Ingredient Analysis

Content determination and chemometric analysis of multi-index components in Zhizhu granules*

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  • 1. China Pharmaceutical University, Nanjing 211198, China;
    2. Jiangsu Hongdian Research Institute of Traditional Chinese Medicine Industry Co.,Ltd., Nanjing 210023,China;
    3. Nanjing Zhongshan Pharmaceutical Co., Ltd., Nanjing 210046, China;
    4. JiangSu Classical Prescriptions Engineering Research Center,Nanjing 210023, China

Received date: 2023-02-02

  Online published: 2024-06-21

Abstract

Objective: To establish an HPLC method for simultaneous determination of seven components(narirutin, naringin, hesperidin, neohesperidin, naringenin, nobiletin and atractylenolide Ⅲ) in Zhizhu granules. And to provide reference for its quality evaluation by using chemometric analysis. Methods: The chromatographic column Waters Symmetry C18(250 mm×4.6 mm,5 μm)was adopted using HPLC-DAD. The mobile phase consisted of acetonitrile (A)-0.1% phosphoric acid (B) in gradient elution with flow rate of 1.0 mL·min-1, the detection wavelength were 220 nm (atractylenolide Ⅲ), 280 nm (narirutin, naringin, hesperidin, neohesperidin and naringenin) and 332 nm (nobiletin). The column temperature was set at 30℃ and the injection volume was 10 μL. Cluster analysis, principal component analysis and orthogonal partial least squares-discrimination analysis were used to distinguish the content determination results. Results: The resolution of each component in 24 batches of Zhizhu granules was good, and the linear relationship between concentration and peak area was good (r>0.999 9). The average recoveries were within 87.6%-114.3%. There were some differences in 24 batches of Zhizhu granules, and 4 different components were screened out, which were naringin, hesperidin, neohesperidin and naringin. The contents of narirutin, naringin, hesperidin, neohesperidin, naringenin, nobiletin and atractylenolide Ⅲ in 24 batches of Zhizhu granules samples were 0.378 4-1.380 1 mg·g-1, 5.125 8-18.137 6 mg·g-1, 0.283 9-1.195 8 mg·g-1, 4.490 3-22.585 0 mg·g-1, 0.022 5-0.349 8 mg·g-1, 0.063 3-0.211 4 mg·g-1 and 0.054 7-0.137 5 mg·g-1, respectively. Conclusion: The established method is accurate, reliable and reproducible, which can provide reference for the quality control of Zhizhu granules.

Cite this article

LI Shi-qi, PENG Yun, GAO Yuan, ZHAO Kai-jun, WANG Hai-li . Content determination and chemometric analysis of multi-index components in Zhizhu granules*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44(2) : 224 -232 . DOI: 10.16155/j.0254-1793.2024.02.04

