Preparation method of compound amino acid injection 18AA

A compound amino acid and injection technology, applied in the field of injection, can solve the problems of aggravated amino acid degradation, short validity period, easy oxidation of amino acids, etc., and achieve the effects of prolonging storage time, ensuring light transmittance and stable properties.

Inactive Publication Date: 2017-02-01
安徽富邦药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] The above-mentioned symptoms are mainly because: (1) cystine is almost insoluble in water, and the high preparation temperature is required in the production process, which aggravates the degradation of amino acid under high temperature conditions and affects the product quality; (2) amino acid is easy to oxidize, and the Nitrogen filling process must be adopted under the preparation conditions, and sodium bisulfite needs to be added as an antioxidant at the same time. Although sodium bisulfite prevents the degradation of amino acids to a certain extent, it also increases adverse effects such as allergy and shock in clinical application. (3) During the long-term storage of the drug, the amino acid is affected by the oxygen in the packaging container and continues to degrade, resulting in the product generally needing to be placed in a cool condition with a short validity period

Method used

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  • Preparation method of compound amino acid injection 18AA
  • Preparation method of compound amino acid injection 18AA
  • Preparation method of compound amino acid injection 18AA

Examples

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Embodiment 1

[0019] This embodiment provides a preparation method of compound amino acid injection 18AA, the formula of the compound amino acid injection (18AA-VII) is existing (the same below), as shown in Table 1; it comprises the following steps:

[0020] (a) Rinse the infusion bottle with alkaline water, drinking water, purified water and water for injection, and then transport it to the filling room; the specific operation of washing the bottle may include the following steps: (a1) Unpacking: Check the specifications of the infusion bottle , batch number, certificate of conformity, and inspection sheet; (a2) Bottle loading: After removing the outer packaging of the infusion bottle in the bottle warehouse, send it to the bottle loading operation table with a truck and lift it to the operation table; (a3) ​​Inspection bottle: there will be Eliminate bottles with obvious bumps, bell mouths, burrs, cracks, and oil stains; the bottom of the bottle should be flat, and the body of the bottle ...

Embodiment 2

[0028] This example provides a preparation method of compound amino acid injection 18AA, the formula of which is basically the same as that in Example 1, the difference is: in step (c), water for injection is added to the full amount to account for 0.02% of its mass fraction Activated carbon was used for needles, and the pH was controlled to be 6.5-8.0 by stirring; it was filtered through a melt-blown filter element, and then filtered with a filter membrane with a pore size of 0.45 μm connected in series to 0.22 μm.

Embodiment 3

[0030] This embodiment provides a preparation method of compound amino acid injection 18AA, its formula is basically the same as that in Example 2, the difference is that the temperature of the preparation of the injection is different, mainly in step (b) and step (c):

[0031] (b) Take water for injection and heat it to 90°C, feed nitrogen gas into it so that the dissolved oxygen content does not exceed 0.5ppm, add arginine and stir to dissolve under the condition of constant nitrogen filling and stirring, and then add valine in order , phenylalanine, alanine, aspartic acid, proline, serine, glutamic acid, glycine, tyrosine, isoleucine, leucine, methionine, threonine and group Stir to dissolve the acid;

[0032] (c) Cool down to 30°C, add lysine acetate, tryptophan, cysteine ​​and sodium bisulfite solution, stir and dissolve, and replenish water for injection to the full amount; add 0.02% activated carbon for needles , stirred and controlled to have a pH of 6.5-8.0; filtered...

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Abstract

The invention relates to a preparation method of a compound amino acid injection 18AA. The method includes the following steps that firstly, infusion bottles are washed and then conveyed to a filling room; secondly, arginine is stirred to be dissolved, and then valine, phenylalanine, alanine, aspartic acid, proline, serine, glutamic acid, glycine, tyrosine, isoleucine, leucine, methionine, threonine and histidine are added in sequence and stirred to be dissolved; thirdly, the solution is cooled to 30-50 DEG C, lysine acetate, tryptophan, cysteine and a sodium bisulfite solution are added, and after stirring is carried out for dissolution, water for injection is supplemented to a full dose; fourthly, after capping and sealing are carried out, sterilization is carried out. In this way, full dissolution of the components is promoted, and the light transmittance of the compound amino acid injection 18AA is guaranteed; besides, the property of the compound amino acid injection is stable, long-time storage is easy, and absorption is promoted.

Description

technical field [0001] The invention belongs to the field of injections, and relates to an amino acid injection, in particular to a preparation method of a compound amino acid injection 18AA. Background technique [0002] Compound amino acid injection (18AA) is a very important amino acid supplement and therapeutic agent, which plays an important role in clinical practice. Amino acids are very unstable in solution and are easily oxidized to produce a series of complex substances harmful to the human body. Since the compound amino acid was put into production and use in the 1960s, sulfite compounds with unique antioxidant properties, such as sodium bisulfite and sodium pyrosulfite, must be added to ensure the stability of the product. Since people did not know that such substances were harmful to the human body at the time, manufacturers usually added them in large quantities without restriction in order to ensure the stability of the product. However, since the 1980s, with...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4172A61K9/08A61P3/02A61K31/195A61K31/198A61K31/401A61K31/405
CPCA61K31/198A61K9/0019A61K9/08A61K31/195A61K31/401A61K31/405A61K31/4172A61K47/02
Inventor 张明刘贤李帼蓉盛程洁赵自育李家仙陈春红黄娟张玉萍
Owner 安徽富邦药业有限公司
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