| 引用本文: | 李奥运,刘振峰,周国发.干法压片密度一致性调控机制与准则模拟研究[J].中国现代应用药学,2022,39(23):3103-3109. |
| LI Aoyun,LIU Zhengfeng,ZHOU Guofa.Simulation Study on the Regulation Mechanism and Criterion of Density Consistency in Compression Dry Granulation[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(23):3103-3109. |
|
| 摘要: |
| 目的 针对干法压片溶解特性与一致性难以调控的共性问题，模拟研究干法压片密度一致性的调控机制与准则。方法 基于Edinburgh Elastic-Plastic Adhesion接触模型，构建干法压片的集粉体螺杆输送与滚压压片于一体的协同耦合模拟仿真方法，提出通过体积流量压缩比调控干法压片相对密度及其一致性的技术，诠释其调控机理。结果 模拟建立了平均相对密度与体积流量压缩比的协同耦合线性关联控制模型，满足压片溶解特性和强度所需的临界体积流量压缩比为0.91，揭示了压片均匀性与稳定性RSD与体积流量压缩比协同耦合演化规律，调控压片均匀性与稳定性RSD<5%的体积流量压缩比取值空间为0.58~1.31。结论 同时保证溶解特性与一致性技术要求的调控准则是干法滚压制粒机的体积流量压缩比应设置在0.91~1.31的取值空间内。 |
| 关键词: 干法制粒 相对密度 关键质量属性 调控机理 模拟 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.23.008 |
| 分类号:R94 |
| 基金项目: |
|
| Simulation Study on the Regulation Mechanism and Criterion of Density Consistency in Compression Dry Granulation |
|
LI Aoyun1, LIU Zhengfeng2, ZHOU Guofa1
|
|
1.School of Resources Environment and Chemical Engineering, Nanchang University, Nanchang 330031, China;2.Yichun Wanshen Pharmaceutical Machinery Co., Ltd., Yichun 336000, China
|
| Abstract: |
| OBJECTIVE To simulate and study the regulation mechanism and criteria of density consistency of compression dry granulation pressin aiming at the common problem that it is difficult to control the dissolution characteristics and consistency of compression dry granulation. METHODS Based on the Edinburgh Elastic-Plastic Adhesion contact model, the collaborative coupling simulation method integrating powder screw conveying and rolling ribbon was constructed, and the control technology was proposed in which the relative density and consistency for rolling ribbon was controlled by means of volume flow compression ratio, the regulation mechanism was explained. RESULTS A synergetic coupling linear correlation control model between average relative density and volume flow compression ratio was established, the critical volume flow compression ratio required to meet the ribbon dissolution characteristics and strength was 0.91, the synergetic coupling evolution law was revealed between the RSD of uniformity and stability and the volumetric flow compression ratio, the value space of volume flow compression ratio was 0.58 to 1.31 in which the RSD of rolling ribbon uniformity and stability was <5%. CONCLUSION The control criterion to ensure the dissolution characteristics and consistency at the same time is that the volume flow compression ratio of dry rolling granulator should be set in the value space of 0.91 to 1.31. |
| Key words: compression dry granulation relative density consistence key quality attributes regulation mechanism simulation |
