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Pharmaceutical combination with stable strontium ranelate and its preparations

A technology of strontium ranelate and a composition, which is applied in the field of strontium ranelate-stabilized pharmaceutical compositions and preparations thereof, can solve problems such as increase in related substances, appearance and color change, etc., and achieves simplified operation and is suitable for large-scale industrial production. , the effect of shortening the synthesis route of raw materials

Inactive Publication Date: 2008-10-29
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since strontium ranelate is composed of an organic part ranelic acid and two stable non-radioactive strontium atoms, the raw material drug itself is relatively stable, but some excipients will interact with it after it is made into a preparation, causing changes in appearance or color. Substance increase

Method used

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  • Pharmaceutical combination with stable strontium ranelate and its preparations
  • Pharmaceutical combination with stable strontium ranelate and its preparations
  • Pharmaceutical combination with stable strontium ranelate and its preparations

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0037]

[0038] Preparation Process:

[0039] The raw and auxiliary materials are respectively passed through a 100-mesh sieve for subsequent use. Mix the prescription amount of excipients thoroughly first. Add the raw material medicine to the excipients, so that the medicine and the excipients are fully mixed. Add an appropriate amount of trishydroxymethyl aminomethane to the binder containing 2% hypromellose (30% ethanol), add the binder to the mixture to make a soft material, pass through a 20-mesh sieve and granulate , dried in a ventilated oven at 55°C for 2 hours, passed through a 18-mesh sieve to granulate the dry granules, determined the content of intermediates, and pressed into tablets.

example 2

[0041] Chewable Tablet Prescription (100 Tablets)

[0042] Strontium ranelate 100g

[0043] Mannitol 60g

[0044] Microcrystalline Cellulose 10g

[0045] Xylitol 0.1g

[0046] 10% povidone (water) q.s

[0047] Sodium Lauryl Sulfate 0.15g

[0048] Magnesium Stearate q.s

[0049] The preparation process is the same as in Example 1.

example 3

[0051] Orally disintegrating tablet prescription (100 tablets)

[0052] Strontium Ranelate 25g

[0053] Mannitol 40g

[0054] Microcrystalline Cellulose 10g

[0055] Crospovidone 12g

[0056] Aspartame 0.1g

[0057] Strawberry essence 0.05g

[0058] 2% hypromellose (30% ethanol) q.s

[0059] Magnesium Lauryl Sulfate 1.8g

[0060] Magnesium Stearate q.s

[0061] The preparation process is the same as in Example 1.

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Abstract

The invention discloses a drug composite to promote the stability of strontium ranelate in the preparation. The invention is characterized in that after the effective dosage of the strontium ranelate for treatment is mixed with medicinal excipients, various dosage forms are produced by adding stabilizer. The dosage of the stabilizer refers to the dosage scope of excipients proscribed in the pharmacopoeia. The experiments and studies determine that the weight percentage of the stabilizer in the drug composite is 0.01-5 percent, which is preferred as 0.01-2 percent. The invention with a simple and unique way solves the color change problem of appearance of strontium ranelate or the problem of material increasing resulting from the excipients like citric acid, aspartame and saccharin sodium contained in the preparation; under the condition of not changing the structure of the strontium ranelate, a certain dosage of stabilizer is added into the excipients to achieve the purpose of the stability of the strontium ranelate. The method simplifies the process and saves the cost, and is more suitable for large-scale industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical composition for stabilizing strontium ranelate drug 5-[bis(carboxymethyl)amino]-2-carboxy-4-cyano-3-thiophene acetate distrontium salt heptahydrate in preparation . Background technique [0002] Strontium Ranelate StrontiumRanelate [0003] Structural formula: [0004] [0005] Molecular formula: C 12 h 6 N 2 o 8 SSr 2 7H20 molecular weight: 639.60 [0006] Osteoporosis is a systemic skeletal disease characterized by low bone mass and degeneration of bone tissue microarchitecture, accompanied by symptoms such as increased bone fragility, susceptibility to fractures, and pain, and is more common in middle-aged and elderly people. Of the fractures, the most common are vertebral fractures, followed by wrist fractures, and hip fractures are the most serious. It is currently estimated that there are 590 million people over the age of 60 in the world, which may exceed the 1 billion mark by 2020, and will ...

Claims

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Application Information

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IPC IPC(8): A61K31/381A61K47/02A61K47/16A61K47/20A61K9/20A61K9/14A61K9/10A61P19/10
Inventor 任晓文黄汉忠李洪起连潇嫣靳朝东李树军
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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