防风饮片标准汤剂
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摘要
目的:制备防风饮片标准汤剂,并进行质量标准的研究,为其临床应用及其他饮片标准汤剂的研究提供科学参考。方法:采用传统水煎煮方法,制备11批防风饮片标准汤剂,进行p H,升麻素苷及5-O-甲基维斯阿米醇苷含量的测定,计算其出膏率与转移率,并对测定方法可行性进行考察。建立HPLC指纹图谱分析方法,采用Hypersil ODS2色谱柱(4. 6 mm×250 mm,5μm),流动相甲醇-进行梯度洗脱,检测波长254 nm,流速1 m L·min~(-1),柱温25℃,并进行相似度评价。结果:11批防风饮片标准汤剂的p H均为5. 5,出膏率在34. 3%～46. 3%,平均出膏率为41. 4%,标准偏差为3. 7%;升麻素苷的转移率在66. 8%～93. 5%,平均转移率为79. 4%,标准偏差为12. 1%; 5-O-甲基维斯阿米醇苷的转移率在70. 4%～98. 2%,平均转移率为83. 4%,标准偏差为10. 8%。各项方法学考察结果 RSD均符合要求。指纹图谱中确定了9个主要共有峰,其相似度> 0. 9。结论:该研究建立的质量评价方法稳定性、精密度和重复性良好,指纹图谱的相似度高,适用于防风饮片标准汤剂的质量评价,并且可为其他相关制剂的质量评价提供科学依据。
Objective: To prepare standard decoction of Saposhnikoviae Radix pieces,and conduct a study on the quality standards,in order to provide the scientific reference for the study of clinical application and other decoction standard decoctions. Method: By the traditional water decocting method,11 batches of standard decoction of Saposhnikoviae Radix pieces were prepared to determine p H,prim-O-glucosylcimifugin and 4'-O-β-Dglucosyl-5-O-methylvisamminol content,calculate the paste rate and transfer rate,and investigate the feasibility of the measurement method. An analytical method for HPLC fingerprint was established. Hypersil ODS2 column( 4. 6 mm × 250 mm,5 μm) was adopted and eluted with methanol-water as the mobile phase in a gradient mode.The detection wavelength was 254 nm,the flow rate was 1 m L·min~(-1),and the column temperature was 25 ℃.The fingerprint analysis method was used to evaluate the similarity of the 11 batches of standard decoction of Saposhnikoviae Radix pieces. Result: Through the determination of 11 batches of standard decoctions of Saposhnikoviae Radix pieces, the average pH value was 5. 5, the paste-out rates were between 34. 3% and46. 3%,and the average paste-out rate was 41. 4%,the standard deviation was 3. 7%,the transfer rate of primO-glucosylcimifugin was 66. 8%-93. 5%, the average metastasis rate was 79. 4%, the standard deviation was12. 1%,the transfer rate of 4'-O-β-D-glucosyl-5-O-methylvisamminol was 70. 4%-98. 2%,the average transfer rate was 83. 40%,the standard deviation of 10. 8%. The results of various methodological studies were consistent with the requirements of RSD. The fingerprinting analysis was performed using similarity evaluation software for traditional Chinese medicine fingerprints,and 9 principal common peaks were identified. The similarity was higher than 0. 9. Conclusion: The quality evaluation method established in this study has a good stability,precision and repeatability. The fingerprints have a high similarity, which is suitable for the quality evaluation of standard decoctions of Saposhnikoviae Radix pieces,and can provide the scientific basis for the quality evaluation of other related preparations.
