黄连琥珀清心丸质量标准研究

doi:10.3976/j.issn.1002-4026.20230165

Abstract

Abstract:

To establish a method for the qualitative and quantitative assay of Huanglian Hupo Qingxin pills and provide abasis for the subsequent establishment of quality standards, the six ingredients in the formula (Aquilariae Lignum Resinatum, Fructus Choerospondiatis, Terminalia Chebula, CoptidisRhizoma, Flos Gossampini, and Semen Myristicae)were identified through microscopical observation. Thin-layer chromatography was used to identify Terminalia Chebula. Berberine hydrochloride concentration was assessed using high-performance liquid chromatography.Microscopical and thin-layer identifications of Huanglian Hupo Qingxin pills were conducted,which revealed a berberine hydrochloride concentration of 0.018 0~0.902 0 mg/mL,exhibiting a good linear relationship. The assay method was found to bescientific, sensitive, and reproducible, with relative standard deviations(RSDs)for precision, stability, and reproducibility tests all below 3.0%. The average recovery rate from spike-and-recovery testing was 101.29%, with an RSD of 2.30%.The established quality standardis simple and reproducible and can be used for studying the quality standards of Huanglian Hupo Qingxin pills.

Key words: Huanglian Hupo Qingxin pills, quality standards, microscopical identification, thin-layer chromatography, high-performance liquid chromatography

CLC Number:

R284.1

ZHANG Xiaodan, HE Xiaodong, GAO Yan, YANG Longfei, ZHANG Guanqun, YU Zixiang, LIU Mingjun, WANG Yafei, GENG Zangjia, ZHAO Bonian. A study on the quality standards of Huanglian Hupo Qingxin pills[J].Shandong Science, 2024, 37(4): 17-25.

Figures/Tables 15

Fig.1

Fig.2

Fig.3

Fig.4

Fig.5

Table 1

Table 2

Table 3

Table 4

Table 5

Table 6

Fig.6

Table 7

Table 8

Table 9

References 15

[1]	胡发墙, 许滔, 巫廷春, 等. 许滔教授基于气脉常通理论运用柴胡枳桔汤治疗胸痹病[J]. 中西医结合心血管病电子杂志, 2022, 10(4):50-52.
[2]	于涛. 胸痹(冠心病)热证研究[D]. 哈尔滨: 黑龙江中医药大学, 2004.
[3]	汪安, 程桂林, 蒲婧哲, 等. 小儿珍贝散质量标准提升研究[J]. 安徽医药, 2022, 26(6):1094-1098.DOI:10.3969/j.issn.1009-6469.2022.06.007.
[4]	张红波, 李前琼, 吕雪凤, 等. 灵芝养肝丸的质量标准研究[J]. 中国民族民间医药, 2019, 28(8):54-57. DOI: 10.3969/j.issn.1007-8517.2019.8.zgmzmjyyzz201908015.
[5]	周剑, 高宋平, 梅新路. 蒙药广枣的研究进展[J]. 海峡药学, 2017, 29(6): 1-5. DOI: 10.3969/j.issn.1006-3765.2017.06.001.
[6]	国家药典委员会. 中华人民共和国药典:2020年版一部[M]. 北京: 中国医药科技出版社, 2020.
[7]	黄锐, 扎西东智, 彭戈, 等. 藏药三味宽筋藤汤散质量标准研究[J]. 中国民族民间医药, 2019, 28(18):33-36 DOI 10.3969/j.issn.1007-8517.2019.18.zgmzmjyyzz201918010.
[8]	国家药典委员会. 中华人民共和国药典:2020年版四部[M]. 北京: 中国医药科技出版社, 2020.
[9]	朱林燕, 孔子铭, 韩泳平. 藏药二十一味寒水石丸的定性鉴别[J]. 中药与临床, 2014, 5(2):60-62.
[10]	万勇, 杨毅生, 付志文, 等. 高效液相色谱法测定清热解毒颗粒中盐酸小檗碱的含量[J]. 药品评价, 2021, 18(5):269-272. DOI: 10.19939/j.cnki.1672-2809.2021.05.04.
[11]	张媛媛, 曾慧婷, 袁源见, 等. 藏药诃子的化学成分与药理活性研究进展[J]. 中国药房, 2018, 29(14):2002-2006.DOI:10.6039/j.issn.1001-0408.2018.14.29.
[12]	张峰, 杨英, 孟萌. 诃子在中、蒙、藏医中的应用及比较[J]. 中兽医学杂志, 2007(6):39-41.
[13]	张幸福, 才毛, 骆桂法. 藏药十味诃子丸的质量控制[J]. 中国实验方剂学杂志, 2014, 20(9):51-55. DOI: 10.13422/j.cnki.syfix.2014090051.
[14]	好斯巴特, 王秀兰, 王欢. 蒙成药赞丹:3 汤薄层色谱鉴别[J]. 中国民族民间医药杂志, 2003(4):233-234.
[15]	陈梦秋. 盐酸小檗碱缓释片的制备工艺及质量标准研究[D]. 武汉: 武汉工程大学, 2018.

