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作者中文名	作者英文名	单位中文名	单位英文名	E-Mail
赵振霞	ZHAO Zhen-xia	河北省药品医疗器械检验研究院	Hebei Institute for Drug and Medical Device Control	347749757@qq.com
耿莲	GENG Lian	河北省药品医疗器械检验研究院	Hebei Institute for Drug and Medical Device Control	genglian_1216@163.com
安丽康	AN Li-kang	河北省药品医疗器械检验研究院	Hebei Institute for Drug and Medical Device Control	anlikang2008@126.com
孔亚萍*	KONG Ya-ping	河北省药品医疗器械检验研究院	Hebei Institute for Drug and Medical Device Control	1019839467@qq.com
刘永利	LIU Yong-li	河北省药品医疗器械检验研究院	Hebei Institute for Drug and Medical Device Control	liuyongli2008@126.com

基金项目:河北特色中药饮片炮制规范化研究及应用示范(22372503D)；

中文摘要:目的：研究建立三七粉与含三七中成药中三七的质量控制方法,提高产品质量控制水平。方法：采用显微鉴别法、薄层鉴别法及超高效液相色谱法、超高效液相色谱串联质谱联用法分别对三七粉及含三七中成药中主要皂苷类成分进行定性、定量研究。结果：分别建立了三七粉及含三七中成药中三七皂苷R₁、人参皂苷Rg₁、人参皂苷Re、人参皂苷Rb₁、人参皂苷Rd等5种成分的薄层色谱鉴别方法与含量测定方法,鉴别特征明显,薄层斑点清晰,分离度良好,含量测定线性关系良好,三七粉平均加样回收率(n=9)分别为99.0%、99.3%、100.6%、101.5%、98.8%,RSD分别为1.4%、1.3%、1.6%、0.7%、1.6%,回收率在98.8%～101.5%,RSD均≤1.6%；三七伤药片平均加样回收率(n=9)分别为95.5%、99.8%、102.0%、98.5%、97.0%,RSD分别为7.3%、2.9%、3.8%、3.3%、4.1%,回收率在95.5%～102.0%,RSD均≤7.3%。结论：建立的方法专属性强,重现性好,适用于三七粉与含三七中成药中三七的质量控制。

中文关键词:三七三七粉薄层鉴别超高效液相色谱法超高效液相色谱串联质谱联用法三七皂苷R₁ 人参皂苷Rg₁ 人参皂苷Re 人参皂苷Rb₁ 人参皂苷Rd

Study on Quality control methed of powder of Panax notoginseng and Chinese Patent Medicines containing Panax notoginseng

Abstract:Objective: To establish quality control methed of powder of Panax notoginseng and Chinese Patent Medicines containing Panax notoginseng. Methods: Microscopic identification method ,TLC,UPLC and UPLC-MS/MS were used for qualitative and quantitative analysis of saponins in powder of Panax notoginseng and Chinese Patent Medicines containing Panax notoginseng. Results: To establish methed of TLC identification and determination of notoginsenoside R₁、ginsenoside Rg₁、ginsenoside Re、ginsenoside Rb₁、ginsenoside Rd in powder of Panax notoginseng and Chinese Patent Medicines containing Panax notoginseng. The method can qualitatively identify the Panax notoginseng. The spots were clear with good separation.The linear relationships of notoginsenoside R₁、ginsenoside Rg₁、ginsenoside Re、ginsenoside Rb₁、ginsenoside Rd were favorable; the recoveries(n=9) of above-mentioned components in Panax notoginseng were 99.0%、99.3%、100.6%、101.5%、98.8%,RSD were 1.4%、1.3%、1.6%、0.7%、1.6%,the recoveries were 98.8%～101.5%,with RSDs of no more than 1.6%；and the recoveries(n=9) of above-mentioned components in Sanqi Shangyao tablets were 95.5%、99.8%、102.0%、98.5%、97.0%,RSD were 7.3%、2.9%、3.8%、3.3%、4.1%,the recoveries were 95.5%～102.0%,with RSDs of no more than 7.3%；. Conclusion: The established method is specific, reproducibility and can be used for quality control of powder of Panax notoginseng and Chinese Patent Medicines containing Panax notoginseng.

keywords:Panax notoginseng powder of Panax notoginseng TLC UPLC UPLC-MS/MS notoginsenoside R1 ginsenoside Rg1 ginsenoside Re ginsenoside Rb1 ginsenoside Rd

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