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补肾健脑胶囊质量标准研究

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目的 建立医院制剂补肾健脑胶囊质量标准.方法观察描述补肾健脑胶囊的性状特征,采用显微鉴别法对方中山茱萸、石菖蒲、牛膝、人参、熟地黄、远志的显微特征进行定性鉴别,采用薄层色谱法对方中龟甲、肉苁蓉进行定性鉴别,按照《中国药典》2020年版四部通则方法对胶囊剂常规检查项进行检验.结果补肾健脑胶囊为硬胶囊,内容物呈棕褐色粉末.显微鉴别可确认山茱萸、石菖蒲、牛膝、人参、熟地黄和远志6种药味的组织特征,针对处方中龟甲和肉苁蓉的薄层色谱鉴别具有较强的专属性.检查项结果显示,水分和崩解时限均符合《中国药典》规定,而装量差异限度检查存在不符合标准规定的情况.结论本方法操作简单,重复性好,结果准确,可作为补肾健脑胶囊的质量控制方法.
Study on Quality Standard of Bushen Jiannao Capsule
Objective To establish the quality standard of Bushen Jiannao capsule.Methods The characteristics of Bushen Jiannao capsule and the microscopic characteristics of Fructus Corni,Acori Tatarinowii Rhizoma,Achyranthes bidentata Blume,Radix Ginseng,Rehmannia glutinosa and Polygala tenuifolia Willd.were observed and described.The qualitative identification of Chinemys reevesii.and desertliving cistanche herb was carried out by thin layer chromatography,and the inspection items were checked according to the method of Chinese Pharmacopoeia.Results Bushen Jiannao capsule wa a hard capsule,the contents were sepia powder.The microscopic identification could confirm the tissue characteristics of six kinds of medicinal tastes:Corni Fructus,Acori Tatarinowii Rhizoma,Achyranthes bidentata Blume,Radix Ginseng,Rehmannia glutinosa and Poly gala tenuifolia Willd.,and the identification of Chinemys reevesii.and desertliving cistanche herb by TLC had strong specificity.The results of the examination showed that the moisture and the disintegration time limit conformed to the provisions of Chinese Pharmacopoeia,but load difference limit inspection did not meet the standard.Conclusion The method is simple,reproducible and accurate,which can be used for the quality control of Bushen Jiannao capsule.

Bushen Jiannao capsuleQuality standardCharacter characteristicsMicroscopic characteristicsThin layer chromatography

丁辉、贾倩、朱仁愿、李坚、吴福祥、丁爱华

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兰州市食品药品检验检测研究院/国家市场监管食品中农药兽药残留监控重点实验室/甘肃省种植中药材外源性污染物监测工程研究中心,甘肃 兰州 730050

补肾健脑胶囊 质量标准 性状特征 显微特征 薄层色谱

国家市场监督管理总局科技项目甘肃省自然科学基金甘肃省自然科学基金甘肃省自然科学基金实验动物专项甘肃省药品监督管理局科研项目甘肃省市场监督管理局科研项目兰州市人才创新创业项目

2021MK11021JR1RA16922JR5RA105922JR5RA10602022GSMPA0067SS-CJG-SP-A2022052022-3-66

2024

10.3969/j.issn.1006-1959.2024.05.017

医学信息
国家卫生部信息化管理领导小组 中国电子学会中国医药信息学分会 陕西文博生物信息工程研究所

医学信息

影响因子：0.161
ISSN：1006-1959
年,卷(期)：2024.37(5)
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