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Lafutidine composition freeze-dried powder injection for injection

A technology of lafutidine and freeze-dried powder injection is applied in the field of medicine and medicine manufacturing, which can solve the problems of atrioventricular conduction block, no chitosan-containing nanoparticles, and pancytopenia, and achieves inhibition of the growth of harmful bacteria, The effect of promoting the reproduction of beneficial bacteria and eliminating the active effect

Inactive Publication Date: 2014-02-05
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

3. H2 receptor blockers may cause shock, allergic-like symptoms, pancytopenia, aplastic anemia, thrombocytopenia, interstitial nephritis, Stevens-Johnson syndrome, toxic epidermal necrosis (Lyell syndrome), striated muscle Lysis, atrioventricular block, insufficiency, etc.
At present, there is no pharmaceutical dosage form containing chitosan nanoparticles

Method used

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  • Lafutidine composition freeze-dried powder injection for injection
  • Lafutidine composition freeze-dried powder injection for injection
  • Lafutidine composition freeze-dried powder injection for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Preparation of lafutidine composition freeze-dried powder for injection, in 1000 pieces.

[0031] prescription:

[0032] Lafutidine 300g

[0033] Chitosan Nanoparticles 400g

[0034] Water for injection 2000ml

[0035] 2. Preparation process:

[0036] 1) Weigh 300g of lafutidine and slowly add it to 1800ml of water for injection, and stir until dissolved while adding.

[0037] 2) Weigh 400g of chitosan nanoparticles into the feed solution to dissolve and mix evenly.

[0038] 3) Add water for injection to the full amount, and detect the content of intermediates.

[0039] 4) Add 0.1% activated carbon, stir and adsorb for 30 minutes, filter out the activated carbon, and then filter the drug solution through 0.45 μm and 0.22 μm microporous membranes until clarification, and calculate the filling volume based on 0.3 g per bottle of lafutidine.

[0040] 5) Make the drug into a sterile aqueous solution, first cool down to -40±2°C during the freeze-drying process, stop co...

Embodiment 2

[0042] Preparation of lafutidine composition freeze-dried powder for injection, in 1000 pieces.

[0043] 1. Prescription:

[0044] Lafutidine 300g

[0045] Chitosan Nanoparticles 500g

[0046] Water for injection 2000ml

[0047] 2. Preparation process:

[0048] 1) Add the prescribed amount of lafutidine into 1800ml water for injection, and stir until dissolved while adding.

[0049] 2) Weigh 500g of chitosan nanoparticles into the feed solution to dissolve and mix evenly.

[0050] 3) Add water for injection to the full amount, and detect the content of intermediates.

[0051] 4) Add 0.1% activated carbon, stir and adsorb for 30 minutes, filter out the activated carbon, and then filter the drug solution through 0.45 μm and 0.22 μm microporous membranes until clarification, and calculate the filling volume based on 0.3 g per bottle of lafutidine.

[0052] 5) Make the drug into a sterile aqueous solution, first cool down to -40±2°C during the freeze-drying process, stop coo...

Embodiment 3

[0054] Preparation of lafutidine composition freeze-dried powder for injection, in 1000 pieces.

[0055] prescription:

[0056] Lafutidine 300g

[0057] Chitosan Nanoparticles 600g

[0058] Water for injection 2000ml

[0059] 2. Preparation process:

[0060] 1) Add the prescribed amount of lafutidine into 1800ml water for injection, and stir until dissolved while adding.

[0061] 2) Weigh 600g of chitosan nanoparticles into the feed solution to dissolve and mix evenly.

[0062] 3) Add water for injection to the full amount, and detect the content of intermediates.

[0063] 4) Add 0.1% activated carbon, stir and adsorb for 30 minutes, filter out the activated carbon, and then filter the drug solution through 0.45 μm and 0.22 μm microporous membranes until clarification, and calculate the filling volume based on 0.3 g per bottle of lafutidine.

[0064] 5) Make the drug into a sterile aqueous solution, first cool down to -40±2°C during the freeze-drying process, stop cooling,...

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Abstract

The invention provides a lafutidine composition freeze-dried powder injection for injection and relates to the field of medicines and medicine manufacturing technique. The lafutidine composition freeze-dried powder injection includes the following raw materials: by weight, 8.34-9.21 parts of lafutidine, 3.75-5.56 parts of chitosan nanoparticles and 87.23-88.13 parts of water for injection. The invention has the following advantages: 1) the composition composed of lafutidine and chitosan nanoparticles according to the ratio of 1:0.5 can raise water solubility of lafutidine and shorten dissolution time of lafutidine, has good stability, has few insoluble particles, and is beneficial to be used in clinic; 2) the composition can promote reproduction of beneficial bacteria in the intestine, inhibit growth of harmful bacteria and achieve the effect of absorbing nutrients, has antiacid and anti-ulcer activities, can prevent medicinal stimulation of the stomach, has better anti-Hp performance, promotes ulcer healing, minimizes recurrence, has high healing rate of mice, and can be used to reduce dosage of lafutidine in clinic and decrease adverse reaction of lafutidine; and 3) the chitosan nanoparticles can replace mannitol to be used as a freeze-drying skeleton agent of the freeze-dried powder injection so as to eliminate the active effect of mannitol on human body.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a lafutidine composition freeze-dried powder for injection. Background technique: [0002] Lafutidine, white or off-white in appearance, its chemical name is (±)-2-(2-furanmethylsulfinyl)-N-[4-[4-(1-piperidylmethyl)- 2-pyridyloxy]-cis-2-butenyl]-acetamide, molecular formula: C22H29N3O4S, molecular weight: 431.55, chemical structure: [0003] [0004] Digestive system disease is one of the most common frequently-occurring diseases, and it is prone to and recurring. Lafutidine is a second-generation H2 receptor antagonist with a unique gastroprotective effect. It is mainly used for the treatment of peptic ulcer, gastritis, reflux esophagitis, gastric ulcer, duodenal ulcer and other related symptoms. Compared with other similar drugs such as cimetidine and famotidine, it has a strong and long-lasting effect. However, the stability and solubility of ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4545A61K47/36A61P1/04
Inventor 汪六一汪金灿肖雪
Owner HAINAN WEI KANG PHARMA QIANSHAN
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