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Ilaprazole freeze-dried composition

A technology of ilaprazole and a composition, applied to a freeze-dried composition of ilaprazole and the field of preparation thereof, can solve the problems of poor stability of ilaprazole and the like, and achieve low moisture content and improved compliance. Effect

Active Publication Date: 2016-10-05
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, ilaprazole and its salts have poor stability, and currently commercially available are mainly ilaprazole enteric-coated tablets
Enteric-coated tablets prevent ilaprazole from being destroyed by gastric acid, but also delay the initial effect of ilaprazole on gastric acid, which is unfavorable for patients who need timely treatment and some patients who cannot take it orally

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] prescription:

[0041]

[0042] Take 1.3L of water for injection and 0.2L of tert-butanol, add mannitol and edetate disodium under stirring, stir and dissolve, adjust the pH to 9.5-10 with NaOH solution, and add Aipla after the solution temperature drops to about 4°C Stir to dissolve azole, adjust the pH to 9.5-10 with 1mol / L NaOH solution and / or 1mol / L hydrochloric acid solution as needed, add water for injection until the volume of the solvent is 2L. The liquid medicine was sterilized and filtered in turn, and then filled into vials with 2 mL of liquid medicine in each bottle, half-plugged with a butyl rubber stopper.

[0043] Freeze-dry the filled medicinal liquid product. Pre-freezing stage: the product is cooled to -30°C and kept for 2 hours; when the product is heated to 5°C, kept for 2 hours; the product is cooled to -15°C and kept for 2 hours; the product is cooled to -40°C and kept for 2 hours. Sublimation and drying stage: reduce the temperature of the co...

Embodiment 2

[0046] prescription:

[0047]

[0048] Take 1.3L of water for injection and 0.1L of tert-butanol, add mannitol and edetate disodium under stirring, stir and dissolve, adjust the pH to 9.5-10 with NaOH solution, and add Aipla after the solution temperature drops to about 10°C Stir to dissolve azole, adjust the pH to 9.5-10 with 1mol / L NaOH solution and / or 1mol / L hydrochloric acid solution as needed, add water for injection until the volume of the solvent is 2L. The liquid medicine was sterilized and filtered in turn, and then filled into vials with 2 mL of liquid medicine in each bottle, half-plugged with a butyl rubber stopper.

[0049] Freeze-dry the filled medicinal liquid product. Pre-freezing stage: the product is cooled to -30°C and kept for 2 hours; when the product is heated to 5°C, kept for 2 hours; the product is cooled to -15°C and kept for 2 hours; the product is cooled to -40°C and kept for 2 hours. Sublimation and drying stage: reduce the temperature of the c...

Embodiment 3

[0052] prescription:

[0053]

[0054] Take 1.5L of water for injection and 0.15L of tert-butanol, add mannitol and edetate disodium under stirring, after stirring and dissolving, adjust the pH to 9.5-10 with NaOH solution, and add Aipla after the temperature of the solution drops to about 6°C Stir to dissolve azole, adjust the pH to 9.5-10 with 1mol / L NaOH solution and / or 1mol / L hydrochloric acid solution as needed, add water for injection until the volume of the solvent is 2L. The liquid medicine was sterilized and filtered in turn, and then filled into vials with 2 mL of liquid medicine in each bottle, half-plugged with a butyl rubber stopper.

[0055] Freeze-dry the filled medicinal liquid product. Pre-freezing stage: the product is cooled to -30°C and kept for 2 hours; when the product is heated to 5°C, kept for 2 hours; the product is cooled to -15°C and kept for 2 hours; the product is cooled to -40°C and kept for 2 hours. Sublimation and drying stage: reduce the t...

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Abstract

The invention provides a freeze-dried composition of ilaprazole and a preparation method of the freeze-dried composition. The ilaprazole freeze-dried composition, which is prepared in accordance with the method provided by the invention, can be kept stable in an environment which is relatively low in pH value, so that the compliance of clinical application is improved.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a freeze-dried composition of ilaprazole and a preparation method thereof. Background technique [0002] Ilaprazole, systematically named 5-(1H-pyrrol-1-yl)-2-[[(4-methoxy-3-methyl)-2-pyridyl]-methyl] -Sulfinyl-1 hydrogen-benzimidazole, a new type of proton pump inhibitor, was first developed by Korea Ilyang Pharmaceutical Co., Ltd., mainly used for duodenal ulcer, gastric ulcer, reflux or corrosive The treatment of esophagitis etc., the structure is shown in formula-I. [0003] [0004] Compared with similar prazole drugs, ilaprazole has obvious advantages in terms of safety and drug efficacy, with faster onset of action, better acid suppression effect, longer in vivo action time, and less dependence on liver P450 enzyme series The CYP2C19 enzyme metabolism in the drug has small individual differences and fewer adverse reactions. [0005] However, ilaprazole and its sal...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61P1/04
Inventor 陈庆财陈祥峰杨奇珍
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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