房 盈a,b ，洪燕龙b,c ，林 晓b ，沈 岚b ，赵立杰b,d
上海中医药大学， a.中药现代制剂技术教育部工程研究中心，b. 中医健康服务协同创新中心， c. 中药学院，上海 201203, d.创新中药研究院
房盈，洪燕龙，林晓，等. 基于粉末直接压片技术的高载药全浸膏临方片剂的成型性与物理稳定性研究［J］. 中国粉体技术，2025，31（4）：1-15.
FANG Ying， HONG Yanlong， LIN Xiao， et al. Study on formability and physical stability of high-drug-loading whole extract temporary prescription tablets based on direct powder compression technology［J］. China Powder Science and Technology，2025，31（4）：1−15.
DOI：10.13732/j.issn.1008-5548.2025.04.009
收稿日期：2024-11-05，修回日期：2025-02-07，上线日期：2025-04-22。
基金项目：国家自然科学基金项目，编号：82474089；上海市自然科学基金项目，编号：23ZR1463500。
第一作者简介：房盈（1998—），女，硕士生，研究方向为中药制剂关键技术研究与应用。E-mail：fangying379@163. com。
通信作者简介：沈岚（1975—），女，教授，博士，博士生导师，研究方向为中药制剂关键技术及新剂型研究。E-mail： alansusu@sina. com。
赵立杰（1980—），女，副研究员，博士，硕士生导师，研究方向为中药制剂关键技术研究与应用。E-mail： zhaolijie761029@126. com。
摘要：【目的】 调研不同基础成型配方制备的中药临方片剂的成型性和在使用周期内的物理稳定性，为临方片剂的处方优化和贮存提供指导。【方法】 通过压缩实验研究2个基础配方的压缩成型性，并在相对湿度为60%、温度为25 ℃的条件下探究片剂的物理性质，包括片剂质量、轴向膨胀、径向膨胀变化，抗张强度以及崩解时限，从而研究片剂质量的稳定性。【结果】 2种配方制备的片剂具有良好的成型性和片剂品质。在稳定性试验期间，大部分片剂的抗张强度在1周时保持相对稳定或略有增加，少数片剂在 1周时出现了较明显的下降，随后又有所上升；同时，多数片剂贮存 1周后，其崩解时限基本稳定，具有良好的稳定性。【结论】 基于临方处方和中药处方设计系统，可以快速筛选临方片剂配方并在稳定性研究期内获得质量合格的片剂。
关键词：临方制剂；片剂；物理稳定性；抗张强度；崩解时限
Objective Temporary prescription preparation is key component of personalized pharmaceutical services， characterized by individualized formulations and diverse dosage forms. However， the strong odor and taste of traditional Chinese medicine （TCM） often reduce patient acceptance and utilization rates， limiting the formulation options for temporary prescription. Tablets， one of the most commonly used solid dosage forms， offer advantages such as color and taste masking and high drug loading. Among tablet preparation methods， direct powder compression is preferred for its simplicity and efficiency， making it suitable for temporary prescription. However， the complexity and hygroscopicity of TCM powders pose significant challenges during tablet compression， including cracking， sticking， and structural instability. These issues highlight the need for careful formulation design.Building on previous research that identified basic tablet-forming formulations， the study aims to evaluate the formability and physical stability of TCM temporary prescription tablets prepared using different base formulations. The findings will provide guidance for optimizing formulations and improving storage conditions for temporary prescription tablets.
Methods In this study， two base formulations were investigated for their compressibility and compactibility using the direct powder compression technique. Tensile strength and disintegration time were used as key assessment indicators. Given that temporary prescription preparations are not subjected to prolonged transportation and storage， the quality standards were set according to the Pharmacopoeia of the People’s Republic of China： a minimum of tensile strength of 1. 7 MPa and a disintegration time of less than 60 min. To assess physical stability， tablets were stored at a relative humidity of 60% and a temperature of 25 ℃. Key parameters， including tablet weight change， axial and radial expansion change， tensile strength， and disintegration time， were monitored to evaluate stability over time.
Results and Discussion Using the expert formulation design system developed in previous research， two formulations （Formulation 1 and Formulation 2） suitable for the direct compression of TCM compound powders were successfully screened. Tablets prepared with both formulations exhibited good formability and met quality requirements. During the stability study， both formulations experienced different degrees of axial and radial expansion. Tablets prepared under controlled tensile strength showed more pronounced expansion during storage than those prepared under controlled compression force. The tensile strength of most tablets remained relatively stable or slightly increased at week 1， though a few showed a more pronounced decrease followed by an increase. Notably， Formulation 2 demonstrated greater tensile strength fluctuations than Formulation 1. Despite these variations， all tablets maintained tensile strength values above 1. 7 MPa throughout the 4-week stability study period， ensuring their suitability for handling and administration. Additionally， the disintegration time of most tablets stabilized after 1 week of storage， indicating that moisture absorption reached equilibrium with ambient humidity.
Conclusion Moisture content is an important factor affecting product stability， especially for hygroscopic TCM powders. Tablets stored in high-humidity environments tend to absorb moisture to reach equilibrium with storage conditions. Storage humidity affects weight changes in tablets and leads to varying degrees of axial and radial expansion. These structural changes can affect inter-particle bonding， thereby influencing the internal structure and quality of the tablets. However， once equilibrium is reached， the physical properties of the tablets tend to stabilize. By utilizing a systematic formulation design approach， temporary prescription tablets with acceptable stability can be rapidly screened and developed.
Keywords：temporary prescription preparation； tablet； physical stability； tensile strength； disintegration time
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