Objective: To prepare standard decoction of Saposhnikoviae Radix pieces,and conduct a study on the quality standards,in order to provide the scientific reference for the study of clinical application and other decoction standard decoctions. Method: By the traditional water decocting method,11 batches of standard decoction of Saposhnikoviae Radix pieces were prepared to determine p H,prim-O-glucosylcimifugin and 4'-O-β-Dglucosyl-5-O-methylvisamminol content,calculate the paste rate and transfer rate,and investigate the feasibility of the measurement method. An analytical method for HPLC fingerprint was established. Hypersil ODS2 column( 4. 6 mm × 250 mm,5 μm) was adopted and eluted with methanol-water as the mobile phase in a gradient mode.The detection wavelength was 254 nm,the flow rate was 1 m L·min~(-1),and the column temperature was 25 ℃.The fingerprint analysis method was used to evaluate the similarity of the 11 batches of standard decoction of Saposhnikoviae Radix pieces. Result: Through the determination of 11 batches of standard decoctions of Saposhnikoviae Radix pieces, the average pH value was 5. 5, the paste-out rates were between 34. 3% and46. 3%,and the average paste-out rate was 41. 4%,the standard deviation was 3. 7%,the transfer rate of primO-glucosylcimifugin was 66. 8%-93. 5%, the average metastasis rate was 79. 4%, the standard deviation was12. 1%,the transfer rate of 4'-O-β-D-glucosyl-5-O-methylvisamminol was 70. 4%-98. 2%,the average transfer rate was 83. 40%,the standard deviation of 10. 8%. The results of various methodological studies were consistent with the requirements of RSD. The fingerprinting analysis was performed using similarity evaluation software for traditional Chinese medicine fingerprints,and 9 principal common peaks were identified. The similarity was higher than 0. 9. Conclusion: The quality evaluation method established in this study has a good stability,precision and repeatability. The fingerprints have a high similarity, which is suitable for the quality evaluation of standard decoctions of Saposhnikoviae Radix pieces,and can provide the scientific basis for the quality evaluation of other related preparations.
引文
[1]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.
[2]杨立伟,王海南,耿莲,等.基于标准汤剂的中药整体质量控制模式探讨[J].中国实验方剂学杂志,2018,24(8):1-6.
[3]朱广伟,李西文,李琦,等.基于传统煎药工艺的龙胆饮片标准汤剂制备及质量评价方法研究[J].中草药,2017,48(20):4253-4260.
[4]国家药典委员会.中华人民共和国药典.一部[M].北京:中国医药科技出版社,2015:149.
[5]赵博,杨鑫宝,杨秀伟,等.防风化学成分的研究[J].中国中药杂志,2010,35(12):1569-1572.
[6]窦红霞,高玉兰.防风的化学成分和药理作用研究进展[J].中医药信息,2009,26(2):15-17.
[7]李阳,王旭,李壮壮,等.防风化学成分分离鉴定[J].中国实验方剂学杂志,2017,23(15):60-64.
[8]刘双利,姜程曦,赵岩,等.防风化学成分及其药理作用研究进展[J].中草药,2017,48(10):2146-2152.
[9]马卉,贡济宇.防风的栽培技术[J].世界最新医学信息文摘,2016,16(23):166-167.
[10]李海涛,徐安顺,张丽霞,等.防风及其地方习用品种的性状与显微鉴别[J].中药材,2013,36(12):1940-1942.
[11]崔文金,焦梦姣,邓哲,等.黄连饮片标准汤剂的制备及质量标准分析[J].中国实验方剂学杂志,2017,23(19):40-45.
[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]董青,赵嵘,代云桃,等.红花标准汤剂的质量评价[J].中国实验方剂学杂志,2017,23(7):12-17.
[14]仝家羽,赵嵘,代云桃,等.当归标准汤剂质量评价体系的建立[J].中国实验方剂学杂志,2017,23(7):18-23.
[15]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.
[16]徐姣,赵嵘,代云桃,等.栀子标准汤剂的质量评价方法考察[J].中国实验方剂学杂志,2017,23(7):30-35.
[17]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.
[18]曹静亚,李晓,宋梦娇,等.连翘标准汤剂质量评价体系的建立[J].中国实验方剂学杂志,2018,24(7):7-12.
[19]戴锦娜,陈晓辉,尚红.防风药材HPLC指纹图谱研究[J].辽宁中医药大学学报,2012,14(12):185-187.
[20]尹雪,黄月纯,魏刚.黄芪、白术、防风单煎、合煎对玉屏风煎剂HPLC指纹图谱的影响[J].中国实验方剂学杂志,2009,15(3):1-3.
