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目的:考察分子量为4 k Da的透明质酸,羧甲基纤维素钠对相转化水凝胶微针的影响以及对药物体外释放的影响。方法:制备含有不同浓度透明质酸或羧甲基纤维素钠的微针,利用显微镜观察微针的外观形态,用高效液相色谱法检测药物的体外释放,并用统计分析软件检测体外释放率的差异性。结果:含有透明质酸的微针出现相分离现象,体外释放24 h,释放率为55%左右;羧甲基纤维素钠的微针未出现相分离现象,体外释放24 h,释放率能达到60%左右,两种微针在3 h和24 h时体外释放率无显著性差异,在12 h时有显著性差异(P<0.05)。结论:透明质酸与聚乙烯醇混合易出现相分离现象,可应用于微针的浓度范围较窄,羧甲基纤维素钠微针不易出现相分离现象。在12 h体外释放方面,含有羧甲基纤维素钠的微针处方优于含有透明质酸的微针处方,但是哪一种辅料更优还需要进一步的实验验证。
OBJECTIVE: To investigate the effect of hyaluronic acid and sodium carboxymethyl cellulose with a molecular weight of 4 kDa on the microneedles of phase inversion hydrogels and the drug release in vitro. Methods: The microneedles containing different concentrations of hyaluronic acid or sodium carboxymethyl cellulose were prepared, the morphology of the microneedles was observed with a microscope, and the in vitro release of the drug was detected by HPLC. Statistical analysis software was used to detect the in vitro release rate difference. Results: The microneedles containing hyaluronic acid showed phase separation, and the release rate was about 55% after being released for 24 h in vitro. The microneedles of sodium carboxymethylcellulose did not appear phase separation and released in vitro for 24 h, the release rate could reach 60%. There was no significant difference in the in vitro release rate between the two microneedles at 3 h and 24 h, with a significant difference at 12 h (P <0.05). Conclusion: Hyaluronic acid and polyvinyl alcohol are prone to phase separation. The range of concentration that can be applied to microneedles is narrow. The separation of sodium carboxymethylcellulose microneedles is not easy. In 12 h of in vitro release, the formulation of microneedles containing sodium carboxymethylcellulose is superior to the formulation of microneedles containing hyaluronic acid, however, which of the excipients is more excellent and needs further experimental verification.