用Box-Behnken设计优化复方药物:阿昔洛韦胶囊报告

Suelen Da Silva Reis, Valdemir Da Silva Quintanilha Junior, Gabriella Da Silva Boto, Thalita Martins Da Silva, Elizabeth Valverde Macedo, C. A. F. Peregrino, S. Mourão, Emeli Moura De Araújo
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引用次数: 0

摘要

校园配药药房在公共卫生中发挥着重要作用。单纯疱疹是人类最常见的病毒性疾病之一,复方制剂对阿昔洛韦胶囊的需求量很大。众所周知,配方的成分会影响药物的有效性。本研究的目的是证明Box-Behnken设计在复方制剂优化中的适用性,并评价辅料对UFF大学药房生产的200 mg阿昔洛韦胶囊溶出度和药物含量的影响。在满足药典标准的前提下,对制剂进行平均重量试验、剂量单位均匀性和体外溶出度评价。统计分析表明,乙醇酸淀粉钠(Aerosil®)对药物含量和溶出度有影响。不同浓度的硬脂酸镁对溶出度没有影响,但会影响测定结果。根据上述反应,采用数值优化方法调整处方变量,得到医嘱开具后在FAU配制配药的最佳处方。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Use of Box–Behnken design for optimization of compounded medication: acyclovir capsules report
Campus compounding pharmacies play an important role in public health. Herpes simplex is one of the most common viral diseases in humans, which generates a great demand for acyclovir capsules in compounding pharmacy. It is well known that the formulation's components influence the effectiveness of the drug. The objective of this study is to show the applicability of Box-Behnken design in optimization of a compounded formulation and to evaluate the effect of excipients on dissolution and drug content in acyclovir 200 mg capsules produced at UFF´s University Pharmacy (FAU). The formulations were prepared and evaluated for average weight test, uniformity of dosage units and in vitro dissolution, while meeting pharmacopoeial specifications. A statistical analysis showed that sodium starch glycolate, Aerosil®, influences drug content and dissolution results. Magnesium stearate shows no influence on the dissolution at different concentrations but influences the assay results. A numerical optimization was applied to adjust the formulation variables based on the foresaid responses, accomplishing the best formulation that will be prepared and dispensed at FAU upon medical prescription.
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