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Research on the content limit of salvianolic acid B in Salvia miltiorrhiza decoction pieces based on the robust Z-score method

Published on Jan. 31, 2026Total Views: 130 times Total Downloads: 27 times Download Mobile

Author: ZHENG Zheng JIN Fenghua LIU Yefei

Affiliation: Hefei Food and Drug Safety Inspection and Testing Center, Hefei 230088, China

Keywords: Salvia miltiorrhiza Salvianolic acid B Robust statistics Z-score method Content limit Quality control

DOI: 10.12173/j.issn.2097-4922.202510012

Reference: ZHENG Zheng, JIN Fenghua, LIU Yefei. Research on the content limit of salvianolic acid B in Salvia miltiorrhiza decoction pieces based on the robust Z-score method[J]. Yaoxue QianYan Zazhi, 2026, 30(1): 71-77. DOI: 10.12173/j.issn.2097-4922.202510012.[Article in Chinese]

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Abstract

Objective  To establish a quantitative method for evaluating the quality of Salvia miltiorrhiza decoction pieces and determine the content limit range of salvianolic acid B.

Methods  Referring to the detection method of raw Salvia miltiorrhiza in the Chinese Pharmacopoeia (2025 Edition), Volume I, the content of salvianolic acid B in 344 batches of Salvia miltiorrhiza decoction pieces produced by different enterprises was determined. Robust Z-score method was used for statistical analysis of the sample data, and the Z-score was calculated based on the median and standardized interquartile range to identify the distribution characteristics of the data.

Results  Calculated on a dry basis, it is suggested that the content limit of salvianolic acid B in Salvia miltiorrhiza decoction pieces be 2.5% to 5.5% (g/g), which covers the robust distribution range of more than 95% of the samples.

Conclusion  This study, combining the pharmacopoeia method with robust statistical techniques, proposes a scientifically reasonable content limit, which can effectively guide the quality control and evaluation of the superiority and inferiority of Salvia miltiorrhiza decoction pieces, providing practical references for the standardization of traditional Chinese medicine decoction pieces.

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References

1.田闵元, 陶晓倩, 韩子璇, 等. 中药配方颗粒药效学及与饮片药效比较研究进展[J]. 沈阳药科大学学报, 2024, 8(41): 957-993. [Tian MY, Tao XQ, Han ZX, et al. Research progress on pharmacodynamics of Chinese medicine formula granules and comparison of pharmacodynamics with decoction pieces[J]. Journal of Shenyang Pharmaceutical University, 2024, 8(41): 957-993.] DOI: 10.14066/j.cnki.cn21-1349/r.2023.0562.

2.中国药典2025年版. 一部[S]. 2025: 80-81.

3.魏西羽, 杨婷, 刘厚汝, 等. 丹酚酸B的药理作用研究进展[J]. 药学研究, 2021, 40(11): 748-752. [Wei XY, Yang T, Liu HR, et al. Research progress on pharmacological effects of salvianolic acid B[J]. Journal of Pharmaceutical Research, 2021, 40(11): 748-752.] DOI: 10.13506/j.cnki.jpr.2021.11.011.

4.徐枫, 周艳茁. Excel在稳健统计Z比分数计算中的应用[J]. 中国卫生检验杂志, 2008, 18(8): 1668-1669. [Xu F, Zhou YZ. The Application of Excel in the calculation of robust statistical Z-score[J]. Chinese Journal of Health Laboratory Technology, 2008, 18(8): 1668-1669.] DOI: 10.3969/j.issn.1004-8685.2008.08.099.

5.邢小茹, 刘涛, 马小爽, 等. 化学分析领域能力验证与稳健统计技术[J]. 理化检验-化学分册, 2016, 52(7): 819-824. [Xing XR, Liu T, Ma XS, et al. Capability verification and robust statistical techniques in the field of chemical analysis[J]. Physical Testing and Chemical Analysis Part B: Chemical Analysis, 2016, 52(7): 819-824.] DOI: 10.11973/lhjy-hx201607016.

