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骨奇泰搽剂质量标准提升研究

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目的 提升骨奇泰搽剂的质量标准。方法 采用薄层色谱(TLC)法对制剂中徐长卿、细辛、威灵仙进行定性鉴别;采用高效液相色谱法同时测定三七皂苷R1、人参皂苷Rg1、人参皂苷Re的含量,色谱柱为Shimadzu WondaSil Superb C18 柱(250 mm×4。6 mm,5µm),流动相为乙腈-水(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 20µL。结果 徐长卿、细辛、威灵仙的TLC图斑点清晰,阴性对照无干扰。三七皂苷R1、人参皂苷Rg1、人参皂苷Re的进样量分别在 0。281 0~5。465 2µg(R2= 1。000 0)、0。479 5~9。207 7µg(R2 = 0。999 8)、0。073 2~1。485 8µg(R2 = 0。999 9)范围内与峰面积线性关系良好;精密度、稳定性、重复性试验的RSD均小于 2。0%;平均加样回收率分别为 98。44%,97。34%,103。51%,RSD分别为 0。81%,1。69%,0。58%(n= 6);4 批样品中,三七皂苷R1、人参皂苷Rg1、人参皂苷Re的平均含量分别为 0。247 6,1。038 8,0。110 2 mg/mL。结论 所建立的方法专属性较强,重复性好,可用于控制骨奇泰搽剂的质量。
Improvement of Quality Standard of Guqitai Liniment
Objective To improve the quality standard of Guqitai Liniment.Methods Thin-layer chromatography(TLC)method was used to qualitatively identify Cynanchi Paniculati Radix et Rhizoma,Asari Radix et Rhizoma and Clematidis Radix et Rhizoma in the preparation.The high-performance liquid chromatography(HPLC)method was used to determine the contents of notoginsenoside R1,ginsenoside Rg1 and ginsenoside Re simultaneously;the chromatographic column was Shimadzu WondaSil Superb C18 column(250 mm×4.6 mm,5 µm),the mobile phase was acetonitrile-water(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 203 nm,the column temperature was 25℃,and the injection volume was 20 µL.Results The TLC chromatograms of Cynanchi Paniculati Radix et Rhizoma,Asari Radix et Rhizoma and Clematidis Radix et Rhizoma had clear spots,and there was no interference from the negative reference.The linear ranges of notoginsenoside R1,ginsenoside Rg1 and ginsenoside Re were 0.281 0-5.465 2 µg(R2 = 1.000 0),0.479 5-9.207 7 µg(R2 = 0.999 8)and 0.073 2-1.485 8 µg(R2= 0.999 9)respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of the above three ingredients were 98.44%,97.34%,and 103.51%,with the RSDs of 0.81%,1.69%and 0.58%(n = 6)respectively.The average contents of notoginsenoside R1,ginsenoside Rg1 and ginsenoside Re in four batches of samples were 0.247 6,1.038 8,0.110 2 mg/mL,respectively.Conclusion The established method is specific and repeatable,which can be used for the quality control of Guqitai Liniment.

Guqitai Linimentquality standardHPLCTLCnotoginsenoside R1ginsenoside Rg1ginsenoside ReAsari Radix et Rhizoma

林奕沁、秦银燕、陈贞伶、何成章、陆华

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广西医科大学第一附属医院,广西 南宁 530021

骨奇泰搽剂 质量标准 高效液相色谱法 薄层色谱法 三七皂苷R1 人参皂苷Rg1 人参皂苷Re 细辛

广西壮族自治区中医药管理局自筹经费科研课题

GXZYZ20210007

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(4)
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