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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5.06～30.35μg.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。
Objective To establish a method for the determination of dissolution of malimin capsule. Methods The dissolution medium containing 1% pepsin hydrochloric acid solution (dilute hydrochloric acid 24 mL and water 1 000 mL) was used as the dissolution medium. The dissolution volume was 900 mL, the rotation speed was 100 r.min-1, the sampling time was 45 min and the wavelength was at 235 nm Absorbance was measured. Results The results showed that there was a good linear relationship between the absorbance and the absorbance (r = 0.999 2) in the range of 5.06 ~ 30.35μg.mL-1. The average recoveries of the two prescriptions were 100.09% (RSD = 1.1%) and 99.61% (RSD = 1.2%). The dissolution of 6 batches of samples was over 80% at 45 min. Conclusion The method is accurate and the results are reliable. It can be used for the determination of the dissolution of malimin capsule.