A lyophilized preparation of a cytochrome C-containing pharmaceutical composition for injection and a preparation method thereof

A technology of cytochrome and freeze-dried preparations, applied in the field of medicine, can solve problems such as unstable content of cytochrome C, unqualified foreign matter in clarity, unstable product quality, etc., shorten the freeze-drying time, increase hardware investment, and stabilize Guaranteed effect

Active Publication Date: 2013-04-24
MAANSHAN BBCA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] (1) Cytochrome C is a protein with iron porphyrin as a prosthetic group. It is a coenzyme biochemical drug with poor stability. Although the excipients in the prescription have a certain protective effect on cytochrome C, according to the existing prescription After the process Cytochrome C has gone through the whole production process, the product quality is unstable, and problems such as clarity and visible foreign matter are often unqualified
[0012] (2) The freeze-drying time reaches 23 hours during the freeze-drying process. The longer the freeze-drying time, the longer the cytochrome C is in a non-dry state, the more unstable the product quality, the greater the energy consumption, and the higher the production cost
[0013] (3) During the storage of the product, the instability of cytochrome C can easily lead to a significant decrease in content and activity

Method used

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  • A lyophilized preparation of a cytochrome C-containing pharmaceutical composition for injection and a preparation method thereof
  • A lyophilized preparation of a cytochrome C-containing pharmaceutical composition for injection and a preparation method thereof
  • A lyophilized preparation of a cytochrome C-containing pharmaceutical composition for injection and a preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The freeze-dried preparation of the cytochrome C-containing pharmaceutical composition for injection of the present invention is made of the following components: cytochrome C 7.5g; L-arginine 3g; edetate disodium 0.20g; mannitol 15g, water for injection to 1000ml.

[0033] Its preparation method is as follows:

[0034] 1) Weigh the prescribed amount of mannitol, add 500ml of water for injection to dissolve, add 2‰ activated carbon, boil, keep warm for 15 minutes, filter and decarbonize to obtain solution ①.

[0035] 2) Cool the solution ① to below 20°C, add the prescribed amount of L-arginine and edetate disodium successively to obtain the solution ②.

[0036] 3) Take the prescribed amount of cytochrome C solution, add water for injection to make up to 300 ml, and obtain solution ③.

[0037] 4) Mix solution ② and solution ③, and then make up the volume to the total amount with cold water for injection, adjust the pH value to 6.7, filter through a 0.22μm pore size ste...

Embodiment 2

[0045] The lyophilized formulation of the cytochrome C-containing pharmaceutical composition for injection of the present invention is made of the following components: cytochrome C 15g; L-arginine 4.5g; edetate disodium 0.3g; mannitol 15g, water for injection added to 1000ml.

[0046] Its preparation method is as follows:

[0047] 1) Weigh the prescribed amount of mannitol, add 500ml of water for injection to dissolve, add 2‰ activated carbon, boil, keep warm for 15 minutes, filter and decarbonize to obtain solution ①.

[0048] 2) Cool the solution ① to below 20°C, add the prescribed amount of L-arginine and edetate disodium successively to obtain the solution ②.

[0049] 3) Take the prescribed amount of cytochrome C solution, add water for injection to make up to 300 ml, and obtain solution ③.

[0050] 4) Mix solution ② and solution ③, and then make up the volume to the total amount with cold water for injection, adjust the pH value to 6.8, filter through a 0.22μm pore siz...

Embodiment 3

[0058] The freeze-dried preparation of the cytochrome C-containing pharmaceutical composition for injection of the present invention is made of the following components: cytochrome C 30g; L-arginine 6g; edetate disodium 0.50g; mannitol 15g, water for injection is added to 1000ml .

[0059] Its preparation method is as follows:

[0060] 1) Weigh the prescribed amount of mannitol, add 500ml of water for injection to dissolve, add 2‰ activated carbon, boil, keep warm for 15 minutes, filter and decarbonize to obtain solution ①.

[0061] 2) Cool the solution ① to below 20°C, add the prescribed amount of L-arginine and edetate disodium successively to obtain the solution ②.

[0062] 3) Take the prescribed amount of cytochrome C solution, add water for injection to make up to 300 ml, and obtain solution ③.

[0063] 4) Mix solution ② and solution ③, and then make up the volume to the total amount with cold water for injection, adjust the pH value to 6.9, filter through a 0.22μm pore...

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Abstract

The present invention relates to a lyophilized preparation of a cytochrome C-containing pharmaceutical composition for injection, and the lyophilized preparation comprises the following components by weight: 75-300 parts of cytochrome C; 30-60 parts of L-arginine; 2-5 parts of disodium edetate; and 150 parts of mannitol. In the lyophilized preparation, disodium edetate and L-arginine are selectd as excipients, thereby helping to improve the stability of cytochrome C; in the preparation process of the liquid pharmaceutical composition, mannitol is used as a lyophilizing excipient, and phosphoric acid or a sodium phosphate solution is used as an pH adjusting agent, thereby enabling the product quality more stable; and after a mannitol solution is treated activated carbon, the cytochrome C is added, thereby preventing the problem of decrease in the cytochrome C level due to the adsorption by activated carbon. The preparation method of the present invention shortens the lyophilized time from 23 hours to 14 to 16 hours, and reduces energy consumption by 30%; while the production capacity is improved by about 30% without increasing hardware input, thereby significantly reducing the cost of production.

Description

technical field [0001] The invention relates to a freeze-dried preparation of a pharmaceutical composition containing cytochrome C for injection and a preparation method thereof, belonging to the field of medicine. Background technique [0002] Freeze-dried preparation of Cytochrome C pharmaceutical composition, common name: Cytochrome C for injection; English name: Cytochrome C for Injection. [0003] This product is a protein with iron porphyrin as a prosthetic group existing in the mitochondria of cells, and it has been purified and separated at present. Pharmaceutical preparations are isolated from animal hearts or yeast, and cytochromes are a link in the respiratory chain. Various cytochromes are arranged in a certain order to form the cytochrome system, and the Fe in its molecules 3+ Under the action of relevant enzymes, it can carry out reversible oxidation-reduction reactions and take on the role of transferring electrons, which is indispensable for cellular respir...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/41A61K9/19A61K47/18A61P39/00A61P9/00
Inventor 尹双青刘永宏
Owner MAANSHAN BBCA PHARMA
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