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Preparation method of compound amino acid (15) dipeptide (2) injecta

A compound amino acid and injection technology is applied in the field of preparation of compound amino acid dipeptide injection, which can solve the problems of reduced drug safety, low quality, and inability to overcome product stability problems.

Active Publication Date: 2014-07-02
北京紫萌医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, due to the sterilization process of this product in the production of preparations, the main raw material glycyl-L-glutamine will be degraded into cyclic (glycyl-L-glutamyl), and glycyl-L-tyramine Amino acid will be degraded into cyclic (glycyl-L-tyrosyl), the quality is far lower than the import standard, which reduces the safety of the drug. There were dozens of domestic pharmaceutical companies applying for this drug around 2007, all of which were unable to overcome the The product stability problem caused by the high-temperature sterilization of this injection was withdrawn by the State Food and Drug Administration

Method used

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  • Preparation method of compound amino acid (15) dipeptide (2) injecta
  • Preparation method of compound amino acid (15) dipeptide (2) injecta
  • Preparation method of compound amino acid (15) dipeptide (2) injecta

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Effect test

Embodiment 1

[0031] The preparation of embodiment 1 compound amino acid (15) dipeptide (2) injection:

[0032] Weigh each amino acid raw material according to the ratio in the table below, 1000ml contains:

[0033]

[0034]Under the protection of nitrogen, take 3000 ml of water for injection with a total volume of 60%, heat it to 60°C, add the prescribed amount of glycyl-L-glutamine and glycyl-L-tyrosine in sequence, dissolve the Finally, add the prescribed amount of arginine, stir and dissolve, quickly add the prescribed amount of aspartic acid, glutamic acid, leucine, isoleucine and phenylalanine that have passed through a 80 mesh sieve, and stir to dissolve. , finally add the prescribed amount of alanine, histidine, lysine acetate, methionine, proline, serine, threonine, tryptophan and valine, stir to dissolve, and use citric acid Adjust the pH to 5.4-5.8, add the full amount of 0.10% (w / v) activated carbon, stir at 60°C for 30 minutes, decarburize and filter, dilute the volume with...

Embodiment 2

[0036] The preparation of embodiment 2 compound amino acid (15) dipeptide (2) injection:

[0037] According to the feeding ratio of Example 1, under the protection of nitrogen, take 3000 milliliters of water for injection with a total volume of 60%, heat it to 60 ° C, add the prescribed amount of arginine, add glycyl-L-glutamine after dissolving Amide and Glycyl-L-Tyrosine, after stirring and dissolving, quickly add aspartic acid, glutamic acid, leucine, isoleucine and phenylalanine passing through a 80-mesh sieve, Stir to dissolve the clear, finally add the prescribed amount of alanine, histidine, lysine acetate, methionine, proline, serine, threonine, tryptophan and valine, stir to dissolve the clear, use Citric acid was used to adjust the pH to 5.4-5.8, and the total amount of 0.10% (w / v) activated carbon was added, stirred at 60°C for 30 minutes, decarbonized and filtered, and the volume was adjusted to 5000 ml with water for injection, and passed through a 0.22 micron fil...

Embodiment 3

[0039] Preparation of embodiment 3 compound amino acid (15) dipeptide (2) injection:

[0040] According to the feeding ratio of Example 1, under the protection of nitrogen, take 3000 milliliters of water for injection with a total volume of 60%, heat it to 60 ° C, add the prescribed amount of glycyl-L-glutamine and glycyl-L- Tyrosine, after dissolving, add arginine, stir to dissolve and dissolve, then add the prescribed amount of alanine, histidine, lysine acetate, methionine, proline, serine, threonine . Use citric acid to adjust the pH to 5.4-5.8, add 0.10% (w / v) activated carbon in full amount, stir at 60°C for 30 minutes, decarbonize and filter, dilute to a total volume of 5000 ml with water for injection, and pass through a 0.22-micron filter membrane , filled with 500ml / bottle, filled with nitrogen, stoppered, and covered with aluminum. Sterilize the product at 121±1°C for 12 minutes according to the set program. After the sterilized product passed the light inspectio...

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Abstract

The invention relates to a preparation method of compound amino acid (15) dipeptide (2) injecta, specifically comprising the following steps of: under the whole-course protection of nitrogen, taking water for injection with a certain quantity, sequentially adding glycyl-L-glutamine, glycyl-L-tyrosine and arginine with prescription quantity, stirring and dissolving, clearly dissolving, adding aspartate, glutamic acid, leucine, isoleucine and phenylalanine with prescription quantity which is not less than 60 screen meshes, dissolving and clearly dissolving, adding alanine, histidine, L-lysine monoacetate, methionine, proline, serine, threonine, tryptophan and valine with prescription quantity, stirring and clearly dissolving, adjusting the pH at 5.4-5.8 by citric acid, adding full dose of 0.10% (w / v) of activated carbon, stirring for 30min under the temperature of 60DEG C, fixing the volume to total volume by the water for injection after filtering in a decarbonizing way, sieving by a filter membrane with 0.22 micrometers, filling, charging nitrogen, adding a plug, pricking an aluminum cap, and sterilizing for 8-12min in a hot-press way under the temperature of 121DEG C (F0 value is larger than 8), wherein the quality of the injecta can achieve the quality standard of an imported drug of the finished product of the German Fresenius Corporation.

Description

technical field [0001] The invention relates to a preparation method of compound amino acid (15) dipeptide (2) injection. It belongs to the field of medical technology. Background technique [0002] The original product name of Compound Amino Acid (15) Dipeptide (2) Injection is It is the world's first balanced amino acid aqueous solution that can supplement glutamine and tyrosine, which was developed and marketed in 1995 by Fresenius Kabi of Germany on the basis of the third-generation balanced amino acid infusion. Contains 20g / L glutamine and 2.28g / L tyrosine. This product has been launched in many European countries and has been used clinically for more than 10 years. It has been imported to China. [0003] The composition of its prescription is as follows, 1000ml of this product contains: [0004] [0005] The amino acid formula conforms to the FAO-WHO model. Compared with the standard TPN solution, it has clinical characteristics such as enhancing intestinal ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/05A61K9/08A61P3/02A61K31/198A61K31/401A61K31/405A61K31/4172
Inventor 谢丹
Owner 北京紫萌医药科技有限公司
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