摘要:
目的: 筛选单硝酸异山梨酯口腔崩解片的处方并考察片剂质量。 方法: 采用正交设计法筛选片剂处方,用HPLC法测定片剂的含量。 结果: 所得的优化处方为:MCC与L-HPC的比例为8:2(32%,8%),CC-Na为3%,甘露醇为15%,乳糖为31%。所得的片剂在20 s内完全崩解,1 min释药80%以上,口感良好。 结论: 选择合适的辅料,可以生产出崩解快、口感好,能够快速起效的口腔崩解片。
Abstract:
Objective: To optimize the formulation of 5-ISMN orally disintegrating tablets,and inspect quality of prepared tablets. Methods: The orthogonal design was used and HPLC was used to determine the concentration. Results: Besides 5-ISMN,the tablets were composed of croscarmellose sodium 3%,mannite 15%,lactose 31%,MCC/L-HPC ratio was 8:2(32%,8%).The prepared tablets disintegrated completely in 20s,dissolved more than 80% in 2min and tasty fine. Conclusion: Choose properly excipients,we can produce orally rapidly-disintegrating tablets of rapidly disintegrating,tasty well and rapid absorption.
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