%,and the RSD = 1.11%.Conclusion The established TLC identification method showed clear spots,good specificity,and non-interfemgin negative samples interference.The results were accurate and stable,suggesting that this method be used to control the preparation standards.
Keywords:Gange Hugan Capsules; Puerarin; TLC; HPLC
酒精性肝病(Alcoholic Live Disease,ALD)是由于长期大量饮酒或者短时间内摄入大量酒精引起的疾病。酒精在代谢过程中的氧化应急作用及炎症反应是引起酒精肝的主要因素[1]。肝脏是机体代谢酒精的主要器官,代谢量达到90%以上,酒精对肝脏的损伤在所有器官中最为明显[1]。有研究表明,酒精性肝病发病与线粒体损伤、代谢过程中的氧化应激、细胞因子的释放和细胞凋亡等有密切关系[1-2]。也有研究[3]表明,某些中药成分对酒精性肝损伤具有保护作用,在改善肝脏功能[4]、调节乙醇代谢[5-6]、减轻氧化应激损伤[7]、抗炎护肝[8]和细胞凋亡[9]等方面,有明显的优势。
甘葛护肝胶囊处方来源于云南中医药大学第三附属医院(昆明市中医医院)的经验方,由青皮、木香、茯苓、人参、三七、橘皮、炒神曲、猪苓、干姜、白术、泽泻、葛花、砂仁、白豆蔻、牡蛎、枸杞子、葛根、余甘子共18味药组成,具有良好的解酒保肝功效[10]。……
