参桂鹿茸丸中人参掺伪检查研究

肖小武; 洪挺; 许妍; 李丹; 姜军华; 戴忠

文章摘要

肖小武,洪挺,许妍,李丹,姜军华,戴忠.参桂鹿茸丸中人参掺伪检查研究[J].中国药事,2023,(4):434-442

参桂鹿茸丸中人参掺伪检查研究

Study on the Adulteration Inspection of Panax ginseng in Shengui Lurong Pills

DOI：10.16153/j.1002-7777.2023.04.010

中文关键词: 参桂鹿茸丸人参西洋参掺伪拟人参皂苷F₁₁

英文关键词: Shengui Lurong pills Panax ginseng Panax quinquefolium adulteration pseudo-ginsenoside F¹¹

基金项目:

作者	单位
肖小武	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
洪挺	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
许妍	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
李丹	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
姜军华	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
戴忠	中国食品药品检定研究院,北京 100050

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中文摘要:

目的：建立参桂鹿茸丸中人参掺伪检查方法，考察企业是否存在使用西洋参或其边脚料替代人参投料的现象，为中药监管提供技术支持。方法：以西洋参特征组分拟人参皂苷F11为掺伪检测依据，采用超高效液相色谱-串联质谱法，采用C₁₈(100 mm×2.1 mm，1.8 μm)色谱柱，以甲醇和0.1%的甲酸水溶液为流动相梯度洗脱，流速 0.3 mL·min^-1，柱温 25 ℃；电喷雾正离子模式(ESI⁺ )，多反应监测 (MRM)模式进行检测。结果：拟人参皂苷F11进样浓度在12.32~616.00 ng·mL^-1范围内呈良好的线性关系(R² ＞0.9999)；重复性试验的RSD为2.1%；平均回收率为102.6%，RSD=2.1%(n=9)；43批样品中，16批样品检出西洋参，检出率高达37%。结论：该方法灵敏、准确，可作为参桂鹿茸丸中人参掺伪的检查方法。

英文摘要:

Objective: To establish the inspection method for the adulteration of Panax ginseng in Shengui Lurong Pills to investigate whether there is a phenomenon of using Panax quinquefolium or its side ingredients to replace Panax ginseng in the manufacture enterprises,so as to provide technical support for traditional Chinese medicine supervision. Methods: The characteristic component of Panax quinquefolium pseudo-ginsenoside F11 was used as the adulteration detection basis. LC-MS method was used with C₁₈(100 mm×2.1 mm, 1.8 μm) as analytical column, methanol and 0.1% aqueous formic acid solution were used as mobile phase for gradient elution, the fl ow rate was 0.3 mL·min^-1, the column temperature was 25 ℃. The analytes were detected by electrospray ionization (ESI+ ) mode combined with multiple reaction monitoring (MRM) mode. Results: The sample concentration of psuedo-ginsenoside F11 showed a good linear relationship in the range of 12.32- 616.00 ng·mL_-1 (R² =0.9999), and the RSD of repeatability test was 2.1%. The average recovery was 102.6% with RSD=2.1% (n=9). Panax quinquefolium was detected in 16 of the 43 batches sample, and the detection rate was up to 37%. Conclusion: The method is sensitive and accurate, which can be applied to the adulteration detection of Panax ginseng in Shengui Lurong Pills.

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