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惠博平,易子漾,陈林,陈海刚,喻嵘,黄建华.左归降糖益肾方HPLC指纹图谱及4种成分的含量测定研究[J].湖南中医药大学学报英文版,2023,43(8):1421-1429.[Click to copy
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| 左归降糖益肾方HPLC指纹图谱及4种成分的含量测定研究 |
| 惠博平,易子漾,陈林,陈海刚,喻嵘,黄建华 |
| (湖南中医药大学, 湖南 长沙 410208;湖南省中医药研究院, 湖南 长沙 410006;华润三九(郴州)制药有限公司, 湖南 郴州 423000) |
| 摘要: |
| 目的 采用HPLC建立左归降糖益肾方指纹图谱，并对4个主要成分进行含量测定。方法 对色谱柱型号、流动相系统、梯度洗脱条件、检测波长以及供试品处理方法等条件进行优化，最终确定了最佳液相条件：选用色谱柱为Welch ultimate AQ-C18（4.6 mm×250 mm，5 μm）；流动相系统为甲醇-0.1%甲酸溶液；紫外检测波长为254 nm；供试品溶液提取溶剂为甲醇溶液。并对8批次左归降糖益肾方HPLC指纹图谱进行相似性分析判断批次间稳定性。结果 利用HPLC指纹图谱确定了左归降糖益肾方21个共有峰，并指认了9个色谱峰；8批次左归降糖益肾方指纹图谱的相似度均大于0.920；4个有效成分马钱苷、盐酸药根碱、盐酸小檗碱和盐酸巴马汀的平均含量分别为（183.93±9.55）、（42.64±4.77）、（198.01±9.49）、（96.36±9.00） μg·mL-1。结论 建立的左归降糖益肾HPLC方指纹图谱方法简便，准确、重现性好，可为左归降糖益肾方的质量控制体系提供参考。 |
| 关键词: 左归降糖益肾方 糖尿病肾病 高效液相色谱法 指纹图谱 含量测定 |
| DOI：10.3969/j.issn.1674-070X.2023.08.012 |
| Received:November 13, 2022 |
| 基金项目:国家自然科学基金项目（82074400）；国家自然科学基金区域创新发展联合基金重点支持项目（U21A20411）；湖南省科学技术厅重点项目（2020SK2101）；博士后面上支持项目（2022M711131）；湖南省科技创新计划（2022RC1227）；湖南中医药大研究生创新课题项目（2022CX188）。 |
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| HPLC fingerprint of Zuogui Jiangtang Yishen Formula and content determination of its four ingredients |
| HUI Boping,YI Ziyang,CHEN Lin,CHEN Haigang,YU Rong,HUANG Jianhua |
| (Hunan University of Chinese Medicine, Changsha, Hunan 410208, China;Hunan Academy of Chinese Medicine, Changsha, Hunan 410006, China;China Resources Sanjiu (Chenzhou) Pharmaceutical Co., Ltd., Chenzhou, Hunan 423000, China) |
| Abstract: |
| Objective To establish the HPLC fingerprint of Zuogui Jiangtang Yishen Formula and to determine the content of its four main ingredients. Methods The chromatographic column type, mobile phase system, gradient elution condition, detection wavelength, and test product treatment were optimized. The optimal liquid phase conditions were:Welch ultimate AQ-C18 (4.6 mm×250 mm, 5 μm) was selected as the chromatographic column, the methanol-0.1% formic acid solution was taken as the mobile phase system, the UV detection wavelength was 254 nm, and methanol solution was set as the extraction solvent of the test solution. And similarity analysis on the HPLC fingerprints of 8 batches of Zuogui Jiangtang Yishen Formula was performed to determine the stability among batches. Results A total of 21 common peaks were determined, and 9 chromatographic peaks were identified from HPLC fingerprint of Zuogui Jiangtang Yishen Formula. The similarity of fingerprints among 8 batches of Zuogui Jiangtang Yishen Formula was greater than 0.920. The average content of the four active ingredients (loganin, jatrorrhizine hydrochloride, berberine hydrochloride, and palmatine chloride) were 183.93±9.55, 42.64±4.77, 198.01±9.49, and 96.36±9.00 μg·mL-1, respectively. Conclusion The established HPLC fingerprint method is simple, accurate, and reproducible, which can provide references for the quality control system of Zuogui Jiangtang Yishen Formula. |
| Key words: Zuogui Jiangtang Yishen Formula diabetic kidney disease high performance liquid chromatography fingerprint content determination |
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