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Pharmaceutical preparation for treatment of osteoporosis and preparation method thereof

A pharmaceutical preparation and osteoporosis technology, applied in the field of pharmaceutical preparations, can solve the problems of upper gastrointestinal mucosal irritation and not improve patients' clinical compliance with drugs, so as to promote drug dissolution, improve bioavailability, and prevent esophagus adhesion Effect

Active Publication Date: 2015-08-19
GANSU LONGSHENRONGFA PHARMACEUTICAL INDUSTRY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN101548978A Although the solid dispersion technology is used to improve the bioavailability, the drug will still cause lo

Method used

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  • Pharmaceutical preparation for treatment of osteoporosis and preparation method thereof
  • Pharmaceutical preparation for treatment of osteoporosis and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] A preparation method for a pharmaceutical preparation (alendronate sodium enteric-coated dripping pill preparation) for treating osteoporosis, comprising the following steps:

[0073] 1) Take the following materials: 1kg of sodium alendronate, 1kg of water-soluble matrix, and 0.1kg of enteric coating;

[0074] 2) Mix alendronate sodium that has been crushed through a 40-mesh sieve with a water-soluble base according to the ratio described in step 1) to obtain a mixture;

[0075] 3) Melt the mixture obtained in step 2) at 60°C and keep stirring to obtain a uniform mixture;

[0076] 4) Transfer the mixed liquid obtained in step 3) to the liquid storage tank of the dripping pill machine for dripping. The dripping conditions are: the temperature of the mixed liquid is 65°C, the stirring speed of the storage tank is 30 rpm, the diameter of the dripper is 2mm, and the dripper The temperature is 60°C, the pressure of the storage tank is 0.02Mpa, the drop distance is 1cm, the ...

Embodiment 2

[0083] A preparation method for a pharmaceutical preparation (alendronate sodium enteric-coated dripping pill preparation) for treating osteoporosis, comprising the following steps:

[0084] 1) Take the following materials: sodium alendronate 1kg, water-soluble base 4kg, enteric coating 0.7kg;

[0085] 2) Mix alendronate sodium that has been crushed through an 800-mesh sieve with a water-soluble base according to the ratio described in step 1) to obtain a mixture;

[0086] 3) Melt the mixture obtained in step 2) at 90°C and keep stirring to obtain a uniform mixture;

[0087] 4) Transfer the mixed liquid obtained in step 3) to the liquid storage tank of the dripping pill machine for dripping. The dripping conditions are: the temperature of the mixed liquid is 90°C, the stirring speed of the storage tank is 90 rpm, the diameter of the dripper is 6mm, and the dripper The temperature is 85°C, the pressure of the storage tank is 0.2Mpa, the drop distance is 5cm, the temperature of...

Embodiment 3

[0094] A preparation method for a pharmaceutical preparation (alendronate sodium enteric-coated dripping pill preparation) for treating osteoporosis, comprising the following steps:

[0095] 1) Take the following materials; sodium alendronate 1kg, water-soluble matrix 2.5kg, enteric coating 0.5kg;

[0096] 2) Mix alendronate sodium that has been crushed through a 300-mesh sieve with a water-soluble base according to the ratio described in step 1) to obtain a mixture;

[0097] 3) Melt the mixture obtained in step 2) at 80°C and keep stirring to obtain a uniform mixture;

[0098] 4) Transfer the mixed liquid obtained in step 3) to the liquid storage tank of the dripping pill machine for dripping. The dripping conditions are: the temperature of the mixed liquid is 80°C, the stirring speed of the storage tank is 65 rpm, and the diameter of the dripper is 4.5mm. The head temperature is 75°C, the pressure of the storage tank is 0.06Mpa, the drop distance is 3cm, the temperature of ...

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Abstract

The invention discloses a pharmaceutical preparation for treatment of osteoporosis. The main components include the following materials by weight: 1 part of alendronate sodium, 1-4 parts of a water-soluble matrix, and 0.1-0.7 part of an enteric coating. The invention also provides a preparation method of the pharmaceutical preparation. Compared with the prior art, the pharmaceutical preparation for treatment of osteoporosis and preparation method thereof provided by the invention have the advantages that: the dosage is advantageous, the dissolution time is short, the preparation is not released in stomach, the stimulation is reduced, the incidence rate of digestive tract adverse reaction is reduced, the osteoporosis treatment effect is good, the bioavailability is high and the medication compliance is good.

Description

[0001] technical field [0002] The invention relates to a pharmaceutical preparation, in particular to a pharmaceutical preparation for treating osteoporosis and a preparation method thereof. Background technique [0003] Osteoporosis (OP) is a metabolic bone disease characterized by low bone mass and microarchitectural destruction of bone tissue, leading to increased bone fragility and susceptibility to fracture. The greatest harm lies in the occurrence of fragility fractures. Osteoporosis is a degenerative disease, the risk of which increases with age. Osteoporosis patients are mostly common and frequently-occurring diseases of the elderly and postmenopausal women. At present, with the extension of human life span and the arrival of an aging society, osteoporosis has become an important health problem for human beings. [0004] Alendronate sodium is a third-generation bisphosphonate drug created by the Italian company Instituto Gentili. It was launched in Italy under th...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/663A61P19/10
Inventor 张喜民仲万春邓月婷任一杰王小芳
Owner GANSU LONGSHENRONGFA PHARMACEUTICAL INDUSTRY CO LTD
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