医院制剂活血散质量标准提高研究

Study on the improvement of quality standard of hospital preparation of blood-quickening powder

目的综合多项指标评价活血散组方药味黄柏质量,全面提升活血散的质量标准。方法综合黄柏的薄层鉴别结果及含量测定结果,评价黄柏的质量;运用指纹图谱技术评价多批次制剂质量、批间稳定性,全过程控制活血散的质量标准。结果薄层斑点显色清晰前五是S1、S2、S4、S12、S14;巴马汀含量前五是S13、S1、S8、S14、S4;小檗碱含量前五是S3、S15、S12、S7、S10。活血散的指纹图谱及含量测定方法各项方法学验证良好,平均相似度为0.901,相似度良好。结论黄柏质量研究为活血散制剂的质量控制提供了参考,建立了活血散HPLC指纹图谱。

Objective To evaluate the quality of medicinal ingredient of phellodendron chinense in prescription of blood-quickening powder by combining several indexes,so as to comprehensively improve the quality standard of the blood-quickening powder.Methods The quality of the medicinal ingredient of phellodendron chinense was evaluated by combining the results of thin-layer identification and content determination of phellodendron chinense.In addition,the fingerprint spectra technology was used to evaluate the batch-to-batch stability of the quality of multiple batches of the preparation and to control the quality standard of the blood-quickening powder in the whole process.Results The top five thin-layer spots with clear color development were S1,S2,S4,S12 and S14.The top five with palmatine content in order were S13,S1,S8,S14 and S4,and the top five with berberine content in order were S3,S15,S12,S7 and S10.The fingerprint spectra and content determination methods of blood-quickening powder were well-validated in all methods,with a good average similarity of 0.901.Conclusion The study of the quality of phellodendron chinense provides a reference for the quality control of the preparation of blood-quickening powder,and helps to establish highperformance liquid chromatography(HPLC)fingerprint spectra of blood-quickening powder.