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目的:建立实时监测罗红胶囊溶出过程的方法,并考察5批罗红霉素胶囊溶出过程的差异。方法:运用标准品法,采用光纤药物溶出度测定(FODT)仪对不同批次罗红霉素胶囊溶出进行实时监测,并与《中国药典》法测定结果比较。结果:不同批次罗红霉素胶囊溶出过程存在差异,药物溶出100%的时间从10min到32min不等;FODT仪法与《中国药典》法测定溶出45min时总溶出率平均值分别为(96.64±2.95)%、(91.76±3.12)%。结论:光纤药物溶出度实时测定法能够有效、快速地测定罗红霉素胶囊体外溶出度,可以作为罗红霉素胶囊半成品溶出度检验手段,促进成品合格率提高。
OBJECTIVE: To establish a real-time monitoring method of Luohong capsule dissolution process, and to investigate the dissolution of five batches of roxithromycin capsules. Methods: The dissolution of roxithromycin capsules in different batches was monitored by FODT using standard method and compared with the results of “Chinese Pharmacopoeia” method. Results: The dissolution rates of roxithromycin capsules in different batches were different. The time for 100% dissolution of the drugs varied from 10 min to 32 min. The average dissolution rates of the total dissolution rate of FODT and Chinese Pharmacopoeia were 45.6% and 96.64% ± 2.95)%, (91.76 ± 3.12)%. Conclusion: The real-time determination method of optical fiber drug dissolution can effectively and rapidly determine the dissolution rate of roxithromycin capsules in vitro, which can be used as the dissolution test of roxithromycin capsules to improve the qualified rate of finished products.