Pharmaceutical composition containing llaprazole or salt thereof and preparation method thereof

A technology of ilaprazole and ilaprazole carboxyl group, applied in the field of medicine, can solve problems such as lack of research work, and achieve the effects of stable quality, effective gastric mucosal bleeding symptoms, and clinical significance

A technology of ilaprazole and ilaprazole carboxyl group, applied in the field of medicine, can solve problems such as lack of research work, and achieve the effects of stable quality, effective gastric mucosal bleeding symptoms, and clinical significance

CN108685918AActive Publication Date: 2018-10-23LIVZON PHARM GRP INC
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  • Pharmaceutical composition containing llaprazole or salt thereof and preparation method thereof
  • Pharmaceutical composition containing llaprazole or salt thereof and preparation method thereof
  • Pharmaceutical composition containing llaprazole or salt thereof and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0096] Embodiment 1 preparation of ilaprazole sodium powder injection

[0097] (1) Taking materials according to prescription: ilaprazole sodium 98.7mg, ilaprazole sulfone 0.2mg, ilaprazole sulfide 0.2mg, ilaprazole carboxylium inner salt 0.3mg, ilaprazole hydroxyl Onium inner salt 0.3 mg, ilaprazole mercaptomethyl onium inner salt 0.3 mg, mannitol 300 mg, EDTA-2Na 10 mg.

[0098](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, fully dissolved and then use 2mol / L sodium hydroxide solution to adjust the pH value to 11, and finally add water for injection at 4°C to 1500mg;

[0099] (3) Filtrate twice with a filter membrane with a pore size of 0.2 μm to sterilize and freez...

Embodiment 2-8

[0101] The prescription of embodiment 2-8 is as shown in table 1, and preparation method is the same as embodiment 1.

[0102] The prescription of table 1 embodiment 1-8

[0103]

experiment example 9

[0105] 1. Clarity detection

[0106] 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.

[0107] Group A ilaprazole composition: according to the preparation method of CN102038648A Example 2, obtain ilaprazole sodium powder injection (referred to as A);

[0108] Group B ilaprazole composition: according to the preparation method of CN 105769778A Example 1, obtain ilaprazole sodium powder injection (referred to as B);

[0109] Group C ilaprazole composition: Ac...

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Abstract

The invention relates to a pharmaceutical composition containing Ilaprazole or a salt thereof and a preparation method thereof. The pharmaceutical composition contains or consists of Ilaprazole or a salt thereof and a Ilaprazole derivative, wherein the amount of the Ilaprazole derivative is not higher than 1.3wt% (less than 1.3wt%). The pharmaceutical composition can be used for treating peptic ulcer bleeding and stress ulcer and preventing upper gastrointestinal hemorrhage caused by severe diseases.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a pharmaceutical composition containing ilaprazole or a salt thereof 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...

Claims

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Application Information

Patent Timeline
23 Oct 2018
Publication
CN108685918A
IPC
A61K31/4439; A61K9/19; A61K47/02; A61P1/04
CPC
A61K47/02; A61P1/04; A61K9/0019; A61K9/19; A61K31/4439; A61K47/26; A61K47/183; A61K47/55
Inventors
王涛; 侯雪梅