曲克芦丁片溶出度测定方法的研究  

Study on dissolution method of troxerutin tablets

作　　者：施洁明[1] 林玲[1] 

机构地区：[1]广州市药品检验所,广东广州510160

出　　处：《广东药学院学报》2012年第3期251-254,共4页Academic Journal of Guangdong College of Pharmacy

摘　　要：目的考察不同厂家曲克芦丁片的体外溶出度,建立曲克芦丁片的溶出度测定方法。方法依照《中国药典》2010年版二部溶出度测定第二法,通过对溶出介质、转速和取样时间的选择,确定曲克芦丁片的溶出度测定方法;采用反相高效液相色谱法测定曲克芦丁的含量,色谱柱为Kromasil-C18柱,流动相为NaH2PO4溶液(pH 4.4)-乙腈(体积比80∶20),检测波长为254 nm,流速为0.5 mL/min,并对方法的线性相关性、回收率、稳定性进行了考察。结果溶出度测定方法确定为:采用桨法,以900 mL水为溶出介质,转速为75 r/min,取样时间为45 min,限度不得低于标示量的80%。结论建立了适用可行的曲克芦丁片的溶出度测定方法,可用来评价和提高产品质量。Objective To investigate dissolution of troxerutin tablets from different enterprises and develop a method for determination of dissolution of troxerutin tablets.Methods According to the second dissolution method described in Pharmacopoeia of the Peoples Republic of China（2010 Edition,volume 2）,to establish the dissolution condition by choosing the optimal dissolution medium,rotational speed and taking solution time.RP-HPLC was used.The sample was analyzed on a Kromasil C18 column using NaH2PO4 solution（pH 4.4） and acetonitrile（80∶20） as mobile phase.The detection wavelength was 254 nm and flow rate was 0.5 mL/min.The methodology was examined for linear relationship,recovery and stability.Results The paddle method was used with 75 r/min rotational speed.900 mL water was selected as release medium and rotational speed was 75 r/min,the solution was withdrawn after exactly 45 minutes.No less than 80% of the labelled amount was dissolved.Conclusion The method was suitable and feasible for the dissolution determination of troxerutin tablets,and might be used for evaluating and improving the quality of troxerutin tablets.

关 键 词：曲克芦丁片 溶出度 高效液相色谱法 桨法 

分 类 号：R927[医药卫生—药学]