摘要
目的:建立复视明胶囊的质量标准。方法:采用薄层色谱法(TLC)对制剂中藁本内酯、橙黄决明素、大黄酚、枸杞子和水蛭进行定性鉴别。采用高效液相色谱法测定制剂中葛根素和人参皂苷Rb_1的含量,色谱柱为Intersil C_(18),流动相为乙腈-0.3%磷酸溶液(梯度洗脱),流速为1.0 mL/min,检测波长为203 nm,柱温为25℃,进样量为10μL。结果:藁本内酯、橙黄决明素、大黄酚、枸杞子和水蛭的TLC图斑点清晰,分离度好,阴性对照无干扰。葛根素、人参皂苷Rb_1检测质量浓度线性范围分别为10.56~337.92μg/m L(r=0.999 7)、17.80~569.70μg/mL(r=0.999 6);定量限分别为2.20、1.86μg/mL,检测限分别为0.12、0.13μg/mL;精密度、稳定性、重复性试验的RSD均小于2.0%;加样回收率分别为95.65%~99.66%(RSD=1.45%,n=6)、96.95%~98.52%(RSD=0.77%,n=6)。结论:所建质量标准可用于复视明胶囊的质量控制。
OBJECTIVE：To establish quality standard of Fushiming capsule. METHODS：TLC was used to qualitatively identify the ligustilide,aurantio obtusin,chrysophanol,fruit of Chinese wolfberry and Whitmania pigra,respectively. HPLC method was used to determine the contents of puerarin and ginsenosides Rb1. The determination was performed on Intersil C18 column with mobile phase consisted of acetonitrile-0.3% phosphoric acid（gradient elution）at flow rate of 1.0 mL/min;the detection wavlength was set at 203 nm,and column temperature was 25 ℃;the sample size was 10 μL. RESULTS：TLC spots of ligustilide,aurantio obtusin,chrysophanol,the fruit of C. wolfberry and W. pigra were clear and well separated without negative interference. The linear range of puerarin and ginsenoside Rb1 were 10.56-337.92 μg/mL（r=0.999 7）and 17.80-569.70 μg/mL（r=0.999 6）. The limits of quantitation were 2.20,1.86 μg/mL,and the limits of detection were 0.12,0.13 μg/mL,respectively. RSDs of precision,stability and reproducibility tests were lower than 2.0%. The recoveries were 95.65%-99.66%（RSD=1.45%,n=6）and 96.95%-98.52%（RSD=0.77%,n=6）,respectively. CONCLUSIONS：Established quality standard can be used for the quality control of Fushiming capsule.
作者
肖会敏
张俏
何悦
刘洋
张明科
王四旺
XIAO Huimin1, ZHANG Qiao2, HE Yue1, LIU Yang3, ZHANG Mingke4, WANG Siwang1(1. Institute of Materia Medica, Fourth Military Medical University, Xi＇ an 710032, China; 2. Shaanxi Chinese Medicine Institute/ Innovative Drug Research Center of Shaanxi Province, Shaanxi Xianyang 712000, China; 3. College of Pharmacy, Shaanxi University of TCM, Shaanxi Xianyang 712000, China; 4. Xi＇ an Lejian Biotechnology Co., Ltd., Xi＇an 710054, Chin)
出处
《中国药房》
CAS
北大核心
2018年第6期749-753,共5页
China Pharmacy
基金
陕西省科学技术厅社会发展科技攻关项目(No.2016SF-349)
