Formulation | PSI | R |
---|
Group I
| Â | Â |
   PHY906-6 | 1 | 1 |
   PHY906-7 | 0.99 | 0.99 |
   PHY906-8 | 0.99 | 0.99 |
   PHY906-10 | 0.97 | 0.99 |
Group II
| Â | Â |
   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
| Â | Â |
   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 |
- 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.