基于特征属性相似性的疏风解毒胶囊安慰剂干法制粒工艺研究

Optimization of dry granulation process of Shufeng Jiedu capsules placebo based on the similarity of characteristic attributes

目的:以剂型特征属性和视觉特征属性的相似性为原则,优化疏风解毒胶囊安慰剂干法制粒的工艺条件。方法:采用单因素考查实验结合L;(3;)正交实验法,以水平速度、压辊转速和滚轮压力3个因素为自变量,以颗粒成型率、脆碎度、色差值和制粒过程评分为因变量,优化疏风解毒胶囊安慰剂的干法制粒工艺参数,并对最佳工艺条件进行验证。在此基础上,分别测定内容物颗粒的物理性质参数(休止角、松散密度、振实密度、水分、崩解时限),评价成型的安慰剂与受试制剂疏风解毒胶囊的剂型特征属性一致性;测定颗粒的色差值,评价二者在视觉特征属性上的一致性。结果:确定最佳干法制粒工艺参数:水平速度34 r·min^(-1),压辊转速6 r·min^(-1)和滚轮压力1.2×10^(6)Pa。3批工艺验证实验结果显示,最佳工艺下制备的安慰剂颗粒成型率在73.67%~75.87%,脆碎度在45.50%~46.39%,色差值在2.34~4.11。在颗粒状态下,安慰剂的剂型特征属性、视觉特征属性与受试制剂一致。结论:优选的安慰剂的最佳制粒工艺合理可行,制粒过程中胚片出片连续、颗粒色泽均一、硬度适中、成型性较好,干法制粒工艺稳定可行,且安慰剂的剂型特征属性、视觉特征属性与疏风解毒胶囊内容物颗粒一致。

Objective:To optimize the dry granulation process of Shufeng Jiedu(SFJD) Capsules placebo based on the similarity of the dosage form characteristic attributes and visual characteristic attributes. Methods:The technological parameters including horizontal speeds, rotate speed of roller and pressure rollers were screened by single factor experiment as well as L_(9)(3^(4)) orthogonal experiment, taking particle formation rate, friability, value of chromatism and comprehensive in granulation process as indexes, and then, the optimum process was verified. On this basis, the physical properties of content particles were determined respectively, including angle of repose, loose and tap bulk density, moisture content and disintegration time, to evaluate the consistency of characteristic attributes of dosage form between the formed placebo and SFJD Capsules;and the chromatism value of the particles was determined to evaluate the consistency of visual characteristic attributes. Results:The optimized process parameters were as follows: horizontal speed 34 r·min^(-1), press roll speed 6 r·min^(-1) and press roll pressure 1.2×10^(6)Pa. Through the process validation of three batches, it was shown that the particle forming rate of SFJD Capsules placebo prepared under the optimum process was between 73.67% and 75.87%, the friability was between 45.50% and 46.39%, the chromatism value was between 2.34 and 4.11. In the granule state, the dosage form characteristic properties as well as visual characteristic properties of placebo were consistent with those of the test preparation. Conclusion:The optimized dry granulation preparation technology is feasible, reasonable and stable, which produces good flakes continuously and granules with color uniformity, suitable rigidity and good formability. And both the dosage form characteristic properties and visual characteristics properties of the placebo are consistent with the contents of SFJD Capsules.