优化连参通淋片的薄膜包衣工艺
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摘要
目的:优化连参通淋片的薄膜包衣工艺。方法:以薄膜包衣预混剂的用量、出风温度、雾化压力、包衣液浓度为考察因素,以崩解、外观合格率为评价指标,采用正交试验设计优化连参通淋片的薄膜包衣工艺。结果:薄膜包衣预混剂的用量、出风温度对包衣工艺具有显著影响,其次为雾化压力,而包衣液浓度对包衣工艺无显著影响,综合确定其最佳工艺为薄膜包衣预混剂用量为4%,出风温度40℃,雾化压力为0.35 MPa,包衣液浓度为7%。结论:优化后所得包衣工艺参数有效可行,结果稳定,可用于连参通淋片的薄膜包衣工艺。
Objective: To optimize film coating process of LianShen TongLin tablets. Methods: The dose of film coating premix, outlet temperature, atomization pressure and the concentrations of coating solution were chosen as the investigation factors, qualification rates of disintegration and appearance as the evaluation indexes, film coating process of LianShen TongLin tablets was optimized using orthogonal design test. Results: The dose of film coating premix, outlet temperature showed significant effects on coating process, atomization pressure the next, while the concentrations of coating solution had no significant effects on coating process, the optimal process was the dose of film coating premix 4%, outlet temperature 40℃, atomization pressure 0.35 MPa and the concentrations of coating solution 7% by comprehensive determination. Conclusion: The parameters of film coating process are valid and feasible after the optimization, the results are stable, and the process could be use for film coating of LianShen TongLin tablets.
Objective: To optimize film coating process of LianShen TongLin tablets. Methods: The dose of film coating premix, outlet temperature, atomization pressure and the concentrations of coating solution were chosen as the investigation factors, qualification rates of disintegration and appearance as the evaluation indexes, film coating process of LianShen TongLin tablets was optimized using orthogonal design test. Results: The dose of film coating premix, outlet temperature showed significant effects on coating process, atomization pressure the next, while the concentrations of coating solution had no significant effects on coating process, the optimal process was the dose of film coating premix 4%, outlet temperature 40℃, atomization pressure 0.35 MPa and the concentrations of coating solution 7% by comprehensive determination. Conclusion: The parameters of film coating process are valid and feasible after the optimization, the results are stable, and the process could be use for film coating of LianShen TongLin tablets.
引文
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[2]李海兵,陈军霞,张华健,等.连参通淋片治疗非淋菌性尿道炎(湿热下注证)Ⅲ期临床试验[J].医学信息,2016,29(24):69-72.
[3]倪永兴.药学应用数理统计[M].北京:军事谊文出版社,1994:131.
[4]国家药典委员会.中华人民共和国药典:四部[M].北京:中国医药科技出版社,2015:118-119.
[5]麦海燕,肖佩玉,黄际薇,等.绿康银杏叶片的薄膜包衣工艺优化研究[J].航空航天医学杂志,2012,6(6):670-671.
[6]梁远园,黄有带,熊艺花,等.妇血安薄膜衣片的质量标准[J].中国医药工业杂志,2013,44(5):487-491.
[7]庄越,曹宝成,萧瑞祥.实用药物制剂技术[M].北京:人民卫生出版社,1999:134-135.
[8]屈云萍,杨宝翠,蔡向杰,等.星点设计-效应面法优化JLY片的制剂工艺[J].食品工业,2016,37(11):79-82.
[9]孙艳平,刘华丽,梁爽,等.片剂中粉体压缩性的研究进展[J].中国药剂学杂志,2013,11(2):27-34.