芍药颗粒剂制备工艺及质量标准  

Preparation Technology and Quality Standard of Herbaceous Peony Granules

作　　者：戴国梁[1] 朱立静[2] 宗阳[2] 何书芬[2] 居文政[1] 

机构地区：[1]南京中医药大学附属医院临床药理科,江苏南京210029 [2]南京中医药大学药学院,江苏南京210029

出　　处：《安徽科技学院学报》2016年第4期31-34,共4页Journal of Anhui Science and Technology University

基　　金：科技部重大新药创制科技重大专项(2012ZX09303009-002);江苏省中医药领军人才(LJ200906);江苏高校优势学科建设工程项目(2010)

摘　　要：目的:优化芍药颗粒剂的制备工艺,对其成品的质量控制方法和稳定性进行研究。方法:对芍药首先采用水提工艺进行提取,并考察浸膏的浓缩干燥工艺,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。结果:芍药水提取实验最佳提取工艺为加10倍量的水、煎煮2次、每次1 h;选择辅料为糖粉和糊精,稠浸膏:糖粉:糊精比例为3∶3∶1,并以90%乙醇为润湿剂,采用湿法制粒的方法,干燥温度为60℃,所制得颗粒剂经检查符合相关要求。结论:所制得的芍药颗粒剂比较适合当前生产要求,质量检查方法方便且易于操作、产品合格率高。Objective： To optimize the preparation technology of herbaceous peony granules,and to study the quality control method and stability of the finished product. Methods： The peony is first dealt with water extracting process for extraction,and the effect of the extract concentration and drying process,by using the orthogonal design method of peony Paeonia lactiflora granules ratio is optimized; finally according to granule quality standard methods of quality inspection. Results： Herbaceous peony extraction experiments show the optimum extraction process with 10 times the amount of water and decocting 2 times,1 h for each time; the choice of materials for the sugar and dextrin,the thick extracts： sugar： dextrin ratio of 3 ∶ 3 ∶ 1 and 90% ethanol as wetting agent by wet granulation method of granules after inspection to meet the relevant requirements. Conclusion： the preparation of the peony granules is suitable for the current production requirements,and quality inspection method is convenient and easy to operate,with high product qualification rate.

关 键 词：芍药 芍药苷 颗粒剂 正交设计 辅料配比 

分 类 号：R944.27[医药卫生—药剂学]