摘要
建立黄白健脾口服液的质量控制方法。采用薄层色谱法(TLC)对制剂中白头翁、葛根、黄连、黄芩、甘草五味药材进行定性鉴别;采用高效液相色谱法(HPLC)测定制剂中有效成分葛根素、盐酸小檗碱含量,并进行方法学考察。结果显示,供试样品中白头翁、葛根、黄连、黄芩、甘草的薄层色谱斑点清晰,与对照品或对照药材在相应区域显示一致斑点,阴性对照样品无相应的斑点;高效液相色谱图中葛根素和盐酸小檗碱峰形良好,分别在24.78~396.40μg/mL和14.90~477.08μg/mL质量浓度范围内线性关系良好,精密度试验、稳定性试验、重复性试验的RSD均小于2%;葛根素平均加样回收率为103.28%,RSD为1.53%,盐酸小檗碱平均加样回收率为95.28%,RSD为1.57%。本试验建立的黄白健脾口服液的质量控制方法可靠稳定,可用于黄白健脾口服液的质量控制。
The purpose was to establish the quality control standard of Huangbai Jianpi oral liquid.The thin-layer chromatography(TLC)method was used to perform qualitative analysis of the herbal components in Huangbai Jianpi oral liquid,and the high performance liquid chromatography(HPLC)was employed for the quantitative detection of the main ingredients.The results showed that the TLC spots of Radix Pulsatillae,Radix Puerariae,Rhizoma Coptidis,Radix Scutellariae,and Radix Glycyrrhizae in the test samples were consistent with the reference substances and herbal materials,with no corresponding spots observed in the negative samples.The peaks of puerarin and berberine hydrochloride in the HPLC chromatogram were well-shaped,demonstrating there was the linear relationship within the concentration ranges of 24.78-396.40μg/mL and 14.90-477.08μg/mL,respectively.The precision tests,stability tests,and repeatability tests had RSD values less than 2%.The average recovery rate of puerarin was 103.28%with RSD of 1.53%,and the average recovery rate of berberine hydrochloride was 95.28%with RSD of 1.57%.The method is reliable and stable and can be used for quality control of Huangbai Jianpi oral liquid.
作者
黄莉萍
王磊
张康
张景艳
郭志廷
王晓娅
徐国伟
王贵波
路晓荣
梁春花
李建喜
HUANG Liping;WANG Lei;ZHANG Kang;ZHANG Jingyan;GUO Zhiting;WANG Xiaoya;XU Guowei;WANG Guibo;LU Xiaorong;LIANG Chunhua;LI Jianxi(Gansu Engineering and Technology Research Center of Traditional Chinese Veterinary Medicine,Lanzhou Institute of Husbandry and Pharmaceutical Sciences of CAAS,Lanzhou Gansu 730050,China)
出处
《中兽医医药杂志》
CAS
2024年第5期14-19,共6页
Journal of Traditional Chinese Veterinary Medicine
基金
“十四五”国家重点研发计划课题(2022YFD1801102)
国家现代农业产业技术体系(CARS-36)
通辽市科技计划项目(TLCXYD202102-02)
中国农业科学院科技创新工程协同创新项目(CAAS-XTCX2016011-01-09)
中国农业科学院科技创新工程中兽医与临床团队建设项目(CAAS-ASTIP-2015-LIHPS-06)
中央引导地方科技发展资金项目子课题(2022ZY0093)。
