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目的:制备尼莫地平固体自微乳化舌下速溶片(NM-S-SMFDST)并进行质量评价。方法:以最大饱和量,口感为指标筛选固体吸附载体的种类,考察其对尼莫地平固体自微乳化粉末流动性及溶出度的影响来确定吸附载体的量;以正交设计方法优化自微乳化舌下速溶片处方,并对外观、乳化后粒径及形态、崩解及润湿时间、含量均匀度、含量、溶出度及口感进行了评价。结果:优化最佳处方比例为:尼莫地平∶自乳化辅料混合物∶Aerosil-300∶甘露醇∶MCC∶PVPP∶阿斯巴甜=3.3%∶37.0%∶28.3%∶12.4%∶8%∶8%∶3%。所制备的NM-S-SMFDST外观及口感良好,乳化后粒径为:(34.4±2.62)nm,1 h累积溶出度达90%以上,崩解、湿润时限、含量以及含量均匀度达到要求。结论:所制得的NM-S-SMFDST处方及工艺合理,质量指标均符合舌下片的要求。
Objective: To prepare and evaluate the quality of self-microemulsified sublingual immediate-release tablets (NM-S-SMFDST). Methods: The types of solid adsorptive carriers were screened with the maximum saturation and mouthfeel as index, and their influence on the fluidity and dissolution of the self-microemulsified nimodipine solid was investigated to determine the amount of adsorbent carrier. The orthogonal design method was used to optimize the self-micro The sublingual tablets were emulsified, and the appearance, the particle size and morphology after emulsification, disintegration and wetting time, content uniformity, content, dissolution and mouthfeel were evaluated. Results: The optimal prescription ratio was: nimodipine: self-emulsifying adjuvant mixture: Aerosil-300: mannitol: MCC: PVPP: aspartame = 3.3%: 37.0%: 28.3%: 12.4%: 8%: 8 %: 3%. The prepared NM-S-SMFDST had good appearance and good mouthfeel. The particle size after emulsification was (34.4 ± 2.62) nm. The cumulative dissolution reached 90% after 1 h. The disintegration, wetting time, content and content uniformity reached the requirements. Conclusion: The prepared NM-S-SMFDST prescription and technology is reasonable, quality indicators are in line with the requirements of the sublingual film.