刘珠（河北省药品检验所 石家庄050011） 高振强  （河北医科大学第三医院）

摘  要  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。

关键词  泮托拉唑钠；口崩片；HPLC；含量测定

Preparation and Quality Control of Pantoprazole SodiumOrally Disintegrating Tablets

Liu Zhu（Hebei Institute for Drug Control，Shijiazhuang 050011，China）；Gao Zhenqiang（Third Hospital of Hebei Medical University）

ABSTRACT  Objective：To prepare the pantoprazole sodium orally disintegrating tablets and determine the content of pantoprazole sodium。Method：Pantoprazole sodium orally disintegrating tablets was prepared by direct compression and its content was determined by HPLC。Result：Hardness of pantoprazole sodium orally disintegrating tablets was 3 kg，he disintegrating time was about 30 seconds，and outward appearance was bright and clean。The linear correlation was within the range of 0.275 - 1.650μg，r=0.999 9。The average recovery was 99.7%，RSD=0.35%（n=5）。Conclusion：The preparative method is simple，the method to determine the content is convenient，accurate and the recovery is high.It is suitable for the preparation and content determination。

KEY WORDS  Pantoprazole sodium；Orally disintegrating table；HPLC；Content determination