基于Box-Behnken法的灵芝孢子粉片剂配方优化

Formulation Optimization of Ganoderma lucidum Spore Powder Tablet Based on Box-Behnken Method

为了优化灵芝孢子粉片剂配方,以破壁灵芝孢子粉为主要原料,采用递次混合法及湿法造粒压片法,以灵芝孢子粉、吸油剂、玫瑰粉的添加量为响应因素,以片剂外形、片重差异、硬度及脆碎度的综合评定值为响应值,采用Box-Behnken响应面法对片剂配方进行优化。结果表明,灵芝孢子粉片剂最佳配方为灵芝孢子粉添加量27%、吸油剂添加量(二氧化硅-β环状糊精为1:1) 20%、玫瑰粉添加量10%、甘露糖醇添加量43%。在此条件下,灵芝孢子粉片剂的综合评定值为21.68。该研究可为灵芝孢子粉片剂的生产提供一定的参考。

In order to study the formulation of Ganoderma lucidum spore powder tablet, the main raw material Ganoderma lucidum spore powder was compressed by the method of successive mixing method and wet granulation compression technology. The effects of various factors on the quality of tablets, such as the addition amount of Ganoderma lucidum spore powder, oil absorbent and rose powder were investigated. Then, the tablet formula by the method of Box Behnken response surface methodology was optimized, taking the comprehensive evaluation values of tablet shape, tablet weight difference,hardness and fragility as response values. The results showed that the best formula of Ganoderma lucidum spore powder tablet was 27% of Ganoderma lucidum spore powder addition, 20% of oil absorbent addition(silica and β-cyclodextrin was 1∶1),10% of rose powder addition and 43% of mannitol addition. Under the above condition, the comprehensive evaluation value of Ganoderma lucidum spore powder tablet was 21.68. This study could provide a reference for the production of Ganoderma lucidum spore powder tablets.