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Table 3 PSI and R-values for the Chemical Fingerprints of Seventeen Batches of PHY906 and HQT

From: A comprehensive platform for quality control of botanical drugs (PhytomicsQC): a case study of Huangqin Tang (HQT) and PHY906

Formulation

PSI

R

Group I

  

   PHY906-6

1

1

   PHY906-7

0.99

0.99

   PHY906-8

0.99

0.99

   PHY906-10

0.97

0.99

Group II

  

   HQT-E

0.94

0.99

   HQT-F

0.81

0.98

   HQT-G

0.84

0.97

   HQT-H

0.87

0.98

   HQT-I

0.89

0.98

   HQT-J

0.84

0.98

   HQT-K

0.82

0.98

   HQT-L

0.86

0.98

Group III

  

   HQT-CSZ2

0.89

0.99

   HQT-SF

0.67

0.97

   HQT-SC

0.95

0.99

   HQT-MT

0.74

0.98

   HQT-KP3

0.93

0.99

   HQT-KD

0.96

0.99

  1. The chemical fingerprint intensity pattern of 39 peaks is used to compare the similarity of seventeen independently manufactured batches of PHY906 or HQT with the clinical batch PHY906-6. Group I consists of four clinical batches: PHY906-6, 7, 8 and 10. Group II consists of eight batches manufactured for sale as Huang Qin Tang by a single vendor: HQT-E, F, G, H, I, J, K and L. Group III consists of six batches that are reported to be Huang Qin Tang and that are manufactured by different vendors with unknown protocols, specifications or quality control: HQT-CSZ, KD, MT, SC, SF and KP3. A PSI value of 1.0 indicates identical patterns of the intensity ratio pattern of the chemical fingerprint between the PHY906-6 and a second batch. A PSI value of 0.0 indicates no similarity of the intensity ratio pattern between the two batches. Batches in Group I are found to be highly similar to PHY906-6 including PHY906-10 that is manufactured six years after batches PHY906-6, 7, 8 using different harvests of the raw herbal starting products. Group II are relatively tightly clustered at a lower PSI value, and while similar to each other are clearly distinguishable from Group I. Group III are poorly clustered, highly variable and span the largest PSI range (0.67 - 0.95). While some batches are very similar to PHY906-6, other batches are quite different. In the lower panel is a full matrix of PSI values comparing PHY906-6, 7, 8, 10 and HQT-F. Intra-batch comparisons indicate the high degree of similarity of the clinical batches (Group I) and the lower degree of similarity of Group I batches with HQT-F.