Objective: To establish the content determination method of Simiao Yongan decoction and Xuanmai Ganjie granules, based on the Scrophulariaceae Radix reference extract(SRRE) and the reference substances of main components in Scrophulariae Radix, so as to explore the feasibility and rationality of the application of traditional Chinese medicine reference extract in the quality control of Chinese formulations in place of monomer reference substance. Methods: The separation was performed by HPLC using a SunFire C18 column(250 mm×4.6 mm, 5 μm) with methanol(A) and 0.05% phosphoric acid aqueous solution(B) as the mobile phase in gradient elution at a flow rate of 1.0 mL·min-1. The detection wavelengths were 210 nm(harpagide), 280 nm(harpagoside) and 330 nm(angoroside C).The column temperature was 35 ℃, and the injection volume was 10 and 20 μL. The HPLC methods were established for the determination of the three components in the two compound preparations by using the three reference standards of harpagide, angoroside C and harpagoside and the SRRE at known contents, and the results were compared by t-test. Results: The contents of the three components in Simiao Yongan decoction were 0.132 9, 0.042 1 and 0.032 5 mg·mL-1, respectively, determined by reference standards, and were 0.133 1, 0.042 0 and 0.032 4 mg·mL-1, respectively, determined by SRRE. The corresponding P values were 0.665, 0.284 and 0.661, respectively. The contents of the three components in Xuanmai Ganjie granules were 0.035 1, 0.012 2 and 0.006 3 mg·mL-1, respectively, determined by reference standards, and were 0.035 3, 0.012 2 and 0.006 4 mg·mL-1, respectively, determined by SRRE. The results of t-test showed that the P-values were all above 0.05 and there was no significant difference between the two methods. Conclusion: The results show that the SRRE can replace the corresponding reference substance to determine the contents in Simiao Yongan decoction and Xuanmai Ganju granules. The results of this study provide a scientific basis for the application of reference extracts in replacement of reference substance in the quality research of traditional Chinese medicine compound preparations, and offer new research ideas for Chinese medicine compound quality control research.
[1] 陆兔林, 翟为民, 蔡宝昌, 等. 对照提取物在中药质量控制中的应用[J].中国中药杂志, 2013, 38(3): 462
LU TL, ZHAI WM, CAI BC, et al. Application of control extract in quality control of traditional Chinese medicine[J].China J Chin Mater Med, 2013, 38(3): 462
[2] 马玲云, 马双成. 中药标准物质的发展现状与展望[J].中国药事, 2010, 24(12): 1232
MA LU, MA SC. Development status and prospects of Chinese medicine reference materials[J].Chin Pharm Aff, 2010, 24(12): 1232
[3] 李铮, 孟兰兰, 傅欣彤, 等. 甘草对照提取物的制备及质量研究[J].药物分析杂志, 2017, 37(4): 664
LI Z, MENG LL, FU XT, et al. Preparation and quality studies of licorice control extracts[J].Chin J Pharm Anal, 2017, 37(4): 664
[4] 席骏钻, 钱怡云, 段金廒, 等. 对照提取物用于当归药材质量控制的研究[J].中国中药杂志, 2014, 39(19): 3803
XI JZ, QIAN YY, DUAN JA, et al. Study on the use of control extracts for the quality control of angelica medicinal materials[J].China J Chin Mater Med, 2014, 39(19): 3803
