Famotidine inclusion compound and preparation method

A technology of famotidine and clathrates, which is applied in the direction of drug combinations, pharmaceutical formulas, and medical preparations of non-active ingredients, etc., which can solve the problems of easy recurrence of stomach problems, long-term storage of drugs, and large dosage , to achieve the effect of enhancing drug stability, maintaining drug efficacy, and reducing discomfort

Inactive Publication Date: 2014-03-26
吉林修正药业新药开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Famotidine is easy to degrade during storage, especially when it is combined with some acidic or alkaline ingredients, it will decompose faster and increase related substances, which is not conducive to long-term storage of the drug and will reduce the efficacy of the product, and even produce Harmful substances that are not beneficial to the human body, because stomach diseases are prone to relapse and have a long cycle, the dosage must be large

Method used

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  • Famotidine inclusion compound and preparation method
  • Famotidine inclusion compound and preparation method
  • Famotidine inclusion compound and preparation method

Examples

Experimental program
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Effect test

Embodiment Construction

[0013] 1. Take 10g of glyceryl behenate and heat it in a water bath at 80°C, stirring and melting at this temperature;

[0014] 2. Add 10 g of famotidine to the molten glyceryl behenate, and keep stirring at 80°C for 30 minutes;

[0015] 3. Put the mixture prepared in step 2 into a spray dryer while it is hot and spray dry to obtain the clathrate of famotidine.

[0016] Blood drug concentration and pharmacokinetic test of preparation prepared by famotidine inclusion compound prepared by the present invention

[0017] In this test, the concentration-time curves of famotidine in plasma were respectively measured by 12 male healthy subjects after oral administration of the compound tablet made from the inclusion compound of the present invention by liquid-mass spectrometry, and according to the blood drug concentration-time data , Calculate the relevant pharmacokinetic parameters to investigate the influence of magnesium hydroxide and calcium carbonate on the pharmacokinetic pro...

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Abstract

The invention provides a famotidine inclusion compound and a preparation method. The inclusion compound comprises famotidine and glyceryl behenate. The preparation method comprises the following steps: the glyceryl behenate is heated to 80 DEG C through water bath or steam, stirring and fusion are performed on the glyceryl behenate at the temperature of 80 DEG C; the famotidine, which is equal to the glyceryl behenate in weight, is added into the fused glyceryl behenate, stirring and mixing are performed for 25-35 minutes at the temperature of 80 DEG C or homogenizing is performed through a homogenizer; the mixture prepared through the step 2 is fed into a spray dryer for drying before cooling, so that the famotidine inclusion compound is obtained. The famotidine inclusion compound has the benefits as follows: because the glyceryl behenate has the characteristics of hydrophobicity, anti-oxidation, hydrolysis prevention and the like, and is used for famotidine inclusion, the water absorption capacity of the famotidine self is reduced, and the famotidine is separated from other substances in the compound, the stability of the drugs is enhanced, the drug therapeutic effect is maintained, the bitter taste of the famotidine is covered up, and the bad taste during taking is reduced.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a preparation method of a famotidine inclusion compound. Background technique [0002] With the acceleration of the pace of life and work and the increase of various social pressures, digestive tract diseases have become common and frequently-occurring diseases in recent years, and stomach diseases account for the first place in digestive tract diseases. According to statistics, the number of stomach diseases in my country has exceeded 100 million. Drugs for diseases account for an increasing proportion of the overall clinical drug use, and the sales amount of anti-acid drugs is the highest. Famotidine is a guanylthiazole H2 receptor antagonist. Although it has obvious inhibitory effect on gastric acid secretion at night, it can also inhibit gastric acid secretion stimulated by pentagastrin. Its inhibitory effect on gastric acid secretion lasts longer than Similar products are...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/14A61K31/426A61P1/04
Inventor 吴萍徐建白冰郭文英王鑫高嵩
Owner 吉林修正药业新药开发有限公司
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