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Famotidine composition for injection

A famotidine and composition technology, which is applied in the field of medicine and medicine manufacturing, can solve the problems of low absolute bioavailability, short in vivo maintenance time, strong first-pass effect, etc., achieve good synergy and reduce first-pass effect , improve the effect of treatment

Inactive Publication Date: 2013-09-18
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although MT has a variety of physiological functions and pharmacological effects, it has unstable oral absorption kinetics, rapid distribution and clearance, and t 1 / 2 Short (30-50min), large individual differences, strong first-pass effect, low absolute bioavailability (1%-37%), and short maintenance time in vivo (1-3h)

Method used

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  • Famotidine composition for injection
  • Famotidine composition for injection
  • Famotidine composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1, preparation of injection famotidine composition freeze-dried powder injection, in 1000 pieces.

[0019] prescription

[0020]

[0021] 2. Preparation process

[0022] a) Add 78g of mannitol to 1500ml of water for injection, stir and add 20g of famotidine to dissolve, then add 0.3g of melatonin and stir evenly;

[0023] b) Add 0.9g of melatonin and 12.18g of moderately substituted hydroxypropyl-β-cyclodextrin into 500ml of water for injection, stir at 50°C for 6 hours, and detect that the encapsulation rate of melatonin is greater than 90%;

[0024] c) After mixing the solutions of groups a and b above, add HCL solution to adjust the pH value to 3.9, add 0.1% activated carbon and stir for 30 minutes to filter out the activated carbon, and then filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , according to famotidine, 20mg per bottle;

[0025] d) Fill according to the test requirements, put it ...

Embodiment 2

[0026] Embodiment 2, preparation of injection famotidine composition freeze-dried powder injection, in 1000 pieces.

[0027] 1. Prescription

[0028]

[0029] 2. Preparation process

[0030] a) Add 78g of mannitol to 1500ml of water for injection, stir and add 20g of famotidine to dissolve, then add 1g of melatonin and stir evenly;

[0031] b) Add 3g of melatonin and 18.14g of moderately substituted hydroxypropyl-β-cyclodextrin into 500ml of water for injection, stir at 50°C for 6 hours, and detect that the encapsulation rate of melatonin is greater than 90%;

[0032] c) After mixing the solutions of groups a and b above, add HCL solution to adjust the pH value to 3.9, add 0.1% activated carbon and stir for 30 minutes to filter out the activated carbon, and then filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , according to famotidine, 20mg per bottle;

[0033] d) Fill according to the test requirements, put it i...

Embodiment 3

[0034] Embodiment three, the preparation of injection famotidine composition freeze-dried powder injection, in 1000

[0035] 1. Prescription

[0036]

[0037] 2. Preparation process

[0038] a) Add 78g of mannitol to 1500ml of water for injection, stir and add 20g of famotidine to dissolve, then add 0.9g of melatonin and stir evenly;

[0039] b) Add 2.7g of melatonin and 17.73g of medium-substituted hydroxypropyl-β-cyclodextrin into 500ml of water for injection, stir at 50°C for 5 hours, and detect that the encapsulation rate of melatonin is greater than 90%;

[0040] c) After mixing the solutions of groups a and b above, add HCL solution to adjust the pH value to 3.9, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect intermediates Content, according to famotidine, 20mg per bottle;

[0041] d) Fill according to the test requirements, put it into a freeze dr...

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Abstract

The invention provides a famotidine composition for injection, and relates to the technical field of medicine manufacturing. The main medicine of the composition comprises famotidine and melatonin, wherein the melatonin comprises a quick release part and a cyclodextrin-included slow release part. According to the famotidine composition for injection provided by the invention, the therapeutic effect of famotidine is improved, instability caused by oral administration of MT (Melatonin) is avoided and MT is quick to distribute and eliminate and the like, and the first pass effect of MT is reduced. The design of dosage combining quick release and slow release is in accordance with secretion characteristic of MT, so that the problem of half-life period of MT is solved and the bioavailability of melatonin is improved. Melatonin combined with famotidine can be used for effectively inhibiting the secretion of gastric acid, so that the composition has a good synergistic effect for treating benign active gastric ulcer.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a famotidine composition for injection, and more specifically, to a freeze-dried composition for injection containing famotidine and melatonin. Background technique: [0002] Famotidine is H 2 Receptor antagonist is a derivative of mithiazole. Its chemical structure is different from cimetidine containing imidazole ring and ranitidine containing furan ring. Its antiacid effect is dose-related. Various H 2 Receptor antagonists have different acid-suppressing effects. Compared with cimetidine, famotidine is 20-37 times higher. Famotidine as H 2 Receptor antagonists, in addition to the treatment of peptic ulcers, are also suitable for the prevention and treatment of ulcers caused by non-steroidal anti-inflammatory drugs, preventing stress ulcers and bleeding in critically ill patients, and treating Zoller-Ellison syndrome, gastric Acid-related diseases ...

Claims

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Application Information

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IPC IPC(8): A61K31/426A61K9/19A61P1/04A61K31/4045
Inventor 汪六一汪金灿郝结兵李彪吴函峰
Owner HAINAN WEI KANG PHARMA QIANSHAN
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