肝爽片薄膜包衣工艺及稳定性研究
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摘要
目的研究肝爽片薄膜包衣的最佳工艺参数,提高肝爽片的稳定性。方法采用正交试验,以崩解时间及包衣合格率为指标,确定肝爽片薄膜包衣的最佳工艺参数。结果肝爽片薄膜包衣的最佳工艺参数:包衣增重率为3%、包衣液浓度为10%、片床温度为40℃。此参数下,薄膜包衣片的性状、崩解时限、芍药苷含量等指标在稳定性考察期内无显著变化;结论肝爽片薄膜包衣工艺简便高效,科学合理,稳定、可行。
Objective To optimize the parameters of film coating technology for Ganshuangtablets in order to improve their stability.Metholds Orthogonal test method was adopted.The disintegration time and partial qualified rate of coating were used as indicators,and the most suitable parameters of film coating technology for Ganshuangtablets were confirmed.Results The most suitable parameters of film coating technology of Ganshuangtablets were:a coating weight gain rate of 3%,a concentration of coating solution of 10%,and a tablet bed temperature of 40℃.The disintegration time of the film coating under this parameter was significantly shortened.The property and paeonifiorin content of these tablets did not significantly change while their stability was studied.Conclusion This film coating technology for Ganshuangtablets is simple and efficient,well-designed,stable and feasible.
Objective To optimize the parameters of film coating technology for Ganshuangtablets in order to improve their stability.Metholds Orthogonal test method was adopted.The disintegration time and partial qualified rate of coating were used as indicators,and the most suitable parameters of film coating technology for Ganshuangtablets were confirmed.Results The most suitable parameters of film coating technology of Ganshuangtablets were:a coating weight gain rate of 3%,a concentration of coating solution of 10%,and a tablet bed temperature of 40℃.The disintegration time of the film coating under this parameter was significantly shortened.The property and paeonifiorin content of these tablets did not significantly change while their stability was studied.Conclusion This film coating technology for Ganshuangtablets is simple and efficient,well-designed,stable and feasible.
引文
[1]国家药品监督管理局.国家中成药标准汇编内科肝胆分册[M].北京:人民卫生出版社,2002:87
[2]国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:118-121;354-356
[3]施伶俐,张然,尚燕芳,等.肝爽丸中芍药苷含量的高效液相色谱测定[J].齐齐哈尔医学院学报,2015,36(36):5486
[4]李玲.薄膜包衣技术的应用[J].中国药业,2007,16(12):21-22
[5]密善武,唐娜,徐琳琳,等.薄膜包衣技术常见问题解决方法探索[J].齐鲁药事,2011,30(12):728-729
[6]刘振华,李忠思,董晓强.复方石韦片的薄膜包衣工艺研究[J].中草药,2010,41(5):727-729
[2]国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:118-121;354-356
[3]施伶俐,张然,尚燕芳,等.肝爽丸中芍药苷含量的高效液相色谱测定[J].齐齐哈尔医学院学报,2015,36(36):5486
[4]李玲.薄膜包衣技术的应用[J].中国药业,2007,16(12):21-22
[5]密善武,唐娜,徐琳琳,等.薄膜包衣技术常见问题解决方法探索[J].齐鲁药事,2011,30(12):728-729
[6]刘振华,李忠思,董晓强.复方石韦片的薄膜包衣工艺研究[J].中草药,2010,41(5):727-729