TABLE 4.
Estimated anticoagulant and antithrombotic potency values for H. forskali fCS
Values are in IU/1 mg of sample, with 95% confidence limits in parentheses. All were tested against the 6th International Standard for Unfractionated Heparin (07/328), except for the HCII assay, which was tested against the 2nd International Standard for LMWH (01/608). OSCS and heparin values are shown for comparison. EP, European Pharmacopeia; NIBSC, National Institute for Biological Standards and Control; USP, United States Pharmacopoeia; AT, antithrombin; LOD, limit of detection; F, Fenton-type depolymerization; P, photochemical depolymerization; dp, degree of polymerization (an average polymer length).
| Sheep plasma (EP) APTT | Human plasma (NIBSC) APTT | USP anti-Xa (AT-dependent) | USP anti-IIa (AT-dependent) | HCII (NIBSC) | |
|---|---|---|---|---|---|
| Native fCS | 131 (125–136) | 68.9 (67.2–70.6) | 0.40 (0.38–0.43) | 0.56 (0.53–0.59) | 120 (112–129) |
| F-fCS-dp20 | 89.5 (82.4–97.4) | 24.4 (22.9–26.0) | 0.46a (0.43–0.49) | <LOD | 7.8 (6.6–9.5) |
| F-fCS-dp9 | 23.7 (21.9–25.6) | 6.3 (6.1–6.6) | 0.181a (0.176–0.185) | <LOD | 0.65 (0.54–0.77) |
| P-fCS-dp10 | 72.5 (70.1–75.0) | 51.4 (49.5–53.3) | 1.10a (0.92–1.30) | <LOD | 13.6b (12.3–15.0) |
| P-fCS-dp6 | 21.0 (15.7–28.1) | 7.70c (7.43–7.98) | 0.28a (0.26–0.29) | <LOD | 0.96b (0.90–1.03) |
| OSCS | 214 (207–222) | 46.3 (45.2–47.3) | 27.1 (25.6–28.9) | 13.9 (13.2–14.7 | 201 (188–215) |
| Heparin | 199 (189–209) | 199 (193–204) | 203 (187–219) | 196 (176–218) | 206 (197–216) |
a Samples did not test parallel to the standard, indicating that they did not behave in the same manner.
b Samples tested well against the LMWH standard.
c The sample did not test well against the standard.