The Changes of Fibrinolytic Activity of Nattokinase in Artificial Gastrointestinal Environment and Human Digestive Juice

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Purpose: To search for the change of fibrinolytic activity of different forms of nattokinase when they were treated in human digestive juice, artifical gastric and intestinal juice differently, and to lay the foundation of a proper pharmaceutical dosage form of nattokinase. To provide direct evidences that Nattokinase products can be administered orally and to screen a suitable dosage form for oral administration of nattokinase.Methods: The non-crushed sample was prepared through the solid fermentation of soybean meal at 37°C for 36 h, and evaporation at 70°C for 8 h, The fine and ultra-fine powder were gotten from the non-crushed sample by the micronizer and ultra micronizer. Nattokinase extract was the supernatant liquid of 0.9% saline of non-crush samples. The nattokinase’s fibrinolytic activity of non-crushed sample, fine powder, ultra-fine powder and extract treated in artifical and human digestive were measured by the Fibrin plate method. Results: Three kind of solid form samples still remain about 80% fibrinolytic activity in artificial gastric juice for 4 h, and the fibrinolytic activity of nattokinase extract is 48.7% at the end of treatment. Treated in artificial gastric juice for 4 hours, then handled in artificial intestinal fluid for 4 h, the final fibrinolytic activity of fine and ultra fine powder is 47.0% and 51.0%. The fibrinolytic activity of extract is 79.8% at the end of treatment in human digestive juice for 4 h. At the beginning of treatment in human digestive juice the enzyme activity of fine and ultra fine powder is 130.8U/mL and 132.1U/mL, however, after treatment for 4 h the enzyme activity is 158.7U/mL and159.6U/mL, which is near to the total enzyme activity of sample. Conclusion: Nattokinase products can be administered orally, and solid preparations of nattokinase are more suitable for oral route. The optimum dosage form for oral administration of nattokinase is enteric-coated capsules containing ultra fine powder.