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Compound amino acid injection 15-HBC composition and preparation method thereof

A 15-HBC and compound amino acid technology, which is applied in the field of preparation of compound amino acid injection (15-HBC) composition and compound amino acid injection (15-HBC) composition, can solve problems such as risk and impact on concentration, and achieve Good effect, guaranteed stability, and eliminated side effects

Active Publication Date: 2014-05-14
湖北一半天制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

We found that edetate calcium sodium has a strong metal ion chelation effect. Although it will not significantly affect the blood calcium concentration, it may affect the concentration of other trace elements in the blood, which makes clinical use a certain risk.

Method used

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  • Compound amino acid injection 15-HBC composition and preparation method thereof
  • Compound amino acid injection 15-HBC composition and preparation method thereof
  • Compound amino acid injection 15-HBC composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] A compound amino acid injection 15-HBC composition, characterized in that every 1000mL injection composition is composed as follows:

[0047]

[0048]

[0049] The pH value of the 15-HBC composition of the injection is 6.0.

[0050] The preparation method of the compound amino acid injection (15-HBC) composition of the above formula, the steps are:

[0051] A. Add 700mL of fresh water for injection into the concentrated preparation tank, boil (100°C), inject pure nitrogen, start stirring, and set aside; all the following operations are carried out under the protection of nitrogen.

[0052] B. Cool down to 85 or 86 or 87 or 88 or 89 or 90°C, add leucine, isoleucine, valine, and methionine in sequence, and stir to dissolve.

[0053] C. After stirring to dissolve, lower the temperature to 75 or 76 or 77 or 78 or 79 or 80°C, add phenylalanine, lysine acetate, threonine, and glycine in sequence, and stir to dissolve.

[0054] D. After stirring and dissolving, lower t...

Embodiment 2-7

[0060] A compound amino acid injection 15-HBC composition, characterized in that the composition of each 1000mL injection composition is as follows, for convenience, the pH value of each formulation composition is written in the last line:

[0061] Components and pH

Example 2

Example 3

Example 4

Example 5

Example 6

Example 7

malic acid

0.3g

2.5g

1.0g

1.3g

1.8g

2.2g

[0062] cysteine ​​hydrochloride

0.1g

0.4g

0.18g

0.26g

0.29g

0.33g

Isoleucine

6.66g

8.5g

6.9g

7.4g

7.9g

8.2g

Leucine

12.78g

15.0g

13.0g

13.4g

13.9g

14.5g

Lysine acetate

4.8g

7.0g

5.2g

5.9g

6.2g

6.7g

Methionine

1.5g

3.5g

1.8g

2.2g

2.9g

3.1g

Phenylalanine

2.2g

4.5g

2.5g

2.9g

3.2g

4.0g

threonine

1.0g

3.5g

1.3g

1.9g

2.4g

3.0g

T...

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PUM

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Abstract

The invention belongs to the technical field of medicine, and particularly discloses a compound amino acid injection 15-HBC composition and a preparation method thereof. The composition contains the following components of isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, glycine, cysteine hydrochloride, malic acid and water for injection. The composition does not contain sulfite-type antioxygen, the malic acid serves as a PH value conditioning agent or a metal ionchelating agent or a stabilizer and can further improve the bioavailability of various amino acids, the cysteine hydrochloride serves as antioxygen, nitrogenization is conducted in the whole production process so as to reduce residual oxygen in the product to enable the quality of the product to be superior to that of on-sale compound amino acid injection 15-HBC products of the same type, and therefore clinical use is safer.

Description

technical field [0001] The invention belongs to the technical field of medicine, more specifically relates to a compound amino acid injection (15-HBC) composition, and also relates to a preparation method of the compound amino acid injection (15-HBC) composition. The present invention is suitable for patients who cannot take nutrition orally or through the intestines, and patients whose nutrition cannot meet their needs. The composition can be infused intravenously to meet the needs of the body to synthesize proteins, and it is used for stress states such as large area burns, wounds and severe infections. Nutritional support for patients with hypercatabolism of muscles, digestive system dysfunction, nutritional deterioration and decreased immune function, and improvement of nutrition for patients after surgery. Background technique [0002] Compound amino acid injection (15-HBC) is a parenteral nutrition drug, which has a special and important position in clinical applicatio...

Claims

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Application Information

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IPC IPC(8): A61K31/4172A61K9/08A61K47/12A61P17/02A61P31/00A61P1/16A61P25/00A61P3/02A61K31/405A61K31/401A61K31/198
Inventor 李金屏甘周阳
Owner 湖北一半天制药有限公司
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