Novel process for preparing heparin sodium crude product

Abstract

The invention discloses a novel process for preparing a heparin sodium crude product. The novel process comprises the following specific preparation process steps: step 1, removing connective tissues, grease and impurities from fresh small intestine mucosa or frozen and unfrozen small intestine mucosa, and mincing into paste; step 2, adding the raw materials prepared in the step 1 into a reaction cylinder, mixing the prepared biological calcium solution with the minced small intestine mucosa paste according to a ratio of 1: 3, adding a bacteriostatic agent accounting for 0.2-0.4% of the total mass of the mixture, uniformly stirring, adding nuclease, and carrying out enzymolysis treatment; step 3, adjusting the pH value of the solution prepared in the step 2 to 8-10 by using a 30-40% sodium hydroxide solution, activating for 1-5 hours, concentrating, drying and crushing to obtain usable biological enzyme powder; and step 4, adding the raw materials prepared in the step 1 into a reaction cylinder, adding a protective agent, stirring, standing for 20-40 minutes, and centrifuging at low temperature to obtain crude heparin sodium. The novel process for preparing the heparin sodium crude product is stable and reliable, simple in equipment, convenient to operate, high in practicability and suitable for being widely popularized and used.

Description

technical field [0001] The invention belongs to the technical field of crude heparin sodium production, and in particular relates to a new process for preparing crude heparin sodium. Background technique [0002] Heparin is a natural bioactive mucopolysaccharide substance discovered from the liver of dogs by McLane in 1916 when he was studying blood coagulation. More than ten years later, developed countries in Europe and the United States discovered and extracted it from bovine lung, and later found that it was extremely rich in small intestinal mucosa of pigs and sheep, and began to conduct medical clinical research. Heparin was officially listed in the United States Pharmacopoeia in 1940, and it is widely used in anticoagulation, prevention of thrombosis, and treatment of cardiovascular and cerebrovascular diseases. my country began to introduce production in the 1970s, and it has a history of nearly 40 years. The current market supply is mainly crude heparin sodium extr...

AI Technical Summary

Problems solved by technology

[0003] The purpose of the present invention is to provide a new process for the preparation of crude heparin sodium to solve the problem that the existing new process for the preparation of crude heparin sodium proposed in the above-mentioned background technology makes the loss of heparin activity large and the product recovery rate low; use low temperature centrifugation and ultrafiltration membrane Fractionation, concentration, long production cycle, slow separation speed, not thorough enough, low product purity