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目的:优化盐酸丙卡特罗(PTH)口腔崩解片的处方。方法:采用正交试验对PTH口腔崩解片的辅料用量进行优化,用直接压片法压片成型,对其硬度、崩解时间、口感、含量均匀度、体外释放度等进行考察。结果:优化的PTH口腔崩解片硬度为3.0 kg,崩解时间小于30 s,口感较好,含量均匀度符合药典要求,与PTH同剂量普通片相比,体外释放明显加快。结论:该处方组成简单、合理,为PTH口腔崩解片的进一步研究奠定了基础。
Objective: To optimize the formulation of procaterol hydrochloride orally disintegrating tablets. Methods: The orthogonal experiment was used to optimize the excipient dosage of PTH orally disintegrating tablets. The tablets were directly compression-molded and their hardness, disintegration time, taste, content uniformity and in vitro release were investigated. Results: The optimized PTH orally disintegrating tablet had a hardness of 3.0 kg and a disintegration time of less than 30 s. The mouthfeel was good and the content uniformity was consistent with the requirements of the pharmacopoeia. Compared with the ordinary tablet of PTH, the in vitro release of PTH was significantly accelerated. Conclusion: The prescription is simple and reasonable, which lays the foundation for the further study of PTH orally disintegrating tablets.