复方枫蓼颗粒制备工艺研究

Study on preparation technology of FengLiao Granule

关键词:  复方枫蓼颗粒  醇提  正交试验  制备工艺

Key words:  FengLiao Granule  Ethanol extraction process  Orthogonal design  Preparation technology

摘要:

摘要：优选复方枫蓼颗粒的提取工艺和制备工艺。方法:通过单因素和正交设计试验，确定最佳提取工艺。并考察浸膏的干燥工艺，采用正交设计法对颗粒剂的辅料配比进行优化，最后按照颗粒剂的质量标准方法进行质量检查。确定复方枫蓼颗粒的最佳醇提取工艺为：10倍量65%的乙醇加热回流提取2次，每次60min，过滤，合并提取液；减压浓缩至密度为1.15~1.20（60℃）的浸膏，80℃真空干燥成粉。枫蓼颗粒剂的成型工艺为：85%乙醇作润湿剂，药物与辅料比例1：1.5，糊精与蔗糖比例3：2制软材，过14目筛，干燥温度60℃，14目筛整粒。本实验确定的提取工艺和制备工艺稳定可行，质量可靠。

Abstract:

To optimize the extracting and processing conditions of Feng Liao Granule . The best extracting and drying process of FengLiao Granule was optimized by single-factor and orthogonal test. The orthogonal design method was used to optimize the ratio of the excipients of the granules, and finally the quality inspection was carried out according to the quality standard method of the granules. The optimal ethanol process of FengLiao Granule was: 10 times the amount of 65% ethanol was heated and refluxed for 2 times, each time for 60 min, filtered, and the extracts were combined; concentrated under reduced pressure to an extract having a density of 1.15 to 1.20 (60 ℃), and vacuum dried at 80 ℃ to form a powder .And the granulation condition was selected: 85% ethanol was regarded as wetting agent, the ratio of drug to excipients was 1:1.5, and the latter included a ratio of dextrin to sucrose of 3:2. then filtered through a 14 mesh screen, dried at 60 ℃. The extracting process and forming process are feasible and stable, and the quality is reliable.