微生态活菌片剂生产中干法制粒粒度分布对产品质量的影响  

Influence of the particle size distribution of dry granulation on the quality of products in the production of probiotic tablets

作　　者：马征途 张雅茹 李可 刘淑兰 韩至 杨飞雁 张进 左志刚 刘彦民 

机构地区：[1]内蒙古双奇药业股份有限公司,内蒙古呼和浩特010010

出　　处：《中国微生态学杂志》2017年第12期1447-1451,共5页Chinese Journal of Microecology

摘　　要：目的探讨干法制粒工艺中粒度分布对微生态活菌片剂质量的影响。方法应用干法制粒工艺制造粉料,通过对不同粒径的片重、硬度和脆碎度进行测定,确定出压制素片的颗粒最佳粒径范围,然后对工艺参数压辊压力、加料速度和压辊转速进行正交试验,选择所制颗粒的粒径与最佳粒径一致的工艺为最优工艺,再通过对最佳工艺压制出的片剂进行稳定性研究,从而验证粒径对产品质量的影响。结果粒径分布在20~80目时,片剂重量、硬度和脆碎度的结果不仅符合标准还较稳定。工艺参数中压辊压力为110KN、加料转速为70rpm、压辊转速为9.0rpm时所压制片剂的粒径范围在20~80目时所占最大,约97.82%。对产品中长双歧杆菌、保加利亚乳杆菌和嗜热链球菌的6个月稳定性检测再次确定粒径分布在20~80目时,产品质量最优。结论干法制粒工艺粉料粒径分布在20~80目时,微生态活菌片剂质量为最优。Objective To explore the influence of particle size distribution of dry granulation process on the quality of microecological probiotic tablets.Methods Dry granulation technology was used to process powder material based on different particle sizes,the tablet weight,hardness and friability were measured to determine the optimal particle size range for uncoated tablet compression.Then,orthogonal experiment was conducted to determine the optimal process parameters,and the stability of the tablets made with the optimal process was tested to verify the influence of particle size on the quality of the tablets.Results With a particle size of 20 to 80 mesh,the tablet weight,hardness and friability not only conformed to the standard but were also relatively stable.When the pressure of compression roller was 110 KN,feeding speed was 70 rpm and roller speed was 9.0 rpm,the particles within size range of 20~80 mesh accounted for about 97.82%.Six-months test on the stability of Bifidobacterium longum,Streptococcus thermophilus and Lactobacillus bulgariain the product demonstrated that the best quality of tablets was achieved at a particle size of 20~80 mesh.Conclusion Best probiotic tablet quality is achieved at a 20~80 mesh by dry granulation technology.

关 键 词：干法制粒 压片 粒径 硬度 脆碎度 

分 类 号：R944.4[医药卫生—药剂学]