助孕养膜安胎合剂的制备工艺及质量标准研究  

Study on Preparation Technology and Quality Standard for Zhuyun Yangmo Antai Mixture(助孕养膜安胎合剂)

作　　者：高家菊 欧大松 丁雄 马云淑 姜丽娟[4] GAO Jiaju;OU Dasong;DING Xiong;MA Yunshu;JIANG Lijuan(School of Chinese Materia Medica,Yunnan University of Chinese Medicine,Kunming 650500,Yunnan,China;Yunnan Key Laboratory of Dai and Yi Medicines,Kunming 650500,Yunnan,China;Yunnan Key Laboratory of Applied Drug Delivery System and Preparation Technology,Kunming 650500,Yunnan,China;Yunnan Hospital of Traditional Chinese Medicine,Kunming 650500,Yunnan,China)

机构地区：[1]云南中医药大学中药学院,云南昆明650500 [2]云南省高校外用给药系统与制剂技术重点实验室,云南昆明650500 [3]云南省彝医药与傣医药重点实验室,云南昆明650500 [4]云南省中医医院,云南昆明650500

出　　处：《辽宁中医杂志》2022年第8期161-165,I0003,共6页Liaoning Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金地区项目(82060723)。

摘　　要：目的 优选助孕养膜安胎合剂的制备工艺并建立其质量标准。方法 以金丝桃苷含量为考察指标,通过L_(9)(3^(4))正交试验设计法筛选助孕养膜安胎合剂最佳制备工艺;采用薄层色谱(TLC)法对制剂中主要药味菟丝子、黄芪、茯苓、川续断进行薄层鉴别,采用高效液相色谱(HPLC)法对有效成分金丝桃苷进行含量测定。结果 最佳制备工艺为:10倍水浸泡1.5 h,煎煮3次,每次1 h,离心纯化10 min;菟丝子、黄芪、茯苓、川续断的TLC图斑点清晰,阴性无干扰;金丝桃苷在0.125~80μg·mL^(-1)线性关系良好(n=7),r=1;精密度、重复性、稳定性的RSD<2%;平均加样回收率102.37%~104%,RSD值均小于1%(n=9)。结论 该制剂的制备工艺可行,建立的定性定量方法便捷、可靠,可作为助孕养膜安胎合剂的质量控制方法。Objective To optimize the preparation technology and set up the quality standard of Zhuyun Yangmo Antai Mixture(助孕养膜安胎合剂).Methods The hyperoside content was used as evaluation index,and the preparation technology of Zhuyun Yangmo Antai Mixture was optimized by L_(9)(3^(4))orthogonal test.Tusizi(Semen Cuscutae),Huangqi(Radix Astragali),Fuling(Poria)and Xuduan(Dipsaci Radix)were identified by thin layer chromatography(TLC)method,and the content of active ingredient hyperoside was determined by High performance liquid chromatography(HPLC)method.Results The optimal preparation process was as following:soaking 1.5 h with 10 times the amount of water,extracting 3 times with 1 h for each time,and centrifuging 10 min for purification.TLC can identify these extractions,the spots of Tusizi(Semen Cuscutae),Huangqi(Radix Astragali),Fuling(Poria)and Xuduan(Dipsaci Radix)were clear,and their negative control showed no interference.The calibration curve of hyperoside was in good linear in the range of 0.125~80μg·mL^(-1)(n=7)(r=1).The RSD values of precision,repeatability and stability were all less than 2%,and the average recoveries ranged from 102.37%~104% with RSD below 1%(n=9).Conclusion The optimized preparation technology is feasible,and the established methods are convenient and reliable.It can be used as the quality control methods for Zhuyun Yangmo Antai Mixture.

关 键 词：助孕养膜安胎合剂 制备工艺 质量标准 薄层色谱 高效液相色谱 

分 类 号：R283[医药卫生—中药学]