摘要
目的确定疏筋解毒颗粒的成型工艺,并进行质量标准研究。方法以辅料种类、药辅比、润湿剂乙醇体积分数为考察因素,以软材性质、制粒难易、颗粒成型率、溶化性、休止角、48 h吸湿率、颗粒外观为评价指标,采用单因素实验确定疏筋解毒颗粒的成型工艺;采用薄层色谱法鉴别处方中的天麻、白芍;高效液相色谱法测定天麻素、白芍苷的含量;按照2020年版《中华人民共和国药典》颗粒剂制剂通则项下的方法检查粒度、溶化性等;选择7个二级物理指标建立物理指纹图谱。结果疏筋解毒颗粒的最佳成型工艺:取疏筋解毒方的干浸膏,粉碎(60目筛),加入糊精与乳糖之比1∶1的辅料,按药辅之比1∶1混匀,喷洒乙醇体积分数80%的润湿剂,采用挤压制粒法,60℃干燥,整粒,即得;天麻和白芍薄层色谱主斑点清晰、圆整,分离度良好,无阴性干扰;天麻素和芍药苷分别在各自范围内线性关系良好(R^(2)≥0.9997),平均加样回收率分别为98.10%、99.74%,RSD分别为1.37%、1.23%。各批样品物理指纹图谱相似度均>0.99。结论制剂成型工艺稳定可行;建立的薄层色谱法和高效液相色谱法专属性强、灵敏度高、重复性好;颗粒物理性状稳定可控,可为疏筋解毒颗粒的质量控制与工业生产提供参考。
Objective To determine the forming process of Shujin Jiedu Granules and to study its quality standard.Methods The types of excipients,the ratio of drug to excipients and the volume fraction of wetting agent ethanol as factors,the properties of soft materials,granulation difficulty,particle forming rate,solubility,angle of rest,48 h moisture absorption rate,and particle appearance as evaluation indexes,the molding process of Shujin Jiedu Granules was determined by single factor experiment.Thin layer chromatography method was used to identify Gastrodiae Rhizoma and Paeoniae Rodix Alba in the prescription.The contents of gastrodin and paeony side were determined by high performance liquid chromatography.The particle size and solubility of granules were checked according to the general Rules of Pharmacopoeia of the People’s Republic of China(2020 edition).Seven secondary physical indicators were selected to establish the physical fingerprint map.Results The optimum forming process of Shujin Jiedu Granules was as follows:take the dry extract of Shujin Jiedu recipe,pulverise it(60 mesh sieve),add the excipients with the ratio of dextrin to lactose 1∶1,mix according to the ratio of drug to excipients 1∶1,spray the wetting agent with 80%ethanol volume fraction,squeeze and press the granule method,dry at 60℃,and get the whole granule.The main spots of gastrodia gastrodia and paeony were clear,round,and well separated without negative interference.Gastrodin and paeoniflorin had good linear relationships in their respective ranges(R^(2)≥0.9997).The average recoveries were 98.10%and 99.74%,and RSD were 1.37%and 1.23%,respectively.The similarity of the physical fingerprint spectra of each batch of samples was all greater than 0.99.Conclusion The preparation molding process is stable and feasible.The established thin layer chromatography and high performance liquid chromatography methods have strong specificity,high sensitivity,and good repeatability,and the physical properties of the particles are stable and controllable,which can provide reference for the quality control and industrial production of Shujin Jiedu Granules.
作者
邓庆庆
王小平
王亚丽
DENG Qingqing;WANG Xiaoping;WANG Yali(College of Pharmacy,Shaanxi University of Chinese Medicine,Shaanxi Province,Xianyang 712046,China;Affiliated Hospital,Shaanxi University of Chinese Medicine,Shaanxi Province,Xianyang 712046,China)
出处
《中国医药导报》
2025年第21期16-21,共6页
China Medical Herald
基金
陕西省科学技大厅社会发展项目(2023-YBSF-665)。
关键词
疏筋解毒颗粒
成型工艺
质量标准
物理指纹图谱
Shujin Jiedu Granules
Preparation process
Quality standard
Physical fingerprint spectrum
