首页|肾宝胶囊的质量标准提升研究

肾宝胶囊的质量标准提升研究

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目的 为控制肾宝胶囊的质量提供参考。方法 在现行质量标准的基础上,建立肾宝胶囊中胡芦巴、黄芪、红参和茯苓的薄层色谱(TLC)鉴别方法,建立测定蛇床子素含量的高效液相色谱(HPLC)法。结果 TLC斑点清晰,阴性无干扰。蛇床子素检测质量浓度的线性范围为 4。0498~121。4944 μg/ml(R2 = 0。99997);精密度、稳定性(24 h)、重复性实验的RSD值均不高于 0。35%(n= 6),加样回收试验根据加入对照品量不同分为高、中、低三组,平均加样回收率分别为 96。05%、96。02%、96。23%(RSD≤1。97%,n= 3)。结论 本研究建立了肾宝胶囊中胡芦巴、黄芪、红参和茯苓的TLC鉴别方法及蛇床子素的含量测定方法,方法均专属性强、重现性好,可用于肾宝胶囊的质量标准提升。
Study on the improvement of quality for Shenbao Capsules
Objective To provide reference for the improving of the quality standard for Shenbao Capsules.Methods On the basis of the previous quality standard,thin-layer chromatography(TLC)identification methods were established for trigonella foenum-graecum,astragali radix,red ginseng and poria cocos.High performance liquid chromatography(HPLC)method was established to determine the content of osthol.Results TLC spots were clear,negative without interference.The linear range of the detected mass concentration of osthol is 4.05~121.49 μg/ml(R2= 0.99997).RSD of precision,stability(24 h)and repeatablitity tests were all no more than 0.35%(n= 6).The sample recovery test was divided into high,medium and low groups according to the amount of reference substance added.The average sample recovery rates were 96.05%,96.02%and 96.23%respectively(RSD≤1.97%,n=3).Conclusion The TLC identification methods of trigonella foenum-graecum,astragali radix,red ginseng and poria cocos in Shenbao Capsule and the content determination method of osthol have been established in this study.The methods have strong specificity and good reproducibility,and can be used to improve the quality standard of Shenbao Capsules.

Shenbao CapsulesIdentificationContent determinationImprovement of quality standard

黄新宇、孙函静、季巧遇

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江西中医药大学药学院,南昌 330004

江中药业股份有限公司,南昌 330004

肾宝胶囊 鉴别 含量测定 质量标准提升

江西省中药制造过程质量控制技术创新中心项目

2021BCD43026

2024

中国处方药
南方医药经济研究所

中国处方药

影响因子:0.649
ISSN:1671-945X
年,卷(期):2024.22(3)
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