冷藏法改善固体分散体溶出样品稳定性研究

Evaluation on Improving Stability of Posaconazole Solid Dispersion Dissolution Samples by Low Temperature Refrigeration

在pH=1.0转换到pH=6.8的溶出环境下,比较了低温冷藏法(2-4℃),溶剂(溶出介质)稀释法,对泊沙康唑固体分散体溶出样品稳定性的影响。以体外溶出为指标,参照《中国药典》及FDA的溶出测定方法,比较低温冷藏法和溶剂稀释法对泊沙康唑固体分散体的体外溶出样品稳定性的影响。结果表明,低温冷藏法和溶剂稀释法相对于未经处理的溶出样品可以在48 h内保持良好的稳定性。

Under the dissolution environment where pH=1.0 was converted to pH=6.8,the effects of low-temperature refrigeration(2-4℃)and solvent(dissolution medium)dilution method on the stability of posaconazole solid dispersion dissolution samples were compared.Taking in vitro dissolution as an indicator,referred to ChP2020 and FDA s dissolution method,the effects of low-temperature storage and solvent dilution methods on the stability of posaconazolesolid dispersions in vitro were compared.The results showed that the low-temperature storage method and solvent dilution method can maintain good stability within 48 h compared with the untreated dissolution sample.