复方颠倒凝胶的设计与评价

Design and evaluation of compound Diandao gel

关键词:  复方颠倒凝胶  处方优化  体外释放  缓释作用

Key words:  compound Diandao gel  prescription optimization  in vitro release  sustained-release effect

摘要:

[目的]制备复方颠倒凝胶并对其理化性质进行初步研究和评价。[方法]采用卡波姆-940制成凝胶基质，以凝胶的胶凝温度和凝胶粘度为考察指标优化和制备复方颠倒凝胶；对其外观、酸碱度及流变学进行评价，并以pH值为7.8的磷酸盐缓冲液（PBS）为释放介质，采用膜透析法考察凝胶的体外释放特性。[结果]处方优化结果为凝胶基质占处方总量的25%，凝胶处方的胶凝温度为33℃。复方颠倒凝胶外观为金黄色透明半固体状，pH值为7，黏度为7533 mPa/s；复方颠倒凝胶在12 h内释放率达到90.38%，符合Ritger-Peppas方程，表明凝胶具有良好的缓释作用。[结论]复方颠倒凝胶制备工艺稳定，其外观、酸碱度、流变学和体外释放性能等理化性质均符合体外应用要求，具有良好的发展前景。

Abstract:

[Objective] The aim of the study was to prepare compound Diandao gel and evaluate physical and chemical properties.[Methods] Carbomer-940 was used to make the gel matrix. Gelatinization temperature of the gel and viscosity of the gel were used as the indicators to optimize the prescription and preparation of compound Diandao gel. Its appearance, pH, rheology were evaluated. And the in vitro release characteristics of the gel were investigated by membrane dialysis method in phosphate buffered saline (PBS) whose pH was 7.8.[Results] The results of prescription optimization were thatthe gel matrixwas 25% of total prescription and gelation temperature of the gel formulationwas 33℃. The appearance of the compound Diandao gel was golden yellow latex-like semi-solid. Its pH of the gel was 7. Its viscosity of the gel was 7 533 mPa·s. In vitro release results were shown that the release rate of compound Diandao gel reached 90.38% in 12 hours. The results were in agreement with the Ritger-Peppas equation and the R value was 0.9562, indicating that the gel has a good sustained-release effect.[Conclusion] The preparation process of compound inverted gel is stable. Its physical and chemical properties including appearance, pH, rheology and in vitro release properties all meet the in vitro application requirements. The compound Diandao gel has a good development prospects.