附子理中丸质量标准研究进展

Pesearch Progress on the Quality Standard of Fuzi Lizhong Pill

目的:归纳总结附子理中丸质量标准研究文献,为完善其质量控制标准提供参考。方法:检索文献并对临床使用的附子理中丸大蜜丸、浓缩丸、水蜜丸和片剂的定性鉴别、指纹图谱、检查和含量测定等相关文献进行归纳和综述。结果:处方中5味中药的显微鉴别和薄层层析鉴别方法都得到研究。通过指纹图谱多成分定性定量分析,发现同一厂家不同批次的质量差异较小,而不同厂家的质量差异较大;君药制附子中的苯甲酰新乌头原碱、苯甲酰乌头原碱、苯甲酰次乌头原碱、新乌头碱、乌头碱和次乌头碱、使药甘草中甘草苷、甘草酸和甘草次酸都作为含量测定成分进行研究。结论:应根据附子理中丸组方特点,建立君药制附子和其他药味中主要成分的指纹图谱定性鉴别和多成分含量测定质量控制方法,从而保证临床用药的安全有效和稳定可控。

Objective： This paper summarizes the literatures on the quality standard of Fuzi Lizhong Pills,and provides reference for improving its quality control standard. Methods： Related literatures on the qualitative identification,fingerprint,inspection and content determination of the Fuzi Lizhong big honeyed pills,water-honeyed pills,water pills and tablets were summarized and reviewed. Results： Prescription of five kinds of traditional Chinese medicine microscopic identification and thin layer chromatography identification methods have been studied. Fingerprints were utilized to quantitatively and quantitatively analyze the multivariate constituents in the prescription, and found that the same manufacturers different batches of small differences, different manufacturers vary greatly. Benzoylmesaconine,benzoylaconitine,benzoylhypaconitine,mesaconitine,aconitine and hypaconitine from processed Fuzi,and liquiritin,glycyrrhizic acid and glycyrrhetinic acid from radix glycyrrhizae were used as the content determination of the components of the study. Conclusion： Based on the characteristics of formula of Fuzi Lizhong, we should establish a qualitative identification of fingerprints,multi-component content determination of quality control methods including the main herb of formula processed Fuzi and the main components of other medicine,thus ensuring the safety and efficacy of clinical medication and stable and controllable.