肾衰康复颗粒质量控制方法研究

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【中图分类号】R284.1 【文献标志码】A 【文章编号】1007-8517(2025)16-0021-06
DOI: 10.3969/j . issn.1007-8517.2025.16. zgmzmjyyzz202516006
Quality Control of Shenshuai Kangfu Granules
REN Ying' HU Ke²SHAN Ruilong1 TIAN Xinliang'LI Yunze1 1.Jieshou County Hospital of Traditional Chinese Medicine ,Jieshou 2365OO,China; 2.Taihe County Market Supervision and Inspection Institute,Taihe 2366OO,China
Abstract:ObjectiveTodevelopamethodfortheThinLayerChromatographyandDeterminationofShenshuai KangfuGranules andprovideascientificbasisforthequalitycontrolofShenshuaiKangfuGranules.MethodTLCmethodwasusedforqualitativeidentificationfRdixetRizomaRei,Dendranthemaindicum,ViolaeHerba.AnHPLCmethodwasusedfordeterminationofeculetin in the preparation. The mobile phase was acetonitrile -0.1% phosphoric acid flowing at 1.0mL/min in a gradient elution manner. The temperature was .The detection wavelengthwas 344nm .ResultRadixetRhizomaRhei,Dendranthemaindicum,Violae HerbawereidentfiedqualitativelybyTC.ThespotsintheTCchromatogaphywereclearandthenegativecontrolshowednonterference.Esculetin showed a good linear relationship with the peak area in range of 0.001073-0.1073mg/mL .The average recovery rate was 100.05% ,RSD was 0.76% ( n=6 ).Conclusion Methods of identification of RadixetRhizoma Rhei,Dendranthema indicum,ViolaeHerbabyTLCwereexclusiveanddurable.Thespecificityandprecisionofthemethodcomplidwithterequiremnts of methodology,which could be used for determinationl of Shenshuai Kangfu Granules.
KeyWords:Shenshuai Kangfu Granules;Thin-layer Chromatography;ContentDetermination;High-performanceLiquid Chromatography;Esculetin
肾衰康复颗粒由肾病科专家周荣军主任医师根据多年的临床经验总结,针对脾肾亏虚,瘀浊内阻,阴阳失调所致(慢性)肾衰等拟定的方剂,具有通腑泄浊,活血化瘀,益气健脾之功效。(剩余8130字)