Objective To establish quality control standards for Yishen Qianggu mixture.
Methods The TLC was used to identify Psoralea corylifolia L. and Curculigo orchioides Gaertn in Yishen Qianggu mixture; the content of salvianolic acid B was determined by HPLC, the chromatographic method of this experiment is an C18 column (250 mm × 4.6 mm, 5 μm) of Elite, mobile phase was acetonitrile-0.5% acetonitrile-formic acid (23 ∶ 77), column temperature was 25 ℃, the detection wavelength was 286 nm, the flow rate was 1.0 mL·min-1, the injection volume was 10 μL.
Results Spots with the same color characteristics were displayed on the corresponding positions of the test substance and the control substance (the control medicinal material), the separation degree was satisfactory, and the negative control substance had no interference; the salvianolic acid B had a good linear relationship within the range of 16.48-527.50 μg·mL-1 (r=1.000 0). The average recovery rate was 97.07% and RSD was 0.94% (n=6), the average content of three batches of samples was 2.146 0 mg·mL-1.
Conclusion The TLC and HPLC methods established in this experiment have simple operation, high repeatability and strong specificity, which could be used for quality control of Yishen Qianggu mixture.
1.于龙, 王亮. 老年骨质疏松症现状及进展[J]. 中国临床保健杂志, 2022, 25(1): 6-11. [Yu L, Wang L. Status and progress of osteoporosis in the elderly[J]. Chinese Journal of Clinical Healthcare, 2022, 25(1): 6-11.] DOI: 10.3969 /J.issn.1672-6790.2022.01.002.
2.中华医学会骨质疏松和骨矿盐疾病分会. 中国骨质疏松症流行病学调查及"健康骨骼"专项行动结果发布[J]. 中华骨质疏松和骨矿盐疾病杂志, 2019, 12(4): 317-318. DOI: 10.3969/j.issn.1674-2591.2019.04.001.
3.夏荣林. 中医药防治老年骨质疏松骨折的研究进展[J]. 内蒙古中医药, 2022, 41(4): 135-137. [Xia RL. Research progress in prevention and treatment of senile osteoporosis fracture with traditional Chinese medicine[J].Inner Mongolia Journal of Traditional Chinese Medicine, 2022, 41(4): 135-137.] DOI: 10.16040/j.cnki.cn15-1101.2022.04.055.
4.中国药典2020年版. 一部[S]. 2020: 195, 106.
5.陈静萍, 熊鑫, 张耕, 等. 一测多评法测定灵丹片中丹参5种指标成分的含量[J]. 医药导报, 2017, 36(6): 679-682. [Cheng JP, Xiong X, Zhang G, et al. Determination of five index components of Salvia miltiorrhiza in Lingdan tablets by one test and multiple evaluation[J]. Herald of Medicine, 2017, 36(6): 679-682.] DOI: 10.3870 /j.issn.1004-0781.2017.06.020.
6.郝振明, 张轶欧, 谢君, 等. 丹参配方颗粒中丹参酮ⅡA、丹酚酸B、丹参素和原儿茶醛的含量研究[J]. 时珍国医国药, 2022, 33(3): 605-607. [Hao ZM, Zhang YO, Xie J, et al. Study on the contents of tanshinone ⅡA, salvianolic acid B, Danshensu and protocatechuic aldehyde in Salvia miltiorrhiza dispensing granules[J]. Lishizhen Medicine and Materia Medica Research, 2022, 33(3): 605-607.] DOI: 10.3969/j.issn.1008-0805.2022.03.26.
7.李垚, 杨德智, 苏斌, 等. 超HPLC法同时检测丹参中 14 种水溶性成分[J]. 医药导报, 2019, 38(12): 1624-1629. [Li Y, Yang DZ, Su B, et al. Simultaneous detection of 14 hydrophilic components in Salvia miltiorrhiza by UPLC[J]. Herald of Medicine, 2019, 38(12): 1624-1629.] DOI: 10.3870 /j.issn.1004-0781.2019.12.018.
8.王文晓, 杨诺, 高欢, 等. HPLC法同时测定冠心丹参片中10种成分[J]. 中成药, 2021, 43(5): 1141-1144. [Wang WX, Yang N, Gao H, et al. Simultaneous determination of ten constituents in Guanxin Danshen Tablets by HPLC[J]. Chinese Traditional Patent Medicine, 2021, 43(5): 1141-1144.] DOI: 10.3969/j.issn.1001-1528.2021.05.005.
9.管小军, 厉君, 黄娜娜, 等. HPLC同时测定紫丹参药材中8种成分含量[J]. 中国中医药信息杂志, 2020, 27(9): 82-86. [Guan XJ, Li J, Huang NN, et al. Simultaneous determination of 8 components in purple Salviae Miltiorrhizae et Rhizoma by HPLC[J]. Chinese Journal of Information on Traditional Chinese Medicine, 2020, 27(9): 82-86.] DOI: 10.3969/j.issn.1005-5304.202002080.
10.李燕, 同晓霞. RP-HPLC同时测定丹膝颗粒中丹酚酸B、丹皮酚和丹参素含量[J]. 食品与药品, 2019, 21(4): 309-312. [Li Y, Tong XX. Simultaneous determination of salvianolic acid b, paeonol and tanshinol in Danxi granules by RP-HPLC[J]. Food and Drug, 2019, 21(4): 309-312.] DOI: 10.3969/j.issn.1672-979X.2019.04.014.
11.姜晓燕, 张琳, 窦志华, 等. 反相HPLC法同时测定丹参中5 种成分含量[J].医药导报, 2016, 35(9): 997-1000. [Jiang XY, Zhang L, Dou ZH, et al. A simultaneous determination of five components in Radix et Rhizoma Salviae miltiorrhizae by RP-HPLC[J]. Herald of Medicine, 2016, 35(9): 997-1000.] DOI: 10.3870/j.issn.1004-0781.2016.09.023.
12.任正肖, 张颖颖. 丹酚酸 B 的化学成分及药理作用的研究进展[J]. 山东化工, 2019, 48(13): 74-75, 82. [Ren ZX, Zhang YY. Research progress on salvianolic acid B of the chemical composition and pharmacological effects[J].Shandong Chemical Industry, 2019, 48(13): 74-75, 82.] DOI: 10.19319/j.cnki.issn.1008-021x.2019.13.030.
13.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.