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目的考察环境湿度对愈创木酚甘油醚缓释片颗粒流动性的影响,探求颗粒流动性变化和片剂质量之间的关系,为该品种的工业化生产提供依据。方法对颗粒的吸湿性进行初步研究,求取颗粒的临界相对湿度(CRH)。以0 d的颗粒和片剂为参比,考察颗粒暴露在RH 33%、60%、75%、84%、92.5%下10 d后流动性的变化,测量相应颗粒制得的片剂的质量指标,探讨颗粒流动性变化与片剂质量之间的关系。结果颗粒的CRH在RH 67%～68%之间。在湿度高于RH 60%下10 d后,颗粒流动性、水分含量、片剂的外观、片重差异极值、脆碎度都有明显改变。以颗粒的压缩度(X1)、休止角(X2)为自变量,片重差异极值(Y1)、脆碎度(Y2)为因变量进行二元回归分析得:Y1=0.192X1+0.092X2-7.398(r=0.992 1),Y2=0.069X1+0.087X2-3.505(r=0.988 1),P<0.001时,在观测范围内具有统计学意义。结论颗粒的生产和储存的环境湿度应小于RH60%,颗粒的休止角和压缩度与片剂的质量指标(片重差异极值、脆碎度)间存在统计学意义上的函数关系。
Objective To investigate the effect of environmental humidity on the particle fluidity of guaifenesin sustained-release tablets and to explore the relationship between the change of particle fluidity and the tablet quality and provide the basis for the industrialized production of this variety. Methods A preliminary study of the hygroscopicity of the particles was performed to determine the critical relative humidity (CRH) of the particles. Using 0 d pellets and tablets as reference, the change of fluidity of the pellets exposed to RH 33%, 60%, 75%, 84%, 92.5% RH for 10 days was measured and the quality of tablets prepared from the corresponding pellets was measured Indicators, to explore the relationship between changes in particle flow and tablet quality. The results of particles CRH RH 67% ~ 68%. After 10 days at RH higher than 60% RH, the fluidity, water content, appearance of tablets, extreme difference of weight and friability of friable tablets all changed obviously. The binary regression analysis of the granularity (X1), the angle of repose (X2) as the independent variable, the difference between the weight of the tablet weight (Y1) and the friability (Y2) as the dependent variable was: Y1 = 0.192X1 + 0.092X2 -7.398 (r = 0.992 1), Y2 = 0.069X1 + 0.087X2-3.505 (r = 0.9881), P <0.001 was statistically significant in the observation range. Conclusion The humidity of the granules should be less than RH60%. The angle of repose and compression degree of the granules have a statistically significant relationship with the quality index (the difference between tablet weight and the friability).