Stable compound omeprazole pharmaceutical composition

A technology of omeprazole sodium and its composition, which is applied in the field of freeze-dried injections containing omeprazole and domperidone, can solve the problems of high production cost, poor solubility, large consumption, etc., so as to reduce production cost and improve solubility , the effect of reducing the volume

Active Publication Date: 2015-04-15
HUBEI RENMIN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since domperidone has good solubility under acidic conditions and poor solubility under alkaline conditions, a large amount of water is needed to dissolve domperidone when preparing lyophilized liquid, which has a great impact on the freeze dryer and requires a large-capacity ampoule Or a large-capacity freeze dryer, and the consumption can be large, and the production cost is high

Method used

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  • Stable compound omeprazole pharmaceutical composition
  • Stable compound omeprazole pharmaceutical composition
  • Stable compound omeprazole pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Freeze-dried powder injection prescription of omeprazole sodium and domperidone

[0030]

[0031]

[0032] Its preparation process: Weigh the prescribed amount of omeprazole sodium, domperidone, mannitol and histidine, dissolve them in 1600ml of water for injection, control the temperature at 30-50°C and stir to dissolve; add hydrochloric acid or hydrogen Sodium oxide solution, adjust the pH value to 10, then add 0.1% (W / V) activated carbon, keep warm for 20 minutes, decarbonize by coarse filtration, add water for injection to 2000ml, mix well, filter with 0.22μm microporous membrane, 100 Fill 1,000 bottles under a high-grade environment, half-stopper, freeze-dry in a freeze-drying box, cork out of the box, and cap.

Embodiment 2

[0034] Freeze-dried powder injection prescription of omeprazole sodium and domperidone

[0035]

[0036] Its preparation process: Weigh the prescribed amount of omeprazole sodium, domperidone, mannitol and histidine, dissolve them in 1600ml of water for injection, control the temperature at 30-50°C and stir to dissolve; add hydrochloric acid or hydrogen Sodium oxide solution, adjust the pH value to 11, then add 0.1% (W / V) activated carbon, keep warm for 20 minutes, decarbonize by coarse filtration, add water for injection to 2000ml, mix well, filter with 0.22μm microporous membrane, 100 Fill 1,000 bottles under a high-grade environment, half-stopper, freeze-dry in a freeze-drying box, cork out of the box, and cap.

Embodiment 3

[0038] Freeze-dried powder injection prescription of omeprazole sodium and domperidone

[0039]

[0040]Its preparation process: Weigh the prescribed amount of omeprazole sodium, domperidone, mannitol and histidine, dissolve them in 1600ml of water for injection, control the temperature at 30-50°C and stir to dissolve; add hydrochloric acid or hydrogen Sodium oxide solution, adjust the pH value to 10.5, then add 0.1% (W / V) activated carbon, keep warm for 20 minutes, coarsely filter and decarbonize, add water for injection to 2000ml, mix well, filter with 0.22μm microporous membrane, 100 Fill 1,000 bottles under a high-grade environment, half-stopper, freeze-dry in a freeze-drying box, cork out of the box, and cap.

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PUM

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Abstract

The invention relates to a stable compound omeprazole pharmaceutical composition consisting of omeprazole, domperidone, a cosolvent histidine and an excipient selected from mannitol and sorbitol, wherein pH value of the solution is 10-11. The composition, which adopts histidine as the cosolvent, not only improves solubility of omeprazole but also functions as a stabilizing agent; and the composition can stabilize the omeprazole through a stabilizing agent such as ethylene diamine tetraacetic acid (EDTA) and salt thereof.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a stable pharmaceutical composition of omeprazole and domperidone, more specifically, to a freeze-dried injection containing omeprazole and domperidone. Background technique [0002] Omeprazole is a proton pump inhibitor (PPI) developed by Astra, which was launched in Europe in March 1988. It can be selectively combined with H + 、K + -ATPase combined to inhibit its activity, clinically applicable to the treatment of gastric ulcer, duodenal ulcer and stress ulcer. [0003] Although omeprazole salt is an excellent gastric acid inhibitor, its clinical application is affected because of its poor stability and high toxicity of residual solvents. Chinese patent ZL95111640.1 discloses omeprazole salt hydrate and its preparation method. This omeprazole salt hydrate has good stability, high purity, no toxic residual solvent, and can be used to prepare frozen drug for intraveno...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/454A61K9/19A61P1/04A61P1/14A61K31/4439
Inventor 孙永平李爱菊赵砥朱胜节毛书平余记川
Owner HUBEI RENMIN PHARMACEUTICAL CO LTD
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