浏览全部资源
扫码关注微信
1.宁夏职业技术学院,银川 750001;
2.宁夏大学 农学院,银川 750021
郭超,硕士,讲师,从事中药制剂开发及质量评价研究,Tel:0951-2135089,E-mail:guochao8321@163.com
冷晓红,正高职高级工程师,从事中药制剂开发及质量评价研究,Tel:0951-2135415,E-mail:lxh-zss@163.com
纸质出版日期:2019-12-20,
网络出版日期:2019-08-27,
收稿日期:2019-02-04,
扫 描 看 全 文
郭超, 焦淑珍, 徐超, 等. 秦艽配方颗粒制备过程中标准汤剂与其不同方法干燥品质量相关性分析[J]. 中国实验方剂学杂志, 2019,25(24):118-123.
Chao GUO, Shu-zhen JIAO, Chao XU, et al. Quality Relevance of Standard Decoction and Different Drying Methods Products for Gentianae Macrophyllae Radix Granules Based on HPLC Fingerprint[J]. Chinese Journal of Experimental Traditional Medical Formulae, 2019,25(24):118-123.
郭超, 焦淑珍, 徐超, 等. 秦艽配方颗粒制备过程中标准汤剂与其不同方法干燥品质量相关性分析[J]. 中国实验方剂学杂志, 2019,25(24):118-123. DOI: 10.13422/j.cnki.syfjx.20192314.
Chao GUO, Shu-zhen JIAO, Chao XU, et al. Quality Relevance of Standard Decoction and Different Drying Methods Products for Gentianae Macrophyllae Radix Granules Based on HPLC Fingerprint[J]. Chinese Journal of Experimental Traditional Medical Formulae, 2019,25(24):118-123. DOI: 10.13422/j.cnki.syfjx.20192314.
目的:
2
建立秦艽标准汤剂及其不同方法干燥品的HPLC指纹图谱,对其质量相关性进行分析评价。
方法:
2
采用HPLC,InertSustain C
18
色谱柱(4.6 mm×250 mm,5 μm),以乙腈-磷酸为流动相进行梯度洗脱,检测波长240 nm,流速0.8 mL·min
-1
,柱温40 ℃。以对照指纹图谱及标准汤剂指纹图谱对秦艽标准汤剂不同方法干燥品从化学成分一致性、共有化学成分含量一致性以及主要化学成分含量和转移率等方面进行质量相关性分析。
结果:
2
建立秦艽标准汤剂对照指纹图谱,根据峰匹配数据确定15批秦艽标准汤剂指纹图谱中10个共有峰,从10个共有峰中指认出马钱苷酸,6′-
O
-
β
-
D
-葡萄糖基龙胆苦苷,獐牙菜苦苷,龙胆苦苷,獐牙菜苷5个化学成分。质量相关性分析结果表明,3种不同干燥方法制得干燥品水溶液与秦艽标准汤剂在化学成分种类及数量上一致性良好。但在共有化学成分含量及主要化学成分转移率方面,减压干燥所得干燥品与标准汤剂的质量低于喷雾干燥与冷冻干燥所得干燥品。
结论:
2
建立了秦艽标准汤剂-不同方法干燥品HPLC指纹图谱,通过化学成分、共有化学成分含量、主要化学成分含量及转移率3方面的质量相关性分析,全面反映了二者质量相关性情况。建议在秦艽配方颗粒制备的关键干燥工艺中采用喷雾干燥或冷冻干燥工艺,该研究为秦艽配方颗粒的制备工艺及质量控制提供了参考依据。
Objective:
2
To establish the fingerprints of standard decoction of Gentianae Macrophyllae Radix-dried products by different methods
and to evaluate the quality correlation.
Method:
2
HPLC
InertSustain C
18
chromatographic column(4.6 mm×250 mm
5 μm)
Gradient elution was performed for the mobile phase of acetonitrile-phospho
detection wavelength at 240 nm and flow rate of 0.8 mL·min
-1
and column temperature was 40 ℃. The quality correlation analysis of different methods for different kinds of Gentianae Macrophyllae Radix standard decoction was carried out from the aspects of chemical composition consistency
common chemical composition consistency
main chemical composition content and transfer rate.
