兰紫解毒颗粒的制备工艺优化及质量控制  

Preparation Process Optimization and Quality Control of Lanzi Jiedu Granules(兰紫解毒颗粒)

作　　者：杨美娜[1] 王世信[1] 丁洪青[1] 闫国强[1] 李宝芬[1] 刘爱朋 YANG Mei-na;WANG Shi-xin;DING Hong-qing;YAN Guo-qiang;LI Bao-fen;LIU Ai-peng(Cangzhou Hospital of Integrated TCM-WM·Hebei,Cangzhou Hebei 061001,China)

机构地区：[1]河北省沧州中西医结合医院,河北沧州061001

出　　处：《中医药导报》2021年第9期73-77,共5页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：河北省中医药管理局科研计划项目(2020496)。

摘　　要：目的:优化兰紫解毒颗粒的制备工艺,并对其进行质量检查。方法:采用湿法制粒,通过单因素实验确定稀释剂种类及配比,采用正交试验设计优化兰紫解毒颗粒的最佳制备工艺,并对其进行质量检查,高效液相色谱法(HPLC)测定兰紫解毒颗粒中(R,S)-告依春、绿原酸的含量,流动相为乙腈-0.05%磷酸水溶液梯度洗脱,(R,S)-告依春、绿原酸检测波长分别为245 nm和327 nm。结果:兰紫解毒颗粒的最佳制备工艺为以糊精、木糖醇(2∶1)为稀释剂,稠膏与稀释剂配比为1∶2,95%乙醇为润湿剂,湿颗粒干燥温度为60℃。3次平行验证实验结果可见,该制备工艺稳定可行,所制得3批颗粒质量均符合《中华人民共和国药典》规定。HPLC测定结果显示,本品每克含(R,S)-告依春和绿原酸计不得少于0.032 mg和0.768 mg。结论:本研究筛选出的兰紫解毒颗粒制备工艺稳定可行,质量可控。Objective:To optimize the preparation process of Lanzi Jiedu Granules and check its quality.Methods:In this study,wet granulation was adopted.The type and ratio of diluent were determined by single factor experiment,and the best preparation process of Lanzi Jiedu Granules was optimized by orthogonal experiment design.And its quality was checked.The content of(R,S)-goyicin and chlorogenic acid in Lanzi jiedu granules was determined by HPLC.The mobile phase was gradient elution of acetonitrile-0.05%phosphoric acid solution and the detection wavelength of(R,S)-goyicin and chlorogenic acid were 245 nm and 327 nm respectively.Results:The optimal preparation process of Lanzi Jiedu Granules was determined as follows.Dextrin∶xylitol=2∶1 was used as diluent.The ratio of thick paste and diluent was 1∶2,and 95%ethanol was used as wetting agent.The drying temperature of wet granules was 60℃.The results of three parallel validation experiments showed that the preparation process was stable and feasible and that the quality of the three batches of particles met the provisions of the Pharmacopoeia of the people’s Republic of China.HPLC results showed that the content of(R,S)-goyicin and chlorogenic acid per gram should not be less than 0.032 mg and 0.768 mg.Conclusions:The preparation process of Lanzi Jiedu Granules screened in this study is stable and feasible,and its quality is controllable.

关 键 词：兰紫解毒颗粒 制备工艺 含量测定 (R S)-告依春 绿原酸 

分 类 号：R286.0[医药卫生—中药学]