[21]李丽,肖永庆,刘元艳.防风饮片的HPLC指纹图谱[J].中国中药杂志,2006,31(15):1284-1285.
[22]马丽杰,杨滨,冯学锋,等.野生与栽培防风中升麻苷和5-O-甲基维斯阿米醇苷的含量测定及指纹图谱分析[J].中国中药杂志,2010,35(13):1731-1734.
[23]周蔚昕,刘涛,张佳,等.川芎饮片标准汤剂指纹图谱研究[J].中草药,2018,49(10):2401-2409.
[24] XU X N,JIANG J H,LIANG Y Z,et al. Chromatographic fingerprint analysis of Fructus Aurantii Immaturus by HPLC-DAD and chemometric methods[J]. J Central South Univ Technol,2011,18(2):353-360.
[2]杨立伟,王海南,耿莲,等.基于标准汤剂的中药整体质量控制模式探讨[J].中国实验方剂学杂志,2018,24(8):1-6.
[3]朱广伟,李西文,李琦,等.基于传统煎药工艺的龙胆饮片标准汤剂制备及质量评价方法研究[J].中草药,2017,48(20):4253-4260.
[4]国家药典委员会.中华人民共和国药典.一部[M].北京:中国医药科技出版社,2015:149.
[5]赵博,杨鑫宝,杨秀伟,等.防风化学成分的研究[J].中国中药杂志,2010,35(12):1569-1572.
[6]窦红霞,高玉兰.防风的化学成分和药理作用研究进展[J].中医药信息,2009,26(2):15-17.
[7]李阳,王旭,李壮壮,等.防风化学成分分离鉴定[J].中国实验方剂学杂志,2017,23(15):60-64.
[8]刘双利,姜程曦,赵岩,等.防风化学成分及其药理作用研究进展[J].中草药,2017,48(10):2146-2152.
[9]马卉,贡济宇.防风的栽培技术[J].世界最新医学信息文摘,2016,16(23):166-167.
[10]李海涛,徐安顺,张丽霞,等.防风及其地方习用品种的性状与显微鉴别[J].中药材,2013,36(12):1940-1942.
[11]崔文金,焦梦姣,邓哲,等.黄连饮片标准汤剂的制备及质量标准分析[J].中国实验方剂学杂志,2017,23(19):40-45.
[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]董青,赵嵘,代云桃,等.红花标准汤剂的质量评价[J].中国实验方剂学杂志,2017,23(7):12-17.
[14]仝家羽,赵嵘,代云桃,等.当归标准汤剂质量评价体系的建立[J].中国实验方剂学杂志,2017,23(7):18-23.
[15]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.
[16]徐姣,赵嵘,代云桃,等.栀子标准汤剂的质量评价方法考察[J].中国实验方剂学杂志,2017,23(7):30-35.
[17]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.
[18]曹静亚,李晓,宋梦娇,等.连翘标准汤剂质量评价体系的建立[J].中国实验方剂学杂志,2018,24(7):7-12.
[19]戴锦娜,陈晓辉,尚红.防风药材HPLC指纹图谱研究[J].辽宁中医药大学学报,2012,14(12):185-187.
[20]尹雪,黄月纯,魏刚.黄芪、白术、防风单煎、合煎对玉屏风煎剂HPLC指纹图谱的影响[J].中国实验方剂学杂志,2009,15(3):1-3.
[21]李丽,肖永庆,刘元艳.防风饮片的HPLC指纹图谱[J].中国中药杂志,2006,31(15):1284-1285.
[22]马丽杰,杨滨,冯学锋,等.野生与栽培防风中升麻苷和5-O-甲基维斯阿米醇苷的含量测定及指纹图谱分析[J].中国中药杂志,2010,35(13):1731-1734.
[23]周蔚昕,刘涛,张佳,等.川芎饮片标准汤剂指纹图谱研究[J].中草药,2018,49(10):2401-2409.
[24] XU X N,JIANG J H,LIANG Y Z,et al. Chromatographic fingerprint analysis of Fructus Aurantii Immaturus by HPLC-DAD and chemometric methods[J]. J Central South Univ Technol,2011,18(2):353-360.