A kind of pharmaceutical preparation for treating 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 enhance the degree of absorption Effect

Active Publication Date: 2018-04-17
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 local irritation to the upper gastrointestinal mucosa, and the patient's clinical compliance to the drug will not be improved

Method used

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  • A kind of pharmaceutical preparation for treating osteoporosis and preparation method thereof
  • A kind of pharmaceutical preparation for treating osteoporosis and preparation method thereof
  • A kind of pharmaceutical preparation for treating osteoporosis and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] The preparation method of the pharmaceutical preparation (alendronate sodium enteric-coated dripping pill preparation) for the treatment of osteoporosis includes the following steps:

[0075] 1) Take the following materials: 1kg alendronate sodium, 1kg water-soluble base, and 0.1kg enteric coating;

[0076] 2) Mix the alendronate sodium that has been crushed through a 40-mesh sieve and the water-soluble base according to the ratio described in step 1) to obtain a mixture;

[0077] 3) Melt the mixture obtained in step 2) at 60°C and continue to stir to obtain a uniformly mixed mixture;

[0078] 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℃, the stirring speed of the storage tank is 30 rpm, the dripper diameter is 2mm, and the dripper The temperature is 60℃, the pressure of the storage tank is 0.02Mpa, the dripping distance is 1cm, the t...

Embodiment 2

[0085] The preparation method of the pharmaceutical preparation (alendronate sodium enteric-coated dripping pill preparation) for the treatment of osteoporosis includes the following steps:

[0086] 1) Take the following materials: 1kg alendronate sodium, 4kg water-soluble base, and 0.7kg enteric coating;

[0087] 2) Mix the alendronate sodium that has been crushed through an 800-mesh sieve and the water-soluble base according to the ratio described in step 1) to obtain a mixture;

[0088] 3) Melt the mixture obtained in step 2) at 90°C and continue to stir to obtain a uniformly mixed mixture;

[0089] 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℃, the stirring speed of the storage tank is 90 rpm, the dripper diameter is 6mm, and the dripper The temperature is 85℃, the pressure of the storage tank is 0.2Mpa, the drip distance is 5cm, the temp...

Embodiment 3

[0095] The preparation method of the pharmaceutical preparation (alendronate sodium enteric-coated dripping pill preparation) for the treatment of osteoporosis includes the following steps:

[0096] 1) Take the following materials: 1kg alendronate sodium, 2.5kg water-soluble base, and 0.5kg enteric coating;

[0097] 2) Mix the alendronate sodium that has been crushed through a 300-mesh sieve and the water-soluble base according to the ratio described in step 1) to obtain a mixture;

[0098] 3) Melt the mixture obtained in step 2) at 80°C and continue to stir to obtain a uniformly mixed mixture;

[0099] 4) Transfer the mixture obtained in step 3) to the liquid storage tank of the dripping pill machine for dripping. The dripping conditions are: the temperature of the mixture is 80℃, the stirring speed of the storage tank is 65 rpm, the dripper diameter is 4.5mm, and the dripping Head temperature 75℃, storage tank pressure 0.06Mpa, drip distance 3cm, condensing medium temperature 11℃, n...

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Abstract

The invention discloses a pharmaceutical preparation for treating osteoporosis, the main components of which include the following materials in parts by weight: 1 part of alendronate sodium, 1-4 parts of water-soluble matrix, and 0.1-0.7 parts of enteric coating , and its preparation method is provided. The beneficial effect of the present invention is that a pharmaceutical preparation for treating osteoporosis and its preparation method provided by the present invention have the following advantages compared with the prior art: the dosage form has advantages, the dissolution time is fast, and it does not release in the stomach. Reduce irritation, reduce the incidence of adverse reactions in the digestive tract, have a good effect on treating osteoporosis, high bioavailability, and good drug compliance.

Description

Technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a pharmaceutical preparation for treating osteoporosis and a preparation method thereof. Background technique [0002] Osteoporosis (OP) is a metabolic bone disease characterized by low bone mass and microstructure destruction of bone tissue, leading to increased bone fragility and susceptibility to fractures. Its greatest harm is the occurrence of fragility fractures. Osteoporosis is a degenerative disease. With age, the risk of disease increases. Osteoporosis patients are mostly common and frequently-occurring diseases of the elderly and postmenopausal women. Currently, with the extension of human life span and the advent of an aging society, osteoporosis has become an important human health problem. [0003] Alendronate is a third-generation bisphosphonate drug, created by the Italian Instituto Gentili company. It was marketed in Italy under the trade name Alendros in 1993, and in th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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