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Scale-up production method of Regadeson Injection

A technology of regadeson and its production method, which is applied in the direction of pharmaceutical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as incomplete application

Active Publication Date: 2018-11-13
NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purpose of the present invention is on the basis of prior art, for the dosing and preparation technology of existing Regadesone Injection is not fully applicable in actual production, and the order of adding different raw materials and auxiliary materials found in the test is prepared There are many practical problems such as the content and impurity of different liquid medicines, and provide a kind of regadesone that can be used easily and quickly in scaled-up industrial production to prepare high content, less impurities, stable and uniform liquid medicine, and high quality standards. Injection Method

Method used

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  • Scale-up production method of Regadeson Injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Add 122.5L of 60°C water for injection into a 200L pre-dissolution tank, use a heating jacket outside the pre-dissolution tank to maintain the temperature in the tank at 60°C, add 52.5kg of 1,2-propylene glycol and stir to dissolve, then add 28.01g of anhydrous Regadeson Stir to dissolve; weigh 3.045kg anhydrous disodium hydrogen phosphate, 1.645kg anhydrous sodium dihydrogen phosphate and 350.02g disodium edetate and stir until completely dissolved. Transfer the liquid in the pre-dissolving tank to the liquid mixing tank, use a heating jacket outside the liquid mixing tank, and also maintain the temperature in the tank at 60°C; add 60°C water for injection to make the volume to 350L, stir for 0.2h, and the liquid mixing takes 0.42h, Take the medicinal liquid to test the content is 99.98%, related substances: total impurities 0.87%, maximum simple impurities 0.39%. After the medicine solution is cooled to room temperature, it is filtered in the workshop, and then filled...

Embodiment 2

[0044] Add 122.5L of 65°C water for injection into a 200L pre-dissolved barrel, use a heating jacket outside the pre-dissolved barrel to maintain the temperature inside the barrel at 65°C, add 52.5kg of 1,2-propanediol and stir to dissolve, then add 29.43g of Regadeson monohydrate Stir to dissolve; weigh 3.818kg disodium hydrogen phosphate dihydrate, 1.892g sodium dihydrogen phosphate monohydrate and 350.25 g disodium edetate and stir until completely dissolved. Transfer the liquid in the pre-dissolving tank to the liquid mixing tank, use a heating jacket outside the liquid mixing tank, and also maintain the temperature in the tank at 65°C; add 65°C water for injection to make the volume to 350L, stir for 0.2h, and the liquid mixing takes 0.38h, The liquid medicine was taken for detection and the content was 100.06%, related substances: total impurities 0.92%, maximum simple impurities 0.43%. After the medicine solution is cooled to room temperature, it is filtered in the work...

Embodiment 3

[0046] Add 122.5L of 75°C water for injection into a 200L pre-dissolved barrel, use a heating jacket outside the pre-dissolved barrel to maintain the temperature in the barrel at 75°C, add 52.5kg of 1,2-propanediol and stir to dissolve, then add 30.73g of Regadeson dihydrate Stir to dissolve; weigh 3.812kg disodium hydrogen phosphate dihydrate, 1.895g sodium dihydrogen phosphate monohydrate and 350.05g disodium edetate and stir until completely dissolved. Transfer the liquid in the pre-dissolving tank to the liquid mixing tank, use a heating jacket outside the liquid mixing tank, and also maintain the temperature in the tank at 75°C; add 75°C water for injection to make the volume to 350L, stir for 0.2h, and the liquid mixing takes 0.45h, The liquid medicine was taken for detection and the content was 100.01%, related substances: total impurities 0.88%, maximum simple impurities 0.37%. After the medicine solution is cooled to room temperature, it is filtered in the workshop, a...

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Abstract

The invention discloses an amplified production method of a Regadenoson injection. The method comprises the following steps: (1) preparing a 15%-35% by mass propylene glycol aqueous solution and heating the solution to 60-75 DEG C or adding propylene glycol into water for injection at 60-75 DEG C to be dissolved to prepare a 15%-35% by mass propylene glycol aqueous solution, then adding Regadenoson to be mixed and dissolved at 60-75 DEG C, then successively adding and dissolving disodium hydrogen phosphate, sodium dihydrogen phosphate and edetate disodium, mixing till disodium hydrogen phosphate, sodium dihydrogen phosphate and edetate disodium are fully dissolved, replenishing water for injection to a constant volume to obtain a medicine liquid; and (2) filtering and canning the prepared medicine liquid, and then sterilizing the medicine liquid to obtain the Regadenoson injection. The process disclosed by the invention solves the problem that the medicine liquid is exposed in a naked environment for a relatively long time. The medicine liquid with high quality is prepared according to a correct feeding sequence, the laboratory experiment is transferred to amplified production in a workshop, and the sterile level of the product is improved; the preparation process has the advantages of being mild in condition, simple and rapid to operate, low in cost, stable in property of medicine liquid, high in quality standard and suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of biomedicine, in particular to a preparation method of Regadeson injection and its enlarged production. Background technique [0002] Regadeson, also known as adenosine, trade name: LEXISCAN, common name for injection: REGADENOSON, molecular formula: C 15 h 18 N 8 o 5 ·H 2 O, molecular weight: 408.37, its structural formula is: [0003] [0004] Regadeson Injection was first launched in the United States by Astellas in 2008, and has grown by 100% every year since its launch, and has now reached a steady annual sales volume of US$500 million. [0005] Nuclide myocardial perfusion imaging (MPI) is recognized as an accurate non-invasive imaging technique for the diagnosis of coronary heart disease and risk stratification of coronary heart disease. It is divided into two types: rest and stress. Stress MPI needs to meet the load standard and inject myocardial perfusion imaging agent before conducting the test. C...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/7076A61K47/10A61K47/02A61P9/08
CPCA61K9/0019A61K9/08A61K31/7076A61K47/02A61K47/10
Inventor 唐咏群黄锡伟田欣欣胡铮娄媛媛
Owner NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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