References

[1] 余靖华,甘炜坚,梁雅超,等.枳术颗粒辅助标准四联疗法治疗Hp阳性慢性萎缩性胃炎的效果[J]. 中外医学研究,2022,20(13):4
YU JH, GAN WJ, LIANG YH, et al. Effect of Zhizhu granule assisted standard quadruple therapy on Hp positive chronic atrophic gastritis[J]. Chin Foreign Med Res, 2022, 20(13): 4
[2] 邢朝富.雷贝拉唑联合莫沙比利与枳术颗粒治疗残胃炎的疗效观察[J]. 临床合理用药杂志,2012,5(18):69
XING ZF. Efficacy of rabeprazole combined with mosapride and Zhizhu granules in the treatment of residual gastritis[J]. J Clin Rational Drug Use, 2012, 5(18):69
[3] 王礼国,陈世芳,吴从吉.枳术颗粒合用奥美拉唑治疗消化性溃疡41例疗效观察[J]. 中国医学创新,2009,6(23):53
WANG LG, CHEN SF, WU CJ. Therapeutic effect of Zhishu granule combined with omeprazole on 41 cases of peptic ulcer[J]. Med Innov China, 2009, 6(23):53
[4] 黄继武.枳术颗粒联合奥美拉唑治疗消化性溃疡的疗效分析[J]. 实用心脑肺血管病杂志,2011,19(1):53
HUANG JW. Effect analysis of Zhishu granule combined with omeprazole in the treatment of peptic ulcer[J]. Pract J Cardiac Cereb Pneum Vasc Dis, 2011, 19(1):53
[5] 王志刚,卢利军.“金芪利水排石”颗粒剂与水丸剂治疗泌尿系结石的临床疗效比较[J]. 甘肃中医学院学报,2014,31(3):61
WANG ZG, LU LJ. Comparison of clinical efficacy of "Jinqi Lishuipaishi" granules and Shui pills in the treatment of urinary calculi[J]. J Gansu Univ Chin Med, 2014, 31(3):61
[6] 周骏,刘美辉,金顺福,等.高效液相色谱法测定枳术颗粒中柚皮苷的含量[J]. 中国药房,2006,17(14):1103
ZHOU J, LIU MH, JIN SF, et al. Content determination of naringin in Zhizhu granules by HPLC[J]. China Pharm, 2006, 17(14): 1103
[7] 王其华,徐云辉,濮存海,等.HPLC法测定枳术颗粒中枳实的5种黄酮类物质[J]. 药学与临床研究,2013,21(3):232
WANG QH, XUN YH, PU CH, et al. Measuring five compounds of flavonoids in immature bitter orange as monarch drug of the Zhizhu Granule by HPLC[J]. Pharm Clin Res, 2013,21(3):232
[8] 张一帆,林志航,汤秋华.一测多评法测定枳术颗粒中四种黄酮类成分的含量[J]. 海峡药学,2020,32(1):80
ZHANG YF, LIN ZH, TANG QH. Simultaneous quantitative analysis of 4 active components in Zhizhu granules using multi-components by single marker[J]. Strait Pharm J, 2020, 32(1): 80
[9] 段营辉,朱樵苏,黄澜,等.高效液相色谱法同时测定清肺抑火丸中13种成分的含量[J]. 中国医院药学杂志.2022,42(14):1399
DUAN YH, ZHU QS, HUANG L, et al. Simultaneous determination of 13 components in Oingfei Yihuo pills by high performance liquid chromatography[J]. Chin J Hosp Pharm, 2022, 42(14): 1399
[10] 刘雯,李峰,孙春亮,等.HPLC同时测定荆防颗粒中6种成分[J]. 中国实验方剂学杂志,2016,22(17):55
LIU W, LI F, SUN CL, et al. Simultaneous determination of six components in Jingfang granule by HPLC[J]. Chin J Exp Tradit Med Form, 2016, 22(17): 55
[11] 刘统治, 金国娥. 浅谈李东垣枳术丸及现代临床运用[J]. 中医药临床杂志,2015,27(3):357
LIU TZ, JIN GE. Discussion of the modern clinical applications of Zhizhu pills of LI Dongyuan[J]. Clin J Tradit Chin Med, 2015, 27(3): 357
[12] 丁玲,于志峰,周加林.加味枳术颗粒治疗糖尿病胃轻瘫的疗效观察[J]. 中国医院用药评价与分析,2018,18(3):349
DING L, YU ZF, ZHOU JL. Observation on efficacy of Jiaweizhizhu granules in treatment of diabetic gastroparesis[J]. Eval Anal Drug-Use Hosp Chin, 2018, 18(3): 349
[13] 臧彬如, 单国顺, 贾天柱,等. UPLC法测定生、制白术配伍枳术丸中10种成分[J]. 中成药, 2020, 42(4):960
ZHANG BR, SHAN GS, JIA TZ, et al. Determination of ten constituents in raw and processed Atractylodes macrocephala compatible Zhizhu pills by UPLC[J]. Chin Tradit Pat Med, 2020, 42(4): 960
[14] 庞茜茜,岳威冶,刘克勤,等.雪梨止咳糖浆中11个成分的含量测定及化学计量学分析[J]. 中国药房,2023,34(1):62
