蒙药益肾散的质量标准研究  

Study on the Quality Standard for Mongolian Medicine Yishen Powder

作　　者：王美丽[1] 海祺山 戴丽丽[1] 田香[3] 白玉霞[1] 

机构地区：[1]内蒙古民族大学蒙医药学院,内蒙古通辽028300 [2]通辽市科左中旗蒙医医院,内蒙古通辽029300 [3]江西中医药大学药学院,南昌330004

出　　处：《中国药房》2017年第6期823-826,共4页China Pharmacy

基　　金：通辽市与内蒙古民族大学科技合作项目(No.SXZD2012011)

摘　　要：目的:建立蒙药益肾散的质量标准。方法:采用薄层色谱法(TLC)对制剂中大黄、诃子进行定性鉴别;采用高效液相色谱法测定制剂中芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚的含量:色谱柱为Inertsil C18,流动相为甲醇-0.1%磷酸溶液(梯度洗脱),流速为1.0 m L/min,检测波长为254 nm,柱温为35℃,进样量为10μL。结果:大黄、诃子的TLC图斑点清晰,分离度好。芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚检测进样量线性范围分别为23.55~117.75 ng(r=0.999 9)、44.72~223.62 ng(r=0.999 8)、43.18~215.90 ng(r=0.999 7)、77.41~387.12 ng(r=0.999 9)、46.02~230.10 ng(r=0.999 7);精密度、稳定性、重复性试验的RSD<2.0%;加样回收率分别为95.80%~99.66%(RSD=1.21%,n=6)、95.01%~98.07%(RSD=0.92%,n=6)、95.06%~97.84%(RSD=0.50%,n=6)、95.19%~97.66%(RSD=1.07%,n=6)、95.07%~98.20%(RSD=0.95%,n=6)。结论:该研究所建标准可用于蒙药益肾散的质量控制。OBJECTIVE：To establish the quality standard for Mongolian medicine Yishen powder. METHODS：TLC was used for the qualitative identification of Rheum palmatum and Terminalia chebula in the preparation;HPLC was used for the contents determination of aloe emodin,rhein,emodin,chrysophanol and physcion：the column was Inertsil C18 with mobile phase of methanol-0.1% phosphoric acid（gradient elution）at a flow rate of 1.0 m L/min,detection wavelength was 254 nm,column temperature was 35 ℃ and the injection volume was 10 μL. RESULTS：The TLC pots of R. palmatum and T. chebula were clear and well-separated,negative control without interference. The linear range was 23.55-117.75 ng for aloe emodin（r=0.999 9）,44.72-223.62 ng for rhein（r=0.999 8）,43.18-215.90 ng for emodin（r=0.999 7）,77.41-387.12 ng for chrysophanol（r=0.999 9）and 46.02-230.10 ng for physcion（r=0.999 7）;RSDs of precision,stability and reproducibility tests were lower than 2.0%;recoveries were95.80%-99.66%（RSD=1.21%,n=6）,95.01%-98.07%（RSD=0.92%,n=6）,95.06%-97.84%（RSD=0.5%,n=6）,95.19%-97.66%（RSD=1.07%,n=6）and 95.07%-98.20%（RSD=0.95%,n=6）. CONCLUSIONS：The established standard can be used for the quality control of Mongolian medicine Yishen powder.

关 键 词：蒙药益肾散 薄层色谱法 高效液相色谱法 含量测定 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]