Result:
2
The control fingerprint of Gentianae Macrophyllae Radix standard decoction was established. According to the peak matching data
there were 10 common peaks in the fingerprint of 15 batches of Gentianae Macrophyllae Radix standard decoction.Among the 10 common peaks
5 chemical constituents of loganic acid
6′-
O
-
β
-
D
-glucosyl gentiopicroside
swertiamarin
gentiopicroside and swertia glycosides were identified. The results of quality correlation analysis showed that the three different drying methods were consistent with the chemical composition and quantity of Gentianae Macrophyllae Radix standard decoction. But in terms of the content consistency of common chemical components and the transfer rate of main chemical components
the quality correlation between the products obtained from vacuum drying and the standard decoction was lower than that obtained from spray drying and freeze-drying.
Conclusion:
2
The fingerprint of different method of Gentianae Macrophyllae Radix standard decoction was established. Through the analysis of the mass correlation of chemical composition consistency
common chemical composition content consistency
main chemical composition content and transfer rate
the mass correlation between them was comprehensively reflected. It is suggested that spray drying or freeze drying should be used for the key drying process of Gentianae Macrophyllae Radix granules. This study provides a reference for the preparation process and quality control of Gentianae Macrophyllae Radix granules.
秦艽配方颗粒标准汤剂减压干燥喷雾干燥冷冻干燥
Gentianae Macrophyllae Radixformula granulestandard decoctionvacuum dryingspray dryingfreeze drying
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.
熊波,郭树鹏,胡林.秦艽的鉴定方法概述[J].中国实验方剂学杂志,2015,21(17):230-234.
郭伟娜,熊文勇,魏朔南.秦艽及其近缘种植物资源在我国的分布[J].中国野生植物资源,2009,28(2):21-23,28.
卢有媛,张小波,杨燕梅,等.秦艽药材的品质区划研究[J].中国中药杂志,2016,41(17):3132-3138.
国家食品药品监督管理局.中药配方颗粒管理办法(征求意见稿)[M].北京:国家食品药品监督管理局,2015:1.
张义娟,田谧.试谈中药配方颗粒的优势与不足[J].中国中医药现代远程教育,2013,11(9):105-106.
张铁军,高文远.中药配方颗粒的研究与应用[M].北京:中国医药科技出版社,2010:9-10.
张红梅,宋景政,谭红胜,等.从汤剂到颗粒剂:中药配方颗粒20年回顾与展望[J].世界科学技术—中医药现代化,2012,14(4):1740-1753.
中华人民共和国药典委员会.中药配方颗粒质量控制与标准制定技术要求(征求意见稿)[M].北京:中华人民共和国药典委员会,2016:1-14.
江世雄.我国中药配方颗粒产业存在问题及对策研究[D].郑州:河南中医药大学,2016.
何惠,李春梅,郁建平.草珊瑚配方颗粒制备及质量标准研究[J].山地农业生物学报,2015,34(4):88-91.
张慧,陈燕,汪佳楠,等.指纹图谱技术在中药配方颗粒质量评价及过程控制中的应用[J].中国中药杂志,2018,43(19):3822-3827.
谭鹏,张海珠,张定堃,等.基于化学表征和生物效价检测的大黄配方颗粒质量评价研究[J].中国中药杂志,2017,42(14):2683-2690.
孙国祥,侯志飞,张春玲,等.色谱指纹图谱定性相似度和定量相似度的比较研究[J].药学学报,2007(1):75-80.
孙国祥,智雪枝,张春玲,等.中药色谱指纹图谱超信息特征数字化评价系统[J].中南药学,2007(6):549-555.
孙国祥,胡玥珊,张春玲,等.构建中药数字化指纹图谱研究[J].药物分析杂志,2009,29(1):160-169.
杨晓瑞,张凯,李泽运,等.靶向轮廓分析核磁定量法测定4种秦艽中龙胆苦苷与马钱苷酸[J].中国实验方剂学杂志,2017,23(6):98-103.
杜盛楠.獐牙菜苦苷热转化产物水溶性成分的化学研究[D].昆明:云南中医学院,2014.
徐蕾.不同产地秦艽成分差异的研究[D].杨凌:西北农林科技大学,2014.
0
浏览量
8
下载量
3
CSCD
关联资源
相关文章
相关作者
相关机构