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目的:研究并建立氢溴酸加兰他敏分散片溶出度测定方法。方法:按中国药典2000年版附录中溶出度项下第三法,分别以水、1%盐酸、5%乙醇等3种溶出介质进行氢溴酸加兰他敏分散片的溶出试验,采用HPLC法测定溶出介质中氢溴酸加兰他敏分散片的浓度。结果:在10-100μg·ml-1范围内,线性关系良好(r=0.9997),平均回收率为100.2±1.30,RSD为1.5%。氢溴酸加兰他敏分散片30min的溶出量大于标示量的90%。结论:所建立的溶出度测定法简单、准确、可靠,可作为控制氢溴酸加兰他敏分散片的质量标准之一。
Objective: To study and establish the dissolution assay of galantamine hydrobromide dispersible tablets. Methods: According to the third method of Chinese Pharmacopoeia 2000 edition, the dissolution test of galantamine hydrobromide dispersible tablets was carried out with three kinds of dissolution media such as water, 1% hydrochloric acid and 5% ethanol, respectively. The concentration of galanthamine hydrobromide dispersible tablets in the dissolution medium was determined. Results: In the range of 10-100μg · ml-1, the linearity was good (r = 0.9997), the average recovery was 100.2 ± 1.30 and the RSD was 1.5%. Dissolution of galantamine hydrobromide dispersible tablets for 30 min was greater than 90% of the indicated amount. Conclusion: The established dissolution assay is simple, accurate and reliable and can be used as one of the quality standards for the control of galantamine hydrobromide dispersible tablets.