参芪活络片处方优化及稳定性研究  

Research on Shenqi Huoluo tablets formulation optimization and stability

作　　者：王曼茹[1] 周丽娟 代寅华 

机构地区：[1]深圳市中医院,广东518033 [2]广州博济医药生物技术股份有限公司,广东广州510670 [3]深圳津村药业有限公司,广东深圳518034

出　　处：《现代医药卫生》2017年第11期1638-1640,共3页Journal of Modern Medicine & Health

摘　　要：目的探讨优化参芪活络片的制剂处方工艺,改善泛油问题,提高药物稳定性。方法按处方比例称取参芪干膏粉,加入适量微晶纤维素、交联羧甲基纤维素钠和不同比例的微粉硅胶(SiO_2)和β环糊精(β-CD)混合均匀后,以75%乙醇作润湿剂,制成适宜的软材,14目制粒,60℃干燥,颗粒加入硬脂酸镁(润滑剂)混合均匀,按规定片重压片,取样测定崩解时限、硬度及脆碎度。对素片进行高温考察和稳定性考察。结果 SiO_2和β-CD的加入量各为10%时,所得片子的硬度、脆碎度、崩解时限有较大的提高,且素片表面未出现油斑。处方工艺重复性良好,产品稳定。结论优化后的处方加入SiO_2和β-CD作吸油剂,能有效提高含油片剂的硬度,改善泛油现象,有利于提高药物的稳定性,为类似的含油中药片剂的研究提供新思路。Objective To investigate optimize the preparation process of Shenqi Huoluo tablets,improve extensive diffusion of oil phenomenon, improve drug stability. Methods According to the proportion of the prescription, dry ointment powder of Shenqi, proper microcrystalline cellulose and sodium cross-linked carboxymethyl cellulose, different the proportion of micro-silica （SiO2）and β-cyclodextrin （β-CD）were well-mixed, 75% ethanol as wetting agent was made suitable softwood, 14 mesh granulating, 60 ℃ dried, granule added with magnesium stearate （lubricant）was well-mixed, according to the specified tablet weight for tablet pressing, sampling for testing disintegration,hardness and friability. High temperature and stability of Shenqi tablets were investigated. Results Addition of 10% SiO2 and 10%β-CD could increase the hardness ,friability and disintegration of the tablet, the surface of tablet had not oil patch. The optimized prescription was reproducible and stable. Conclusion The optimized prescription of adding SiO2 and β-CD as sorbents,can effectively improve extensive diffusion of oil phenomenon and improve the hardness of the tablet, it is conducive to improve the stability of drugs, provide new ideas for the research of extensive diffusion of oil similar to the traditional Chinese medicine tablets.

关 键 词：处方 药物 药物稳定性 片剂 参芪活络片 

分 类 号：R927.11[医药卫生—药学]