Quantitative transfer relationships of Rubia yunnanensis Diels formula granules based on standard decoctions

doi:10.19803/j.1672-8629.20220721

Abstract

Abstract: Objective To study the quantitative transfer relationships of Rubia yunnanensis Diels granules based on extraction rates, contents of Rubinaphthin A and characteristic chromatograms of standard decoctions. Methods The standard decoction samples of Rubia yunnanensis Diels were prepared before a method for determination of contents and characteristic chromatograms was established. The quantitative transfer relationships between herb-herbal pieces, standard decoctions, and formula granules were studied. Results The results of study on 15 batches of standard decoctions showed that the extraction rates ranged from 15.3% to 28.4%, the content of Rubinaphthin A in Rubia yunnanensis Diels ranged from 15.83 mg·g^-1 to 29.39 mg·g^-1 and the transfer rate ranged from 21.79% to 40.47%. A total of six characteristic chromatogram were identified, with two characteristic peaks identified for peak 1 of Rubinaphthin A and peak 4 of Rubinaphthin A. Fifteen batches of Rubia yunnanensis Diels herbs and herbal pieces and three batches of pilot formula granules from different sources were collected. The content of Rubinaphthin A in Rubia yunnanensis Diels herbs ranged from 14.32 mg·g^-1 to 19.79 mg·g^-1, from 12.71 mg·g^-1 to 18.81 mg·g^-1 in herbal pieces, and from 18.71 mg·g^-1 to 19.80 mg·g^-1 in formula granules. The transfer rate of herbal pieces to herbs ranged from 64.41% to 119.62%, that of standard decoction to herbal pieces from 21.79% to 40.47%, and that of herbal pieces to formula granules from 26.10% to 28.73%. Six characteristic peaks were detected in Rubia yunnanensis Diels herbs, herbal pieces and formula granules, and the relative retention time was within the specified range. Conclusion The quantitative transfer relationships between herb-herbal pieces, standard decoctions, and formula granules of Rubia yunnanensis Diels are stable and within the range of standard decoctions, indicating that the quality of Rubia yunnanensis Diels formula granules is stable and equivalent to standard decoctions.

Key words: Rubia yunnanensis Diels, rubinaphthin A, standard decoction, formula granules, characteristic chromatogram, quantitative transfer relationship, extraction rate, transfer rate

CLC Number:

R927.11

WANG Xiang, SUN Shuai, WANG Xinguo, NIU Liying. Quantitative transfer relationships of Rubia yunnanensis Diels formula granules based on standard decoctions[J]. Chinese Journal of Pharmacovigilance, 2023, 20(8): 891-898.

