光纤化学传感在线过程检测缬沙坦胶囊溶出度

Process monitoring the dissolution of valsartan capsules by fiber-chemical sensor

目的:建立在线过程检测缬沙坦胶囊溶出度方法。方法:采用光纤传感过程分析技术(FODT)检测缬沙坦胶囊在pH6.8,pH4.5,pH1.2及水4种溶出介质中的溶出情况,并与中国药典方法相比较。结果:4种溶出介质中,缬沙坦在16.3～97.8μg.mL-1范围内线性关系良好(r>0.999),平均回收率101.9%。不同批次缬沙坦胶囊的制剂工艺稳定,均匀度好。缬沙坦胶囊在pH6.8和pH4.5缓冲液中30 min时溶出度大于80%,符合中国药典规定,但在pH1.2及水介质中,30 min时溶出度只有35.5%,55.6%。结论:FODT法将过程分析用于检测固体制剂溶出度不需取样而连续检测,可获取完整溶出曲线和相关数据。缬沙坦胶囊在不同溶出介质的溶出度明显不同。口服固体制剂药物的溶出度有必要考察不同pH的溶出介质。

OBJECTIVE To establish a method which can on-line monitor the dissolution of valsartan capsules.METHODSThe dissolubility of valsartan capsules was detected in the following 4 mediums： water,pH 1.2,pH 4.5,pH 6.8 by fiber-optic dissolution test and compared with the pharmacopoeia method.RESULTS There was a good linear relationship（r〉0.999） within 16.3-97.8 μg · mL-1concentrations in 4 different mediums,the average recovery rate was 101.9%.The preparation process of different batches valsartan capsules was stable and with good uniformity.The dissolution in pH 6.8 and pH 4.5 mediums at 30 min of valsartan capsules was concordant with Pharmacopoeia,and dissolution profiles in pH 1.2 and water mediums at 30 min were only 35.5% and 55.6%.CONCLUSION Fiber-optic dissolution test system monitors the dissolution of solid preparation by continuous detection and without sampling,and gets overall data.The dissolution profiles of valsartan capsules were quite different in 4 mediums.It is necessary to examine the dissolution of oral solid preparation in the different pH mediums.