压力范围对片剂压缩方程拟合结果的影响

The influence of pressure range on the fitting results of tablet compression equation

本文针对常用片剂可压缩性、可压实性和成片性方程,研究压力范围改变对不同压缩方程拟合结果和拟合参数的影响,确定不同方程的最佳压力范围。以塑性材料微晶纤维素(MCC)PH102、脆性材料喷雾干燥乳糖和中药三七粉为研究对象,采用不同直径模具组合的方式,获得片剂压缩曲线。对于Heckel方程,观察不同拟合压力起点与起始点间距对Heckel方程R;的影响。对于Kawakita方程、Gurnham方程、Ryshkewitch-Duckworth(R-D)方程和Power方程,分别在15~200、15~300和15~400 MPa三个不同压力范围内拟合。MCC、乳糖和三七粉的Heckel曲线最佳线性压力范围分别为20~170、20~220和10~90 MPa,"压力起点-压力间距-R^(2)"3D散点图是寻找Heckel方程线性区域的有效方法。压力范围的改变对Kawakita方程、Gurnham方程和R-D方程曲线拟合效果和压缩参数值的影响较小。15~200 MPa的低压力可满足不同物料Kawakita方程、Gurnham方程、R-D方程和Power方程的拟合需求。因此,针对不同的压缩方程,通过优选压力范围,才能保证优良的拟合效果,并使获得的压缩参数更具有可靠性和可解释性。

According to the commonly used tablet compressibility,compactability and tabletability equation,the influence of pressure range on the fitting results and parameters of different compression equations was studied,and the optimal pressure range of different equations was determined.Plastic material microcrystalline cellulose(MCC)PH102,brittle material spray dried lactose and Chinese medicine Sanqi were used as experimental objects,the compression curves of tablets were obtained by the combination of dies with different diameters.For Heckel equation,the shape of Heckel section of different materials is not uniform,and the specified linear fitting range cannot be obtained,therefore,different distances between fitting pressure starting point and starting point were set to observe the influence of pressure range on R^(2)of Heckel equation.The Kawakita equation,Gurnham equation,Ryshkewitch-Duckworth(R-D)equation and Power equation are fitted in three different pressure ranges of 15-200,15-300 and 15-400 MPa,respectively.In order to find the best linear region of Heckel equation,the 3 D scatter diagram of"starting point of pressure,pressure range and R^(2)"is drawn.The best linear pressure ranges of Heckel curves of MCC,lactose and Sanqi were 20-170,20-220 and 10-90 MPa,respectively.It is proved that the3 D scatter diagram is an effective method to find the linear range of Heckel equation.The change of pressure range has little influence on the curve fitting effect and compression parameters of Kawakita equation,Gurnham equation and Ryshkewitch-Duckworth equation.The low pressure range of 15-200 MPa can meet the fitting requirements of Kawakita equation,Gurnham equation,R-D equation and Power equation for different materials.Therefore,only by optimizing the pressure range,can the good fitting effect be ensured and the obtained compression parameters be more reliable and interpretable.