Rabeprazole sodium combined medicament and preparation process thereof

Abstract

The invention provides a rabeprazole sodium combined medicament and a preparation process thereof. The rabeprazole sodium combined medicament is characterized by comprising the following raw materials as components in proportion by weight: 5-10 of ilaprazole sodium, 20-30 of composition of reduced glutathione and hepatocyte growth-promoting factors in proportion by weight of 1:10, and 50-60 of diammonium glycyrrhizinate. According to a pharmaceutically allowable dose of rabeprazole sodium, pharmaceutical preparations in dosage forms of injection, lyophilized powder injection, enteric coated tablets, enteric coated capsules, spray and the like of the rabeprazole sodium combined medicament are respectively prepared for treating gastric ulcer.

Description

technical field [0001] The invention relates to a combination medicine of bereprazole sodium and a preparation process thereof. Background technique [0002] The gastric and duodenal mucosa has a natural and perfect mechanism to resist the erosion of gastric acid and pepsin, but when it is damaged by Helicobacter pylori and non-steroidal anti-inflammatory drugs, peptic ulcer disease will occur. Australian scholars Warren and Marshall reveal the etiology, and have H 2 Receptor antagonist therapy drugs are effective in treatment, and 22 years later, the two were awarded the 2005 Nobel Prize in Medicine. In the 1980s, there were proton pump inhibitor drugs for the treatment of peptic ulcer disease, compared with H 2 Inhibitor treatments are more powerful and long-lasting. Bereprazole sodium is a typical representative drug, which is currently one of the first-line first-line drugs for the treatment of peptic ulcer disease. However, the bereprazole sodium freeze-dried inject...

AI Technical Summary

Problems solved by technology

However, the bereprazole sodium freeze-dried injection of the prior art still adopts the activated carbon depyrogenation process in the preparation production, resulting in the tiny particles of activated carbon and heavy metal ions remaining in the medicinal liquid, which are brought into the blood of the human body during intravenous infusion. Bring medicinal damage to the body, and the present invention research finds, the pyrogen in the activated carbon adsorption liquid medicine is not thorough, and reason is: the one, most pharmaceutical factories adopt activated carbon to add weight to be below 0.08% of the volume of the liquid medicine; The second is that activated carbon itself does not depyrogenize and activate

This study also found that the heavy metal ions and iron ions brought by activated carbon are oxidative hazards to the drug; the auxiliary excipient of the freeze-dried injection prepared by the prior art uses low-molecular dextran-40, which has allergic effects on the human body, and some people After dripping a few drops of low-molecular dextran-40 infusion, an allergic reaction occurred. The amount of low-molecular dextran-40 used as an excipient for bereprazole sodium has reached the minimum amount of allergies. The skeleton of the excipient, mannitol has an adverse reaction to blood vessel irritation; the preparation of bereprazole sodium in the prior art does not protect the oxidation and peroxidation of bereprazole sodium during manufacture, storage, transportation, use and entering the body. Adverse reactions of the drug caused by photooxidation

Images