| 引用本文: | 姜军华,许妍,罗跃华,李后如,施宝顺.脉络宁颗粒的质量标准提升研究[J].中国现代应用药学,2021,38(20):2537-2541. |
| JIANG Junhua,XU Yan,LUO Yuehua,LI Houru,SHI Baoshun.Study on the Improvement of Mailuoning Granule's Quality Standard[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(20):2537-2541. |
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| 脉络宁颗粒的质量标准提升研究 |
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姜军华1, 许妍1, 罗跃华1, 李后如2, 施宝顺3
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1.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, 南昌 330029;2.江西银涛药业有限公司, 江西 抚州 344100;3.景德镇市市场和质量监督管理综合检验检测中心, 江西 景德镇 360200
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| 摘要: |
| 目的 提升脉络宁颗粒的产品质量标准。方法 对现有质量标准进行增修订，修订组方中牛膝和玄参的薄层色谱（TLC）鉴定方法，增加石斛的HPLC鉴定方法，修订玄参的HPLC含量测定法。结果 脉络宁颗粒中牛膝和玄参的TLC图谱均与对应的对照药材及对照品在相同位置上显现相同颜色的斑点，且阴性对照样品无干扰，石斛的HPLC图谱中供试品色谱中呈现与对照品色谱峰保留时间相一致的色谱峰，且阴性对照样品无干扰。玄参含量测定采用AlltimaTMC18色谱柱（4.6 mm×250 mm，5 μm）；流动相为乙腈-0.03%磷酸溶液（梯度洗脱）；流速为1.0 mL·min-1；检测波长为203 nm（0~20 min）、280 nm（20~40 min），柱温25℃。哈巴苷、哈巴俄苷进样量分别在0.070 51~1.057 6，0.021 42~0.321 4 μg内线性关系良好（r均>0.999 7）；平均加样回收率分别为97.87%，100.96%，RSD均<2%（n=6）。结论 本研究建立的方法操作简便、准确可靠、专属性强，提升和完善了该制剂的质量标准。 |
| 关键词: 脉络宁颗粒 鉴别 含量测定 薄层色谱法 高效液相色谱法 质量标准 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.20.010 |
| 分类号:R917 |
| 基金项目:江西省中医药管理局科技计划项目（2020A0369） |
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| Study on the Improvement of Mailuoning Granule's Quality Standard |
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JIANG Junhua1, XU Yan1, LUO Yuehua1, LI Houru2, SHI Baoshun3
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1.Jiangxi Institute for Drug Control, NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine, Jiangxi Province Engineering Research Center of Drug and Medical Device Quality, Nanchang 330029, China;2.Jiangxi Yintao Pharmaceutical Co., Ltd., Fuzhou 344100, China;3.Jingdezhen Market and Quality Supervision and Management Comprehensive Inspection and Testing Center, Jingdezhen 360200, China
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| Abstract: |
| OBJECTIVE To improve the product quality standard of Mailuoning granules. METHODS The existing quality standards were added and revised, the thin layer chromatography(TLC) identification method of Achyranthis Bidentatae Radix and Scrophulariae Radix in the formula was revised, and the HPLC identification method of Dendrobii Caulis was added, the HPLC determination method of Scrophulariae Radix was revised. RESULTS The TLC patterns of Achyranthis Bidentatae Radix and Scrophulariae Radix in Mailuoning granules showed spots of the same color on the same position as the corresponding control medicinal materials or the reference substance, and the negative control had no interference. The HPLC pattern of Dendrobii Caulis for testing the product chromatogram presented a chromatographic peak consistent with the retention time of the reference chromatographic peak, and the negative control had no interference. The content of Scrophulariae Radix was determined using AlltimaTM C18 chromatographic column(4.6 mm×250 mm, 5 μm), the mobile phase was acetonitrile-0.03% phosphoric acid solution(gradient elution), the flow rate was 1.0 mL·min-1; the detection wavelength was 203 nm(0-20 min) and 280 nm(20-40 min). The column temperature was 25℃. The linear range of harpagide and harpagoside was 0.070 51-1.057 6 and 0.021 42-0.321 4 μg(r>0.999 7); the average recoveries were 97.87% and 100.96%(RSD<2%, n=6). CONCLUSION The developed methods is simple, accurate, reliable and specific, which can improve the quality standard of this preparation. |
| Key words: Mailuoning granules identification content determination TLC HPLC quality standard |
