金刚藤总黄酮栓的工艺研究

Study on Preparation Technology of Smilax China L. Total Flavonoids Suppositories

目的筛选金刚藤总黄酮栓的处方及工艺参数。方法采用热熔法制备金刚藤总黄酮栓:采用单因素试验筛选空白机基质中聚乙二醇(PEG)型号、金刚藤总黄酮栓的注模温度;采用正交试验设计处方,以外观、硬度、融变时限及溶出度为指标,筛选处方及工艺。结果金刚藤总黄酮栓的最佳处方工艺为:金刚藤总黄酮12 g(10%)、PEG1500 60 g(50%)、S40 36 g(30%)、甘油12 g(10%),制成100粒。制得栓剂外观光滑无气泡,硬度适宜不变形,融变时限符合《中国药典》标准,30 min溶出度80%以上。结论筛选的处方及工艺稳定可行,可为金刚藤总黄酮栓的质量标准提供实验依据,为进一步研究提供基础。

Objective To screen the formulation and preparation technology of Smilax china L. total flavonoids suppositories. Methods The hot-melt method was used to prepare the suppositories of total flavonoids from Smilax china L. The injection molding temperature and the type of polyethylene glycol were determined by single factor screening, and the formulation was optimized by orthogonal design with the appearance, hardness, melting time and dissolution as indexes. Results The optimal formulation was total flavonoids of 12 g(10 %), PEG1500 of 60 g(50 %), S40 of 36 g(30 %) and glycerol of 12 g(10 %) in 100 tablets. The suppositories had smooth appearance without bubble, suitable hardness without deformation, and the melting time was in accordance with the standard listed in Chinese Pharmacopoeia. Its dissolution rate was over 80 % in 30 minutes. Conclusion The optimal formulation can be stable and feasible, which can provide the experimental basis for the quality standard and further study of the suppositories.