菟丝子颗粒的制备工艺和质量标准研究  

Study on Preparation Technology and Quality Standard of Cuscutae Semen Granules

作　　者：侯秋苑 冯白茹 殷蕾 申茹 HOU Qiu-yuan;FENG Bai-ru;YIN Lei;SHEN Ru(Huizhou Health Sciences Polytechnic,Huizhou 516028,China)

机构地区：[1]惠州卫生职业技术学院,广东惠州516025

出　　处：《食品与药品》2022年第6期498-502,共5页Food and Drug

基　　金：2019年度惠州市科技专项资金资助项目(编号:2019X0706017)。

摘　　要：目的 探索菟丝子颗粒的制备工艺,建立其质量标准。方法 以颗粒流动性、引湿性及成型率等为主要考察指标,确定菟丝子颗粒的辅料及配比。采用薄层色谱法(TLC)对方中的菟丝子进行定性鉴别;采用高效液相色谱法(HPLC)测定菟丝子颗粒中金丝桃苷的含量。结果 辅料为微晶纤维素与乳糖(配比1:5),菟丝子浸膏与辅料的配比为1:2.5。薄层斑点清晰,分离良好,辅料无干扰。金丝桃苷进样浓度在0.01~0.50 mg/ml范围内线性关系良好;平均加样回收率为101.9%,RSD为1.8%。结论 菟丝子颗粒的制备工艺简单合理,稳定可行,定性定量方法操作简单,专属性强,重现性好,可用于菟丝子颗粒的质量控制。Objective To explore the preparation technology and establish the quality standard of Cuscutae Semen Granules.Methods The kinds of excipients and their ratio of Cuscutae Semen Granules were screened using fluidity,moisture absorption and forming rate of granules as main indexes.The Cuscutae Semen was identified by thin layer chromatography(TLC).The content of hyperin in Cuscutae Semen Granules was determined by HPLC.Results The excipients screened were microcrystalline cellulose and lactose(with ratio of 1:5),and the ratio of Cuscutae Semen extract and excipient was 1:2.5.TLC spots were clear and well separated,and the excipients showed no interference.The linear range of hyperin was 0.01-0.50 mg/ml.The average recovery was 101.9 %,with RSD of 1.8 %.Conclusion The preparation technology of Cuscutae Semen Granules is simple,reasonable,stable and feasible.The qualitative and quantitative methods are simple,specific and reproducible,which can be used for quality control of Cuscutae Semen Granules.

关 键 词：菟丝子颗粒 制备工艺 质量标准 薄层色谱法 高效液相色谱法 金丝桃苷 

分 类 号：R943[医药卫生—药剂学]