基于一测多评和色度识别的侧柏炭内外在质控方法研究

Study on internal and external quality control methods of Platycladi Cacumen Carbonisata based on QAMS and color recognition

为有效解决临床常用止血药侧柏炭存在的炮制过重的问题,该研究以槲皮素为内标,采用一测多评法(QAMS)建立了可同时测定侧柏炭6种黄酮类成分含量的内在质控新方法,在一测多评法与外标法(ESM)测定结果比较的基础上,制订了异槲皮苷不得少于0.0020%,槲皮苷不得少于0.050%,槲皮素不得少于0.030%,山柰酚不得少于0.010%,穗花双黄酮不得少于0.010%,扁柏双黄酮不得少于0.050%的含量限度标准。同时通过对侧柏叶及不同炒制程度侧柏炭的色度检测,寻找不同炮制程度对侧柏炭色度影响规律,通过拟合曲线,建立了侧柏炭色度识别的外在质控方法,明确了色度值ΔL^(*),Δb^(*)和ΔE的标准范围分别为-50.00^-44.00,6.00~11.00,45.00~50.00。该研究将建立的内外在质控标准的有效结合可用于更加全面客观的评价侧柏炭炮制程度和质量,保障其临床疗效,同时该研究为进一步补充完善侧柏炭质控标准提供参考和依据。

In order to effectively solve the over-processing problem of Platycladi Cacumen Carbonisata,which was commonly used as a hemostatic drug in clinical application,we used the quantitative analysis method of multi-components by single marker(QAMS)in this study,with quercetin as internal reference to simultaneously determine the content of six flavonoids which can be used to control the internal quality of Platycladi Cacumen Carbonisata.Based on the comparison of QAMS and external standard method(ESM)results,the limit standards of contents were established as follows:isoquercitroside≥0.0020%,quercitroside≥0.050%,quercetin≥0.030%,kaempferol and amentoflavone both≥0.010%,hinokiflavone≥0.050%.Based on the color detection of Platycladi Cacumen and Platycladi Cacumen Carbonisata with different processing degrees,the law of influence of different processing degrees on the color of Platycladi Cacumen Carbonisata was found.A new external quality standard of Platycladi Cacumen Carbonisata was established by fitting curve of color recognition for the external quality control,based on which the standard ranges ofΔL^(*),Δb^(*)andΔE were-50.00--44.00,6.00-11.00 and 45.00-50.00 respectively.Effective combination of established internal and external quality control standards by this study can be used to evaluate the processing degree and quality of Platycladi Cacumen Carbonisata more comprehensively and objectively,which can guarantee its clinical efficacy.At the same time,this study also provides reference and basis for further improving the quality control standard of Platycladi Cacumen Carbonisata.