健脾固肾颗粒的制备工艺和质量标准研究  

Study on Production Process and Quality Standard of Jianpi Gushen Granulas

作　　者：吴典伟 陈展祥 陈雪婷 张靖年 黄茂胜 张建军 陈超 WU Dianwei;CHEN Zhanxiang;CHEN Xueting;ZHANG Jingnian;HUANG Maosheng;ZHANG Jianjun;CHEN Chao(Shantou Hospital of Traditional Chinese Medicine,Shantou,Guangdong 515000;Guangdong Second Traditional Chinese Medicine Hospital(Guangdong Province Engineering Technology Research Institute of Traditional Chinese Medicine),Guangzhou,Guangdong 510095)

机构地区：[1]汕头市中医医院,广东汕头515000 [2]广东省第二中医院(广东省中医药工程技术研究院),广东广州510095

出　　处：《中医康复》2024年第11期41-46,共6页Traditional Chinese Medicine Rehabilitation

基　　金：广东省科技创新战略专项(No.STKJ202209074)。

摘　　要：目的:优选健脾固肾颗粒的提取工艺和成型工艺,建立其质量标准。方法:通过正交试验设计优选最佳提取工艺;采用单因素试验确定最佳成型工艺;采用薄层色谱法对处方中的麸炒白术、酒女贞子和黄柏进行定性鉴别。结果:最佳制备工艺为处方药材加8倍量水,提取2次,每次1 h;提取液浓缩至相对密度为1.10~1.15(80℃),以0.8~1.5倍浸膏量的糊精为辅料,在喷雾速度10~30 g/min,雾化压力2~3 bar,进风温度150~160℃和药液温度70~80℃的条件下,喷雾制粒;TLC鉴别方法具有较高的特异性和无干扰性。结论:健脾固肾颗粒的制备工艺合理且切实可行,薄层鉴别方法便捷可靠,为该制剂的开发利用提供试验依据。Objective:To optimize the extraction and forming process of Jianpi Gushen granules and establish its quality standard.Methods:Orthogonalexperiment design was used to optimize the extraction process.Single factor test was used to determine the optimal manufacturing process.Thethin layer chromatography(TLC)was performed to identify Atractylodis Macrocephalae Rhizoma,Ligustri Lucidi Fructus,Phellodendri ChinensisCortex of the Jianpi Gushen Granulas.Results:The optimum production process was to add 8 times water and extract 2 times for 1 h each time.Theextraction solution was concentrated to a relative density of 1.10~1.15(80℃),With 0.8 to 1.5 times the amount of extractum dextrin,and sprayedgranulated under the conditions of spray speed of 10~30 g/min,atomization pressure of 2~3 bar,inlet air temperature of 150~160℃and liquid temperatureof 70~80℃.TLC had an impressive specialization,with no interference observed in comparison to the negative.Conclusion:The productionprocess of Jianpi Gushen Granulas is rational and executable,and the simplicity and reliability of the thin-layer identification method are notable,which provides the experimental basis for the development and utilization of this preparation.

关 键 词：健脾固肾颗粒 配制工艺 质量标准 

分 类 号：R283[医药卫生—中药学]