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目的:制备灯盏花素分散片,验证处方、工艺的稳定性。方法:以崩解时限为指标,采用正交试验设计优化最佳处方,制备灯盏花素分散片,通过初步稳定性试验评价该制剂的质量。结果:L-HPLC和CMS-Na两种崩解剂采用内外加法联合使用效果最优,最佳处方崩解时间为89 s,30 min体外溶出百分率为(97.75±1.32)%,明显高于普遍片,初步稳定性试验表明制剂质量稳定。结论:自制灯盏花素分散片处方组成合理,制备工艺可操作性强、重现性好,能适应工业大生产的要求。
Objective: Preparation of Breviscapine dispersible tablets, verify the prescription, the stability of the process. Methods: According to the disintegration time as an index, orthogonal design was used to optimize the optimal prescription. Breviscapine dispersible tablets were prepared, and the quality of the preparation was evaluated by preliminary stability test. Results: The optimal combination of L-HPLC and CMS-Na disintegrator was the best combination of internal and external dosage, the best prescription disintegration time was 89 s and the percentage of in vitro dissolution was (97.75 ± 1.32)% after 30 min, which was significantly higher than that of common Tablet, the initial stability test showed that the quality of the preparation stable. Conclusion: The prescription of Breviscapine dispersible tablets is reasonable, the preparation process is feasible, reproducible and can adapt to the requirements of industrial production.