摘要
目的开展心脑一号颗粒剂工艺研究,为院内制剂备案奠定基础。方法应用现代提取技术,采用正交试验方法考察水提工艺;采用单因素分析方法考察醇沉浓度;采用单因素分析方法对制粒工艺进行研究,并进行工艺验证。结果最佳提取工艺为加水量8倍,煎煮3次,每次1.5 h,醇沉浓度为60%时醇沉效果最佳;最佳制粒工艺为:按1∶1.5的比例加入浸膏与糊精,加入0.5%的甜蜜素,选择85%的乙醇作为湿润剂。经验证成型性较好,含水量适宜,颗粒制备工艺稳定可行。结论心脑一号颗粒剂工艺方法稳定可靠,粒度良好,口感适宜,可进一步开发为院内制剂,以造福广大患者。
Objective To study the process of Xinnao No.1 Granules in order to lay the foundation for in-hospital preparation filing.Methods The water extraction process was investigated by modern extraction technology and orthogonal test method.The univariate analysis method was adopted to investigate the alcohol precipitation concentration and to study the granulation process,and the process was also validated.Results The best extraction process was to add 8 times of water,decoct 3 times for 1.5 hours each time,and obtain the best alcohol precipitation effect at the alcohol precipitation concentration of 60%.The best granulation process was to add extract with dextrin in the ratio of 1∶1.5 and 0.5%sweetener,and use 85%ethanol as wetting agent.It was validated that the granule formability was good with suitable water content,indicating that the granulation process was stable and feasible.Conclusion The granulation process of Xinnao No.1 Granules is stable and reliable,with appropriate particle size and granule taste,which can be further developed as an in-hosp ital preparation for the benefit of patients.
作者
周萍
葛岩
茹妍
马子君
ZHOU Ping;GE Yan;RU Yan;MA Zijun(Department of Pharmacy,Xinyi Hospital of Traditional Chinese Medicine,Jiangsu,Xinyi 221400,China;Clinical Department,Shanghai MedKey Medical Technology Development Co.,Ltd.,Shanghai 200000,China;Department of Pharmacy,People’s Hospital of Jinta County,Gansu,Jinta 735300,China)
出处
《中国医药科学》
2022年第17期67-70,共4页
China Medicine And Pharmacy
关键词
心脑一号颗粒剂
工艺制备
正交试验
单因素考察方法
Xinnao No.1 Granules
Granulation process
Orthogonal test
Uni variate investigation method