[5] 刘绍勇, 张文明, 潘建超, 等. 对照提取物用于金银花药材的质量控制方法研究[J].中国中药杂志, 2013, 38(13): 2147
LIU SY, ZHANG WM, PAN JC, et al. Study on the quality control method of control extract used in honeysuckle medicinal materials[J].China J Chin Mater Med, 2013, 38(13): 2147
[6] 戴宇, 邓赟, 宋川霞, 等. 对照提取物的国内外发展研究概况[J].中药与临床, 2015, 6(4): 49
DAI Y, DENG Y, SONG CX, et al. Overview of the research on the development of control extracts at home and abroad[J].Pharm Clin Chin Mater Med, 2015, 6(4): 49
[7] 陈沛, 金红宇, 孙磊, 等. 对照提取物在中药整体质量控制中的应用[J].药物分析杂志, 2016, 36(2): 185
CHEN P, JIN HY, SUN L, et al. Application of control extracts in the overall quality control of traditional Chinese medicine[J].Chin J Pharm Anal, 2016, 36(2): 185
[8] 中华人民共和国药典2020年版. 四部[S].2020: 442
ChP 2020. Vol Ⅳ[S].2020: 442
[9] 周德勇, 张乐, 姜艳艳, 等. 薄荷酚类对照提取物HPLC含量测定研究及其在薄荷药材质量控制中的应用[J].药物分析杂志, 2018, 38(4): 582
ZHOU DY, ZHANG L, JIANG YY, et al. Study on HPLC content determination of menthol reference extract and its application in quality control of peppermint medicinal materials[J].Chin J Pharm Anal, 2018, 38(4): 582
[10] 周德勇, 骆宜, 苏磊, 等. 决明子萘并吡喃酮类对照提取物研究及其在决明子药材质量控制中的应用[J].中国中药杂志, 2017, 42(17): 3385
ZHOU DY, LUO Y, SU L, et al. Study on the control extracts of Cassia seed naphthopyrone and its application in quality control of cassia seed[J].China J Chin Mater Med, 2017, 42(17): 3385
[11] 杨丽丽, 姜艳艳, 蒋丽娟, 等. 枳实黄酮对照提取物研究及其在枳实药材质量控制中的应用[J].中国中医药信息杂志, 2019, 26(9): 73
YANG LL, JIANG YY, JIANG LJ, et al. Study on the control extract of Fructus Aurantii flavonoids and its application in quality control of Fructus Aurantii[J].Chin J Inf Tradit Chin Med, 2019, 26(9): 73
[12] 何风艳, 戴忠, 何轶, 等. 西红花苷对照提取物的研究及其在西红花饮片质量控制中的应用[J].中国中药杂志, 2015, 40(12): 2378
HE FY, DAI Z, HE Y, et al. Study on the control extract of crocin and its application in quality control of saffron decoction pieces[J].China J Chin Mater Med, 2015, 40(12): 2378
[13] 朱月, 王瑞忠, 张聿梅, 等. 双酯型乌头生物碱对照提取物的制备及其应用研究[J].中国药品标准, 2016, 17(4): 252
ZHU Y, WANG RZ, ZHANG YM, et al. Preparation and application of control extracts of diester aconite alkaloid[J].Drug Stand China, 2016, 17(4): 252
[14] 周超, 何轶, 鲁静, 等. 黄芪异黄酮对照提取物的制备及其在黄芪药材含量测定中的应用[J].药物分析杂志, 2014, 34(3): 523
ZHOU C, HE Y, LU J, et al. Preparation of astragalus isoflavone control extract and its application in the determination of Astragalus medicinal materials[J].Chin J Pharm Anal, 2014, 34(3): 523
[15] 中华人民共和国药典2020年版. 一部[S].2020: 121, 852
ChP 2020. Vol Ⅰ[S].2020: 121, 852
[16] 郭子娴, 郑亮, 王梦月, 等. 四妙勇安汤标准煎液煎煮工艺的建立[J].中成药, 2021, 43(5): 1300
GUO ZX, ZHENG L, WANG MY, et al. Establishment of standard decoction technology for Simiao Yongan decoction[J].Chin Tradit Pat Med, 2021, 43(5): 1300
[17] 杨帆, 蒋丽娟, 陈晓鹤, 等. 玄参对照提取物研究及其在玄参药材质量控制中的应用[J].中国中药杂志, 2021, 46(9): 2207
YANG F, JIANG LJ, CHEN XH, et al. Research on Scrophulariae Radix control extract and its application in quality control of Scrophulariae Radix[J].China J Chin Mater Med, 2021, 46(9): 2207
[18] 聂黎行, 戴忠, 马双成. 中药对照制剂研制指导原则和技术要求[J].中国中药杂志, 2017, 42(19): 3672
NIE LX, DAI Z, MA SC. Guiding principles and technical requirements for the development of comparative preparations of traditional Chinese medicines[J].China J Chin Mater Med, 2017, 42(19): 3672