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Sodium ilaprazole medicine composition freeze-dried powder injection for treating peptic ulcer

A technology for ilaprazole sodium and peptic ulcer, which is applied in the field of medicine, can solve the problems of low insoluble particles, low impurity content, and poor stability, and achieve the effect of low impurity content, high purity, and good stability

Inactive Publication Date: 2015-11-18
QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] But above-mentioned crystalline form still has the problem of lower drug efficacy, poorer stability, the inventor starts from the research on the existence state of ilaprazole sodium solid chemical substance, and has prepared a kind of ilaprazole sodium compound through a large number of tests Crystal, after testing, it was surprisingly found that the new crystal compound has high purity, good fluidity, good stability, low impurity content, and is not easy to absorb moisture. It is safe and reliable in clinical application. High efficacy and bioavailability, good stability, good stability after compatibility with solvents, very low content of insoluble particles, very suitable for clinical application

Method used

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  • Sodium ilaprazole medicine composition freeze-dried powder injection for treating peptic ulcer
  • Sodium ilaprazole medicine composition freeze-dried powder injection for treating peptic ulcer
  • Sodium ilaprazole medicine composition freeze-dried powder injection for treating peptic ulcer

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1: Preparation of ilaprazole sodium crystal

[0030] 1) Prepare mixed solution A by mixing dimethylformamide and isopropanol at a volume ratio of 1:4;

[0031] 2) Take the ilaprazole sodium raw material, add the mixed solution A prepared in step 1), wherein the ratio of the volume of the mixed solution A to the mass of ilaprazole sodium is 10ml:1g, stir to dissolve all Add 0.1% g / ml activated carbon to the resulting solution for decolorization and filtration to obtain a clear solution;

[0032] 3) Prepare mixed solution B with isopropyl ether and dichloromethane at a volume ratio of 1:4.5;

[0033] 4) At room temperature, add mixed solution B to the clear solution obtained in step 2) under an ultrasonic field with a power of 0.8KW, where the amount of mixed solution B added is 5 times the volume of mixed solution A, and turn off the ultrasonic field after adding , cooled to -5°C, allowed to stand for 4 hours, crystals were precipitated, and dried to obtain ...

Embodiment 2

[0035] Embodiment 2: the preparation of ilaprazole sodium freeze-dried powder injection:

[0036] Prescription: in parts by weight as shown in Table 1

[0037] Table 1 Ilaprazole Sodium Composition Prescription

[0038]

[0039] Take the ilaprazole sodium compound of the present invention, stir and dissolve it with water for injection, add the prescribed amount of low-molecular-weight dextran, adjust the pH value to 8.0-9.0, then stir until the pH remains constant, then add water for injection until the volume of the solution is 150 times the weight of ilaprazole sodium, then coarsely filter with activated carbon, pass through 1.0μm, 0.45μm, 0.22μm microporous membranes in turn to sterilize and filter, filter into the sterile room, measure the pH and content after passing the filling , press half the stopper, put it into a freeze-drying box that has been cooled to -50°C, freeze-dry, press the stopper out of the box, and roll the cap.

[0040] The freeze-drying process is ...

Embodiment 3

[0041] Embodiment 3: the preparation of ilaprazole sodium freeze-dried powder injection:

[0042] Prescription: in parts by weight as shown in Table 2

[0043] Table 2 Ilaprazole Sodium Composition Prescription

[0044]

[0045] Take the ilaprazole sodium compound of the present invention, stir and dissolve it with water for injection, add the prescribed amount of low-molecular-weight dextran, adjust the pH value to 8.0-9.0, then stir until the pH remains constant, then add water for injection until the volume of the solution is 150 times the weight of ilaprazole sodium, then coarsely filter with activated carbon, pass through 1.0μm, 0.45μm, 0.22μm microporous membranes in turn to sterilize and filter, filter into the sterile room, measure the pH and content after passing the filling , press half the stopper, put it into a freeze-drying box that has been cooled to -50°C, freeze-dry, press the stopper out of the box, and roll the cap.

[0046] The freeze-drying process is ...

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Abstract

The invention discloses a sodium ilaprazole medicine composition freeze-dried powder injection for treating peptic ulcer, and belongs to the technical field of medicines. The sodium ilaprazole medicine composition freeze-dried powder injection comprises sodium ilaprazole and an excipient, wherein the excipient is low molecular dextran; sodium ilaprazole is a novel crystal compound different from that reported in the prior art, and the X-ray powder diffraction pattern of sodium ilaprazole is measured by utilizing Cu-K alpha rays and shown in Figure 1. Experiments prove that the novel crystal sodium ilaprazole compound is high in purity, liquidity and stability, low in impurity content and hygroscopicity, and safe and reliable in clinical application; the sodium ilaprazole medicine composition freeze-dried powder injection prepared by utilizing the novel crystal sodium ilaprazole compound is high in bioavailability and stability; the stability of the sodium ilaprazole medicine composition freeze-dried powder injection remains high after the sodium ilaprazole medicine composition freeze-dried powder injection is compatible with a solvent; the content of insoluble particles is extremely low. Therefore, the sodium ilaprazole medicine composition freeze-dried powder injection is particularly suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a drug ilaprazole sodium composition freeze-dried powder injection for treating peptic ulcer. Background technique [0002] Ilaprazole, also known as IY-81149, is a new type of irreversible proton pump inhibitor developed by Ilyang Pharmaceutical Company in Korea. Its inhibitory effect on Helicobacter pylori (HP) is stronger than that of omeprazole. It is 1 / 4 of omeprazole, less likely to produce drug resistance, and has no obvious toxic and side effects; compared with the original similar products, ilaprazole has overcome the delay in gastric emptying caused by the original similar products to varying degrees , parietal cell swelling and obvious rebound of gastric acid secretion after drug withdrawal, etc., and can enhance the curative effect on dysmotility-like functional dyspepsia (GERD) and other acid-related diseases, and the onset is faster and the acid-suppressing effect B...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61P1/04C07D401/14
Inventor 刘学键
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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