Minodronate tablets and preparation method thereof

A technology of minodronic acid tablets and minodronic acid, which is applied in the direction of pharmaceutical formulations, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problems of large production fault tolerance and achieve rapid absorption Complete, rapid onset of action, enhanced dissolution rate

Active Publication Date: 2012-12-12
JIANGSU SHENLONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] Therefore, we need a kind of minodronic acid sheet and preparation method that can overcome above-mentioned defect, on the one hand, can reduce drug irritation, improve patient's medication compliance, improve absorption rate, make medicine better serve majority of patients; On the one hand, the production of the prescription and process is relatively fault-tolerant, and the use of ordinary machinery and equipment can guarantee the quality of the product

Method used

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  • Minodronate tablets and preparation method thereof
  • Minodronate tablets and preparation method thereof
  • Minodronate tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Embodiment 1 (prescription technology that does not use solid dispersion technology)

[0046] Prescription (1000 tablets):

[0047]

[0048] Preparation Process:

[0049] 1), take the minodronic acid, lactose, microcrystalline cellulose, croscarmellose sodium and magnesium stearate of prescription quantity, sieve, mix homogeneously;

[0050] 2), compress into tablets to obtain minodronic acid tablets.

Embodiment 2

[0051] Embodiment 2 (prescription technology that does not add additive)

[0052] Prescription (1000 tablets):

[0053]

[0054] Preparation Process:

[0055] 1) Preparation of solid dispersion: heat the prescribed amount of polyethylene glycol to 80°C and keep it warm until completely melted, then add the prescribed amount of minodronic acid, stir until completely dissolved, continue stirring and cool to 0~- Place at 4°C, 0~-4°C for 24 hours to make it brittle, crush it, and pass through a 60-mesh sieve to obtain a solid dispersion of minodronic acid;

[0056] 2), take microcrystalline cellulose, lactose, crospovidone and magnesium stearate of recipe quantity, mix with minodronic acid solid dispersion;

[0057] 3), compressing into tablets to obtain minodronic acid tablets.

Embodiment 3

[0059] Prescription (1000 tablets):

[0060]

[0061] Preparation Process:

[0062] 1) Preparation of solid dispersion: heat the prescribed amount of polyethylene glycol to 80°C and keep it warm until completely melted, slowly add polyvinyl alcohol, stir until dissolved, then add the prescribed amount of minodronic acid, stir until completely dissolved Afterwards, continue to stir and cool to 0~-4°C, place it under the condition of 0~-4°C for 24 hours to make it solid and brittle, crush it, pass through a 60-mesh sieve, and obtain the minodronic acid solid dispersion;

[0063] 2), take microcrystalline cellulose, lactose, croscarmellose sodium and magnesium stearate of recipe quantity, mix with minodronic acid solid dispersion;

[0064] 3), compressing into tablets to obtain minodronic acid tablets.

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Abstract

The invention discloses minodronate tablets and a preparation method thereof. The tablets comprise the following components in parts by weight: 10-20 parts of minodronate solid dispersion, 30-80 parts of diluent, 3-10 parts of disintegrant, and 0.5-2 parts of lubricant, wherein the minodronate solid dispersion is prepared from minodronate, polyethylene glycol and polyvinyl alcohol. The minodronate tablets provided by the invention can reduce drug irritation, improve patient compliance, and increase absorption rate, so that the drug can provide better service for patients. In addition, the fault tolerance of prescription and production process is large, so that minodronate tablets are safe and effective and have controllable quality.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a minodronic acid tablet and a preparation method thereof. Background technique [0002] As modern society rapidly enters into an aging society, bone and calcium metabolism diseases such as osteoporosis have become one of the chronic diseases that plague the health of middle-aged and elderly people in various countries. Fractures and bedridden diseases caused by the disease reduce the quality of life and increase the risk of death. improve. There are 25 million people with osteoporosis in the United States, and about 12 million people with osteoporosis in Japan. And my country has about 70 million people with osteoporosis, which is the country with the largest number of patients. The salient feature of this type of disease is the bone resorption of the patient. Due to pathological or physiological factors exceeding the bone formation, the bone mass per unit volume is reduced, ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/675A61K47/34A61K47/38A61P19/10A61K47/10
Inventor 胡传良徐成秦勇金春周自桂苏晋
Owner JIANGSU SHENLONG PHARMA
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