Combination medicament of ilaprazole sodium and preparation process thereof

Abstract

The invention provides a combination medicament of ilaprazole sodium. The medicament is characterized by comprising the following raw materials in percentage by weight: 5-10 percent of ilaprazole sodium, 25-35 percent of reduction composition containing glutathione and tiopronin with a weight ratio of 1:10 and 45-55 percent of diammonium glycyrrhizinate. The invention also provides a preparation process of the medicament. According to a pharmaceutically acceptable dosage of the ilaprazole sodium, the combination medicament can be respectively prepared into medical preparations of the dosage forms of injections of the combination medicament of the ilaprazole sodium, freeze-drying injections of combination medicament of the ilaprazole sodium, coated tablets of the combination medicament of the ilaprazole sodium, enteric capsules, sprays, and the like and is used for treating gastric ulcer.

Description

technical field [0001] The invention relates to a combination drug of ilaprazole 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. Ilaprazole 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 freeze-dried injection of ilaprazole sodium ...

AI Technical Summary

Problems solved by technology

However, the freeze-dried injection of ilaprazole sodium in the prior art still adopts activated carbon depyrogenation process in the production of preparations, resulting in tiny particles of activated carbon and heavy metal ions remaining in the medicinal solution, 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 ilaprazole sodium has reached the minimum amount of allergies. The skeleton of the excipient, mannitol has a stimulating adverse reaction to blood vessels; the preparation of ilaprazole sodium in the prior art does not protect the oxidation and peroxidation of ilaprazole sodium in the process of manufacture, storage, transportation, use and entering the body. Adverse reactions of the drug caused by photooxidation

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