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.