五味子配方颗粒制备工艺改进  

Improvement of the preparation process of Schisandrae Chinensis Fructus granules

作　　者：李海兵[1] 艾凌艳[1] 苏小莲[1] 谢彦兵[1] LI Hai-bing;AI Ling-yan;SU Xiao-lian;XIE Yan-bing(Department of Pharmacy,The 908th Hospital of Chinese People′s Liberation Army Joint Logistic Support Force,Yingtan 335000,China)

机构地区：[1]中国人民解放军联勤保障部队第九〇八医院药械科

出　　处：《国际药学研究杂志》2019年第7期557-561,共5页Journal of International Pharmaceutical Research

摘　　要：目的优化五味子配方颗粒的最佳制备工艺,得到稳定、质量合格的制剂。方法五味子药材采用水煎煮法提取。采用正交实验与综合评分法优选五味子颗粒中五味子提取工艺条件,以得膏率和五味子醇甲提取率为考察指标,考察不同加水倍数、提取时间、提取次数对指标的影响。同时,对浓缩、干燥、制粒工艺一并考察,得到最佳制备工艺。五味子醇甲的含量测定采用HPLC法。结果在《中国药典》2015年版HPLC法测定条件下,五味子醇甲在进样量0.03598~0.28784μg范围内呈良好线性关系(r=1.0000),回收率99.32%,RSD为2.17%。最佳提取工艺:水提取3次,每次0.5 h,3次加水量分别为饮片量的8倍、6倍、6倍;最佳浓缩工艺:在60℃,-0.08 MPa真空度下浓缩至一定浓度;最佳干燥工艺:置于60℃,真空度-0.09 MPa下减压干燥;最佳制粒工艺:加适量糊精,以90%乙醇为润湿剂,过14目筛制粒,60℃干燥,整粒,制得成品。结论该法可行,工艺简单,制剂稳定,适合大规模生产。Objective To optimize the preparation process of Schisandrae Chinensis Fructus granules(SCFG)to obtain a stabilized and qualified SCFG-preparation.Methods The Schisandrae Chinensis Fructus raw materials were extracted by decoction with water,and the extraction process was optimized by the orthogonal test.In the orthogonal test,the yield of total extract and the extraction rate of schizandrin were used as evaluation index,and the effect of solid-liquid ratio,decoction time and extraction times on the indexes were investigated to optimize the related parameters of these fac tors.Meanwhile,the concentration process,drying process and granulation process were also investigated to finally opti mize the preparation process of SCFG products.The content of schizandrin was determined by the HPLC method.Re sults Under the HPLC conditions in the Pharmacopia of the People′s Republic of China(2015 edition),schizandrin showed a good linearity in the range of 0.03598-0.28784μg(r=1.0000),with the average recovery rate 99.32%and RSD 2.17%.The conditions for the optimized extraction process were 3 times of extraction,with 0.5 h of each decoction time and with the 1∶8,1∶6 and 1∶6 solid-liquid ratio in turn.The conditions for the optimized concentration process were concentrating at 60℃and-0.08 MPa vacuum to a certain concentration.The conditions for the optimized drying pro cess were drying at 60℃and-0.09 MPa vacuum to a dryness.The conditions for the optimized granulation process were adding appropriate amount of dextrin,using 90%alcohol as moistening agent,and sifting with 14 mesh sieve and desic cating at 60℃.Conclusion The improved method is feasible,simple,stable and suitable for large-scale production of SCFG products.

关 键 词：五味子配方颗粒 五味子醇甲 正交实验 制备工艺 

分 类 号：R92[医药卫生—药学]