复方地芬诺酯片体外溶出度试验方法的建立  

Establishment of the Method for Dissolution Test of Compound Diphenoxylae Tablets in vitro

作　　者：刘晓哲 

机构地区：[1]南阳市食品药品检验所,河南南阳473061

出　　处：《中国药房》2014年第21期1989-1991,共3页China Pharmacy

摘　　要：目的：建立复方地芬诺酯片的体外溶出度测定方法。方法：采用桨法,以盐酸溶液（9→1 000）为溶出介质,转速为75 r/min,溶出取样时间为60 min;采用高效液相色谱法测定制剂中主成分盐酸地芬诺酯的含量。色谱柱为Welchrom C18,流动相为三乙胺磷酸溶液-乙腈（45∶55,pH 3.1）,流速为1.0 ml/min,检测波长为230 nm,柱温为30℃。取同批样品6片进行溶出度均一试验。结果：盐酸地芬诺酯检测质量浓度线性范围为0.634～6.34μg/ml（r=0.999 8）,平均回收率为99.30%（RSD=0.89%,n=3）;样品溶出度均一性良好（RSD=1.45%,n=6）。11批样品溶出60 min时溶出量为72%～94%。结论：建立的方法快速、简便,可以用于复方地芬诺酯片的质量控制。OBJECTIVE：To establish the method for dissolution test of Compound diphenoxylae tablets in vitro.METHODS：The paddle method was used with hydrochloric acid（9→1 000）as dissolution medium at rotation speed of 75 r/min with dissolution time of 60 min.The content of Compound diphenoxylae tablets was determined by HPLC.The separation was performed on Welchrom C18column with mobile phase consisted of triethylamine phosphoric acid-acetonitrile（45 ∶ 55,pH 3.1）at the flow rate of 1.0 ml/min.Detection wavelength was set at 230 nm,and column temperature was 30 ℃.The dissolution homogeneity test was conducted among 6 tablets from same batch.RESULTS：The linear range of diphenoxylae hydrochloride was 0.634-6.34 μg/ml（r= 0.999 8）with an average recovery of 99.30%（RSD=0.89%,n=3）.Those samples showed sound dissolution homogeneity（RSD=1.45%,n=6）.Accumulative dissolution of 11 batches of samples was 72%-94% within 60 min.CONCLUSIONS：The method is rapid and convenient.It can be applied for the quality control of Compound diphenoxylae tablets.

关 键 词：复方地芬诺酯片 溶出度 HPLC 

分 类 号：R927.2[医药卫生—药学]