摘要
建立了玉屏风口服液多糖(YPF-P)的特征降解谱,并基于此完善该制剂的质量控制,通过体积分数70%乙醇溶液沉淀得到YPF-P,同时去除口服液中的辅料蔗糖.优化的YPF-P部分降解条件为0.5 mol/L盐酸溶液,温度80℃,时间4 h,随后采用毛细管区带电泳法(CZE)对经过1-苯基-3-甲基-5-吡唑啉酮(PMP)衍生后的YPF-P部分降解产物进行测定.CZE条件为未涂层熔融石英毛细管柱(50 cm×50μm i.d.,有效长度41 cm),运行缓冲液40 mmol/L硼砂缓冲液(pH 10.1),检测波长245 nm,运行电压10 kV,重力进样15 cm×20 s,柱温为室温.根据L 9(34)正交设计组合不同来源的玉屏风处方药材,制备9份玉屏风模拟样品,采用中位数法综合各特征降解谱得到YPF-P特征降解谱对照谱图,并对不同批次样品YPF-P特征降解谱进行聚类分析.结果表明:不同来源和组合的YPF-P特征降解谱差异显著,证明多糖特征降解谱可用于YPF-P成分的分析,也可为其他中药复方制剂多糖成分质量控制的深入研究提供参考.
The characteristic degradation profile of Yupingfeng oral liquid polysaccharide(YPF-P)was established in this paper,and the quality control of this preparation was improved based on the profile.YPF-P was obtained by the precipitation of 70%ethanol solution,and the excipient sucrose in the oral liquid was removed in the meantime.The optimized partial degradation conditions of YPF-P were as follows:0.5 mol/L hydrochloric acid solution,temperature 80℃,time 4 h.The degradation products derived by 1-phenyl-3-methyl-5-pyrazolinone(PMP)were separated by capillary zone electrophoresis(CZE)under the following conditions:uncoated fused silica capillary column(50 cm×50μm i.d.,effective length 41 cm)was used,and the running buffer was 40 mmol/L borax buffer(pH 10.1),detection wavelength was set at 245 nm with operating voltage 10 kV,gravity injection 15 cm×20 s was employed,and the column temperature was room temperature.According to the L 9(34)orthogonal design,nine Yupingfeng simulated samples were prepared by combining the prescription medicinal materials with different sources of Yupingfeng.The reference YPF-P characteristic degradation profile was obtained by synthesizing the above nine profiles using median method,and the cluster analysis of the characteristic degradation profiles of YPF-P from different batches was carried on.The results indicated that the characteristic degradation profiles of YPF-P from different batches and simulated samples were significantly different,which proved that the characteristic degradation profiles of polysaccharide could be used for the analysis of YPF-P,and could also provide reference for the in-depth study of the quality control of polysaccharide in other Chinese herbal medicine compound preparations.
作者
马梦楠
张钰
李欣珂
刘进宝
刘丹
郭怀忠
MA Mengnan;ZHANG Yu;LI Xinke;LIU Jinbao;LIU Dan;GUO Huaizhong(College of Pharmaceutical Sciences,Hebei University,Baoding 071002,China;Key Lab of Pharmaceutical Quality Control of Hebei Province,Baoding 071002,China)
出处
《河北大学学报（自然科学版）》
CAS
北大核心
2023年第6期616-623,共8页
Journal of Hebei University(Natural Science Edition)
基金
河北省自然科学基金资助项目(H2021201018,H2016201221)
河北省创新能力计划项目(20567605H)。
关键词
玉屏风口服液
多糖
特征降解谱
毛细管区带电泳法
中药复方制剂
Yupingfeng oral liquid
polysaccharide
characteristic degradation profile
capillary zone electrophoresis
Chinese herbal medicine compound preparation
