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Creatine phosphate sodium freeze-dried preparation and method for preparing same

A technology of creatine phosphate sodium and freeze-dried preparations, which is applied in the field of myocardium protection drug creatine phosphate sodium freeze-dried preparations and its preparation, which can solve the problems of large water content of sterile powder injections, slow dissolution speed of sterile powder injections, and phosphate creatine injections. Sodium acid is easy to decompose and other problems, to achieve the effect of improving solubility and stability, fast dissolution speed, safety and reliability

Inactive Publication Date: 2010-06-16
杨军
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the preparation of creatine phosphate sodium is the aseptic powder injection that the raw material directly packs, but the water content of the sterile powder injection is large, which makes the creatine phosphate sodium easy to decompose and unstable; moreover, the dissolution rate of the sterile powder injection is slow, Inconvenience to use

Method used

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  • Creatine phosphate sodium freeze-dried preparation and method for preparing same
  • Creatine phosphate sodium freeze-dried preparation and method for preparing same
  • Creatine phosphate sodium freeze-dried preparation and method for preparing same

Examples

Experimental program
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Effect test

Embodiment 1

[0019] Take 500g of creatine phosphate sodium (manufactured by Beijing Lixiang Pharmaceutical Co., Ltd.) and 100g of mannitol (manufactured by Shandong Jiejing Group), add an appropriate amount of water for injection, and stir to dissolve completely. Add activated carbon according to the consumption of 0.05% (g / ml), stir at room temperature for 60 minutes, filter and decarbonize, and obtain the filtrate to sterilize with a 0.22 μm microporous filter element, after the filtrate is subpackaged, freeze-dry, seal, obtain phosphoric acid of the present invention Sodium creatine lyophilized formulation A.

Embodiment 2

[0021] Take 500 g of creatine phosphate sodium (manufactured by Beijing Lixiang Pharmaceutical Co., Ltd.) and 150 g of lactose, add an appropriate amount of water for injection, and stir to completely dissolve it. Add active carbon according to the consumption of 0.1% (g / ml), stir at room temperature for 60 minutes, filter and decarbonize, and the resulting filtrate is sterilized with a 0.22 μm microporous filter element, after the filtrate is subpackaged, freeze-dried and sealed to obtain the phosphoric acid of the present invention Sodium creatine freeze-dried formulation B.

Embodiment 3

[0023] Take 500g of creatine phosphate sodium (manufactured by Beijing Lixiang Pharmaceutical Co., Ltd.) and 200g of dextran (manufactured by Shandong Jinyang Pharmaceutical Co., Ltd.), add an appropriate amount of water for injection, and stir to dissolve completely. Add active carbon according to the consumption of 0.5% (g / ml), stir at 50 ℃ for 30 minutes, filter and decarbonize, and the obtained filtrate is sterilized with a 0.22 μm microporous filter element, after the filtrate is subpackaged, freeze-dried and sealed to obtain the Sodium creatine phosphate freeze-dried formulation C.

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Abstract

The invention relates to a creatine phosphate sodium freeze-dried preparation and a method for preparing the same. The mass ratio of creatine phosphate sodium to an excipient in the creatine phosphate sodium freeze-dried preparation is 1: 0.05 to 1: 20. The method for preparing the creatine phosphate sodium freeze-dried preparation comprises the steps of: adding active carbon to a solution containing the creatine phosphate sodium and the excipient, stirring, removing pyrogen, then filtering, decarburizing, filtering again, degerming, and packing filtrate in a split charging manner to obtain the creatine phosphate sodium freeze-dried preparation after freeze drying. The preparation, indicated by solubility tests, influencing factor tests, accelerating tests and long term stability tests, has the advantages of quick solution velocity and good stability, compared with the conventional creatine phosphate sodium powdery preparation. In addition, the freeze-dried preparation is produced in a relatively closed environment and the security of products is more reliable.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a freeze-dried preparation of creatine phosphate sodium, a cardioprotective drug, and a preparation method thereof. Background technique [0002] Creatine Phosphate Sodium (Creatine Phosphate Sodium) is an indispensable energy storage substance naturally present in the human body. After injection of exogenous Creatine Phosphate Sodium, it will significantly improve the contractile function of the failing heart and the energy of the ischemic myocardium. metabolism, and stabilize the myocardial fibrous membrane, thereby having a significant cardioprotective effect. [0003] As a cardioprotective drug, creatine sodium phosphate is not only highly effective but also low-toxic, and its therapeutic value ranks first among similar drugs. It is not only an important drug for the treatment of myocardial infarction and heart failure, but also an efficient ca...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/661A61P9/04A61P9/10
Inventor 杨军
Owner 杨军
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