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A kind of production preparation method of compound amino acid (15) dipeptide (2) injection

A compound amino acid and injection technology, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. It can solve the problems of easily exceeding the standard of oxidative degradation impurities, exceeding the standard of aluminum salt, and the decrease of product light transmittance and other problems, to achieve the effect of saving production preparation time and preventing oxidative degradation

Active Publication Date: 2022-06-03
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the original research products may have problems such as excessive aluminum salts, oxidative degradation impurities of amino acid products may easily exceed the standard, and the light transmittance of the product will decrease during the storage process.

Method used

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  • A kind of production preparation method of compound amino acid (15) dipeptide (2) injection
  • A kind of production preparation method of compound amino acid (15) dipeptide (2) injection
  • A kind of production preparation method of compound amino acid (15) dipeptide (2) injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

acid, lysine acetate, histidine, proline, serine, aspartic acid, and stir to dissolve.

[0038] The temperature of the medicinal solution was lowered to 60 °C, and glutamic acid, glycyl glutamyl, and glycyl tyrosine were added. Stir to dissolve, add

Add citric acid to 10L with water for injection and adjust the pH to 5.8.

[0039] Filling: the whole preparation and filling process control the dissolved oxygen content of the medicinal solution less than 3mg / L or less, and the residual oxygen content is less than 1% or less.

Fill the liquid medicine into a three-layer co-extrusion bag for infusion and seal it.

[0040] Sterilization: sterilize the samples by autoclaving at 121 °C for 8 min.

[0041] Packing: the sterilized product and the oxygen absorber are packed into the barrier bag bag by bag to carry out vacuum packaging.

According to quality standard, 3 batches of samples of small test are detected, and the results are as shown in Table 1.

Table 1 adopts 3 batches of s...

Embodiment 2

[0049] Preparation: add 1850L of water for injection in the preparation tank, continue to fill with nitrogen, and heat to 80 °C. Using a closed feeding tank, feeding

[0050] The temperature of the medicinal solution was lowered to 60 °C, and glutamic acid, glycyl glutamyl, and glycyl tyrosine were added. Stir to dissolve, add

[0051] Filling: the whole preparation, the canning process controls the dissolved oxygen content of the medicinal solution to be less than 3mg / L or less, and the residual oxygen content is less than 1% or less.

[0052] Sterilization: The sample was autoclaved at 121° C. for 8 min.

[0053] Packing: the sterilized product and the oxygen absorber are packed into the barrier bag bag by bag to carry out vacuum packaging.

[0056]

[0057]

[0058]

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Abstract

The invention discloses a production and preparation method of a compound amino acid (15) dipeptide (2) injection, which comprises the following steps: adding water for injection to 70% to 80% of the total amount, continuously filling nitrogen, and heating to above 80°C; The closed feeding tank is used for feeding, and citric acid, leucine, valine, threonine, tryptophan, arginine, alanine, isoleucine, phenylalanine, methionine are put in first. , lysine acetate, histidine, proline, serine, aspartic acid, stir to dissolve; cool down to below 60°C, add glutamic acid, glycylglutamyl, glycyltyrosine; stir Dissolve, add water for injection to the full amount, then add citric acid to adjust the pH value to 5.5-6.0. The liquid medicine is filled into a three-layer co-extrusion film-made bag for infusion, and the plug is sealed; the filled sample is autoclaved and packaged; the dissolved oxygen amount and the residual oxygen amount of the medicine liquid are controlled during the preparation process. The invention is beneficial to ensure the quality stability of the product within the validity period and the safety of clinical medication.

Description

A kind of production and preparation method of compound amino acid (15) dipeptide (2) injection technical field The present invention relates to the technical field of medicine, be specifically related to belong to the technical field of parenteral nutrition preparations, more specifically relate to a A production and preparation method of compound amino acid (15) dipeptide (2) injection. Background technique Compound amino acid (15) dipeptide (2) injection is parenteral nutrition medicine, is applicable to can not be orally or enterally replenish nutrition nutrition, as well as patients whose needs cannot be met by nutritional supplementation through these routes, especially for patients with moderate to severe catabolic conditions condition patients. This product is developed by Fresenius Kabi, trade name: Glamin (Gu Anguang), approved in May, 1995, in Germany, Switzerland It is listed in Germany, Sweden, Finland, Denmark and Austria. In April 2004, it was appro...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/198A61K31/401A61K31/405A61K31/4172A61K47/12A61J3/00A61J1/10A61J1/14A61P3/02
CPCA61K9/0019A61K9/08A61K47/12A61K31/198A61K31/405A61K31/4172A61K31/401A61J3/00A61P3/02A61J1/10A61J1/14A61K2300/00
Inventor 蔡作清刘思川刘文军袁南南王云川王昌斌
Owner SICHUAN KELUN PHARMA CO LTD