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冠心生脉丸质量标准提升

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目的 提升冠心生脉丸质量标准.方法 TLC法定性鉴别人参和三七,分析采用硅胶G薄层板,以三氯甲烷-甲醇-水(13 ∶ 7 ∶ 2)10℃以下放置的下层溶液为展开剂,10%硫酸乙醇溶液为显色剂.HPLC法测定人参皂苷Rg1、人参皂苷Re、人参皂苷 Rb1、人参皂苷 Rd 的含量,分析采用 Thermo Accucore-C18 色谱柱(4.6 mm×150 mm,2.6 μm);流动相乙腈-水,梯度洗脱;体积流量 0.8 mL/min;柱温20℃;检测波长203 nm.结果 TLC斑点清晰,阴性无干扰.4 种成分在各自范围内线性关系良好(R2≥0.999 9),平均加样回收率 91.21%～106.86%,RSD 0.68%～1.43%.结论 该方法专属性、重复性良好,可为冠心生脉丸质量控制提供参考.
Quality standard improvement for Guanxin Shengmai Pills
AIM To improve the quality standard for Guanxin Shengmai Pills.METHODS TLC was adopted in the qualitative identification of Ginseng Radix et Rhizoma and Notoginseng Radix et Rhizoma,the analysis was performed on a silica G thin layer plate,along with the low layer solution of chloroform-methanol-water(13 : 7 : 2)stood at below 10℃ as a mobile phase,and 10％sulfuric acid ethanol solution as a derivatization reagent.HPLC was applied to determining the contents of ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1 and ginsenoside Rd,the analysis was performed on a 20℃ thermostatic Thermo Accucore-C18 column(4.6 mm×150 mm,2.6 μm),with the mobile phase comprising of acetonitrile-water flowing at 0.8 mL/min in a gradient elution manner,and the detection wavelength was set at 203 nm.RESULTS The clear TLC bands present without negative interference.Four constituents showed good linear relationships within their own ranges(R2≥0.999 9),whose average recoveries were 91.21％-106.86％with the RSDs of 0.68％-1.43％.CONCLUSION This specific and reproducible method can provide a reference for the quality control of Guanxin Shengmai Pills.

Guanxin Shengmai PillsGinseng Radix et RhizomaNotoginseng Radix et Rhizomaginsenosidesqualitative identificationcontent determinationTLCHPLC

刘静玉、金武燮、谷丽华、吴立宏、王峥涛

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上海中医药大学中药研究所,中药标准化教育部重点实验室,国家中医药管理局中药新资源与质量评价重点实验室,上海 201203

上海中药标准化中心,上海 201203

冠心生脉丸 人参 三七 人参皂苷 定性鉴别 含量测定 TLC HPLC

国家自然科学基金重点项目上海市公共卫生三年行动计划上海市卫生健康委项目

82130115ZY2021-2023-0215ZYCC2019013

2024

10.3969/j.issn.1001-1528.2024.03.003

中成药
国家食品药品监督管理局,信息中心中成药信息站,上海中药行业协会

中成药

CSTPCD北大核心
影响因子：1.217
ISSN：1001-1528
年,卷(期)：2024.46(3)
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