蟾酥凝胶贴膏成型工艺的研究
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摘要
目的:以蟾酥制备外用止痛的蟾酥凝胶贴膏,通过对蟾酥凝胶贴膏的空白基质进行优选,从而确定最佳的空白基质配比;对蟾酥凝胶贴膏中蟾酥的加入量进行考察,确定其最佳的载药量。方法:通过预试验确定蟾酥凝胶贴膏的基质组成,该凝胶贴膏的基质配方组成采用正交试验法进行优选,将剥离强度作为蟾酥凝胶贴膏的主要考察指标,将膏体的涂展性作为辅助的观察指标。在保证凝胶贴膏成型性良好的前提下,以每贴基质中蟾酥的最大含量作为该凝胶贴膏的载药量。结果:混合保湿剂组成为甘油-丙二醇(13∶1),基质配方确定为混合保湿剂、水、聚丙烯酸钠、羧甲基纤维素钠、明胶、卡波姆,其比例为4.0∶3.0∶0.4∶0.1∶0.2∶0.25,在pH值为8时制备的蟾酥凝胶贴膏各种指标均较好。蟾酥凝胶贴膏载药量定为每贴50 mg。结论:确定的蟾酥凝胶贴膏基质配方和载药量制成的凝胶贴膏成型性和黏附性较好,载药量大,工艺合理可行,能适合生产的需要。
Objective:Bufonis Venenum gel plaster for pain relieving was prepared. The blank matrix of Bufonis Venenum gel plaster was tested so as to determine the optimized composition ratio of the blank matrix. Also the loading amount of Bufonis Venenum was tested to determine the optimized amount.Method:Through preliminary test the composition of matrix was determined. The matrix formulation of the gel plaster was optimized by the orthogonal test,and the peel strength was used as a main indicator of the gel plaster,and the spreadability of the plaster was used as an auxiliary observation index. Under the premise of ensuring good moldability of the gel plaster,the maximum amount of Bufonis Venenum in each matrix was used as the loading amount of Bufonis Venenum for the gel plaster. Results:The composition of the mixed moisturizer was glycerol-propylene glycol(13∶1),and the ratio of the matrix composition was determined to be a mixed moisturizer,water,sodium polyacrylate,sodium carboxymethylcellulose,gelatin,and carbomer,with the ratio of 4.0 ∶3.0 ∶0.4 ∶0.1∶0.2∶0.25. The indexes of gel plaster paste prepared at pH 8 were the best. The loading amount of Bufonis Venenum was set at 50 mg per sticker. Conclusion:The Bufonis Venenum gel plaster prepared with the optimized composition and the drug-loading amount is of better moldability and adhesion,large drug loading,reasonable and feasible process,and it is suitable for production.
Objective:Bufonis Venenum gel plaster for pain relieving was prepared. The blank matrix of Bufonis Venenum gel plaster was tested so as to determine the optimized composition ratio of the blank matrix. Also the loading amount of Bufonis Venenum was tested to determine the optimized amount.Method:Through preliminary test the composition of matrix was determined. The matrix formulation of the gel plaster was optimized by the orthogonal test,and the peel strength was used as a main indicator of the gel plaster,and the spreadability of the plaster was used as an auxiliary observation index. Under the premise of ensuring good moldability of the gel plaster,the maximum amount of Bufonis Venenum in each matrix was used as the loading amount of Bufonis Venenum for the gel plaster. Results:The composition of the mixed moisturizer was glycerol-propylene glycol(13∶1),and the ratio of the matrix composition was determined to be a mixed moisturizer,water,sodium polyacrylate,sodium carboxymethylcellulose,gelatin,and carbomer,with the ratio of 4.0 ∶3.0 ∶0.4 ∶0.1∶0.2∶0.25. The indexes of gel plaster paste prepared at pH 8 were the best. The loading amount of Bufonis Venenum was set at 50 mg per sticker. Conclusion:The Bufonis Venenum gel plaster prepared with the optimized composition and the drug-loading amount is of better moldability and adhesion,large drug loading,reasonable and feasible process,and it is suitable for production.
引文
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[16]武爱玲,赵新杰.活血接骨止痛凝胶膏基质配方研究[J]中国中医药信息杂志,2016,23(2):100-102.
[17]张超,吕华瑛.正交试验法筛选骨平巴布膏的基质处方[J].中国实验方剂学杂志,2009,15(4):39-41.
[18]国家药典委员会.中华人民共和国药典(一部)[S].北京:化学工业出版社,2015:383.
[19]王瑾,杨明,李剑.中药巴布膏剂的研究进展及存在的问题[J].中医药业,2009,18(24):15-17.
[20]徐晖,王绍宁,谷野,等.巴布膏剂研制的一些问题[J]中医外治杂志,2005,14(6):3-4.
[21]卢毅,张彤,陶建生.卡波姆在药剂学中的应用[J].中国医药工业杂志,2007,38(6):457-460.
[2]杨华生,黎晓丽,吴璐,等.中药凝胶贴膏质量研究进展与思考[J].中医外治杂志,2016,25(3):3-5.
[3]张剑飞,边际.巴布剂贴膏基质的工艺研究[J].山东医药工业,2001,20(5):3.
[4]国家药典委员会.中华人民共和国药典(一部)[S].北京:化学工业出版社,2000:22.
[5]国家药典委员会.中华人民共和国药典(一部)[S].北京:化学工业出版社,2010:附录9.
[6]国家药典委员会.中华人民共和国药典(四部)[S].北京:化学工业出版社,2015:22.
[7]徐男,马承严,林桂涛,等.复方蟾酥镇痛巴布膏提取工艺的研究[J].山东中医杂志,2008,27(5):342-344.
[8]林桂涛,徐男,盛华刚,等.复方蟾酥镇痛巴布膏剂基质配方研究[J].中国实验方剂学杂志,2011,17(18):19-22.
[9]张超,林桂涛,王远国.骨平巴布膏提取工艺研究[J].山东中医药大学学报,2007,31(2):156-158.
[10]林桂涛,齐红.正交试验法优选乳康巴布剂基质配比研究[J].山东中医药大学学报,2006,30(4):341-342.
[11]冯金鹰.蟾酥巴布膏的研究[D].济南:山东中医药大学,2010.
[12]董礼,徐希明,余江南.中药凝胶膏剂研究概述[J].中国药师,2011,14(1):129-132.
[13]王剑,田景振.凝胶贴膏基质的性能评价[J].国际医药卫生导报,2016,22(16):2528-2529,2533.
[14]刘淑芝,费虹,汤亚池,等.中药巴布剂制备工艺的实验研究[J].中国实验方剂学杂志,2001,7(3):9-11.
[15]郭建文,杨艳平.中药巴布剂成型工艺的研究[J].西北药学杂志,2005,20(3):120-121.
[16]武爱玲,赵新杰.活血接骨止痛凝胶膏基质配方研究[J]中国中医药信息杂志,2016,23(2):100-102.
[17]张超,吕华瑛.正交试验法筛选骨平巴布膏的基质处方[J].中国实验方剂学杂志,2009,15(4):39-41.
[18]国家药典委员会.中华人民共和国药典(一部)[S].北京:化学工业出版社,2015:383.
[19]王瑾,杨明,李剑.中药巴布膏剂的研究进展及存在的问题[J].中医药业,2009,18(24):15-17.
[20]徐晖,王绍宁,谷野,等.巴布膏剂研制的一些问题[J]中医外治杂志,2005,14(6):3-4.
[21]卢毅,张彤,陶建生.卡波姆在药剂学中的应用[J].中国医药工业杂志,2007,38(6):457-460.