摘要
目的探讨参杞强精颗粒成型工艺优化方案,并考察其成品稳定性。方法采用单因素试验考察湿法制粒工艺。以浸膏粉与辅料的配比(A)、乙醇浓度(B)、润湿剂用量(C)为主要影响因素,以吸湿率、溶化率、成型率、休止角为评价指标,采用L9(34)正交试验法优选参杞强精颗粒成型工艺。同时,考察参杞强精颗粒的长期稳定性和加速稳定性。结果正交试验法优选的最佳成型工艺为浸膏粉与辅料配比为1∶1,乙醇浓度为65%,0.3%甜菊素的颗粒口感较好,润湿剂用量为15~20 mL,生产环境的相对湿度应控制在70%以下。在稳定性考察过程中加速试验和长期试验均符合规定。结论优化后的成型工艺方法科学合理,稳定可行,操作简便,所制得颗粒符合各项指标的相关规定,且稳定性好,可为参杞强精颗粒的生产及其后续研究开发提供实验依据。
Objective To investigate the optimization scheme of the molding process of Shenqi Qiangjing granules,and to investigate the stability of the finished product.Methods The wet granulation process was investigated by single factor test.Taking the ratio of the extract powder to the excipients(A),ethanol concentration(B)and wetting agent dosage(C)as the main influencing factors,the moisture absorption rate,melting rate,molding rate and angle of repose as the evaluation indexes,the L9(34)orthogonal test method was used to optimize the molding process of Shenqi Qiangjing granules.At the same time,the long-term stability and accelerated stability of Shenqi Qiangjing granules were investigated.Results The optimum molding process optimized by orthogonal test was as follows:the ratio of extract powder to excipients was 1∶1,the ethanol concentration was 65%,the particle taste of 0.3%stevioside was better,the amount of wetting agent was 15-20 mL,and the relative humidity of the production environment should be controlled below 70%.In the process of stability investigation,the accelerated test and long-term test were in accordance with the regulations.Conclusion The optimized molding process is scientific and reasonable,stable and feasible,and easy to operate.The prepared granules meet the relevant regulations of each index and have good stability,which can provide experimental basis for the production of Shenqi Qiangjing granules and its subsequent research and development.
作者
甘典辉
刘金花
马家宝
李鑫
夏冰雨
李晓霞
唐爱存
GAN Dianhui;LIU Jinhua;MA Jiabao;LI Xin;XIA Bingyu;LI Xiaoxia;TANG Aicun(The First Affiliated Hospital of Guangxi University of Chinese Medicine,Nanning,Guangxi 530023,China;Guangxi University of Chinese Medicine,Nanning,Guangxi 530200,China)
出处
《现代医药卫生》
2024年第9期1450-1455,共6页
Journal of Modern Medicine & Health
基金
广西壮族自治区重点研发计划项目(桂科AB22035073)
广西壮族自治区中医药管理局科研项目(GXZYA20230085)
广西壮族自治区中医药适宜技术开发与推广项目(GZSY22-18)。
关键词
参杞强精颗粒
正交试验法
成型工艺优化
稳定性
Shenqi Qiangjing granules
Orthogonal test method
Molding process optimization
Stability
