干姜标准汤剂的质量评价
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摘要
目的:建立干姜饮片标准汤剂的质量控制方法。方法:对不同产地药材进行DNA条形码基原鉴定;根据中药饮片标准汤剂制备原则,将鉴定为干姜的饮片制备成标准汤剂并进行分析,同时对提取方法、分析方法进行方法学验证,计算出膏率和6-姜辣素的转移率等参数。建立干姜饮片标准汤剂的质量标准;采用UPLC-Q-TOF-MS对主要色谱峰进行结构确认,明确干姜标准汤剂中的主要化学成分。结果:所有药材经鉴定均为干姜(Zingiber offcinale),在该文所建立的制备条件下,6-姜辣素的标准曲线为Y=661. 56X+2. 493 3(r=0. 999 3),精密度试验测得RSD为0. 5%,表明仪器精密度良好。重复性试验测得RSD为0. 3%,结果表明该方法重复性良好。稳定性试验测得RSD为0. 4%,结果表明供试品溶液在24 h内稳定性良好。加样回收率为97. 2%,RSD为0. 6%,表明该方法准确可靠。转移率范围为31. 8%～57. 4%,出膏率范围为9. 6%～23. 1%,12批干姜饮片标准汤剂指纹图谱相似度> 90. 0%。结论:建立的系统评价干姜标准汤剂的质量评价方法稳定可行,同时建立了规范的干姜标准汤剂制备方法及其质量评价体系。
Objective: To establish the quality control methods for the standard decoction of Zingiberis Rhizoma. Method: DNA barcode primitives were identified for the medicinal materials from different origins;according to the standard of Chinese herbal medicine decoction preparation principle, the identified Zingiberis Rhizoma was prepared into standard decoction for analysis. Meanwhile,the extraction method and analysis method were validated from methodologies,and the transfer rate of 6-gingerol as well as the extraction rate of standard decoction of Zingiberis Rhizoma were calculated. In addition, the quality standard of standard decoction of Zingiberis Rhizoma was also established based. The structures of main chromatographic peaks were identified by ultra-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry(UPLC-Q-TOFMS) to clarify the main chemical constituents in the standard decoction of Zingiberis Rhizoma. Result: All the samples were identified as Zingiberis Rhizoma. Under the conditions established in this paper,the standard curve of 6-gingerol was Y = 661. 56 X + 2. 493 3(r = 0. 999 3),and the RSD was 0. 5% in precision test,indicating that the instrument precision was good. The repeatability test showed that the RSD was 0. 3%,indicating that the method had good repeatability. The stability test showed that the RSD was 0. 4%,indicating that the test solution had good stability within 24 h. The recovery rate was 97. 2% and the RSD was 0. 6%,indicating that the method was accurate and reliable. 6-gingerol's transfer rate ranged from 31. 8% to 57. 4% and the extraction rate was within the range of 9. 6%-23. 1%. The fingerprint similarity of 12 batches of Zingiberis Rhizoma standard decoction was >90%. Conclusion: The established quality control method for Zingiberis Rhizoma was stable and feasible;meanwhile,the standard preparation method for Zingiberis Rhizoma and its quality evaluation system were also established in this study.
Objective: To establish the quality control methods for the standard decoction of Zingiberis Rhizoma. Method: DNA barcode primitives were identified for the medicinal materials from different origins;according to the standard of Chinese herbal medicine decoction preparation principle, the identified Zingiberis Rhizoma was prepared into standard decoction for analysis. Meanwhile,the extraction method and analysis method were validated from methodologies,and the transfer rate of 6-gingerol as well as the extraction rate of standard decoction of Zingiberis Rhizoma were calculated. In addition, the quality standard of standard decoction of Zingiberis Rhizoma was also established based. The structures of main chromatographic peaks were identified by ultra-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry(UPLC-Q-TOFMS) to clarify the main chemical constituents in the standard decoction of Zingiberis Rhizoma. Result: All the samples were identified as Zingiberis Rhizoma. Under the conditions established in this paper,the standard curve of 6-gingerol was Y = 661. 56 X + 2. 493 3(r = 0. 999 3),and the RSD was 0. 5% in precision test,indicating that the instrument precision was good. The repeatability test showed that the RSD was 0. 3%,indicating that the method had good repeatability. The stability test showed that the RSD was 0. 4%,indicating that the test solution had good stability within 24 h. The recovery rate was 97. 2% and the RSD was 0. 6%,indicating that the method was accurate and reliable. 6-gingerol's transfer rate ranged from 31. 8% to 57. 4% and the extraction rate was within the range of 9. 6%-23. 1%. The fingerprint similarity of 12 batches of Zingiberis Rhizoma standard decoction was >90%. Conclusion: The established quality control method for Zingiberis Rhizoma was stable and feasible;meanwhile,the standard preparation method for Zingiberis Rhizoma and its quality evaluation system were also established in this study.