References

[1] HAO YD, MA K, WEN RQ, et al. Discussion on current national standards for traditional chinese medicine dispensing granules[J/OL]. Chinese Journal of Experimental Traditional Medical Formula(中国实验方剂学杂志). (2022-12-05)[2022-12-10].https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CAPJ&dbname=CAPJLAST&filename=ZSFX20221204001&uniplatform=NZKPT&v=CBx30l9aYtQRLxbQqgk3nWj92EaLy78HatIBIQ7IyVCYz6_vAz4tYBwMbrRysBH2.
[2] ZHANG W, SUN YF, JIN CS, et al.Research status and prospect of traditional Chinese medicine formula granules[J].Chinese Traditional and Herbal Drugs(中草药), 2022, 53(22): 7221-7233.
[3] YUE QX, SUN YF, YANG A.Study on quality marker of Paeoniae Radix Alba based on quality transfer process of medicinal materials-decoction pieces-standard decoctions[J]. Chinese Traditional and Herbal Drugs(中草药), 2023, 54(2): 553-560.
[4] SHANG S, QI J, YANG LW, et al.A brief analysis of the key points of the research on the quality standard of granules of traditional Chinese medicine formulas[J]. Drug Standards of China(中国药品标准), 2022, 23(6): 567-570.
[5] Yunnan Medical Products Administration. Standards for Chinese Herbal Medicine in Yunnan Province, (云南省中药材标准)[M]. Kunming: Yunnan Science and Technology Press Co, LTD. 2005: 11-12.
[6] YING L.Study on the law of medication of Yunnan ethnic medicine in the treatment of heart disease[D]. Kunming: Yunnan University of Chinese Medicine, 2020.
[7] REN HB, WANG X, GAO L, et al.Quantitative study on the characteristic atlas and index components of the Yi medicine Rubia yunnanensis Diels[J]. J Chin Med Mater(中药材), 2022(6): 1416-1420.
[8] GAO Y, SU Y, HUO Y, et al.Identification of antihyperlipidemic constituents from the roots of Rubia yunnanensis Diels[J]. J Ethnopharmacol, 2014, 155(2): 1315-1321.
[9] GAO Y, GAO XY, ZHANG ZQ.Study on preparation and law of quality value transmitting of Chuanxiong Dispensing Granules[J]. Journal of Tianjin University of Traditional Chinese Medicine(天津中医药大学学报), 2022, 41(5): 638-643.
[10] SUN YF, YUE QX, DU QQ, et al.Quantity value transfer and process optimization of Radix Paeoniae Alba Formulated granules: a study bassed on quality markers[J]. J Anhui Univ Chinese Med(安徽中医药大学学报), 2022, 41(6): 76-82.
[11] ZHANG ZY, DING J, CAO GY, et al.Quality standard for Hujisheng Formula Granules based on standard decoction[J]. Chinese Traditional Patent Medicine(中成药), 2022, 44(9): 2793-2798.
[12] The National Health Commission of People's Republic of China. Notice of the National Administration of Traditional Chinese Medicine and the Ministry of Health on printing and distributing the management norms of traditional Chinese medicine decoction room in medical institutions(No.3 of 2009)[J]. Gazette of the National Health Commission of People's Republic of China(中华人民共和国国家卫生健康委员会公报), 2009, 71(6): 29-31.
[13] National Medical Products Administration. The National Medical Products Administration on the release of Chinese medicine formula granules Notice of Technical Requirements for Quality Control and Standard Setting (No.16 of2021)[EB/OL]. (2021-01-26)[2022-12-10].https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/2021021-0145453181.html.
[14] CAO GY, NING B,QIN JN, et al. Analysis on quality standard of fraxini cortex (fraxinus chinensis) dispensing granules based on standard decoction[J/OL]. Chinese Journal of Experimental Traditional Medical Formula(中国实验方剂学杂志).(2022-11-22)[2022-12-10].https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CAPJ&dbname=CAPJLAST&filename=ZSFX20221118006&uniplatform=NZKPT&v=CBx30l9aYtR_Si2Lmkci9nRKLRTkElsKwwiQHvYek5MnJJoiToT5WqVGB8SRHv0G.
[15] YIN WJ, HE JY, XU X, et al.Evaluation of key production processes of Schizonepetae Herba formula granules based on characteristic chromatogram and quantitative transfer relationship[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2020, 45(6): 1357-1362.
[16] QI J, YANG LW, ZHANG X, et al.Brief analysis of national standard application requirements of Chinese medicine formula granules[J]. Drug Standards of China(中国药品标准), 2022, 23(5): 455-460.
[17] ZHAO XQ, XU L, LI Q, et al.Transformation Relationship between Neomangiferin and Mangiferin in Rhizoma Anemarrhenae under Water Decocting[J]. Chinese Journal of Drug Evaluation(中国药物评价), 2022, 39(4): 304-308.
[18] XUE PY, CHEN P, GUO D.Optimization of water extraction process of cassiae semen and the quantity transfer of index components in cassiae semen formula granules[J]. China Pharmaceuticals(中国药业), 2019, 28(16): 5-8.
[19] LIU SQ, WANG SL, GAO XL, et al.Variation of saponins in radix bupleuri during decoction process[J]. Traditional Chinese Drug Research ＆ Clinical Pharmacology(中药新药与临床药理), 2013, 24(6): 602-606.
[20] YANG XW, ZHANG L.Scientific exploration on decoction of ginseng by water: decoction leading to transformation of chemical structure of ginsenosides[J]. Mod Chin Med(中国现代中药), 2019, 21(8): 1009-1015.
[21] LI YY, WANG Y, ZHANG NP, et al.Effects of different harvest seasons on anthraquinone contents of Polygoni Multiflflori Radix based on UPLC-MS/MS[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2022, 19(12): 1277-1284.
[22] WANG B, LI DM, WANG CS, et al.Determination of 5 saponins in Xuesaitong injection by quantitative analysis of multi components by single marker[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2022, 19(9): 982-986, 993.
[23] YANG XW, ZHANG L.Scientific exploration on decoction of ginseng by water: decoction leading to transformation of chemical structure of ginsenosides[J]. Mod Chin Med(中国现代中药), 2019, 21(8): 1009-1015.