Determination and quality evaluation of monoester alkaloids in Xiaohuoluo pills

Published on Jan. 26, 2025Total Views: 140 times Total Downloads: 27 times Download Mobile

Author: WANG Fei LIU Xin NAN Ronghua  LUO Dingqiang

Affiliation: Shaanxi Institute for Food and Drug Control, Xi’an 710000, China

Keywords: Xiaohuoluo pills Monoester alkaloids Content determination Quality evaluation Benzoyl newaconitine Benzoyl aconitine Benzoyl hypaconitine

DOI: 10.12173/j.issn.2097-4922.202406115

Reference: WANG Fei, LIU Xin, NAN Ronghua, LUO Dingqiang. Determination and quality evaluation of monoester alkaloids in Xiaohuoluo pills[J]. Yaoxue QianYan Zazhi, 2025, 29(1): 59-65. DOI: 10.12173/j.issn.2097-4922.202406115.[Article in Chinese]  Copied

Abstract
Full-text
References

Abstract

Objective To establish a method for determining the content for benzoyl newaconitine, benzoyl aconitine, and benzoyl hypaconitine in Xiaohuoluo pills, and to improve the quality control standards of it.

Methods HPLC method was used with a Shim pack Scepter C₁₈ column (250 mm×4.6 mm, 5 μm). The mobile phase was acetonitrile and 0.1% phosphoric acid solution (22 ∶ 78), the flow rate was 1.0 mL/min, the detection wavelength was 232 nm, the column temperature was 35 ℃, and the injection volume is 10 μL. The total content of benzoyl newaconitine, benzoyl aconitine, and benzoyl hypaconitine was determined, and the quality of Xiaohuoluo pills was evaluated accordingly.

Results The linear relationships of benzoyl newaconitine, benzoyl aconitine, and benzoyl hypaconitine were good within the mass range of 0.077 4-1.548 0, 0.016 2-0.324 0 and 0.016 1-0.322 0 μg, respectively (r≥ 0.999 8). Their average recovery rates were 97.81%, 96.29% and 100.06%, and the RSD were 1.38%, 1.88% and 1.58% (n=6), respectively. Based on the measurement results, limit standard of not less than 55.1 μg/g for the three types of ester alkaloids were determined. Among the 149 batches of samples from 28 enterprises, the contents of 5 batches were below the proposed limit, all from the same enterprise.

Conclusion The established HPLC method has high accuracy and strong specificity. The content limit standard for ester alkaloids in Xiaohuoluo pills established in this study can be served as an important supplement to the quality evaluation of this compound medicine.

Full-text

Please download the PDF version to read the full text: download

References

1.中国药典2010年版. 一部[S]. 2020: 602.

2.郑琴, 陆浩伟, 郝伟伟, 等. 乌头类双酯型生物碱水解转化规律及含量计算方法研究[J]. 中国药学杂志, 2011, 46(9): 652-656. [Zheng Q, Lu HW, Hao WW, et al. Study on hydrolysis of aconitum alkaloids and quantitaive analysis method of their hydroly sates[J]. Chinese Pharmaceutical Journal, 2011, 46(9): 652-656.] https://www.cnki.com.cn/Article/CJFDTotal-ZGYX201109006.htm.

3.赵振霞, 苏建, 曹春琪, 等. 小活络丸中乌头类生物碱成分含量测定方法的建立[J]. 中国药事, 2023, 37(7): 798-807. [Zhao ZX, Su J, Cao CQ, et al. Establishment of content determination method of aconitum alkaloids in Xiaohuoluo pills[J]. Chinese Pharmaceutical Affairs, 2023, 37(7): 798-807.] DOI: 10.16153/j.1002-7777.2023.07.009.

4.马云娜, 徐远涛, 焦洁, 等. 反相高效液相色谱法同时测定骨刺消痛胶囊中3种单酯型生物碱的含量[J]. 中南药学, 2018, 16(3): 412-415. [Ma YN, Xu YT, Jiao J, et al. Simultaneous determination of 3 monoester aconitum alkaloids in GuciXiaotong capsules by RP-HPLC[J]. Central South Pharmacy, 2018, 16(3): 412-415.] DOI: 10.7539/j.issn.1672-2981.2018.03.016.

5.任桂林, 韩丽, 王小平，等. 小金丸中制草乌单酯型生物碱类成分的含量测定[J]. 中国实验方剂学杂志, 2014, 20(21): 123-126. [Ren GL, Han L, Wang XP, et al. Determination of monoester-alkaloids from aconiti kusnezoffii radix cocta in Xiaojin Wan[J]. Chinese Journal of Experimental Traditional Medical Formulae, 2014, 20(21): 123-126.] DOI: 10.13422 /j.cnki.syfjx.2014210123.

6.段富津. 方剂学[M]. 上海: 上海科学技术出版社, 1995: 8.

7.陈炬, 庞尧斌, 郭静. 基于源流探析君臣佐使配伍法[J]. 湖南中医杂志, 2022, 38(3): 91-93. [Chen J, Pang YB, Guo J. Based on the source analysis of the compatibility of the sovereign-minister-assistant-envoy[J]. Hunan Journal of Traditional Chinese Msdicine, 2022, 38(3): 91-93.] DOI: 10.16808/j.cnki.issn1003-7705.2022.03.029.

8.吴丹丹, 刘艳, 郭鹏飞, 等. 不同产地川乌炮制前后差异性成分研究[J]. 广西植物, 2022, 42(5): 820-832. [Wu DD, Liu Y, Guo PF, et al. Different components between Aconiti radix and its processed product from different regions[J]. Guihaia, 2022, 42(5) : 820-832.] DOI: 10.11931/guihaia.gxzw202109056.

9.曹瑞果. 炮制对生川乌生物碱的影响[J]. 实用中医药杂志, 2020, 36(12): 1661-1663. [Cao RG. Effect of processing on alkaloids of Aconiti radix[J]. Journal of Practical Traditional Chinese Medicine, 2020, 36(12): 1661-1663.] https://www.cnki.com.cn/Article/CJFDTotal-ZYAO202012099.htm.

10.刘闯, 田颖颖, 赵新月, 等. 草乌炮制研究概况[J]. 中国中医药图书情报杂志, 2024, 48(2): 260-264. [Liu C, Tian YY, Zhao XY, et al. Review of the research on the preparation of Aconiti kusnezoffii radix[J]. Chinese Journal of Library and Information Science for Traditional Chinese Medicine, 2024, 48(2): 260-264.] DOI: 10.3969/j.issn.2095-5707.202304053.

11.兰庆同. 制草乌炮制工艺研究[J]. 世界最新医学信息文摘, 2019, 19(35): 270, 275. [Lan QT. Research on processing technology of Aconitum kusnezoffii reichb[J]. World Latest Medicine Information, 2019, 19(35): 270, 275.] DOI: 10.19613/j.cnki.1671-3141.2019.35.156.

12.莫伟, 马恩耀, 周劲松, 等. 基于化学计量方法检测不同产地制川乌的质量[J]. 中南农业科技, 2023, 44(12): 48-51, 60. [Mo W, Ma EY, Zhou JS, et al. Based on stoichiometric method, the quality of Radix aconiti preparata from different origins was detected[J]. South-Central Agricultural Science and Technology, 2023, 44(12): 48-51, 60.] DOI: 10.3969/j.issn.1007-273X.2023.12.013.