Quality control of Tibetan medicine Baimai Ointment based on multi-component determination, fingerprint and multivariate statistical analysis / 中草药

ABSTRACT

Objective: To establish a fingerprint method of Baimai Ointment (BO) and determine the content of its main components. The BO of 14 batches from two production areas was scientifically and comprehensively evaluated based on multivariate statistical analysis, which provided the basis for the quality control. Methods: HPLC method was used to determine the content of liquiritin, ammonium glycyrrhizinate, nardosinone and curcumin in BO, and the fingerprint of BO was established. The fingerprint similarity analysis, cluster analysis, principal component analysis (PCA) and factor analysis were performed to comprehensively evaluate the different batches of BO in two producing areas. Results: The methodological determination of liquiritin, ammonium glycyrrhizinate, nardosinone and curcumin met the requirements, and the content was 0.051-0.200 mg/g, 0.136-0.622 mg/g, 0.030-0.345 mg/g, 0.001-0.069 mg/g, respectively. The established fingerprints of BO were calibrated with 17 common peaks. Three chromatographic peaks of liquiritin, ammonium glycyrrhizinate and nardosinone were identified by reference. The similarity of 14 batches of sample was greater than 0.975. In the cluster analysis, 14 batches of BO from two producing areas can be divided into four categories, among which batches S1-S11 produced by Linzhi City of Tibet were grouped into one category. And S12 produced in Lanzhou City of Gansu Province was clustered into one class, and S13 was clustered into one class, S14 was grouped into one class. The results of PCA and factor analysis showed that the comprehensive scores of the three batches of S12-S14 produced in Lanzhou City of Gansu Province were higher than the 11 batches of S1-S11 produced by Linzhi City of Tibet, presumably because of the changes in production conditions or sources of medicinal materials. The result was consistent with cluster analysis. Conclusion: This study is the first to establish a scientific and reliable quality control method of Tibetan medicine BO based on multi-component determination, fingerprint and multivariate statistical analysis. It can be used not only for the quality control of Baimai Ointment, but also for the comprehensive evaluation of batch quality consistency. It provides reference for the improvement of the quality standard of BO and the quality evaluation among Chinese medicine batches.