Preparation technology of carbazochrome sodium sulfonate for injection

Abstract

The invention discloses a preparation technology of carbazochrome sodium sulfonate for injection, solving the shortcoming of the conventional preparation technology of carbazochrome sodium sulfonate injection. The preparation technology is low in cost, high in yield, and high in stability of the quality of carbazochrome sodium sulfonate. The preparation technology comprises the following steps of: (1) adding mannitol to about 25% of infusion water based on preparation amount, heating to completely dissolve, then adding 0.2% (W / V) medical carbon based on the preparation amount, boiling for 30 minutes, and decarburizing and filtering; (2) getting 30% of injection water based on the preparation amount, cooling to reach temperature less than 40 DEG C, adding absolute carbazochrome sodium sulfonate, stirring to completely dissolve, and adding the solution to the mannitol filtrate to uniformly mix; and (3) adjusting the pH (Potential of Hydrogen) of the liquid medicine into 5.5 to 6.0 by 10% of sodium hydroxide solution, adding the injection water until reaching the preparation amount, stirring uniformly, rechecking the pH between 5.5 and 6.0, sequentially filtering by microfiltration membranes of 0.45 microns and 0.22 microns, delivering semi-finished products for inspection, and filling after passing the inspection. By adopting the preparation technology, the market competitiveness of the carbazochrome sodium sulfonate is improved, the convenience is provided for market sales of the carbazochrome sodium sulfonate, and the preparation technology is worthy for popularization.

Description

technical field [0001] The invention relates to a preparation process of injections, in particular to a new production process of sodium carbosulfonate for injection which is superior to the traditional process. Background technique [0002] The main component of sodium carbosulfonate for injection is sodium carbosulfonate, chemical name: 1-methyl-6-oxo-2,3,5,6-tetrahydroindole-5-semicarbazone-2-sulfonic acid Sodium salt trihydrate. It is orange-yellow freeze-dried block or powder; it is hygroscopic and easily soluble in water. For urinary system, upper gastrointestinal tract, respiratory tract and obstetrics and gynecology bleeding diseases. The curative effect on the urinary system is more significant, and it can also be used for the prevention and treatment of surgical bleeding. Because of its good curative effect and few side effects, the market demand is large. [0003] There are several domestic enterprises producing it, and the preparation and production processes ...

AI Technical Summary

Problems solved by technology

[0006] The present invention aims at the defect that the rejection rate of lamp inspection is too high in the traditional preparation process of sodium carbosulfonate injection in the past, and proposes to reduce the dosage of the original excipient (mannitol) from 120 mg / ml to 40 mg / ml, effectively reducing the lamp time. Check the scrap rate, improve the product yield, reduce the product cost, and ensure the quality stability of the product