Liu Dong-Han, Xue Yu-Tao, Luo Ju-Yuan, Liang Jun, Tian Wan-Wan, Zhang Qi, Liu Lei-Lei, Zhang Yu-Ming, DU Shou-Ying, Bai Jie, Lu Yang, Wu Hui-Chao
Beijing University of Chinese Medicine Beijing 102488,China.
Zhongguo Zhong Yao Za Zhi. 2019 Dec;44(24):5421-5428. doi: 10.19540/j.cnki.cjcmm.20191001.302.
By preparing 10 batches of the material reference of Linggui Zhugan Decoction,the methodology of the characteristic spectrum of the material reference was created. The creaming rate range,the contents and the transfer rate range of cinnamaldehyde,glycyrrhizin and glycyrrhizic acid,the characteristic peaks and the similarity range of the characteristic spectrum of Linggui Zhugan Decoction were determined to clarify key quality attributes of the material reference of Linggui Zhugan Decoction. In the 10 batches of the material reference of Linggui Zhugan Decoction,the similarity of characteristic spectrum was higher than 0. 9. Furthermore,after summarizing the characteristic peak information,we knew that Fuling had two characteristic peaks,Guizhi had six characteristic peaks,Baizhu had two characteristic peaks and Gancao had 11 characteristic peaks. The average creaming rate of the material reference of the ten batches was( 12. 13 ± 0. 35) %. The average content of cinnamaldehyde was 0. 32%,the average transfer rate was 10. 69%,the content of cinnamaldehyde in the different batches was between 0. 22% and 0. 42%,and the transfer rate was between 7. 48% and13. 90%. The average content of glycyrrhizin was 0. 84%,the average transfer rate was 50. 39%,the content of glycyrrhizin in the different batches was between 0. 42% and 1. 26%,and the transfer rate was between 35. 27% and 65. 51%. The average content of glycyrrhizic was 1. 88%,the average transfer rate was 40. 74%,the content of glycyrrhizic in the different batches was between 0. 94% and2. 82%,and the transfer rate was between 28. 52% and 52. 96%. In this paper,the quality value transmitting of substance benchmarks of Linggui Zhugan Decoction was analyzed by the combination of characteristic spectrum,creaming rate and the content of index component. A scientific and stable method was preliminarily established,which provided scientific basis for the quality control and formulation development of Linggui Zhugan Decoction.
通过制备10批苓桂术甘汤物质基准，建立了物质基准特征图谱的方法学。确定了苓桂术甘汤物质基准的乳膏率范围、桂皮醛、甘草苷和甘草酸的含量及转移率范围、特征图谱的特征峰及相似度范围，以阐明苓桂术甘汤物质基准的关键质量属性。10批苓桂术甘汤物质基准中，特征图谱相似度均高于0.9。此外，总结特征峰信息可知，茯苓有2个特征峰，桂枝有6个特征峰，白术有2个特征峰，甘草有11个特征峰。10批物质基准的平均乳膏率为（12.13±0.35）%。桂皮醛平均含量为0.32%，平均转移率为10.69%，不同批次桂皮醛含量在0.22%～0.42%之间，转移率在7.48%～13.90%之间。甘草苷平均含量为0.84%，平均转移率为50.39%，不同批次甘草苷含量在0.42%～1.26%之间，转移率在35.27%～65.51%之间。甘草酸平均含量为1.88%，平均转移率为40.74%，不同批次甘草酸含量在0.94%～2.82%之间，转移率在28.52%～52.96%之间。本文通过特征图谱、乳膏率和指标成分含量相结合的方式，分析了苓桂术甘汤物质基准的质量传递规律，初步建立了科学稳定的方法，为苓桂术甘汤的质量控制及制剂研发提供了科学依据。
