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布地奈德直肠原位温敏凝胶的处方设计与优化
引用本文:沈婷,陈林,谢兴亮,张正爽,许小红,张全. 布地奈德直肠原位温敏凝胶的处方设计与优化[J]. 中国药科大学学报, 2018, 49(6): 689-694
作者姓名:沈婷  陈林  谢兴亮  张正爽  许小红  张全
作者单位:成都医学院药学院,成都医学院药学院,成都医学院药学院,成都医学院药学院,成都医学院药学院,成都医学院药学院
基金项目:四川省教育厅成果转化重大培育资助项目(No.18CZ0026);四川省大学生创新性实验资助项目(No.201713705060)
摘    要:优化布地奈德直肠原位温敏凝胶的制剂处方。采用冷法配制凝胶溶液,反转试管法测定胶凝温度,以胶凝温度为指标,采用星点设计-效应面法,对泊洛沙姆407(P407)、泊洛沙姆188(P188)以及羟丙甲基纤维素(HPMC)的用量进行优化,并考察在大鼠体内的胶凝情况,以Franz扩散池法考察释放性能。确定的最优处方为布地奈德0.002%,HPMC 0.93%,P188 2.00%,P407 18.31%。优化确定了布地奈德直肠用原位温敏凝胶的制剂处方,其能够在直肠广泛与黏附,并长时间释放药物。

关 键 词:布地奈德;直肠原位温敏凝胶;胶凝温度;处方优化;质量评价;星点设计-效应面法

Preparation and evaluation of the formulation of budesonide rectal in situ thermogel
SHEN Ting,CHEN Lin,XIE Xingliang,ZHANG Zhengshuang,XU Xiaohong and ZHANG Quan. Preparation and evaluation of the formulation of budesonide rectal in situ thermogel[J]. Journal of China Pharmaceutical University, 2018, 49(6): 689-694
Authors:SHEN Ting  CHEN Lin  XIE Xingliang  ZHANG Zhengshuang  XU Xiaohong  ZHANG Quan
Abstract:To prepare a budesonide rectal thermogel. The gel solution was prepared by cold method, and the gelation temperature of the gel solution was determined by reverse tube method. The amount of poloxamer 407(P407), poloxamer 188(P188)and hydroxy propyl methyl cellulose(HPMC)was optimized by central composite design/response surface method. The in vivo gelation character was investigated after rectal administration of the budesonide thermogel into the rat, and the in vitro drug release from the gel was examined by the Franz diffusion cell method. Finally, the optimal formulation includes 0. 002% budesonide, 0. 93% HPMC, 2. 00% P188, and 18. 31% P407. It is preferable to obtain the appropriate formulation for budesonide rectal in situ thermogel, which can achieve wide distribution and adhesion to the rectum, as well as long-term drug release.
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