烧伤Ⅱ号喷膜剂的制备及其质量评价
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摘要
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 burn Ⅱ spray 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 burn Ⅱ spray 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 burnⅡ spray 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 burn Ⅱ film 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.
Objective: To investigate the formulation and preparation technology of burn Ⅱ spray 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 burn Ⅱ spray 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 burnⅡ spray 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 burn Ⅱ film 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.
引文
1中国人民解放军医疗机构制剂规范[S].2015年版.71-72
2齐笑,赵雪,赵雪琪,等.喷膜剂的研究进展[J].实用药物与临床,2018,21(4):463-466
3张世川,国大亮,刘岩,等.喷膜剂制备工艺与质量控制研究进展[J].药物评价研究,2015,69(7):512-517
4张世川,国大亮,刘岩,等.喷膜剂制备工艺与质量控制研究进展[J].药物评价与研究,2015,38(4):435-438
5汪雪君,谭飞,李森,等.喷膜剂的研究进展[J].生物加工过程,2018,16(5):202-225
6朱玉莲,黄华,丁晓莉,牛远志.化瘀消肿喷膜剂的制备工艺研究[J].中药材,2015,38(11):2399-2403
7中国药典[S].2015年版.四部.77-78
8段海龙,余晓东,刘刚,等.鱼腥草烫伤喷膜剂的制备及其对试验性烫伤的治疗作用[J].时珍国医国药,2014,25(12):2914-2915
9吕翠叶,瞿勇,尹娜娜.愈疡生肌方熏洗联合壳聚糖生物膜护伤喷膜剂治疗84例糖尿病足的疗效[J].实用糖尿病杂志,2018,14(1):26-27
10陈志远,曹维鹏,施妃,等.外用壳聚糖喷膜剂与湿润烧伤膏在小儿烫伤治疗中的疗效比较[J].吉林医学,2015,36(18):4111-4112
2齐笑,赵雪,赵雪琪,等.喷膜剂的研究进展[J].实用药物与临床,2018,21(4):463-466
3张世川,国大亮,刘岩,等.喷膜剂制备工艺与质量控制研究进展[J].药物评价研究,2015,69(7):512-517
4张世川,国大亮,刘岩,等.喷膜剂制备工艺与质量控制研究进展[J].药物评价与研究,2015,38(4):435-438
5汪雪君,谭飞,李森,等.喷膜剂的研究进展[J].生物加工过程,2018,16(5):202-225
6朱玉莲,黄华,丁晓莉,牛远志.化瘀消肿喷膜剂的制备工艺研究[J].中药材,2015,38(11):2399-2403
7中国药典[S].2015年版.四部.77-78
8段海龙,余晓东,刘刚,等.鱼腥草烫伤喷膜剂的制备及其对试验性烫伤的治疗作用[J].时珍国医国药,2014,25(12):2914-2915
9吕翠叶,瞿勇,尹娜娜.愈疡生肌方熏洗联合壳聚糖生物膜护伤喷膜剂治疗84例糖尿病足的疗效[J].实用糖尿病杂志,2018,14(1):26-27
10陈志远,曹维鹏,施妃,等.外用壳聚糖喷膜剂与湿润烧伤膏在小儿烫伤治疗中的疗效比较[J].吉林医学,2015,36(18):4111-4112