A kind of pharmaceutical composition containing ilaprazole sodium and preparation method thereof

A composition and drug technology, applied in the field of medicine, can solve problems such as lack of research work

Active Publication Date: 2020-09-22
LIVZON PHARM GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, at present, there is a lack of further research work on how to more effectively control the bleeding of acute gastric mucosal lesions, severe stress reactions such as acute gastric mucosal damage such as multiple trauma, and the prescription of ilaprazole powder injection with more stable quality

Method used

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  • A kind of pharmaceutical composition containing ilaprazole sodium and preparation method thereof
  • A kind of pharmaceutical composition containing ilaprazole sodium and preparation method thereof
  • A kind of pharmaceutical composition containing ilaprazole sodium and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0085] Embodiment 1 preparation of ilaprazole sodium powder injection

[0086] (1) Taking materials according to prescription: ilaprazole sodium (purity 99.9%) 97.7mg, ilaprazole sulfone 0.2mg, ilaprazole sulfide 0.2mg, ilaprazole carboxylium inner salt 0.3mg, Ilaprazole Hydroxylium Inner Salt 0.3mg, Ilaprazole Methylonium Inner Salt 0.3mg, Ilaprazole Methylonium Inner Salt 0.2mg, Ilaprazole Thiocyanate Inner Salt 0.2mg, Ilaprazole disulfide dimer 0.2mg, ilaprazole trisulfide dimer 0.2mg, ilaprazole nitrogen oxide 0.2mg, mannitol 300mg, EDTA-2Na 10mg.

[0087] (2) Dissolve mannitol and edetate disodium with water for injection, adjust the pH value to 10.5 with 2mol / L sodium hydroxide solution, add the ilaprazole sodium (purity 99.9%) weighed in step (1) , ilaprazole sulfone, ilaprazole sulfide, ilaprazole carboxyl onium inner salt, ilaprazole hydroxyl onium inner salt, ilaprazole mercaptomethyl onium inner salt, ilaprazole methyl onium Inner salt, ilaprazole thiocyanate inne...

Embodiment 2-9

[0089] Embodiment 2-9 Preparation of ilaprazole sodium powder injection

[0090] The prescription of embodiment 2-9 is as shown in table 1, and preparation method is the same as embodiment 1.

[0091] Table 1

[0092]

experiment example 10

[0094] 1. Clarity detection

[0095] Get 30mg of the ilaprazole sodium powder injection prepared in Example 1 and the ilaprazole sodium powder injection prepared in the following three groups of A, B, and C, add water for injection to 1g, open the mouth of the bottle, ℃, 16℃, 25℃, 40℃, observe the change of solution color and solution clarity. Another 30 mg of mannitol and 1 mg of EDTA2Na were dissolved in an appropriate amount of water for injection, and water for injection was continued to be added to 1 g as a blank group, and the test was carried out at the same time. The results are shown in Table 2.

[0096] Group A ilaprazole composition: according to the preparation method of CN102038648A Example 2, obtain ilaprazole sodium powder injection (referred to as A);

[0097] Group B ilaprazole composition: according to the preparation method of CN 105769778A Example 1, obtain ilaprazole sodium powder injection (referred to as B);

[0098] Group C ilaprazole composition: Acco...

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PUM

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Abstract

The invention relates to a pharmaceutical composition containing ilaprazole sodium and a preparation method thereof. The pharmaceutical composition is prepared from the ilaprazole sodium and ilaprazole derivatives, wherein the ilaprazole derivatives comprise ilaprazole sulfone, ilaprazole thioether, ilaprazole carboxyl ylide, ilaprazole hydroxyl ylide, ilaprazole mercaptomethyl ylide, ilaprazole methyl ylide, ilaprazole thiocyanmethyl ylide, ilaprazole dithiodimer, ilaprazole trithiodimer and ilaprazole nitrogen oxide. The pharmaceutical composition can be used for treating peptic ulcer hemorrhage and stress ulcer, and preventing upper gastrointestinal hemorrhage caused by serious illnesses.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a pharmaceutical composition containing ilaprazole sodium and a preparation method thereof. Background technique [0002] Ilaprazole (Ilaprazole Sodium), chemical name: 5-(1 hydrogen-pyrrol-1-yl)-2~[[(4-methoxy-3-methyl)-2-pyridyl]-methanol Base]-sulfinyl-1 hydrogen-benzimidazole sodium salt. Ilaprazole is the latest generation of proton pump inhibitor (PPI) developed and marketed by Livzon Group, which is widely used in various acid-related gastrointestinal diseases, such as duodenal ulcer, gastric ulcer and reflux esophagitis Wait. Compared with other PPIs, ilaprazole has the strongest antacid activity, no individual differences in treatment, and stronger ability to control acid at night, and is expected to become a core product in the PPI market. [0003] Chinese patents CN1184970C and CN1225240C respectively disclose ilaprazole oral tablet and its microparticle preparatio...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D401/14A61K31/4439A61K9/14A61K9/19A61P1/04A61P7/04
CPCA61K9/145A61K9/19A61K31/4439A61P1/04A61P7/04C07D401/14
Inventor 王涛侯雪梅成彩华陆文岐孔祥生张象娜涂增清张裕容吴小红李菁谌红丹陈嘉璐
Owner LIVZON PHARM GRP INC
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