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Omeprazole compound

A technology of omeprazole and compounds, applied in the field of omeprazole compounds, can solve the problems of activated carbon without depyrogenation, no protection, drug oxidation hazards, etc.

Inactive Publication Date: 2015-11-18
邓学峰
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the omeprazole freeze-dried injection of the prior art still adopts the activated carbon depyrogenation process in the production of the preparation, resulting in the tiny particles of activated carbon and heavy metal ions remaining in the liquid medicine, which are brought into the blood of the human body during infusion of Jingmai. Bring medicinal damage to the body, and the present invention research finds, the pyrogen in the activated carbon adsorption liquid medicine is not thorough, and reason is: the one, most pharmaceutical factories adopt activated carbon to add weight to be below 0.08% of the volume of the liquid medicine; Second, activated carbon itself does not depyrogenate and activate
This study also found that the heavy metal ions and iron ions brought by activated carbon are oxidative hazards to the drug; the lyophilized injection auxiliary excipient prepared by the prior art uses mannitol as the skeleton of the excipient, and mannitol has adverse reactions to blood vessels. The preparation of omeprazole in the prior art does not protect the group with the sulfur atom from the adverse reactions caused by the oxidation, peroxidation, and photooxidation of the group in the manufacture, storage, transportation, use, and entry into the body.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2

[0007] Embodiment 2: The omeprazole compound provided by the present invention is composed of the following medicinal ingredients in a weight ratio: Omeprazole: 60 poloxamer 15 lecithin 100 cholesterol 30 Preparation process: take lecithin, Cholesterol, poloxamer and omeprazole, add 6mL of absolute ethanol and dissolve in a water bath at 55°C until dissolved, inject into the hydration medium containing 20mL of phosphate buffer solution with a pH of 6.0-8.0 with a syringe while stirring, and stir to hydrate For 30 minutes, remove ethanol by rotary evaporation (55°C, vacuum degree 0.1MPa), cool rapidly, homogenize with ultra-high pressure (pressure 25000PSI, cycle 2-4 times), and then aseptically distribute in 316L stainless steel trays, freeze-dry as usual, Make the moisture in the compound solid ≤ 5.0%. Oral, granule and other dosage form pharmaceutical preparations of a compound of omeprazole are conventionally prepared.

Embodiment 3

[0008] Example 3 The omeprazole compound provided by the present invention is composed of the following medicinal ingredients by weight ratio: Omeprazole: 40 poloxamer 10 lecithin 60 cholesterol 20 Preparation process: take lecithin and cholesterol in proportion , poloxamer and omeprazole, add 6mL of absolute ethanol in a water bath at 55°C until dissolved, inject into the hydration medium containing 20mL of phosphate buffer solution with a pH of 6.0-8.0 with a syringe while stirring, and stir for 30min , remove ethanol by rotary evaporation (55°C, vacuum degree 0.1MPa), rapidly cool down, homogenize with ultra-high pressure (pressure 25000PSI, cycle 2-4 times), then aseptically distribute in 316L stainless steel trays, freeze-dry as usual, make Moisture in compound solids ≤ 5.0%. Oral, granule and other dosage form pharmaceutical preparations of a compound of omeprazole are conventionally prepared.

Embodiment 4

[0009] Example 4 The omeprazole compound provided by the present invention is composed of the following medicinal ingredients by weight ratio: Omeprazole: 20 poloxamer 10 lecithin 80 cholesterol 25 Preparation process: take lecithin and cholesterol in proportion , poloxamer and omeprazole, add 6mL of absolute ethanol in a water bath at 55°C until dissolved, inject into the hydration medium containing 20mL of phosphate buffer solution with a pH of 6.0-8.0 with a syringe while stirring, and stir for 30min , remove ethanol by rotary evaporation (55°C, vacuum degree 0.1MPa), rapidly cool down, homogenize with ultra-high pressure (pressure 25000PSI, cycle 2-4 times), then aseptically distribute in 316L stainless steel trays, freeze-dry as usual, make Moisture in compound solids ≤ 5.0%. Oral, granule and other dosage form pharmaceutical preparations of a compound of omeprazole are conventionally prepared.

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PUM

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Abstract

The invention discloses an omeprazole compound and a preparation method thereof. The omeprazole compound comprises medical components in percentage by weight as follows: 20%-60% of omeprazole, 5%-15% of poloxamer, 20%-100% of lecithin and 15-30% of cholesterol. The omeprazole compound is high in stability and long in drug action time, has small side effects, can inhibit gastric acid secretion and protect gastric mucosa and also has the effect of killing helicobacter pylori, and a preparation method is advanced.

Description

technical field [0001] The invention relates to a compound of omeprazole and a preparation process thereof. Background technique [0002] Peptic ulcer (peptic ulcer) is one of clinically common and frequently-occurring diseases. my country is an area with a high incidence of ulcers. According to statistics, about 10% of the population has suffered from this disease in their lifetime, and about 40% of the population in the world suffers from peptic ulcer disease every year. Clinically, duodenal ulcer is more common than gastric ulcer, and the ratio of the two is about 1.56-5.6:1. Gastric ulcer and duodenal ulcer are chronic diseases with high recurrence coefficient, and require long-term treatment, especially for patients with gastric ulcer and duodenal ulcer caused by Helicobacter pylori infection. For patients, the price factor of medicines is very important. Therefore, the majority of patients urgently need products with good curative effect, high safety, low price, sma...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K31/4439A61K47/34A61K47/24A61K47/10A61P1/04
Inventor 邓学峰
Owner 邓学峰