The specification of ulinastatin for injection was issued by the State Medical Products Administration in The Circular on the Publication of the Catalogue of the Fourth Batch of Chemical Products in the Drug Administration Circular No. 106 [2002] of April 16, 2002. The specification published by the National Medical Products Administration is a recommended reference sample after the specification is revised. Enterprises may put forward Suggestions for revision if they have any doubts.
[Indications] shall be consistent with the original approval; (adverse reactions), (drug interactions) and other items, the enterprise shall not provide less than the sample. For the blank items or incomplete items in the sample specification, the enterprise shall be required to fill in according to the actual situation, such as commodity name, specification, etc.
[Pharmacology and Toxicology]
This strain is a refined glycoprotein extracted from human urine and belongs to protease inhibitor. It can inhibit trypsin and other trypsin activities, and is often used in the treatment of pancreatitis. In addition, the product has the functions of stabilizing lysosomal membrane, inhibiting the release of lysosomal enzyme and inhibiting the production of myocardial inhibitory factors, so it can be used in the rescue treatment of acute circulatory failure.