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脂脱劲颗粒质量标准提升研究

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目的 建立脂脱劲颗粒的质量标准.方法 采用薄层色谱(TLC)法定性鉴别制剂中的制何首乌、女贞子、茯苓、木瓜;采用高效液相色谱(HPLC)法测定制剂中芍药苷的含量,色谱柱为Agilent Hedera Lichrospher柱(250 mm×4.6 mm,5 μm),流动相为乙腈-0.1%磷酸水溶液(18∶82,V/V),流速为 1.0 mL/min,检测波长为 230 nm,柱温为 35℃,进样量为 10 μL.结果 制何首乌、女贞子、茯苓、木瓜的TLC图斑点清晰,分离度好,且阴性对照无干扰.芍药苷质量浓度在 21~168 μg/mL范围内与峰面积线性关系良好(r=0.9995,n=5);精密度、稳定性、重复性试验结果的RSD均小于3.0%,平均加样回收率为100.64%,RSD为1.64%(n=9).结论 该方法操作简便,结果准确可靠,可用于脂脱劲颗粒的质量控制.
Improvement of Quality Standard of Zhituojing Granules
Objective To establish a quality standard of Zhituojing Granules.Methods Polygoni Multiflori Radix Praeparata,Ligustri Lucidi Fructus,Poria and Chaenomelis Fructus in the preparation were qualitatively identified by the thin-layer chromatography(TLC)method.The content of paeoniflorin in the preparation was determined by the high-performance liquid chromatography(HPLC)method;the chromatographic column was the Agilent Hedera Lichrospher column(250 mm×4.6 mm,5 μm),the mobile phase was acetonitrile-0.1%phosphoric acid aqueous solution(18∶82,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 230 nm,the column temperature was 35℃,and the injection volume was 10 μL.Results The TLC chromatograms of Polygoni Multiflori Radix Praeparata,Ligustri Lucidi Fructus,Poria and Chaenomelis Fructus showed clear spots,good resolution,and there was no interference from the negative reference.The linear range of paeoniflorin was 21-168 μg/mL(r=0.9995,n=5).The RSDs of precision,stability and repeatability tests were all lower than 3.0%.The average recovery rate of paeoniflorin was 100.64%with an RSD of 1.64%(n=9).Conclusion This method is easy,accurate and reliable,which can be used for the quality control of Zhituojing Granules.

Zhituojing Granulesquality standardTLCHPLCcontent determination

唐安福、苏倩雯、崔恩忠、汤淏、潘海娟

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中国人民解放军东部战区总医院,江苏 南京 210002

脂脱劲颗粒 质量标准 薄层色谱法 高效液相色谱法 含量测定

中国人民解放军军队医疗机构制剂标准提高科研专项课题

14ZJZ16-3

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(16)
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