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.

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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

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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

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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