摘要
目的建立连三叶触变凝胶剂的质量标准。方法采用薄层色谱法(TLC)对连三叶触变凝胶剂中的黄连、三白草、鸡冠花进行鉴别;采用高效液相色谱法(HPLC)测定制剂中盐酸小檗碱含量。结果本品TLC鉴别专属性强,阴性对照无干扰。HPLC检测盐酸小檗碱在0.046 7~0.700 5μg·mL^(-1)范围内呈良好的线性关系(r=1.000 0),平均回收率为96.06%,RSD=0.76%(n=6)。结论本研究所建的方法简便可行、结果准确可靠,可用于连三叶触变凝胶剂的质量控制。
Objective To establish the quality standard for Lian San Ye Thixotropic Gel （LSYTG）. Methods Rhizoma Coptidis, Rhizoma seu Herba Saururi Chinensis, Infloreseentia Celosiae Cristatae in LSYTG were identified by thin layer chromatography（TLC）. The content of berberine hydrochloride in the preparation was determined by high performance liquid chromatography（HPLC）. Results TLC identifieation method was specific and the negative control had no interference. The content of berberine hydrochloride showed a good linearity in the range of 0.046 7-0.700 5μg·mL^-1（r=1.000 0） and the average reeovery was 96.06 %（RSD=0.76 %, n=6）. Conclusion The method is simple, feasible, accurate with high specificity. It can be used for the quality control of LSYTG.
出处
《中药新药与临床药理》
CAS
CSCD
北大核心
2017年第3期368-371,共4页
Traditional Chinese Drug Research and Clinical Pharmacology
基金
广东省应用型科技研发专项资金项目(2016B020239005)
广东省中医药管理局项目(20171196)
广东省自然科学基金-博士启动(2014A030310059)
关键词
连三叶触变凝胶剂
盐酸小檗碱
薄层色谱
高效液相色谱
质量标准
Lian San Ye Thixotropic Gel
berberine hydrochloride
thin layer chromatography
high performance liquid chromatography
quality standard
