摘要
以对乙酰氨基酚为主药,壳聚糖、β-甘油磷酸钠、泊洛沙姆P407、聚乙烯醇等辅料,胶凝温度、胶凝时间和体外累积释放度作为评价指标,应用正交试验法筛选最优处方工艺。通过最优处方工艺验证和稳定性、pH敏感性、盐浓度、溶胀-去溶胀性能、可降解性能等实验,考察最优处方工艺制备的含药水凝胶是否符合质量标准。结果表明:含药水凝胶的最佳制备工艺为泊洛沙姆P407质量为13g,壳聚糖质量为5.5g,β-甘油磷酸钠质量为2.0 g,对乙酰氨基酚的质量为1.5 g。优化后的含药水凝胶胶凝温度为38.5±0.5℃,胶凝时间为21 s,溶出度为81.58%,均符合要求;含药水凝胶在p H=2.5溶液中溶胀率最大,在pH=9.0溶液中溶胀率最小,交替放置于p H=2.5和pH=9.0溶液中,具有溶胀-去溶胀可逆行为。随着盐溶液浓度升高,含药水凝胶的胶凝时间也随之增加。另外,含药水凝胶能够被溶菌酶所降解。含药水凝胶放置于室温下7天后无任何变化。
Taking acetaminophen as the main drug,chitosanβ-sodium glycerophosphate,poloxamer P407,polyvinyl alcohol as supplementary materials,using gelling temperature,gelling time and cumulative release in vitro as evaluation indicators,the optimal formulation and technology were screened out by the orthogonal test.Through the verification of the optimal prescription process and the experiments of stability,pH sensitivity,salt concentration,swelling-deswelling performance and biodegradability,it was investigated whether the gel containing drug prepared by the optimal prescription process met the quality standards.The results showed that the best preparation process of gel containing medicinal water was that the mass of poloxamer P407 was 13 g,and the mass of chitosan was 5.5 g,the mass of sodium β-glycerophosphate was 2.0 g,and the mass of acetaminophen was 1.5 g.After optimization,the gelling temperature of the gel containing drug water was 38.5±0.5℃,the gelling time was 21 s,and the dissolution rate was 81.58%,all of which met the requirements.The drug-containing aqueous gel had the largest swelling rate in pH=2.5 solution and the smallest swelling rate in pH=9.0 solution.It was placed alternately in pH=2.5 and pH=9.0solutions,with a reversible swelling deswelling behavior.With the increase of salt solution mass fraction,the gelation time of medicated water gel also increased.In addition,the medicated gel could be degraded by lysozyme.The medicinal water containing gel had no change after being placed at room temperature for 7 d.
作者
赵欢欢
李文斌
ZHAOHuan-huan;LI Wen-bin(The First Affiliated Hospital of Hebei North University,Zhangjiakou Hebei 075000,China)
出处
《当代化工》
CAS
2023年第4期878-883,889,共7页
Contemporary Chemical Industry
基金
河北省卫生厅重点科技研究计划(项目编号:20200554)。
关键词
扑热息痛
水凝胶
制备工艺
Paracetamol
Hydrogel
Preparation process
