烧伤Ⅱ号喷膜剂的制备及其质量评价

Study on Preparation Technology and Quality Evaluation of Burn Ⅱ Spray Film

目的:探讨烧伤Ⅱ号喷膜剂的处方及制备工艺,并对其质量进行评价。方法:以成膜时间、喷雾效果及成膜性能为考察指标,采用正交设计试验,对影响成膜因素的甲基纤维素(MC)、羟丙甲纤维素(HPMC)及甘油量进行优化,并采用高效液相色谱法对烧伤Ⅱ号喷膜剂中主要活性成分儿茶素和黄芩苷进行含量测定,以成膜时间、透气性及吸湿性等指标对其质量进行评价。结果:制备烧伤Ⅱ号喷膜剂的最佳制备工艺为HPMC 0. 08 g、MC0. 40 g及甘油2. 00%;平均成膜时间为4 min,HPLC测得平均每喷主药含量儿茶素为0. 676 mg/喷、黄芩苷为0. 039 mg/喷,平均透气性和吸湿性分别为17. 7%和14. 2%。结论:按最佳工艺制备的烧伤Ⅱ号喷膜剂成膜时间短,喷雾效果及成膜性能较好,每喷主药含量、膜的透气性与吸湿性均符合要求。

Objective:To investigate the formulation and preparation technology of burnⅡspray film and evaluate its quality.Methods:Taking the film-forming time,spraying effect and film-forming performance as the indices,the amounts of methyl cellulose(MC),hydroxypropyl methylcellulose(HPMC)and glycerol influencing the film-forming factors were optimized by orthogonal design,and the contents of catechin and baicalin,the main active ingredients in burnⅡspray film,were determined by HPLC,and the quality was evaluated by the film-forming time,permeability,hygroscopicity and so on.Results:The optimum preparation process of burnⅡspray was HPMC 0.08%,MC 0.40%and glycerol 2.00%,the average film-forming time was 4 min,the average content of catechin was 0.676 mg/spray,and baicalein was 0.039 mg/spray,and the average permeability and hygroscopicity was 17.7%and 14.2%,respectively.Conclusion:The preparation of burnⅡfilm sprayer by the best process is short in film-forming time,and has good spray effect and film formation performance.The content of each spray,the permeability and hygroscopicity of the membrane meet the requirements.