PANG QQ, YUE WY, LIU KQ, et al. Content determination and chemometric analysis of 11 components in Xueli Zhike syrup[J]. China Pharm, 2023, 34(01): 62
[15] 黄砚,刁灏瑒,张雁.克咳片中8个成分的含量测定[J]. 药物分析杂志,2020,40(2):337
HUANG Y, DIAO HY, ZHANG Y. Determination of 8 constituents in Keke tablets[J]. Chin J Pharm Anal, 2020, 40(2): 337
[16] 方达锋,马恩耀,冯冲,等.基于主成分分析与聚类分析的不同产地白芍质量评价研究[J]. 特种经济动植物,2023,26(1):14
FANG DF, MA EY, FENG C, et al. Study on quality evaluation of Paeony from different producing areas based on principal component analysis and cluster analysis[J]. Spec Econ Anim Plants, 2023, 26(1):14
[17] 李卓群,王海丽,贵书琪,等.小儿感冒舒颗粒HPLC指纹图谱建立与化学模式识别[J]. 中国现代应用药学,2021,38(22):2820
LI ZQ, WANG HL, GUI SQ, et al. HPLC fingerprint establishment and chemistry pattern recognition of Xiaoer Ganmaoshu Granules[J]. Chin J Mod Appl Pharm, 2021, 38(22): 2820
[18] 项锋,叶继锋,侯齐书.基于PCA和PLS-DA算法的不同生长阶段贯叶金丝桃药材HPLC指纹图谱研究[J]. 药物分析杂志,2020,40(3):568
XIANG F, YE JF, HOU QS. Study on HPLC fingerprint of Hyperici Perforati Herba at different growth stage based on PCA and PLS-DA[J]. Chin J Pharm Anal, 2020, 40(3): 568
[19] 何佳,黄文康,马相锋,等.基于主成分分析与PLS-DA分析研究浙麦冬道地性与等级评价标准[J]. 中国药学杂志,2021,56(4):285
HE J, HUANG WK, MA XF, et al. Geoherbalism and grand evaluation of Zhejiang Ophiopogon japonicas based on PCA and PLS-DA[J]. Chin Pharm J, 2021, 56(4): 285
[20] 王国锋.基于指纹图谱及偏最小二乘法-判别分析(PLS-DA)评价肝爽颗粒的质量[J]. 中国药师,2022,25(10):1865
WANG GF. Quality evaluation of Ganshuang granules by HPLC fingerprint and PLS-DA[J]. China Pharm, 2022, 25(10): 1865
[21] 杨玉环,张灵煜,郭秋平,等.枳实、枳壳的生物活性成分及其应用研究进展[J]. 食品与药品,2021,23(5):476
YANG YH, ZHANG LY, GUO QP, et al. Bioactive components of Fructus Aurantii Immaturus and Fructus Aurantii and their application[J]. Food Drug, 2021, 23(5): 476
[22] 钟民勇,乔日发,魏飞亭,等.枳壳、枳实胃肠动力作用及其机制的研究概况[J]. 江西中医药,2021,52(12):68
ZHONG MY, QIAO RF, WEI FT, et al. Research overview on gastrointestinal motility and its mechanism of Fructus Aurantii and Fructus Aurantii[J]. Jiangxi J Tradit Chin Med, 2021, 52(12): 68
[23] 赵文龙,吴慧,单国顺,等.麸炒白术“减酮减燥,增酯增效”炮制理论的再印证[J]. 中国中药杂志,2013,38(20):3493
ZHAO WL, WU H, SHAN GS, et al. Verification of processing theory of" reducing ketone and dryness, and increasing ester and effect" for bran-fried atractylodes[J]. China J Chin Mater Med, 2013, 38(20): 3493
[24] 曾丽华,伍振峰,王芳,等.中药制剂质量均一性的现状问题及保证策略研究[J]. 中国中药杂志,2017,42(19):3826
ZENG LH, WU ZF, WANG F, et al. Status,problems and warranty strategy of quality uniformity for traditional Chinese medicine preparations[J]. China J Chin Mater Med, 2017, 42(19): 3826
[24] 陆超颖,王佳丽,王洪兰,等.不同基原积实药材的质量差异评价研究[J]. 中草药,2022,53(14):4493
LU CY, WANG JL, WANG HL, et al. Study on quality difference of Aurantii Fructus Immaturus from different otigins[J]. Chin Tradit Herb Drugs, 2022, 53 (14): 4493
[26] 刘现磊,李琨,张辉,等.市售丹参配方颗粒的UPLC指纹图谱及化学模式识别研究[J]. 药物分析杂志,2022,42(11):2000
LIU XL, LI K, ZHANG H, et al. UPLC fingerprint and chemical pattern recognition study on commercial available Danshen formula granules[J]. Chin J Pharm Anal, 2022, 42(11): 2000
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