一种含有发酵虫草菌粉CS-4超微粉的片剂工艺研究

Study on the Tablet Technology of Fermented Cordyceps Sinensis Powder CS-4 Ultrafine Powder

目的:研究一种含有发酵虫草菌粉CS-4超微粉的片剂制备工艺。方法:采用湿法制粒压片,并对发酵虫草菌粉CS-4超微粉的粒径分布和电镜扫描进行分析,以混合粉末的高温高湿实验现象为评价指标对各类辅料进行筛选;以混合颗粒的出片力、崩解时间、硬度、脆碎度、抗张强度为考察指标优选粘合剂和润滑剂,再进行体外释放度考察,确定最佳处方,并与市售的金水宝片进行体外释药对比研究。结果:优选的最佳处方为发酵虫草菌粉CS-4超微粉:微晶纤维素:蔗糖:氢氧化铝为25∶3∶5∶5,10%浓度的明胶溶液用量为5%,润滑剂用量为1%。结论:该工艺处方合理,片剂成形性好,质量稳定,可有效解决发酵虫草菌粉CS-4超微粉压片成形性差的问题,适合规模化生产应用。

Objective:To study the preparation technology of tablets made by fermented cordyceps sinensis powder CS-4 ultrafine powder.Methods:Wet granulation was used to make tablets,the particle size distribution and electron microscope scanning of the fermented cordyceps sinensis powder CS-4 ultrafine powder were analyzed and the phenomena of high temperature and high humidity of the mixed powder were used as evaluation indexes to screen various kinds of supplementary materials.Pressure,disintegration time,hardness,friability,tensile strength of mixed particle were used as evaluation indexes to screen adhesive and lubricant.Then,the in vitro release degree of tablets was investigated to determine the best prescription,and compared with the commercially available Jinshuibao tablets.Results:The optimal prescription was fermented cordyceps sinensis powder CS-4 ultrafine powder,microcrystalline cellulose,sucrose,aluminum hydroxide was 25 to 3 to 5 to 5,gelatin solution with concentration of 10%was 5%,and lubricant was 1%.Conclusion:The process formulation is reasonable,the tablet has good formability and stable quality,which can effectively solve the problem of poor formability of tablet pressing of fermented cordyceps sinensis powder,and is suitable for large-scale production and application.