麦白霉素胶囊溶出度测定方法研究

Study on Dissolution Test of Meleumycin Capsules

摘要: 目的建立麦白霉素胶囊溶出度测定方法。方法以含1%胃蛋白酶的盐酸溶液(稀盐酸 24 mL加水至1 000 mL)为溶出介质，溶出体积为900 mL，转速为100 r·min^-1，取样时间45 min，在235 nm波长处测定吸收度。结果麦白霉素在5.06~30.35 μg·mL^-1内与吸光度有良好的线性关系(r=0.999 2)，两种处方的样品平均回收率分别为100.09%(RSD=1.1%)和99.61%(RSD=1.2%)，6批样品45 min溶出度均在80%以上。结论本方法准确，结果可靠，可用于麦白霉素胶囊的溶出度测定。

Abstract: OBJECTIVE To establish a method for the determination of dissolution of meleumycin capsules. METHODS The dissolution of meleumycin capsules was determined by UV spectrophotometry at 235 nm，using 900 mL hydrochloric acid solution(24 mL hydrochloric acid test solution was dilluted to 1 000 mL with water) containing 1% pepsin as the medium. The rotation speed was 100 r·min^-1 and the sampling time was 45 min. RESULTS The method showed a good linear relationship in the range of 5.06-30.35 μg·mL^-1(r=0.999 2). The average recoveries were 100.09%(RSD=1.1%) and 99.61%(RSD=1.2%) for two different types of samples, respectively. The dissolutions of 6 batches of samples were all above 80%. CONCLUSION The method is accurate and reliable, and it can be applied for the determination of the dissolution of meleumycin capsules.