基于黏性中药何熟方纯化前后质控参数变化及其凝胶比较  

The changes of the quality control parameters of viscous traditional Chinese medicine Heshu Recipe and the comparison of corresponding gel before and after purification

作　　者：何怡静 李孝栋[1] HE Yijing;LI Xiaodong(School of Pharmacy,Fujian University of Traditional Chinese Medicine,Fuzhou 350122,China)

机构地区：[1]福建中医药大学药学院,福建福州350122

出　　处：《沈阳药科大学学报》2021年第6期606-612,共7页Journal of Shenyang Pharmaceutical University

基　　金：福建省科技平台建设项目(2010Y2004)。

摘　　要：目的分析何熟方大孔吸附树脂纯化前后质控参数的变化,开展纯化前后药液凝胶的比较,建立一种质量可控的粘性中药何熟方凝胶制备的方法。方法采用高效液相色谱方法,测试何熟方大孔吸附树脂纯化前后药液中二苯乙烯苷的含量,测定两种药液的黏度,再分别制成凝胶,比较凝胶形成过程和黏度的变化。结果高效液相方法可行、准确,二苯乙烯苷在5~200 mg·L^(-1)浓度范围内与峰面积呈良好线性关系(r=0.9998),平均加样回收率95.14%,RSD为0.87%。大孔吸附树脂纯化方法可行、稳定,药液吸附12 h,水洗脱体积2 BV,洗脱流速4 mL·min^(-1),纯化前后药液中二苯乙烯苷的含量较为一致,但纯化后药液的黏度比纯化前的显著降低;纯化后药液制得的凝胶胶凝现象明显,黏度小,可涂抹均匀,延展性好。结论何熟方中的粘性杂质可通过大孔吸附树脂纯化除去,纯化后药液的药效物质含量不变,制得的何熟方凝胶黏度稳定,质量可控,为粘性中药剂型的制备和质量稳定提供了有益的启示。Objective To establish a method for the preparation of a viscous traditional Chinese medicinecalled Heshu Gel with controllable quality in order to analyze the change of the quality control parameters in Heshu Recipe before and after purification by macroporous adsorption resin and makeacomparison of the gels produced by these two drug extract.Methods The content of stilbene glucoside in Heshu Recipe before and after purification by macroporous adsorption resin was tested by HPLC,and viscosity of these two drug extracts were measured.the changes of the formation processes and the viscosity of their gels were compared.Results The HPLC method was feasible and accurate.The linear range of stilbene glucoside was 5-200 mg·L^(-1)(r=0.9998),and the average recovery was 95.14%with RSD of 0.87%.The purification method of macroporous adsorption resin was feasible and stable.The adsorption time of drug solution was 12 h,the volume of water elution was 2BV withthe flow rate of 4 mL·min-1,and thecontent of stilbene glycoside in the drug solution was consistent before and after the purification,while the viscosity after purification was much lower than before.After purification,the gel obtained from the drug solution is obviously gelatinized with a lower viscosity and better ductility,and could be evenlysmeared.Conclusion The viscous impurities in Heshu Recipe can be removed by macroporous adsorption resin,and the effective substances remain unchanged.The viscosity of the prepared Heshu Gelis stable withcontrollable quality,which provides the references for the preparation of quality stable viscous traditional Chinese medicine formulation.

关 键 词：黏性中药 何熟方 质控参数 大孔吸附树脂 凝胶 

分 类 号：R28[医药卫生—中药学]