殷子夕, 林晓, 洪燕龙, 赵立杰, 沈岚. 基于关联规则分析口崩片辅料应用的研究进展J. 药学学报, 2026, 61(1): 135-146. DOI: 10.16438/j.0513-4870.2025-0474
引用本文: 殷子夕, 林晓, 洪燕龙, 赵立杰, 沈岚. 基于关联规则分析口崩片辅料应用的研究进展J. 药学学报, 2026, 61(1): 135-146. DOI: 10.16438/j.0513-4870.2025-0474
YIN Zi-xi, LIN Xiao, HONG Yan-long, ZHAO Li-jie, SHEN Lan. Research progress on the application of excipients for orally disintegrating tablets based on association rule analysisJ. Acta Pharmaceutica Sinica, 2026, 61(1): 135-146. DOI: 10.16438/j.0513-4870.2025-0474
Citation: YIN Zi-xi, LIN Xiao, HONG Yan-long, ZHAO Li-jie, SHEN Lan. Research progress on the application of excipients for orally disintegrating tablets based on association rule analysisJ. Acta Pharmaceutica Sinica, 2026, 61(1): 135-146. DOI: 10.16438/j.0513-4870.2025-0474

基于关联规则分析口崩片辅料应用的研究进展

Research progress on the application of excipients for orally disintegrating tablets based on association rule analysis

  • 摘要: 关联规则是描述两个或多个事物之间的关联性的一种模型, 其中Apriori算法是用于从大规模数据集中发现频繁项集的经典方法。本文采用Apriori算法对28种市售与77种文献口崩片处方进行辅料使用规律分析, 并对口崩片处方的辅料使用频次、制备工艺、片重进行统计分析, 同时探究了甘露醇对口崩片口感的影响。结果表明, 市售口崩片侧重矫、掩味剂与着色剂的添加以提高依从性; 文献口崩片侧重添加助流、矫味、润滑剂等以提高口崩片片剂品质。粉末直压是目前主流的口崩片制备工艺, 在此工艺下, 甘露醇、微晶纤维素、硬脂酸镁是口崩片组成的核心辅料, 交联聚维酮为最常用的超崩剂, 阿司帕坦为最常用的矫味剂, 且甘露醇可在一定程度上改善口崩片口感并减少甜味剂的添加。最终展望了应用于口崩片的辅料的发展前景。通过统计、分析及归纳, 本文以期为口崩片的处方设计及口崩片辅料的应用、开发提供参考。

     

    Abstract: The association rule analysis is a model that describes the correlation between two or more things. The Apriori algorithm is a classic method of association rule analysis used to discover frequent item sets from large-scale datasets. In this review, the Apriori algorithm was used to analyze the usage rules of excipients from 28 formulations of commercially available orally disintegrating tablets (ODTs) and 77 formulations of ODTs collected from literatures. Statistical analyses were conducted on the usage frequency of excipients, preparation processes, and tablet weight of the ODTs. Meanwhile, the influence of mannitol on the taste of ODTs was explored. The results show that commercially available ODTs focus on the addition of flavoring and taste-masking agents as well as colorants to improve compliance. ODTs in literatures focus on adding glidants and flavoring agents to improve the quality of ODTs. Powder direct compression is currently the mainstream process for preparing ODTs. Mannitol, microcrystalline cellulose, and magnesium stearate are the core excipients for the composition of ODTs prepared by this method. Crospovidone is the most commonly used super-disintegrating agent, and aspartame is the most commonly used flavoring agent. Moreover, mannitol can improve the taste of ODTs to a certain extent and reduce the addition of sweeteners. Finally, the development of excipients for ODTs was prospected. Through statistics, analysis and induction, this review aims to provide references for the formulation design of ODTs as well as application and development of excipients for ODTs.

     

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