七清止泻颗粒的制备及质量控制  

Preparation and Quality Control of Qiqing Zhixie Granules

作　　者：张欣 侯佳琪 辛怡霖 李青云 唐熙 潘康锁 李引乾[1] ZHANG Xin;HOU Jia-qi;XIN Yi-lin;LI Qing-yun;TANG Xi;PAN Kang-suo;LI Yin-qian(College of Veterinary Medicine,Northwest A&F University,Yangling,Shaanxi,712100,China;Shaanxi Agricultural Inspection and Testing Center,Xi’an,Shaanxi,710016,China)

机构地区：[1]西北农林科技大学动物医学院,陕西杨凌712100 [2]陕西省农业检验检测中心,陕西西安710016

出　　处：《动物医学进展》2023年第1期59-64,共6页Progress In Veterinary Medicine

基　　金：陕西省重点研发计划项目(2020NY-032);陕西省农业农村厅项目(畜牧专项资金-XN15)。

摘　　要：为了探究七清止泻颗粒的制备工艺和其质量标准,通过正交试验以提取次数、提取时间、加水量三个因素进行水提,确定最佳提取工艺,采用湿法制粒,通过优化辅料和润湿剂确定最佳制粒工艺,最后评价不同批次样品质量,建立标准曲线,测定七清止泻颗粒君药有效成分黄芩苷的含量。结果表明,最佳提取工艺为加处方药材质量的10倍量水、提取1.5 h、提取2次;最佳制粒工艺为加入糊精和蔗糖质量比为7∶3的辅料,混合成80 g,用950 mL/L乙醇作为润湿剂制成颗粒剂;在最佳提取和制粒工艺下,试制4个批次样品质量良好,差异性小,均符合《中华人民共和国兽药典》规定,君药有效成分黄芩苷不少于4.00%。说明该制备工艺稳定可行,重复性良好,质量控制方法准确可靠,可用于七清止泻颗粒的质量控制,为下一步药理学试验及后续中试试验的扩大生产奠定了良好基础。In order to explore the preparation process and quality standards of Qiqing Zhixie Granules,the orthogonal experiment was conducted to determine the optimal extraction process by water extraction with three factors of extraction times,extraction time and water addition.The wet granulation was used,and the optimal granulation process was determined by optimizing excipients and wetting agents.Finally,the quality of different batches of samples was evaluated,and the standard curve was established to determine the content of baicalin,the effective component of the monarch drug of Qiqing Zhixie Granules.The results showed that the optimum extraction process was as follows:adding 10 times the amount of water,extracting 1.5h,extracting twice.The best granulation process is adding dextrin and sucrose mass ratio of 7∶3,mixed into 80g,with 95%ethanol as wetting agent to make granules.Under the optimal extraction and granulation process,the quality of the four batches of samples was good and the difference was small,which met the requirements of Veterinary Pharmacopoeia of the People’s Republic of China,and the effective component baicalin of the monarch drug was not less than 4.00%.This indicated that the preparation process was stable,feasible,reproducible,and the quality control method was accurate and reliable,which could be used for the quality control of Qiqing Zhixie Granules,and laid a good foundation for the further pharmacological experiment and the subsequent pilot test.

关 键 词：七清止泻颗粒 制备工艺 质量控制 正交试验 

分 类 号：S859.7[农业科学—临床兽医学] S853.731[农业科学—兽医学]