摘要
【目的】为了探讨临方片剂的处方优化和贮存,研究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。【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周时出现较明显的下降,随后又有所上升;多数片剂贮存1周后,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。
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.
作者
房盈
洪燕龙
林晓
沈岚
赵立杰
FANG Ying;HONG Yanlong;LIN Xiao;SHEN Lan;ZHAO Lijie(Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine of Ministry of Education,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Shanghai Innovation Center of Traditional Chinese Medicine Health Service,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;School of Pharmacy,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Innovation Research Institute of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
出处
《中国粉体技术》
2025年第4期105-119,共15页
China Powder Science and Technology
基金
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。
关键词
临方制剂
片剂
物理稳定性
抗张强度
崩解时限
temporary prescription preparation
tablet
physical stability
tensile strength
disintegration time
