精天颗粒的制备工艺研究
Study on the preparation process of Jingtian Granule
赵伟 1陈树和 2闫斌 2郑琼芳 1巴元明3
作者信息
- 1. 湖北中医药大学药学院,湖北武汉 430065
- 2. 湖北中医药大学药学院,湖北武汉 430065;湖北省中医院/湖北中医药大学附属医院,湖北武汉 430061
- 3. 湖北省中医院/湖北中医药大学附属医院,湖北武汉 430061
- 折叠
摘要
目的 优选精天颗粒的最佳制备工艺.方法 以出膏率和红景天苷含量综合评分为指标,通过正交试验设计优选提取工艺;以红景天苷含量、干膏粉收率及其性状为指标,优选最佳的浓缩与干燥参数;以吸湿率和一次性成型率为指标,通过单因素试验考察辅料用量、正交试验法优选最佳干法制粒参数.结果 最优的制备工艺为:加饮片重量的8倍量水,浸泡30min,煎煮2次,每次2h合并滤液;滤液在60～70℃下减压至相对密度为1.08～1.11(60℃)的清膏,后添加投料饮片重量5％的麦芽糊精进行喷雾干燥,调整干燥的进风温度180℃左右,收粉;加入适量麦芽糊精,混匀,进行干法制粒,即得.结论 本研究所建立的精天颗粒制备工艺稳定可行、质量可控,可为其院内制剂开发提供药学研究依据.
Abstract
Objective To optimise the best preparation process of Jingtian Granule.Methods The extraction process was preferred by orthogonal experimental design with the comprehensive scores of paste yield and Salidroside content as the indexes;the optimal concentration strength and drying parameters were preferred with the content of rhodiola rosea glycoside,the yield of dry paste powder and its properties as the indexes;the optimal dry granulation parameters were preferred with the hygroscopicity rate and one-time moulding rate as the indexes,and the auxiliary dosage was investigated by one-way test and orthogonal experimental method.Results The optimal preparation process was as follows:add 8 times the weight of the decoction pieces in water,soak for 30 min,and decoct twice,each time for 2 h,combined filtrate.The filtrate was concentrated under reduced peressure at 60～70℃ to a clear paste with a relative density of 1.08～1.11(60℃).The decoction was decompressed at 60～70℃ to a concentrate with a relative density of 1.08～1.11(60℃),and then add 5％maltodextrin of the weight of the tablets to be spray dried,and then adjust the drying inlet temperature of 180℃ to collect the powder;add the appropriate amount of maltodextrin,mix well,and then dry granulate,i.e.,to obtain a dry granule.The powder was collected;appropriate amount of maltodextrin was added,mixed well,and dry granulation was carried out,which was obtained.Conclusion The preparation process of Jingtian Granule established in this study is stable and feasible with controllable quality,which can provide a basis for pharmacological research for the development of its in-hospital preparation.
关键词
精天颗粒/正交试验/制备工艺/红景天苷Key words
Jingtian Granule/Orthogonal test/Preparation process/Salidroside引用本文复制引用
出版年
2024
NETL
NSTL
万方数据