妇康宁片药物成分的定性鉴定与芍药苷含量测定  

Study on Revised Quality Standards of Fukangning Tablets

作　　者：宋前流[1] 胡双丰 

机构地区：[1]宁波天一职业技术学院,浙江宁波315100 [2]宁波市药品检验所,浙江宁波315040

出　　处：《现代实用医学》2009年第7期696-697,701,共3页Modern Practical Medicine

摘　　要：目的增订妇康宁片质量检测项目,旨在提高和完善现行标准。方法采用显微和薄层色谱(TLC)技术,拟定了君药与臣药两项定性鉴别,显微鉴别目标选定白芍、香附、当归及三七,TLC鉴别益母草;用RP-HPLC法测定制剂中芍药苷含量,色谱柱为Hypersil C18,流动相:甲醇-水(40︰60),检测波长230nm。结果定性鉴别专属性强;定量分析所含的芍药苷能与其他成分达到基线分离,芍药苷在0.228～4.560g内呈良好的线性关系(=0.9997),平均加样回收率为100.72%,=2.03%(n=5)。结论本法操作简便,结果准确,具有较好的重现性与稳定性,可较全面地对妇康宁片加以质量控制。Objective To increase a new testing protocol for the quality control of Fukangning Tablets,de-signed to enhance and improve the existing standards.Methods Two qualitative identifications of the Jun medicine and Chen medicine were worked out using microscopic and thin-layer chromatography（TLC）technology.Radix Paeoniae Alba,Rhizoma Cyperi,Angelica sinensis and Radix Notoginseng can be identified by Microscopic method and Herba Leonuri can be identified by TLC;RP-HPLC Method was established for determination of paeoniflorin in Fukangning Tablets.A Hypersil C18 column was used with methanol-water（40：60）as mobile phase.The detection wavelength was 230nm.Results Qualitative identification had a strong specificity;Paeoniflorin contained in quantitative analysis was able to achieve the baseline separation with other ingredients.A good linear range of Paeoniflorin was within 0.228 ～ 4.560μg（r=0.9997）,the average recovery rate of added sample was 100.72%,RSD = 2.03%（n=5）.Conclusion The method is simple,accurate and with a good reproducibility and stability,which can be applied for the comprehensive quality control of Fukangning Tablets.

关 键 词：妇康宁片 白芍 益母草 质量控制 

分 类 号：R28[医药卫生—中药学]