[1]王作敏,薛金涛,荆　云,等.心脉佳I胶囊的质量标准研究[J].新乡医学院学报,2017,34(2):107-109.[doi:10.7683/xxyxyxb.2017.02.007]
　WANG Zuo-min,XUE Jin-tao,JING Yun,et al.Study on quality standard of Xinmaijia I capsule[J].Journal of Xinxiang Medical University,2017,34(2):107-109.[doi:10.7683/xxyxyxb.2017.02.007]
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心脉佳I胶囊的质量标准研究
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《新乡医学院学报》[ISSN:1004-7239/CN:41-1186/R]

卷:
34
期数:
2017年2
页码:
107-109
栏目:
基础研究
出版日期:
2017-02-05

文章信息/Info

Title:
Study on quality standard of Xinmaijia I capsule
作者:
王作敏1; 薛金涛1; 荆　云1; 李春燕1; 2; 马亚星1; 曹明祥1; 李　鹏1; 万光瑞1
（1.新乡医学院药学院，河南　新乡　453003；2.新乡医学院三全学院药学院，河南　新乡　453003）
Author(s):
WANG Zuo-min1; XUE Jin-tao1; JING Yun1; LI Chun-yan1; 2; MA Ya-xing1; CAO Ming-xiang1; LI Peng1; WAN Guang-rui1
(1.School of Pharmacy，Xinxiang Medical University，Xinxiang 453003，Henan Province，China；2.Sanquan Medical College，Xinxiang Medical University，Xinxiang 453003，Henan Province，China)
关键词:
心脉佳; 薄层色谱法; 高效液相色谱法; 白藜芦醇; 丹参酮IIA
Keywords:
Xinmaijia; thin layer chromatography; high performance liquid chromatography; resveratrol; tanshinone IIA
分类号:
R927.2
DOI:
10.7683/xxyxyxb.2017.02.007
文献标志码:
A
摘要:
目的　对中药新药心脉佳I胶囊的质量标准进行研究，为其质量标准的制定提供依据。方法　采用薄层色谱法对制剂中白藜芦醇、丹参酮IIA和葛根素进行定性鉴别，并检查其性状、崩解时限、装量差异、水分等项目，采用高效液相色谱法测定丹参酮IIA的含量。结果　白藜芦醇、丹参酮IIA和葛根素薄层色谱斑点清晰，阴性对照无干扰。3批心脉佳I胶囊的装量差异符合药典要求，平均崩解时间为（12.28±5.37)min，平均水分含量为(2.60±0.26)%。丹参酮IIA每粒平均含量为(6.75±0.33)mg。结论　本研究所建立的方法灵敏、简便、准确、重复性好，可作为心脉佳I胶囊的质量控制标准。
Abstract:
Objective　To study the quality standard of Xinmaijia I capsule，and provide the basis for the formulation of its quality standard.Methods　The thin layer chromatography(TLC) was applied to identify the properties，disintegration time limited，content uniformity and moisture content of resveratrol，tanshinone IIA and puerarin.The high performance liquid chromatography(HPLC) was used to detecte the content of tanshinone IIA.Results　Resveratrol，tanshinone IIA and puerarin could be detected by TLC with clear spots and the negative sample without interference.The three batches samples were in good agreement with the requirements of content uniformity，and the average disintegration time was (12.28±5.37)min，the average moisture content was (2.60±0.26)%.The average content of tanshinone IIA was (6.75±0.33)mg per capsule.Conclusion　The methods established in this study are sensitive，simple，accurate and with good reproducibility，which can be used for the quality control of Xinmaijia I capsule.

参考文献/References:

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更新日期/Last Update: 2017-02-05