Objective: To establish a quality consistency assessment method to evaluate the consistency of product quality of Liuwei Dihuang concentrated pills (LDCP) among different manufacturers. Methods: Firstly, high performance liquid chromatography (HPLC) was used to determine the content of the six index components in LDCP, and analyze the content differences between different batches of the same manufacturer and the current product quality of different manufacturers. Secondly, quality consistency parameters, i.e., intra-batch content consistency differences (PA), inter-batch content consistency differences (PB), and fingerprint similarity (PC), were constructed to assess the consistency of product quality among the different manufacturers. And lastly, the consistency parameters were taken as the variables and subjected to the principal component analysis (PCA) to classify the consistency of the LDCP samples of the seven manufacturers to be fitted and differentiated. Results: The contents of the six index components in thirty-five batches of LDCP samples from seven manufacturers totaled 1.48-2.99 mg per pill, the RSDs of the contents of different components were 4.9%-29.7%, and the consistency parameters of the seven products were 4.2%-15.1% for PA, 26.4%-49.5% for PB, and 92.9%-98.2% for PC. There were some differences in the homogeneity of contents in samples from different manufacturers, and the contents of the product varied significantly between batches, with P value of 64.5-75.8, indicating that the difference in the consistency of samples from different manufacturers was relatively small. But under certain conditions, the seven manufacturers can be classified into three categories, with B and J as a category, Z and R as a category, and X, F, and S as a category. Conclusion: This study provides a simple and effective method for monitoring and distinguishing the quality consistency of commercially available LDCP products, and the experimental results can provide a reference for the sample quality homogeneity of LDCP manufacturers.
LAO Yong-zhen, ZHANG Jun, LIU Yan-ping, ZHAO An-yi, GUO Cong, XU Ling-chuan, LIU An, LIU Yan
. Quality consistency of Liuwei Dihuang concentrated pills was evaluated by high performance liquid chromatography combined with stoichiometry*[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(3)
: 532
-541
.
DOI: 10.16155/j.0254-1793.2024.03.19
[1] 詹国平,朱丽芳,蔡家宝,等.不同厂家六味地黄浓缩丸的质量分析[J]. 北方药学,2022,19(12):1
ZHAN GP, ZHU LF, CAI JB, et al. Quality analysis of Liuwei Dihuang concentrated pills from different manufacturers[J]. J North Pharm, 2022, 19(12):1
[2] 夏昀卿,李如,高松,等.不同厂家六味地黄浓缩丸组分结构特征与质量控制探究[J]. 中国中药杂志,2020,45(14):3369
XIA YQ, LI R, GAO S, et al. Structure characteristics and quality control of Liuwei Dihuang concentrted pills from different manufacturers[J]. Chin J Chin Mater Med, 2020, 45(14):3369
[3] 冯霞霞,易红,闫利华,等.从六味地黄制剂多剂型间的质量差异探索中成药质量控制[J]. 中国实验方剂学杂志,2021,27(2):138
FENG XX, YI H, YAN LH, et al. Discussion for quality control of chinese patent drugs from quality difference among different dosage forms of Liuwei Dihuang preparations [J]. Chin J Exp Tradit Med Form, 2021, 27(2):138
[4] 张小博.不同厂家六味地黄浓缩丸的质量分析[J]. 中国民族民间医药,2016,25(10):23
ZHANG XB. Quality comparative analysis of Liuweidihuang concentrated pills with different manufacturers [J]. Chin J Ethno-med Ethnopharm, 2016, 25(10):23
[5] 封亮,贾晓斌,范晨怡,等.HPLC测定六味地黄浓缩丸及药材的指纹图谱[J]. 中成药,2008,30(12):1720
FENG L, JIA XB, FAN CY, et al. Fingerprint analysis of Liuwei Dihuang concentrated pills and its crude durgs by HPLC [J]. Chin Tradit Patent Med, 2008, 30(12):1720
[6] YE J, ZHANG X, DAI WX, et al. Chemical fingerprinting of Liuwei Dihuang Pill and simultaneous determination of its major bioactive constituents by HPLC coupled with multiple detections of DAD, ELSD and ESI-MS [J]. J Pharmaceut Biomed, 2009, 49(3): 638
[7] YAN B, YANG LP, MA DD, et al. Comprehensively evaluating the quality consistency of Liuwei Dihuang pill by five-wavelength overall fused HPLC fingerprints combined with simultaneous determination and antioxidant activity [J]. J Chromatogr Sci, 2017, 55(10):1026
[8] ZHAO AY, XIAO LK, CHEN S, et al. Comprehensive quality consistency evaluation strategy and analysis of compound danshen tablet [J]. J Pharm Biomed, 2022, 219:114951
[9] 赵桉熠. 以复方丹参制剂等三种制剂为示范的中成药“一致性”质量评价策略及应用研究[D]. 太原:山西医科大学,2021
ZHAO AY. The Quality Evaluation Strategy and Application Study on “Consistency” of Chinese Patent Drugs Using the Fufang Danshen Preparations and Other Three preparation as the Demonstration [D]. Taiyuan: Shanxi Medical University, 2021
[10] 中华人民共和国药典2020年版. 一部 [S]. 2020:195
ChP 2020. VolⅠ[S]. 2020:195
[11] 朱秀清,雷文华,黄雨洋,等.5-羟甲基糠醛在食品中的变化及其安全性研究进展[J]. 食品安全质量检测学报,2022,13(15):4983
ZHU XQ, LEI WH, HUANG YY, et al. Research progress in changes of 5-hydroxymethylfurfural in food and its safety [J]. J Food Saf Qual, 2022, 13(15):4983
[12] 刘青,彭红艳,马春霞,等.不同植物来源单宁和没食子酸对常见致病菌的体外抑菌效果研究[J]. 中国畜禽种业,2022,18(9):37
LIU Q, PENG HY, MA CX, et al. Study on in vitro bacteriostatic effect of tannin and gallic acid from different plant sources on common pathogenic bacteria [J]. Chin Livest Poul Breed, 2022, 18(9):37
[13] 李聪,周威.芍药苷对伴刀豆球蛋白诱导的小鼠急性肝损伤的保护作用[J]. 中国临床药理学杂志,2022,38(5):427
LI C, ZHOU W. Protective effect of paeoniflorin on acute liver injury induced by concanavalin A in mice [J]. Chin J Clin Pharmacol, 2022, 38(5):427
[14] 李天娇,包永睿,王帅等.中药质量控制与评价创新方法研究进展及应用[J]. 中草药,2022,53(20):6319
LI TQ, BAO YR, WANG S, et al. Research progress and application of innovative methods for quality control and evaluation of traditional Chinese medicine[J]. Chin Tradit Herb Drugs, 2022, 53(20):6319
[15] 马双成,王莹.我国中药质量控制模式及思路研究进展十年回顾[J/OL]. 中国药学杂志,2023 [2023-11-21]. http://kns.cnki.net/kcms/detail/11.2162.R.20230104.2122.001.html
MA SC, WANG Y. Review on the research progress of traditional Chinese medicine quality control models and ideas in the past decade[[J/OL]. Chin Pharm J, 2023. [2023-11-21]. http://kns.cnki.net/kcms/detail/11.2162.R.20230104.2122.001.html
