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五淋丸质量标准提升研究

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目的 提升五淋丸的质量控制标准。方法 在现行标准的基础上,增加了绿原酸、栀子苷、芍药苷、当归、川芎的薄层鉴别方法,以及栀子苷、芍药苷的HPLC含量测定方法。HPLC含量测定条件:Anpel Athena C18色谱柱(250 mm×4。6 mm,5μm),流动相为乙腈-0。1% 磷酸溶液(11:89),检测波长240 nm,柱温为30℃,流速为1。0 mL/min。结果 经方法学验证表明,所建立的薄层色谱方法阴性均无干扰,斑点清晰,耐用性好。栀子苷和芍药苷分别在0。0454~0。8173μg(r=0。9997)和0。0427~0。5125μg(r=0。9996)之间与峰面积的线性关系良好,平均回收率分别为96。0%、103。2%,其RSD值分别为1。6%、0。9%。结论 本研究所建立的五淋丸质量控制方法专属性较强,重现性及耐用性好,可用于五淋丸的质量控制。
Quality Standard Improvement of Wulin Pills
Objective To improve the quality control standard of wulin pills. Methods Based on the original standard,the TLC identification methods of chlorogenic acid,gardenoside,paeoniflorin,angelica and ligusticum wallichii were added,and the HPLC content determination method of gardenoside and paeoniflorin was established:Anpel Athena C18 (250 mm×4.6 mm,5 μm) was used to chromatgraphic separation with 0.1% phosphoric acid-acetonitrile (89∶11) as the mobile phase at a flow velocity of 1.0 mL/min. The column temperature was 30 ℃ and the detection wavelength was set at 240 nm. Results The methodological validation showed that the established TLC methods were proved to be no negative interference,clear spots and good durability. A good linear relationship between the peak area and the content of gardenoside and paeoniflorin was at 0.0454~0.8173 μg (r=0.9997) and 0.0427~0.5125 μg (r=0.9996),respectively. The average recovery rates were 96.0% and 103.2%,and their RSDs were 1.6% and 0.9%,respectively. Conclusion The established methods in this study have strong specificity,good reproducibility and durability,which could be used to control the quality of wulin pills.

Wulin pillsQuality standardChlorogenic acidGardenosidePaeoniflorin

李丹、邬秋萍、刘艳梅、段权洪、刘敏、赵雯

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江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌 330029

江西医学高等专科学校,江西上饶 334099

五淋丸 质量标准 绿原酸 栀子苷 芍药苷

2024

药品评价
江西省药学会

药品评价

影响因子:0.672
ISSN:1672-2809
年,卷(期):2024.21(8)