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Technetium [ 99 tc] methylene diphosphonate preparation and preparation method thereof

A technology of methylene diphosphonate and methylene diphosphonic acid, which is applied in the directions of in vivo radioactive preparations, anti-inflammatory agents, pharmaceutical formulations, etc. problems, to achieve the effect of improving quality and stability, high complexing rate, and reducing production costs

Active Publication Date: 2017-05-17
CHENGDU YUNKE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] Main purpose of the present invention is to exist in the above-mentioned prior art 99 The complexation rate of Tc and MDP is low, which affects the curative effect of the drug, and the problem that the preparation is easily polluted in the clinical operation provides a method that can effectively improve the 99 Technetium of Tc and MDP complexation rate[ 99 Tc] methylene bisphosphonate formulations

Method used

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  • Technetium [ <sup>99</sup> tc] methylene diphosphonate preparation and preparation method thereof
  • Technetium [ <sup>99</sup> tc] methylene diphosphonate preparation and preparation method thereof
  • Technetium [ <sup>99</sup> tc] methylene diphosphonate preparation and preparation method thereof

Examples

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Effect test

Embodiment 1

[0029] Technetium listed in this example [ 99 Tc] methylene diphosphonate freeze-dried powder injection, the composition is as follows: in 7mL vials, containing high technetium [ 99 Sodium Tc] acid 0.05μg (with 99 Tc), methylene diphosphonic acid 5mg, SnCl 2 0.5 mg.

[0030] Preparation:

[0031] In a sterile environment at 25°C, the formulation amount is high technetium[ 99 Sodium Tc] acid solution, aqueous solution of methylene diphosphonic acid and SnCl 2 Hydrochloric acid solution mixed, sodium hydroxide to adjust the pH value of the solution to 5.0, and water for injection to make up the volume, so that each milliliter of solution 99 Tc is 0.05μg, methylene diphosphonic acid 5mg, SnCl 2 0.5 mg. The prepared drug solution is sterilized and filtered, and quickly divided into vials. The volume of the drug solution in each 7mL vial is 1mL. The vials containing the drug solution are placed in a freeze-drying box and freeze-dried to form a freeze-dried powder. injecti...

Embodiment 2

[0037] Technetium listed in this example [ 99 Tc] methylene diphosphonate freeze-dried powder injection, the composition is as follows: in 7mL vials, containing high technetium [ 99 Sodium Tc] acid 0.2μg (with 99 Tc), methylene diphosphonic acid 20mg, SnCl 2 2mg.

[0038] Preparation:

[0039] In a sterile environment at 20°C, the high technetium [ 99 Sodium Tc] acid solution, aqueous solution of methylene diphosphonic acid and SnCl 2 Hydrochloric acid solution mixed, sodium hydroxide to adjust the pH value of the solution to 5.4, and then add water for injection to make up the volume, so that in each milliliter of solution 99 Tc content is 0.2μg, methylene diphosphonic acid is 20mg, SnCl 2 2mg. The prepared drug solution is sterilized and filtered, and quickly divided into vials. The volume of the drug solution in each 7mL vial is 1mL. The vials containing the drug solution are placed in a freeze-drying box and freeze-dried to form a freeze-dried powder. injection. ...

Embodiment 3

[0045] Technetium listed in this example [ 99 Tc] methylene diphosphonate freeze-dried powder injection, the composition is as follows: in 7mL vials, containing high technetium [ 99 Sodium Tc] acid 1μg (with 99 Tc), methylene diphosphonic acid 100mg, SnCl 2 5mg.

[0046] Preparation:

[0047] In a sterile environment at 30°C, the formulation amount is high technetium[ 99 Sodium Tc] acid solution, aqueous solution of methylene diphosphonic acid and SnCl 2 hydrochloric acid solution mixed, sodium hydroxide to adjust the pH value of the solution to 5.2, and then add water for injection to make up the volume, so that each milliliter of solution 99 Tc content is 1μg, methylene diphosphonic acid is 100mg, SnCl 2 is 5mg. The prepared drug solution is sterilized and filtered, and quickly divided into vials. The volume of the drug solution in each 7mL vial is 1mL. The vials containing the drug solution are placed in a freeze-drying box and freeze-dried to form a freeze-dried po...

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Abstract

The invention relates to the field of pharmaceutical chemistry, and specifically elates to a technetium [99Tc] methylenediphosphonate preparation and a preparation method thereof. The technetium [99Tc] methylenediphosphonate preparation preparation provided by the invention is lyophilized powder for injection. Unit preparation comprises: 0.05-1mug of sodium pertechnetate [99Tc] (calculated according to 99Tc); 5-100mg of methylene diphosphonic acid, and 0.5-5mg of stannous chloride. The invention further discloses a preparation method of the technetium [99Tc] methylenediphosphonate lyophilized powder for injection. With the technetium [99Tc] methylenediphosphonate lyophilized powder for injection provided by the invention, the complexation rate of 99Tc and methylene diphosphonic acid is effectively improved, stability and effectiveness of technetium [99Tc] methylenediphosphonate preparation is improved, a bacterial contamination risk of pre-clinical preparation is avoided, and production cost is reduced.

Description

technical field [0001] The invention belongs to the technical field of medicinal chemistry, in particular to a technetium[ 99 Tc] methylene bisphosphonate formulations and methods for their preparation. Background technique [0002] Technetium [ 99 Tc] methylene diphosphonic acid injection (referred to as " 99 Tc-MDP") is a drug for the treatment of rheumatoid arthritis and orthopedic diseases. 99 Tc-MDP through trace elements 99 The electron loss and valence change of Tc can remove free radicals in the body, ensure the activity of SOD (superoxide dismutase) in the body, and inhibit the production of immune complexes; 99 The MDP (methylene diphosphonate) component in Tc-MDP can reduce the activity of matrix metalloproteinases by chelating metal ions, thereby inhibiting the destruction of collagenase on articular cartilage; 99 Tc is loaded into the joint cavity, so that it can exert a long-term therapeutic effect on the lesion at a very short distance. 99 Tc-MDP can inh...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K51/00A61K9/19A61P19/02A61P29/00A61K31/663
Inventor 李明起邓启民王翰蒋雪程作用李茂良李敏钟国标苑娇梅王邦金段玉春石刚曹嘉强王基明赵仕健
Owner CHENGDU YUNKE PHARMA
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