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Strontium ranelate orally disintegrating tablets and preparation method thereof

A technology of orally disintegrating tablets and strontium ranelate, applied in the field of orally disintegrating strontium ranelate tablets and its preparation, can solve problems such as not being suitable for taking, and achieve extensive social and economic benefits, fast absorption, and bioavailability high degree of effect

Active Publication Date: 2012-07-04
天津药物研究院药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For these patients, dry suspensions, granules, oral liquids, especially chewable tablets, are not suitable for taking

Method used

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  • Strontium ranelate orally disintegrating tablets and preparation method thereof
  • Strontium ranelate orally disintegrating tablets and preparation method thereof
  • Strontium ranelate orally disintegrating tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Prescription: (mass ratio)

[0025]

[0026] Preparation:

[0027] According to the ratio shown in the prescription, pass microcrystalline cellulose, mannitol and crospovidone through a 40-mesh sieve, pass strontium ranelate and magnesium stearate through a 60-mesh sieve, and pass citric acid and aspartame through a 100-mesh sieve. Mesh sieve. Then add them all into the mixing granulator and mix for 15 minutes until they are evenly mixed. Determination of intermediate content. According to the content, each tablet contains 2 g of strontium ranelate and is pressed into tablets to obtain strontium ranelate orally disintegrating tablets.

[0028] Tests and results:

[0029] The orally disintegrating tablet prepared in Example 1, its in vitro release test method is as follows: select the II method of the Chinese Pharmacopoeia 2010 edition appendix XC dissolution test method, take 1000ml of hydrochloric acid solution (9→1000) as the dissolution medium, and the rotatin...

Embodiment 2

[0032] Prescription: (mass ratio)

[0033]

[0034] Preparation:

[0035] The ratio shown in the prescription, pass microcrystalline cellulose, lactose and croscarmellose sodium through a 40-mesh sieve, pass strontium ranelate and magnesium stearate through a 60-mesh sieve, pass citric acid and aspartame Pass through a 100 mesh sieve. Then add them all into the mixing granulator and mix for 15 minutes until they are evenly mixed. Determination of intermediate content. According to the content, each tablet contains 2 g of strontium ranelate and is pressed into tablets to obtain strontium ranelate orally disintegrating tablets.

[0036] Tests and results:

[0037] The orally disintegrating tablet prepared in Example 2, its in vitro release test method is as follows: select the II method of the Chinese Pharmacopoeia 2010 edition appendix XC dissolution test method, take 1000ml of hydrochloric acid solution (9 → 1000) as the dissolution medium, and the rotating speed is 50 ...

Embodiment 3

[0039] Prescription: (mass ratio)

[0040]

[0041] Preparation:

[0042] The ratio shown in the prescription, pass microcrystalline cellulose, mannitol and crospovidone through a 40-mesh sieve, pass strontium ranelate, magnesium stearate and microsilica gel through a 60-mesh sieve, pass citric acid and stevioside through a 100-mesh sieve Mesh sieve. Then add them all into the mixing granulator and mix for 15 minutes until they are evenly mixed. Determination of intermediate content. According to the content, each tablet contains 2 g of strontium ranelate and is pressed into tablets to obtain strontium ranelate orally disintegrating tablets.

[0043] Tests and results:

[0044] The orally disintegrating tablet prepared in Example 3, its in vitro release test method is as follows: select the II method of the Chinese Pharmacopoeia 2010 edition appendix XC dissolution test method, take 1000ml of hydrochloric acid solution (9→1000) as the dissolution medium, and the rotatin...

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Abstract

The invention relates to strontium ranelate orally disintegrating tablets and a preparation method of the tablets. The strontium ranelate orally disintegrating tablets are characterized in that the strontium ranelate orally disintegrating tablets are prepared from the following components by mass: 1-2 parts of strontium ranelate, 0.5-2 parts of filler, 0.1-0.5 parts of disintegrant, 0.02-0.2 parts of corrective, and 0.02-0.2 parts of lubricant. The preparation method comprises the following steps: sieving strontium ranelate, filler, corrective and lubricant, and mixing in a mixing machine; and selecting a proper mold, and tableting with a tableting machine to obtain strontium ranelate orally disintegrating tablets. Compared with the existing preparation, the strontium ranelate orally disintegrating tablets prepared using the method of the invention is more suitable for patients to take, increases the compliance of patients, and has the adavntages of rapid absorption, high bioavailability and the like in addition to convenience in administration. Therefore, the development of this project can obtain wide social and economic benefits.

Description

technical field [0001] The invention relates to a strontium ranelate orally disintegrating tablet and a preparation method thereof. Background technique [0002] Strontium ranelate, English name strontium ranelate, also known as strontium ranelate. Its chemical name is distrontium 5-[bis(carboxymethyl)amino]-2-carboxy-4-cyano-3-thiophene acetate, CAS RN.135459-87-1. It is mainly used for the treatment and prevention of osteoporosis in postmenopausal women. It has attracted much attention because of its unique dual effects of inhibiting bone resorption and promoting bone formation. [0003] Strontium ranelate was first developed by the French company Servier, and it was listed in the European Union in September 2004. The dosage form is dry suspension, the trade name is Protelos, and the specification is 2g / bag. [0004] There are many patents on the synthesis of strontium ranelate, including multiple patents on different hydrates and different intermediates that have been...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/381A61K47/32A61K47/38A61P19/10
Inventor 刘亚梅杨昕傅雪晶周学海
Owner 天津药物研究院药业有限责任公司
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