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Medicine lansoprazole composition freeze-dried powder injection for treating digestive system diseases

A technology for digestive system diseases and freeze-dried powder injection, applied in the field of medicine, can solve problems such as unsatisfactory results and influence on drug quality, and achieve the effects of excellent fluidity, good stability and low content of insoluble particles

Inactive Publication Date: 2015-10-28
QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] However, according to the chemical structure characteristics of lansoprazole, lansoprazole easily produces the following impurity A, impurity B and impurity E during production and storage, and these trace impurities will affect the quality of the drug
Although some crystal forms of the above-mentioned lansoprazole have improved its hygroscopicity, solubility or stability to a certain extent, the inventors' results are not ideal after investigating the impurities of the above-mentioned certain crystal forms

Method used

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  • Medicine lansoprazole composition freeze-dried powder injection for treating digestive system diseases
  • Medicine lansoprazole composition freeze-dried powder injection for treating digestive system diseases
  • Medicine lansoprazole composition freeze-dried powder injection for treating digestive system diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1: Preparation of Lansoprazole Crystals

[0035] (1) Dissolve lansoprazole in a mixed solvent of methanol and dimethyl sulfoxide, the amount of solvent required for each gram of lansoprazole is 100ml, and the volume ratio of methanol and dimethyl sulfoxide is 4:1.5;

[0036] (2) After heating to 30°C to dissolve, add seed crystals after cooling to room temperature;

[0037] (3) Cool to below 0°C, stir and crystallize, the crystallization temperature is -15°C, filter, dry, collect crystals to obtain lansoprazole crystals.

[0038] The X-ray powder diffraction pattern that the prepared lansoprazole crystal uses Cu-Kα ray measurement to obtain is as follows figure 1 shown.

Embodiment 2

[0039] Example 2: The preparation of lansoprazole freeze-dried powder injection:

[0040] Prescription: in parts by weight as shown in Table 1

[0041] Table 1 Lansoprazole composition prescription

[0042]

[0043] Get the lansoprazole compound of the present invention, stir and dissolve with water for injection, add the trehalose of prescription quantity, adjust the pH value to be 8.0-9.0, then stir until the pH is constant, add water for injection until the solution volume is lansoprazole 100 times the weight, 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 to pass, fill, press half the plug, Put it into a freeze-drying box that has been cooled to -45°C, freeze-dry at a low temperature, press the plug out of the box, and cover it.

[0044] Described freeze-drying is:

[0045] Pre-freezing: freeze-dry the aliquoted drug so...

Embodiment 3

[0048] Example 3: The preparation of lansoprazole freeze-dried powder injection:

[0049] Prescription: in parts by weight as shown in Table 2

[0050] Table 2 Lansoprazole composition prescription

[0051]

[0052] Get the lansoprazole compound of the present invention, stir and dissolve with water for injection, add the trehalose of prescription quantity, adjust the pH value to be 8.0-9.0, then stir until the pH is constant, add water for injection until the solution volume is lansoprazole 100 times the weight, 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 to pass, fill, press half the plug, Put it into a freeze-drying box that has been cooled to -45°C, freeze-dry at a low temperature, press the plug out of the box, and cover it.

[0053]Described freeze-drying is:

[0054] Pre-freezing: freeze-dry the aliquoted drug solutio...

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Abstract

The invention discloses a medicine lansoprazole composition freeze-dried powder injection for treating digestive system diseases, and belongs to the technical field of medicine. The medicine lansoprazole composition comprises lansoprazole and excipient, wherein the excipient is mycose; the lansoprazole is a novel crystal form compound; the X-ray powder diffraction pattern measured by a Cu-K alpha ray is shown as the Figure 1; the lansoprazole is lansoprazole different from that reported in the prior art. Experiments prove that the lansoprazole crystal form compound provided by the invention does not contain impurities E; in addition, the contents of impurities A and impurities B are obviously reduced; the content change is small along with the prolonging of storage time; the fluidity is good; the dissolubility is obviously improved. The freeze-dried powder injection prepared from the novel crystal form compound has the advantages that the stability is good; the stability is good after the novel crystal form compound is matched with solvents; the insoluble particulate content is extremely low; the freeze-dried powder injection is very suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a drug lansoprazole composition freeze-dried powder injection for treating digestive system diseases. Background technique [0002] Lansoprazole is a benzimidazole derivative with anti-acid effect developed by Takeda Corporation of Japan in December 1991. It acts on the H+-K+-ATPase of gastric parietal cells, so that the H+ of parietal cells cannot be transported into the stomach It is used to treat gastric ulcer, duodenal ulcer and reflux esophagitis, and to eradicate Helicobacter pylori. [0003] Lansoprazole is a new type of proton pump inhibitor, which is an upgraded product of omeprazole. Lansoprazole has introduced fluorine into the side chain at the 4-position of the pyridine ring and has a trifluoroethoxy substituent, so that its bioavailability is relatively low. Omeprazole is increased by more than 30%, and its lipophilicity is stronger than that of omeprazole. Therefor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61P1/04C07D401/12
Inventor 刘明辉
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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