6.陈宇军, 卓泽滨, 张宗取, 等. 稳健统计技术在能力验证中的应用研究[J]. 标准科学, 2022, (12): 114-118. [Chen YJ, Zhuo ZB, Zhang ZQ. Discussions on robust statistic techniques for proficiency testing[J]. Standard Science, 2022, (12): 114-118.] DOI: 10.3969j.issn.1674-5698.2022.12.020.

7.刘金东, 张雨, 芦新根, 等. 迭代稳健统计法用于金矿石中银含量测定的实验室间比对[J]. 化学分析计量, 2021, 30(2): 73-76. [Liu JD, Zhang Y, Lu XG, et al. Inter laboratory comparison of determination of silver in gold ore by using iterative robust statistical method[J]. Chemical Analysis And Meterage, 2021, 30(2): 73-76.] DOI: 10.3969/j.issn.1008-6145.2021.02.016.

8.郭丹, 杨洋, 史岚, 等. 2017年至2021年上海市药品质量抽检不合格数据分析[J]. 药品评价, 2023, 20(1): 10-13. [Guo D, Yang Y, Shi L, et al. Analysis of the results of unqualified drug sampling and testing in Shanghai from 2017 to 2021[J]. Drug Evaluation, 2023, 20(1): 10-13.] DOI: 10.19939/j.cnki.1672-2809.2023.01.03.

9.吴婷, 杨文凤, 张慧文, 等. 实验室间比对结果统计方法的探讨[J]. 中国药学杂志, 2016, 51(2): 135-138. [Wu T, Yang WF, Zhang HW, et al. Exploration of statistical methods of analysis of inter-laboratory comparison resultsults[J]. Chinese Pharmaceutical Journal, 2016, 51(2): 135-138.] DOI: 10.11669/cpj.2016.02.013.

10.何杜朋, 陈锦桃, 孙彩云, 等. 中药饮片质量的影响因素分析及对策研究[J]. 内蒙古中医药, 2018, 37(9): 96-97. [He DP, Chen JT, Sun CY, et al. Analysis of factors affecting the quality of traditional Chinese medicine decoction pieces and research on countermeasures[J]. Nei Mongol Journal of Traditional Chinese Medicine, 2018, 37(9): 96-97.] DOI: 10.3969/j.issn.1006-0979.2018.09.064.

11.中国药典2025年版. 四部[S]. 2025: 165.

12.张万良, 胡泽萍, 周立红, 等. 中国、美国和欧盟植物药注册法规和技术要求比较研究[J]. 中国食品药品监管, 2023, 239(12): 120-129. [Zhang WL, Hu ZP, Zhou LH, et al. A comparative study of botanical drug registration regulations and technical requirements in China, the USA, and the European Union[J]. China Food Drug Administration, 2023, 239(12): 120-129.] DOI: 10.3969/j.issn.1673-5390.2023.12.013.

13.唐清, 匡艳辉, 李雯珊, 等. 基于指纹图谱和一测多评(QAMS)法的丹红化瘀口服液质量评价研究[J]. 中草药, 2022, 53(6): 1663-1670. [Tang Q, Kuang YH, Li WS, et al. Quality evaluation of Danhong Huayu oral solution based on fingerprint combined with quantitative analysis of multi-components by single marker[J]. Chinese Traditional and Herbal Drugs, 2022, 53(6): 1663-1670.] DOI: 10.7501/j.issn.0253-2670.2022.06.008.

14.韩吴琦, 李清芳, 黄永丽, 等. 对中药饮片质量标准研究的思考[J]. 中国药房, 2011, 22(47): 4510-4512. [Han WQ, Li  QF, Huang YL, et al. Consideration on the research of quality standards for TCM decoction pieces[J]. China Pharmacy, 2011, 22(47): 4510-4512.] DOI: CNKI:SUN:ZGYA.0.2011-47-045.

15.孙喜灵, 姜伟炜, 刘琳, 等. 论中医理法方药知识创新的基础与支点[J]. 中医杂志, 2013, 54(4): 277-279. [Sun XL, Jiang WW, Liu L, et al. On the foundation and pivot of knowledge innovation in traditional Chinese medicine theory, principles, prescriptions, and medicines[J]. Journal of Traditional Chinese Medicine, 2013, 54(4): 277-279.] DOI: CNKI:SUN:ZZYZ.0.2013-04-005.

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