创面用复方喷雾膜剂的制备及其性质研究

目的 研制创面用复方喷雾膜剂（compound spraying film,CSF）,并进行质量评价.方法 采用物理混合法制备CSF,评价其成膜性能和机械性能;以HPLC法测定其含量和释药行为;建立大鼠创面模型,评价其创面愈合效果.结果 CSF的成膜温度为（30±2）℃,成膜时间为（29±6）s,机械性质良好.CSF含人参皂苷（GRg1） （5.82±0.08）mg/g,体外释药以骨架溶蚀为主,释药动力学符合零级方程和Ritger-Peppas方程特征.CSF用于治疗大鼠背部机械创伤,愈合百分率均显著高于复方水溶液组和空白喷雾膜剂组（P＜0.05）.结论 CSF使用方便,性质优良,促愈效果明显,具有良好的应用前景.

Preparation and valuation of compound spraying film for wound

Objective To prepare and evaluate a novel compound spraying film（CSF） for wound. Methods CSF was pre- pared by physical mixing method, and filming ability and mechanical character were evaluated. The content and drug release behavior of CSF were determined by HPLC method. Rat wound model was established to evaluate the therapeutic effect. Results Its temperature of filming was （ 30 ±2 ） ℃, time of filming was （ 29 ± 6 ） s and its mechanical character was fine. The content of Rgl was （ 5.82 ± 0.08 ） mg/g. The drug release mechanism was erosion, and the drug release kinetics fitted zero order and Ritger - Peppas equations. The heal- ing percentage in CSF group was higher than control groups （ P 〈 0.05 ）. Conclusion CSF was user - friendly and effective for wound healing. It has a good application prospect.