提取方式	平均峰面积	平均质量分数/(mg·g^-1)
超声	4 659.908 3	1.68
回流	4 751.439 8	1.72
浸泡	3 172.073 9	1.15

提取时间/min	平均峰面积	平均质量分数/(mg·g^-1)
20	2 483.895 3	1.79
30	2 715.187 4	1.96
40	2 671.193 6	1.93

称样量/g	溶剂/mL	平均峰面积	平均质量分数/(mg·g^-1)
0.257 79	25	754.747 8	2.18
0.504 85	25	1 522.304 3	2.20
1.005 51	25	2 717.163 4	1.96
2.004 95	25	4 659.142 3	1.68

柱温/℃	峰面积	质量分数/(mg·g^-1)
25	1 724.941 5	2.32
30	1 728.019 7	2.35
35	1 763.545 6	2.38

流速/(mL·min^-1)	保留时间/min	质量分数/(mg·g^-1)
0.8	32.009	2.30
1.0	27.468	2.31
1.2	24.336	2.18

A study on the quality standards of Huanglian Hupo Qingxin pills

RichHTML

PDF (PC)

Like

Knowledge

Abstract

Cite this article

share this article

Figures/Tables 15

References 15

Related Articles 1

Metrics

Comments

Recommended 0

编号	质量浓度/(mg·mL^-1)	峰面积	线性关系方程
1	0.018 0	783.298	y=34 505x+458.31 R²=0.999 4
2	0.045 1	2 010.763
3	0.090 2	4 048.403
4	0.451 0	15 750.504
5	0.902 0	31 675.404

编号	称样量/g	测得量/mg	加入量/g	样品质量分数/(mg·g^-1)	回收率/%	平均回收率/%	δ_RSD/%
1-1	0.252 62	1.012	0.463	0.558	98.15
1-2	0.252 62	1.010	0.463	0.558	97.74
2-1	0.251 07	1.024	0.463	0.555	101.33
2-2	0.251 07	1.015	0.463	0.555	99.38
3-1	0.253 71	1.046	0.463	0.561	104.87
3-2	0.253 71	1.045	0.463	0.561	104.60	101.29	2.30
4-1	0.251 74	1.022	0.463	0.556	100.67
4-2	0.251 74	1.022	0.463	0.556	100.62
5-1	0.252 26	1.035	0.463	0.557	103.24
5-2	0.252 26	1.024	0.463	0.557	100.68
6-1	0.254 16	1.028	0.463	0.562	100.71
6-2	0.254 16	1.041	0.463	0.562	103.47

色谱柱	保留时间/min	质量分数/(mg·g^-1)
Thermofisher C18	27.468	2.31
GL Sciencesinc C18	48.893	2.11

批号	质量分数/(mg·g^-1)	平均质量分数/(mg·g^-1)
20201022	2.134	2.20
20201023	2.232
20201024	2.243