摘要
目的优化益胃膏的制备工艺,并建立可靠的质量控制方法。方法以盐酸小檗碱含量和浸膏得率为指标,通过正交实验设计优化提取工艺,并考察浓缩和成型工艺;采用薄层色谱法(thin-layer chromatography,TLC)对君药黄芪、苦参进行定性鉴别;采用高效液相色谱法(high-performance liquid chromatography,HPLC)测定益胃膏中盐酸小檗碱的含量。结果优化后的制备工艺为加水煎煮2次,分别加8倍水和6倍水,每次1 h,合并煎液,过滤,取上清液浓缩至相对密度为1.18~1.33(80~90℃)的浸膏,加入炼糖和炼蜜混匀,浓缩至相对密度为1.38,即得益胃膏。TLC斑点清晰,分离度良好。HPLC结果显示盐酸小檗碱的质量浓度在0.4~8.0μg·mL^(-1)范围内线性关系良好,平均回收率为98.87%,平均含量为0.484 mg·mL^(-1)。结论优化的制备工艺科学合理、稳定可行,质量标准有效可控,可用于益胃膏的质量控制。
Objective To optimize the preparation process of Yiwei Paste and establish a reliable quality control method.Methods By using the content of berberine hydrochloride and the yield of the extract as indicators,the extraction process was optimized through orthogonal experimental design.The concentration and shaping processes were also examined.Thin-layer chromatography(TLC)was employed for qualitative identification of the principal medicinal materials,Astragalus membranaceus and Sophora flavescens.High-performance liquid chromatography(HPLC)was used to determine the content of berberine hydrochloride in Yiwei Paste.Results The optimized preparation process involved decocting with water twice,adding 8 times and 6 times the volume of water respectively,for 1 hour each time.The combined decoctions were filtered,and the supernatant was concentrated to a relative density of 1.18-1.33 to obtain the extract.The extract was mixed with refined sugar and honey,and concentrated to a relative density of 1.38.TLC spots were clear with good separation.HPLC results showed that the concentration of berberine hydrochloride was linearly related to the peak area within the range of 0.4-8.0μg·mL^(-1),with an average recovery rate of 98.87%and an average content of 0.484 mg·mL^(-1).Conclusion The optimized preparation process is scientific,rational,and feasible.The established quality standards are effective and controllable,and can be used for the quality control of Yiwei Paste.
作者
张雪盈
王云静
贾雨熹
何杰
叶玉杰
ZHANG Xueying;WANG Yunjing;JIA Yuxi;HE Jie;YE Yujie(Wuhan University of Science and Technology,Wuhan 430000,China)
出处
《西北药学杂志》
2025年第3期126-131,共6页
Northwest Pharmaceutical Journal
关键词
益胃膏
提取工艺
盐酸小檗碱
质量标准
Yiwei Paste
extraction process
berberine hydrochloride
quality standard
作者简介
通信作者:叶玉杰,讲师。E-mail:178508596@qq.com。
