儿舒平颗粒制备工艺优选  

Optimization of Preparation Process of Ershuping Granules

作　　者：严文利[1] 周德勇 龚韬[1] 朱青[1] 宋京美[1] 王夏 杨薇 李蜀平[1] YAN Wenli;ZHOU Deyong;GONG Tao;ZHU Qing;SONG Jingmei;WANG Xia;YANG Wei;LI Shuping(Beijing Institute of Clinical Pharmacy,Beijing,China 100035)

机构地区：[1]北京市临床药学研究所,北京100035

出　　处：《中国药业》2022年第17期50-54,共5页China Pharmaceuticals

基　　金：国家科技重大专项课题重大新药创制项目[2018ZX09721003-009-006]。

摘　　要：目的 优选儿舒平颗粒的制备工艺。方法 以柴胡皂苷a、龙胆苦苷、芍药苷为指标性成分,以加水量、提取次数、提取时间为考察因素,以上述3种成分的转移率为评价指标,采用L(3~4)正交试验法优选儿舒平颗粒的水提取工艺;以颗粒的吸湿性、流动性和成型性为评价指标,比较湿法制粒和喷雾制粒工艺的成品效果。结果 最佳水提取工艺为加10倍量水,提取3次,每次1.0 h。喷雾制粒法制得颗粒的吸湿性、流动性和成型性优于湿法制粒。最终确定颗粒成型条件为喷雾制粒,底料为糊精与甘露醇(3︰1,m/m)的混合物,底料和干膏的比例为2︰1(m/m),加入0.5%阿斯巴甜作为矫味剂。结论 优选得到的儿舒平颗粒工艺稳定可行,可应用于工业化生产。Objective To optimize the preparation process of Ershuping Granules.MethodsSaikosaponin a,gentiopicroside and paeoniflorin were taken as the index components,and the L(3~4) orthogonal test was used to optimize the water extraction process of Ershuping Granules with the amount of water addition,extraction times and extraction time as the investigation factors,and with transfer rates of the above three components as the evaluation indexes.The hygroscopicity,fluidity and formability of granules were taken as the evaluation indexes to compare the effects of the wet granulation and the spraying granulation.ResultsThe optimal water extraction process was as follows:adding 10 times the amount of water,and extracting three times with 1.0 h each time.The hygroscopicity,fluidity and formability of granules prepared by the spraying granulation were better than those by the wet granulation.The determined forming condition of granules was spraying granulation,the base material was the mixture of dextrin and mannitol (3∶1,m/m),the ratio of base material to dry extract was 2∶1 (m/m),and aspartame with the dosage of 0.5%of the final granules was added as the flavoring agent.ConclusionThe optimal process of Ershuping Granules is stable and feasible,which can be used for industrial production.

关 键 词：儿舒平颗粒 提取工艺 成型工艺 柴胡皂苷A 龙胆苦苷 芍药苷 

分 类 号：R932[医药卫生—生药学] TQ460.6[医药卫生—药学]