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目的:制备泮托拉唑钠口腔崩解片并对其含量进行测定。方法:采用直接压片法制备。HPLC法测定其含量。结果:制备的泮托拉唑钠口腔崩解片外观光洁,硬度为3kg,崩解时间小于30s;含量测定线性范围为0.275~1.650μg,r=0.9999,平均回收率为99.7%,RSD=0.35%。结论:该制备方法简单,含量测定方法简便、准确,回收率高,可用于泮托拉唑钠口崩片的制备及含量测定。
Objective: To prepare pantoprazole sodium orally disintegrating tablet and determine its content. Method: Prepared by direct compression method. HPLC method to determine its content. Results: The pantoprazole sodium orally disintegrating tablets had smooth appearance, hardness of 3kg and disintegration time of less than 30s. The linear range of determination was 0.275 ~ 1.650μg with r = 0.9999 and the average recovery was 99% .7%, RSD = 0.35%. Conclusion: The preparation method is simple, the determination of content is simple, accurate, high recovery rate, can be used for the preparation and content determination of pantoprazole sodium orally disintegrating tablets.