郎氏扶正颗粒的制备及质量标准研究  

Preparation Method and Quality Standards Research of Langshi Fuzheng Granules

作　　者：刘奇[1] 张玲[1] 郎玉麟 毛磊[1] 张如松[1] 杨苏蓓[3] 

机构地区：[1]浙江中医药大学药学院,浙江杭州310053 [2]杭州郎氏皮肤病研究所,浙江杭州310023 [3]浙江省中药研究所,浙江杭州310023

出　　处：《中华中医药学刊》2014年第1期196-199,共4页Chinese Archives of Traditional Chinese Medicine

摘　　要：目的：建立郎氏扶正颗粒的制备方法及质量标准。方法：采用水提醇沉工艺制备郎氏扶正颗粒;采用高效液相色谱法对黄芪甲苷和斯皮诺素进行含量测定;采用薄层色谱法对黄芪和白术进行定性鉴别。结果：采用高效液相色谱测定黄芪甲苷和斯皮诺素的含量：黄芪甲苷和斯皮诺素分别在0.476～7.616μg（r=0.9994）、0.0771～1.2339μg（r=0.9999）的线性范围良好,加样回收试率分别为97.45%（n=6）、101.93%（n=5）。采用薄层色谱法对方中黄芪和白术的薄层色谱进行定性鉴别,特征性强,重现性好。结论：本制剂制备方法合理、简便、可行,所建立的质量标准可为郎氏扶正颗粒的临床应用疗效提供保证。Objective：To establish the preparation method and the quality standards of Langshi Fuzheng granules. Methods ： Langshi Fuzheng granules were prepared with the water extraction and alcohol precipitation technique ; the contents of astragaloside IV and spinosin were determined by high performance liquid chromatography （ HPLC ）, and Astragalus and Rhizoma Atractylodis Macrocephalae were identified by thin layer chromatography （TLC）. Results：Using the HPLC method to determinate the astragaloside IVand spinosin in the granules, the linear range of them were from 0.476μg to 7. 616μg （r =0. 9994） and from 0. 0771μg to 1. 2339 μg （r =0. 9999） and the average recovery rates were 97.45% （n = 6）, 101.93% （n = 5 ）respectively. The TLC method used in the identification of Astragalus and Rhizoma Atractylodis Macrocephalae was highly specific with good reproducibility. Conclusion ：The preparation method was reasonable, simple and feasible, and the established quality standards can provide the guarantee for clinical efficacy.

关 键 词：郎氏扶正颗粒 质量标准 高效液相色谱法 薄层色谱法 

分 类 号：R284.1[医药卫生—中药学]