摘要
目的建立以乙基纤维素为囊材的阿替洛尔缓释微囊载药量测定方法,考察pH环境对微囊释药行为的影响。方法采用HPLC法测定微囊的载药量,固定相为Grace Smart RPC18柱(250mm×4.6mm,5μm);流动相为甲醇-pH 3.0磷酸盐缓冲液(30∶70);流速为1mL.min-1;检测波长为226nm;柱温为25℃。分别以水、0.1mol.L-1盐酸溶液、pH 6.8的磷酸盐缓冲液为释放介质,采用桨法测定微囊累积释放度,应用SPSS 13.0软件对3种介质下含药微囊的释放行为进行单因素方差分析。结果辅料对载药量的测定无影响,线性范围为8～64μg.mL-1,r=0.999 8,平均回收率为100.2%,各项精密度符合要求。pH的变化对药物释放无影响。结论建立的载药量测定方法良好,可用于载药量的测定。
Objective To establish a method to determine the drug-loading rate of atenolol sustained release microcapsules with ethyl cellulose as the capsule material.Dissolution behavior was studied in different pH values. Methods The drug-loading rate by HPLC.The column was Grace Smart RPC18（250 mm×4.6 mm,5 μm）.The mobile phase was methanol-pH 3.0 buffer phosphate（30∶70）.The flow rate was 1 mL·min-1.The detective wavelength was 226 nm.The column temperature was 25 ℃.Water,0.1 mol·L-1 hydrochloric acid solution and pH 3.0 buffer phosphate were respectively used as the release medium to study the cumulative release rate of microcapsules by the paddle method. Results The excipient had no effect on the determination of the medicine.The linear range was 8-64 μg·mL-1（r=0.999 8）.The average recovery was 100.2%.The precision met the requirement.The release behavior under the 3 media was analyzed by oneway ANOVA.The variance of pH did not influence the drug release. Conclusion The method is feasible,which can be used for the determination of drug loading rate.
出处
《中南药学》
CAS
2012年第1期30-32,共3页
Central South Pharmacy
关键词
阿替洛尔
缓释微囊
载药量
体外释放度
atenolol
sustained-release microcapsule
drug loading rate
drug release
