Compound medicine contg. famotidine cyclodextrin clathrate, and its prepn. method

A technology of cyclodextrin inclusion complex and famotidine, which is applied in the direction of drug combination, medical preparation containing active ingredient, non-active ingredient of polymer compound, etc. Reach and other problems to achieve the effect of increasing medication compliance

Inactive Publication Date: 2006-11-29
SUZHOU DAWNRAYS PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Although the above technology can improve the stability of famotidine in long-term placement, there are many obvious defects. First, the process is cumbersome, and the particles need to be coated in a fluidized bed. The particle size of famotidine has an impact on the coating, which will The uneven coating of the granules affects the quality of the final product. What is more critical is that it is difficult for famotidine to reach the pharmaceutically required standard of "the dissolution rate of the main drug of the tablet reaches more than 75% within 45 minutes" after coating , directly affect the absorption of drugs in the gastrointestinal tract, thereby affecting the efficacy of drugs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0107] Preparation of Famotidine-β-cyclodextrin Inclusion Complex

[0108] Famotidine 10g

[0109] β-cyclodextrin 40g

[0110] Purified water 250ml

[0111] Preparation method: Heat 200ml of purified water to about 90°C, keep warm in a water bath, add 40g of β-cyclodextrin and stir continuously, after completely dissolving, cool down to 75-78°C and keep warm in a water bath, add 10g of famotidine, stir until completely Dissolve, then heat and stir for 1 hour, then naturally cool to room temperature to 12 hours while stirring, filter with suction, dry at 50°C for about 4 hours, take it out and pass through a 50-mesh sieve to obtain famotidine-β-cyclodextrin inclusion complex things.

Embodiment 2

[0113] Preparation of Famotidine-β-cyclodextrin Inclusion Complex

[0114] Famotidine 10g

[0115] β-cyclodextrin 40g

[0116] Purified water 250ml

[0117] Preparation method: heat 800ml of purified water, keep it warm in a water bath, add 40g of β-cyclodextrin and stir continuously, cool down to 50°C in a water bath and keep warm after completely dissolving, add 10g of famotidine, stir until completely dissolved, then cool naturally while stirring Keep warm in a water bath between 40-30°C for 7 days, concentrate under reduced pressure at 50°C to 150ml, filter with suction, dry at 50°C for about 4 hours, take it out and pass through a 50-mesh sieve to obtain famotidine-β-cyclodextrin clathrate, detection.

[0118] 1) The results of differential thermal analysis show that famotidine has an endothermic peak at about 160°C, and β-cyclodextrin has an obvious endothermic peak at 50°C-120°C, which is due to dehydration; famotidine and The physical mixture of β-cyclodextrin has ...

Embodiment 3

[0121] Preparation of Compound Famotidine Tablets (1000 Tablets)

[0122] Famotidine-β-cyclodextrin (contains famotidine 5g) 25g

[0123] Magnesium hydroxide 165g

[0124] Calcium carbonate 800g

[0125] Microfiber Cellulose 100g

[0126] 40g pregelatinized starch

[0127] Magnesium Stearate 2g

[0128] Preparation:

[0129] Weigh the prescribed amount of calcium carbonate, magnesium hydroxide, microcrystalline cellulose and pregelatinized starch, and put them all in a three-phase mixer and mix them thoroughly for several minutes to make them evenly mixed. Add appropriate amount of 50% ethanol solution, granulate and dry.

[0130] Add the famotidine-β-cyclodextrin inclusion compound and magnesium stearate prepared by the method in Example 2, mix evenly, and compress into tablets.

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PUM

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Abstract

A compound medicine taken orally is prepared from famotidine, cyclodextrin and antiacid through including the famotidine particles by cyclodextrin, and mixing the inclusion compound with antiacid.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a stable compound composition containing famotidine and antacids. Background technique [0002] Digestive system disease is one of the most common frequently-occurring diseases, and the total incidence rate accounts for about 10-20% of the population. Peptic ulcer, inflammation, mucosal damage caused by alcohol and drugs, and gastrointestinal discomfort, the incidence rate in China can reach at least 10% of the population, that is, 120 million people suffer from the disease every year, and gastrointestinal diseases are prone to and recurrent , so the market capacity of its therapeutic drugs is considerable. In addition, with the development of our society, environmental changes, population structure and changes in people's lifestyles, the incidence of digestive tract diseases is still increasing year by year. [0003] Common digestive tract diseases such as esophagiti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/426A61K9/20A61K47/40A61P1/04A61P1/14
Inventor 马成孝蔡春萍
Owner SUZHOU DAWNRAYS PHARM CO LTD
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