CAJ | 학술논문

以HPMC和卡波姆为骨架缓释材料，采用正交实验设计方法，通过累积释放度综合评分进行评价，最终确定克林霉素磷酸酯阴道缓释片的处方组成为：克林霉素磷酸酯119 g（相当于克林霉素100 g）， HPMC K4M 350 g，卡波姆934160 g，乳糖113.5 g，硬脂酸镁7.5 g。自研缓释片释放度符合中国药典要求，且体外释放行为符合Higuchi模型和Ritger-Peppas方程，表明药物释放机制是扩散与溶蚀并存的双重机制。
이HPMC화잡파모위골가완석재료，채용정교실험설계방법，통과루적석방도종합평분진행평개，최종학정극림매소린산지음도완석편적처방조성위：극림매소린산지119 g（상당우극림매소100 g）， HPMC K4M 350 g，잡파모934160 g，유당113.5 g，경지산미7.5 g。자연완석편석방도부합중국약전요구，차체외석방행위부합Higuchi모형화Ritger-Peppas방정，표명약물석방궤제시확산여용식병존적쌍중궤제。
Using comprehensive score of the cumulate release rate as response value , orthogonal experimental design were used to determine the dosage of HPMC K 4 M with Carbomer 934 as matrix materials.The optimal formulation (1 000 units) was Clindamycin Phosphate 119 g ( Equivalent to Clindamycin 100 g), HPMC K4M 350 g, Carbomer 934 160 g, Lactose 113.5 g and magnesium stearate 7.5 g.The dissolution rate of clindamycin phosphate vaginal sustained-release tablets met the requirements of CP 2010 and release behavior in vitro fitted to the Higuchi model and Ritger-Peppas equation , and the release mechanism in vitro was diffusion combined with corrosion.