Urinary-Trypsin Inhibitor, a glucoprotein proteinase inhibitor, inhibits various enzymes including trypsin, chymotrypsin, lactate, lipase, hyaluronidase, and several pancreatic enzymes. It is utilized in the treatment of conditions such as acute pancreatitis, chronic recurrent pancreatitis, and various shock states including hemorrhagic, traumatic, and endotoxic shock. The inhibitor exhibits a strong inhibitory effect on proteases, sugar hydrolases, and fat hydrolases. The precursor of Ulinastatin undergoes proteolytic processing, resulting in distinct functioning proteins. This inhibitor belongs to the Kunitz-type protease inhibitor superfamily and plays a crucial role in numerous physiological and pathological processes. The gene encoding Uristatin is located within a cluster of lipocalin genes on chromosome 9. Elevated Ulinastatin secretion serves as an early indicator of renal tubular involvement and possesses radical scavenging properties. Bikunin, a component of Ulinastatin, is localized to the cell membrane. Both free uristatin and bikunin are readily excreted in urine and primarily circulate in plasma bound to heavy chains, forming the proinhibitor form. The molecular weight of UTI is estimated to be around 20kDa based on calculations and approximately 40kDa based on SDS-PAGE analysis. Ulinastatin has been shown to interact specifically with the ORF3 protein of the hepatitis E virus and is involved in facilitating the export of alpha microglobulin from hepatocytes.
Human Urinary Trypsin Inhibitor is sourced from human urine.
It appears as a sterile white powder that has undergone lyophilization (freeze-drying).
The product is lyophilized from a solution containing 1mg/ml of the active ingredient, without any additional additives.
To reconstitute the lyophilized UTI, it is recommended to dissolve it in sterile 18MΩ-cm H2O at a concentration of at least 100µg/ml. The resulting solution can be further diluted in other aqueous solutions if needed.
For storage of the lyophilized UTI, keep it refrigerated between 2-8°C. Avoid freezing the product. After reconstitution, UTI should be stored at 4°C for a maximum of 2-7 days. For long-term storage, keep it frozen below -18°C. It's important to avoid repeated freeze-thaw cycles to maintain the product's stability.
Human UTI exhibits an activity level of 2350 IU per milligram.
Ulinastatin has been clinically used for the treatment of several conditions, including:
In Japan, it is marketed under the brand name Miraclid and is used to treat endoscopic retrograde cholangiopancreatography (ERCP)-induced pancreatitis . Studies have shown that ulinastatin can reduce the incidence of ERCP-induced pancreatitis and postoperative pancreatitis following pancreaticoduodenectomy . In India, it is marketed under various brand names such as Ulihope, Ulicrit-Liquid, Ulinase, and U-Tryp . In China, it is marketed under the brand name Techpool Roan and is approved for the treatment of acute pancreatitis, chronic recurrent pancreatitis, and acute circulatory failure .
Ulinastatin is an acid-resistant protease inhibitor that is released from the high-molecular-weight precursor I alpha T1 . It inactivates several serine proteases, which are enzymes that play a role in inflammation and coagulation . By inhibiting these proteases, ulinastatin helps to reduce inflammation and prevent tissue damage .
Research has shown that ulinastatin can be effective in reducing mortality in patients with severe sepsis . In a multicenter randomized controlled study conducted in India, ulinastatin was found to decrease 28-day all-cause mortality in patients with severe sepsis . The study also showed that ulinastatin reduced the incidence of new-onset organ failure, increased ventilator-free days, and shortened hospital stays .