| 引用本文: | 田芳,谭梓君,何小芳,吴孟华,张英,曹晖,马志国.枳壳饮片标准汤剂质量评价研究[J].中国现代应用药学,2021,38(1):42-48. |
| TIAN Fang,TAN Zijun,HE Xiaofang,WU Menghua,ZHANG Ying,CAO Hui,MA Zhiguo.Study on Quality Evaluation of Aurantii Fructus Standard Decoction[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(1):42-48. |
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| 枳壳饮片标准汤剂质量评价研究 |
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田芳1,2, 谭梓君3,4, 何小芳1,5, 吴孟华1,5, 张英1,5, 曹晖1,5, 马志国1,5
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1.暨南大学岭南传统中药研究中心, 广州 510632;2.广东医科大学附属医院, 广东 湛江 524000;3.暨南大学药学院, 广州 510632;4.广东一方制药有限公司, 广东省中药配方颗粒企业重点实验室, 广东 佛山 528244;5.国家中药现代化工程技术研究中心岭南资源分中心, 广州 510632
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| 摘要: |
| 目的 建立枳壳标准汤剂的质量控制方法，为枳壳配方颗粒及其他枳壳产品的质量评价提供参考。方法 按照标准汤剂制备要求，制备13批枳壳饮片标准汤剂，建立HPLC特征图谱。采用高效液相色谱串联四极杆飞行时间质谱（high performance liquid chromatography-quadrupole time-of-flight mass spectrometry，HPLC-Q-TOF-MS），电喷雾离子源，在正负离子模式下采集数据，对主要色谱峰进行定性鉴别。采用HPLC测定标准汤剂中芸香柚皮苷、柚皮苷、橙皮苷、新橙皮苷4种成分含量，计算标准汤剂的出膏率、4种成分转移率和pH。结果 HPLC特征图谱中共6个共有峰，通过质谱定性分析结合对照品比较，对6个共有峰进行了指认，分别为新北美圣草苷、芸香柚皮苷、柚皮苷、橙皮苷、新橙皮苷和枳属苷，13批枳壳饮片标准汤剂相似度均>0.98。枳壳标准汤剂中芸香柚皮苷、柚皮苷、橙皮苷、新橙皮苷质量分数分别为0.07%~0.26%，1.30%~3.40%，0.14%~0.34%，0.85%~3.64%，转移率分别为31.4%~50.6%，31.3%~48.9%，22.9%~48.2%，25.3%~50.9%；出膏率为19.3%~30.71%；pH为3.45~4.64。结论 建立的系统评价枳壳饮片标准汤剂的质量方法稳定可行，为枳壳标准汤剂及其相关制剂的质量评价提供科学依据。 |
| 关键词: 枳壳标准汤剂|特征图谱|黄酮苷类|高效液相色谱串联四极杆飞行时间质谱|含量测定 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.01.007 |
| 分类号:R944.6 |
| 基金项目:广东省重点领域研发计划（第五批）项目（2020B1111110005） |
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| Study on Quality Evaluation of Aurantii Fructus Standard Decoction |
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TIAN Fang1,2, TAN Zijun3,4, HE Xiaofang1,5, WU Menghua1,5, ZHANG Ying1,5, CAO Hui1,5, MA Zhiguo1,5
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1.Research Center for TCM of Lingnan(Southern China), Jinan University, Guangzhou 510632, China;2.Affiliated Hospital of Guangdong Medical University, Zhanjiang 524000, China;3.College of Pharmacy, Jinan University, Guangzhou 510632, China;4.Guangdong Yi Fang Pharmaceutical Co., Ltd., Guangdong Provincial Key Laboratory of Traditional Chinese Medicine Formula Granule, Foshan 528244, China;5.National Engineering Research Center for Modernization of Traditional Chinese Medicine Lingnan Resources Branch, Guangzhou 510632, China
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| Abstract: |
| OBJECTIVE To establish the quality control methods of Aurantii Fructus standard decoction and to provide reference for quality evaluation of Aurantii Fructus formula granules and other Aurantii Fructus products. METHODS According to the standard decoction preparation requirements, 13 batches of Aurantii Fructus standard decoctions were prepared and HPLC fingerprint was established. The main chromatographic peaks were identified under the positive and negative ion mode by high performance liquid chromatography-quadrupole-time-of-flight mass spectrometry(HPLC-Q-TOF-MS) and electrospray ionization source. The four chemical components(narirutin, naringin, hesperidin and neohesperidin) in the standard decoction were determined by HPLC. The extract rate, the transfer rate of the four flavonoid glycosides, and the pH of the standard decoction were calculated. RESULTS Six common peaks in the fingerprint were assigned by qualitative analysis of mass spectrometry and standard comparison, namely neoeriocitrin, narirutin, naringin, hesperidin, neohesperidin and poncirin. The fingerprint similarities of the 13 batches of standard decoctions were >0.98. The content ranges of narirutin, naringin, hesperidin and neohesperidin in the standard decoction were 0.07%-0.26%, 1.30%-3.40%, 0.14%-0.34%, 0.85%-3.64%, respectively. The transfer rates of the four components were 31.4%-50.6%, 31.3%-48.9%, 22.9%-48.2%, 25.3%-50.9%, respectively. The dry extract rates were 19.3%-30.71% and pH values were 3.45-4.64. CONCLUSION The established systematic evaluation method of the quality of the Aurantii Fructus standard decoction is stable and feasible and can provide a scientific basis for the quality evaluation of Aurantii Fructus standard decoction and related preparations. |
| Key words: Aurantii Fructus standard decoction|fingerprint|flavonoid glycoside|HPLC-Q-TOF-MS|content determination |
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