摘要
目的通过星点设计-效应面优化法优化三七总皂苷生物黏附型缓释片处方。方法以卡波姆971P和乳糖的用量为考察因素,以2、8、16、24h的累积释放度为考察指标,采用二次多项式模型描述指标和两因素间的数学关系,根据模型绘制效应图,设定释药目标值,通过重叠等高线图确定优化处方,最后进行验证。结果 Rg1的累积释放度随卡波姆971P用量的增加而显著降低,随乳糖用量的增加而增加;确定了优化区域为:卡波姆971P用量为53～72mg,乳糖用量为78～162mg。结论采用星点设计-效应面法,得到了三七总皂苷生物黏附型缓释片处方的优化模型,实现了缓释片的处方优化。
OBJECTIVE To optimize the formulation of Panax notoginseng saponins（PNS） bioadhesive sustained-release tablets by central composite design-response surface methodology（CCD-RSM）.METHODS In the formulation designed with CCD RSM,the amounts of carbomer 971P and lactose were regarded as independent variables,and percentages of in vitro cumulative release at 2,8,16 and 24 h were regarded as dependent variables.Quadratic model was used to estimate the relationship between the dependent and the independent variables,and the optimal formulation was selected with application of hypothesized in vitro cumulative release（%） in overlay contour plot.RESULTS The quantitative relationships between two factors and four evaluation indexes were characterized.The cumulative release percent of the preparation was declined with the increasing of the proportion of carbomer 971P and was increased with the increasing of the proportion of lactose.On the basis of overlapping 2D contour,the optimize region was determined as follow：carbomer 971P 53-72 mg,lactose 78-162 mg.CONCLUSION The multi-objective simultaneous optimization of PNS bioadhesive sustained-release tablets formulation could be achieved by the central composite design and response surface methodology.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2010年第4期406-408,共3页
West China Journal of Pharmaceutical Sciences
基金
四川省教育厅重点实验室专项资金项目(200ZD017)
关键词
三七总皂苷
星点设计
效应面法
缓释片
Panax notoginseng saponins
Central composite design
Response surface methodology
Sustained release tablets
