复方独正片的质量标准研究
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篇名: 复方独正片的质量标准研究
TITLE:
摘要: 目的:建立复方独正片的质量标准。方法:采用薄层色谱法(TLC)对制剂中独正杆、刺老苞、刺五加、三七进行定性鉴别;采用高效液相色谱法测定制剂中紫丁香苷、齐墩果酸、人参皂苷Rg1、人参皂苷Rb1、三七皂苷R1的含量:色谱柱为Inertsil ODS-SP C18,流动相为乙腈-水(梯度洗脱),流速为1.0 mL/min,检测波长为215 nm,柱温为25 ℃,进样量为10 μL。结果:独正杆、刺老苞、刺五加、三七的TLC斑点清晰,分离度好,阴性对照无干扰。紫丁香苷、齐墩果酸、人参皂苷Rg1、人参皂苷Rb1、三七皂苷R1检测进样量线性范围分别为0.056~0.337 μg(r=0.999 8)、0.022~0.130 μg(r=0.999 9)、0.030~0.182 μg(r=0.999 5)、0.010~0.061 μg(r=0.999 8)、0.038~0.226 μg(r=0.999 9);精密度、稳定性、重复性试验的RSD<3.0%;加样回收率分别为100.55%~103.80%(RSD=2.0%,n=9)、100.00%~104.56%(RSD=3.0%,n=9)、97.06%~102.94%(RSD=2.1%,n=9)、97.06%~102.94%(RSD=2.0%,n=9)、96.67%~100.00%(RSD=1.5%,n=9)。结论:该研究所建标准可用于复方独正片的质量控制。
ABSTRACT: OBJECTIVE: To establish the quality standard of Compound duzheng tablets. METHODS: TLC method was used for qualitative identification of Vitis davidii, Aralia chinensis, Acanthopanax senticosus and Panax notoginseng in the preparation. The contents of syringoside, oleanolic acid, ginsenoside Rg1, ginsenoside Rb1 and notoginsenoside R1 were determined by HPLC. The determination was performed on Inertsil ODS-SP C18 column with mobile phase consisted of acetonitrile-water (gradient elution) at the flow rate of 1.0 mL/min. The detection wavelength was set at 215 nm, and the column temperature was 25 ℃. The sample size was 10 μL. RESULTS: TLC spots of V. davidii, A. chinensis, A. senticosus and P. notoginseng were clear and well-separated without interference from negative control. The linear ranges of syringoside, oleanolic acid, ginsenoside Rg1, ginsenoside Rb1 and notoginsenoside R1 were 0.056-0.337 μg(r=0.999 8), 0.022-0.130 μg(r=0.999 9), 0.030-0.182 μg(r=0.999 5), 0.010-0.061 μg(r=0.999 8), 0.038-0.226 μg(r=0.999 9), respectively. RSDs of precision, stability and reproducibility tests were all lower than 3.0%. The recoveries were 100.55%-103.80%(RSD=2.0%,n=9),100.00%-104.56%(RSD=3.0%,n=9),97.06%-102.94%(RSD=2.1%,n=9)、97.06%-102.94%(RSD=2.0%,n=9),96.67%-100.00%(RSD=1.5%,n=9). CONCLUSIONS: Established standard can be used for the quality control of Compound duzheng tablets.
期刊: 2017年第28卷第15期
作者: 漆立军,黄华斌,覃鸿恩
AUTHORS: QI Lijun,HUANG Huabin,QIN Hong’en
关键字: 复方独正片;质量标准;薄层色谱法;高效液相色谱法
KEYWORDS: Compound duzheng tablets; Quality standard;TLC;HPLC
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