鹿角灵芝中灵芝多糖提取物滴丸成型工艺的优化

Optimized prescription of Ganoderma Lucidum Polysaccharide Extract Dropping Pill

目的探讨鹿角灵芝中灵芝多糖提取物滴丸处方条件,优化最佳处方。方法运用星点设计-效应面法优选鹿角灵芝中灵芝多糖提取物滴丸处方,以PEG6000和Poloxamer 188为联合载体,采用熔融法制备滴丸,并以主药的质量分数及Poloxamer 188的质量分数作为考察因素,以丸重差异以及5、10、60min溶出度为评价指标,采用二次多项式拟合建立考察因素与评价指标之间的数学关系,根据所建立的数学模型描绘效应面,经效应面预测最佳处方,并进行验证性试验。结果灵芝多糖提取物滴丸的最佳处方为,主药质量分数22%,Poloxamer 188质量分数40%,各项考察指标的预测值与实测值偏差均较小,模型具有良好的预测性。结论星点设计一效应面优化法可以很好地用于鹿角灵芝中灵芝多糖提取物滴丸处方优化。

OBJECTIVE To study the feasibility of optimization the prescription of Ganoderma Lucidum Poly-saccharide Extract Dropping Pill.METHODS The central composite design and response surface method were used to optimize prescription of Ganoderma Lucidum Polysaccharide Extract Dropping Pill with PEG 6000 and Poloxamer 188 as combined carrier.And Ganoderma Lucidum Polysaccharide Extract Dropping Pill was prepared through melt-ing method.Independent variables were Ganoderma Lucidum Polysaccharide Extract content and Poloxamer 188 con-tent,while dependent variables were weight variable of pills and the dissolution rate of 5,10,60min.Quadratic poly-nomial fit-ting is adopted to estimate the mathematical relationship between independent and dependent varia-bles.Response surfaces were delineated according to the established mathematic models and optimum prescriptions were predicted from there.And confirmatory tests were carried out in the end.RESULTS The best prescription of Ganoderma Lucidum Polysaccharide Extract Dropping Pill was that Ganoderma Lucidum Polysaccharide Extract con-tent was 22%,while Poloxamer 188 content was 40%.Bias between observed and predicted values of all inspection indexes were negligible,indicating the high predictability of the fit models.CONCLUSION The central composite design and r-esponse surface method can be fairly used for optimizating the prescription of Ganoderma Lucidum Poly-saccharide Extract Dropping Pill,and provide new way for further exploration.