引文
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[6]董艳,姚魁武,王阶.辨姜及其炮制品药理和临床运用特点[J].中国中药杂志,2018,43(10):2020-2024.
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[9]陈士林,刘安,李琦,等.中药饮片标准汤剂研究策略[J].中国中药杂志,2016,41(8):1367-1375.
[10]陈士林,姚辉,韩建萍,等.中药材DNA条形码分子鉴定指导原则[J].中国中药杂志,2013,38(2):141-148.
[11]祝明,陈碧莲,石上梅.中药指纹图谱技术在中国药典2015年版一部中的应用[J].中国现代应用药学,2016,33(5):611-614.
[12]张鹏,邬兰,李西文,等.人参饮片标准汤剂的评价及应用探讨[J].中国实验方剂学杂志,2017,23(7):2-11.
[13]于小红,赵嵘,代云桃,等.党参标准汤剂质量评价的建立[J].中国实验方剂学杂志,2017,23(7):24-29.
[14]李琦,章军,崔文金,等.黄芩饮片标准汤剂的制备和质量标准评价[J].中国实验方剂学杂志,2017,23(7):36-40.
[15]焦梦姣,邓哲,章军,等.含挥发性成分中药饮片标准汤剂的制备和质量标准研究——以牡丹皮为例[J].中国中药杂志,2018,43(5):891-896.
[16]徐姣,赵嵘,代云桃,等.中药饮片标准汤剂的质量评价案例——连翘[J].中国中药杂志,2018,43(5):868-872.
[2]孙凤娇,李振麟,钱士辉,等.干姜化学成分和药理作用研究进展[J].中国野生植物资源,2015,34(3):34-37.
[3]崔婉华,王彦志,李泽之.干姜化学成分的分离鉴定[J].中药材,2018,41(2):334-337.
[4] QIAO X,LIN X H,JI S,et al. Global profiling and novel structure discovery using multiple neutral loss/precursor ion scanning combined with substructure recognition and statistical analysis(MNPSS):characterization of terpene-conjugated curcuminoids in curcuma longa as a case study[J]. Anal Chem,2016,88(1):703-710.
[5]叶刚飒,余书洪,杨卫芳,等.生姜的有效成分与药理作用研究进展[J].浙江树人大学学报:自然科学版,2011,11(3):24-27.
[6]董艳,姚魁武,王阶.辨姜及其炮制品药理和临床运用特点[J].中国中药杂志,2018,43(10):2020-2024.
[7]吴智高.浅谈中药制剂的工艺与质量[J].海峡药学,2008,20(12):87-88.
[8]国家中医药管理局、卫生部关于印发医疗机构中药煎药室管理规范的通知(国中医药发[2009]3号)[N].中华人民共和国卫生部公报,2009-03-07.
[9]陈士林,刘安,李琦,等.中药饮片标准汤剂研究策略[J].中国中药杂志,2016,41(8):1367-1375.
[10]陈士林,姚辉,韩建萍,等.中药材DNA条形码分子鉴定指导原则[J].中国中药杂志,2013,38(2):141-148.
[11]祝明,陈碧莲,石上梅.中药指纹图谱技术在中国药典2015年版一部中的应用[J].中国现代应用药学,2016,33(5):611-614.
[12]张鹏,邬兰,李西文,等.人参饮片标准汤剂的评价及应用探讨[J].中国实验方剂学杂志,2017,23(7):2-11.
[13]于小红,赵嵘,代云桃,等.党参标准汤剂质量评价的建立[J].中国实验方剂学杂志,2017,23(7):24-29.
[14]李琦,章军,崔文金,等.黄芩饮片标准汤剂的制备和质量标准评价[J].中国实验方剂学杂志,2017,23(7):36-40.
[15]焦梦姣,邓哲,章军,等.含挥发性成分中药饮片标准汤剂的制备和质量标准研究——以牡丹皮为例[J].中国中药杂志,2018,43(5):891-896.
[16]徐姣,赵嵘,代云桃,等.中药饮片标准汤剂的质量评价案例——连翘[J].中国中药杂志,2018,43(5):868-872.