基于抗菌效价检测的板蓝根颗粒制备过程质量变化评价

目的对板蓝根颗粒制备过程中抗菌活性及化学成分的变化进行评价。方法按照《中国药典》2010年版收载的板蓝根颗粒制备工艺,分别对药材→水提浓缩→醇沉→干燥这4个制备环节所得样品进行化学分析,并采用管碟法检测各样品的抗菌效价。结果板蓝根颗粒在4个环节的制备过程中,成品的化学指纹图谱共有峰数下降了32%,腺苷、尿苷的量也呈递减趋势,同时抗菌效价也下降了60%。结论目前板蓝根颗粒在满足纯化、成型工艺要求的过程中,药效可能损失较大,应以药效或效价作指导,加强其制备工艺的合理性研究。

Evaluation on quality change of Isatidis Radix Granule during preparation process based on antibacterial potency

Objective To study the component and quality changes in the preparation process of Isatidis Radix Granule.Methods According to the preparation method recorded by Chinese Pharmacopoeia,the samples via water extracted,concentrated,precipitated by ethanol,and dried were analyzed.The antibacterial effect was detected by cylinder-plate method.Results After preparation,the common peaks in the fingerprint chromatograms of Isatidis Radix Granule were decreased by 32% and the contents of adenosine and uridine were also declined.The antimicrobial potency of Isatidis Radix Granule was decreased by 60%.Conclusion During the preparation process,the antimicrobial potency of Isatidis Radix Granule is declined greatly.So the preparation technique of Isatidis Radix Granule should be guided by it’s pharmacodynamic action or potency.