CAJ | 학술논문

考察HPMC/果胶/氯化钙骨架片中两个自变量果胶/氯化钙重量比和骨架总重量对吲哚美辛释放的影响.采用二因素五水平星点设计,效应面法优化Peppas方程拟合参数n、K和T0.1(10%释放时间).自变量埘双相释放参数n和K值有显著影响,n、K和T0.1值可用二次多项式拟合,线性拟合效果不佳.数学模型拟合和效应面结果表明果胶/氯化钙重量比和骨架总重量两个凶素问有显著交互作变形用.在具有较大n和T0.1.值和较小K值的优化处方中,其果胶/氯化钙的比例约为1.0.骨架总重量处于中间值,约200 mg.优化处方具有很好的预测性,n、K和T0.1值的预测偏差介于-7.33%和6.26%之间.星点设计可用于优化和预测药物从HPMC/果胶/氯化钙骨架片的释放.
고찰HPMC/과효/록화개골가편중량개자변량과효/록화개중량비화골가총중량대신타미신석방적영향.채용이인소오수평성점설계,효응면법우화Peppas방정의합삼수n、K화T0.1(10%석방시간).자변량시쌍상석방삼수n화K치유현저영향,n、K화T0.1치가용이차다항식의합,선성의합효과불가.수학모형의합화효응면결과표명과효/록화개중량비화골가총중량량개흉소문유현저교호작변형용.재구유교대n화T0.1.치화교소K치적우화처방중,기과효/록화개적비례약위1.0.골가총중량처우중간치,약200 mg.우화처방구유흔호적예측성,n、K화T0.1치적예측편차개우-7.33%화6.26%지간.성점설계가용우우화화예측약물종HPMC/과효/록화개골가편적석방.
We studied the effect of two independent variables,the pectin/calcium chloride weight ratio and the overall matrix weight in HPMC/pectin/calcium matrix tablet,on the release of indomethacin.A two-factor 5-level central composite experimental design was employed.Responses of the Peppas correlation parameters n and K and the 10% release time (T0.1) were optimized by response surface methodology.Significant effect of the independent variables on the biphasic release parameters,n and K,was observed.N,K and T0.1 were well fitted with the second-order quadratic equations rather than linear equations.Moreover,the mathematic fitting and the response surfaces showed significant cross-interaction between the pectin/calcium chloride ratio and the overall matrix weight.The optimal formulation with larger n,longer T0.1 and smaller K consisted of medium pectin/calcium chloride ratio around 1.0 and medium matrix weight around 200 mg.Validation studies on the optimal formulations showed good predictability of the n,K and T0.1 values with biases within the range of-7.33% and 6.26%.Our results support that central composite design can be used to optimize drug release from HPMC/pectin/calcium matrix tablet with high predictability.