Preparation of regulatory documents for sodium heparin

Abstract

Heparin is a direct-acting anticoagulant that regulates many biochemical and physiological processes. The quality of each drug or substance entering the market to the consumer, its packaging, storage conditions and shelf life, as well as quality control methods are established in accordance with the State Pharmacopoeia of the Russian Federation. However, despite the widespread use of heparin in medical practice, the State Pharmacopoeia of the Russian Federation XIV 2018 does not prescribe articles on the substance and drugs containing it as an active substance. Quality control of medicines is undoubtedly relevant. Thus, a negligent attitude in 2008 in China led to the fact that at the early stages of production, the drug was added to the sulfated chondroitin sulfate, which, like heparin, has anticoagulant properties, but is 100 times cheaper. As a result of the use of this drug, there have been more than 100 deaths in the United States and hundreds of serious adverse reactions in patients in Europe. In this regard, the purpose of this study is to determine the quality of heparin-containing injectable drugs.