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Ilaprazole sodium composition freeze-dried powder injection serving as medicine for treating stomach diseases

A technology of ilaprazole sodium and freeze-dried powder injection, applied in the field of medicine, can solve the problems of low insoluble particles, low impurity content, and difficulty in hygroscopicity, and achieve the effects of low impurity content, high purity, and difficulty in hygroscopicity.

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 crystal form still has the problems such as lower drug effect, poorer stability etc., the inventor starts with researching on the existence state of ilaprazole sodium solid chemical substance, has prepared a kind of ilaprazole sodium through a large number of tests Compound 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. The freeze-dried powder injection prepared by using the new crystal compound 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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  • Ilaprazole sodium composition freeze-dried powder injection serving as medicine for treating stomach diseases
  • Ilaprazole sodium composition freeze-dried powder injection serving as medicine for treating stomach diseases
  • Ilaprazole sodium composition freeze-dried powder injection serving as medicine for treating stomach diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1: Preparation of ilaprazole sodium crystals

[0032] (1) Dissolve ilaprazole sodium in a mixed solvent of acetone and dimethyl sulfoxide, the required amount of solvent per gram of ilaprazole sodium is 100ml, and the volume ratio of acetone and dimethyl sulfoxide is 4: 1.5;

[0033] (2) After heating to 30°C to dissolve, add seed crystals after cooling to room temperature;

[0034] (3) Cool to below 0°C, stir and crystallize, the crystallization temperature is -15°C, filter, dry, collect crystals to obtain ilaprazole sodium crystals.

[0035] The X-ray powder diffraction pattern that the prepared ilaprazole sodium crystal uses Cu-Kα ray to measure is as follows figure 1 shown.

Embodiment 2

[0036] Example 2: Preparation of Ilaprazole Sodium Freeze-dried Powder Injection

[0037] Prescription: in parts by weight as shown in Table 1

[0038] Table 1 Ilaprazole Sodium Composition Prescription

[0039]

[0040] Take the ilaprazole sodium compound of the present invention, stir and dissolve it with water for injection, add the prescribed amount of trehalose, adjust the pH value to 8.0-9.0, and then stir until the pH remains constant, then add water for injection until the solution volume is ilaprazole 120 times the weight of azole sodium, then coarsely filter with activated carbon, and then pass through 1.0μm, 0.45μm, 0.22μm microporous membranes to sterilize and filter, filter into a sterile room, measure the pH and content to pass, fill, press half Stopper, put it into a freeze-drying box that has been cooled to -45°C, freeze-dry at low temperature, press the stopper out of the box, and roll the cap.

[0041] Described freeze-drying is:

[0042] Pre-freezing: ...

Embodiment 3

[0045] Example 3: Preparation of Ilaprazole Sodium Freeze-dried Powder Injection

[0046] Prescription: in parts by weight as shown in Table 2

[0047] Table 2 Ilaprazole Sodium Composition Prescription

[0048]

[0049] Take the ilaprazole sodium compound of the present invention, stir and dissolve it with water for injection, add the prescribed amount of trehalose, adjust the pH value to 8.0-9.0, and then stir until the pH remains constant, then add water for injection until the solution volume is ilaprazole 120 times the weight of azole sodium, then coarsely filter with activated carbon, and then pass through 1.0μm, 0.45μm, 0.22μm microporous membranes to sterilize and filter, filter into a sterile room, measure the pH and content to pass, fill, press half Stopper, put it into a freeze-drying box that has been cooled to -45°C, freeze-dry at low temperature, press the stopper out of the box, and roll the cap.

[0050] Described freeze-drying is:

[0051] Pre-freezing...

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Abstract

The invention discloses an Ilaprazole sodium composition freeze-dried powder injection serving as medicine for treating stomach diseases, and belongs to the technical field of medicine. A composition comprises ilaprazole sodium and an excipient. The excipient is trehalose. The ilaprazole sodium is a novel-crystal-form compound, the X-ray powder diffraction pattern measured through Cu-Kalpha rays is shown as figure 1, and the ilaprazole sodium is different from ilaprazole sodium reported in the prior art; experiments show that the novel-crystal-form compound is high in purity, good in fluidity and stability, low in impurity content, not prone to absorbing moisture and safe and reliable in clinical application; the freeze-dried powder injection prepared through the novel-crystal-form compound is high in effect and bioavailability and good in stability; after compatibility is carried out on the powder injection and solvents, stability is good, the content of insoluble particles is quite small, and the powder injection is quite suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a freeze-dried powder injection of ilaprazole sodium composition for treating stomach diseases. 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 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/36A61P1/04C07D401/14F26B5/10
Inventor 刘学键
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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