Compound glycyrrhizin injection preparation

A technology of glycyrrhizin injection and monoammonium glycyrrhizinate, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, organic active ingredients, etc., can solve the problem of inability to obtain sufficient stability, potential safety hazards, and effective ingredients in injection color. , pH changes, etc.

Inactive Publication Date: 2010-07-07
BEIJING KAWIN TECH SHARE HLDG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the above-mentioned preparations, since the addition of sodium sulfite and edetate calcium sodium is harmful to the human body itself, its dosage must be strictly controlled during use, which is likely to bring potential safety hazards; and the above-menti

Method used

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  • Compound glycyrrhizin injection preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Effect of Addition of Basic Amino Acids on the Solubility of Glycyrrhizin (Monoammonium Glycyrrhizinate)

[0047] Prescription 1 Prescription 2 Prescription 3

[0048] Monoammonium Glycyrrhizinate 5.3g 5.3g 5.3g

[0049] Cysteine ​​Hydrochloride 2g 2g 2g

[0050] Glycine 40g 40g 40g

[0051] L-Arginine - 3.5g -

[0052] L-Lysine - - 2.8g

[0053]Dissolving step: Weigh each recipe composition, put it into a Erlenmeyer flask, heat and stir in a water bath at 40±2°C for 30 minutes, let it cool at room temperature, filter, transfer the filtrate to a 1000ml volumetric flask, distill the volume to the mark with distilled water, and set aside , to determine the content of monoammonium glycyrrhizinate.

[0054] test methods:

[0055] Chromatographic conditions and system suitability test used octadecylsilane bonded silica gel as filler; acetonitrile-0.01mol / L phosphoric acid solution (38:62) as mobile phase; detection wavelength was 257nm. The theoretical...

Embodiment 2

[0061] Prescription: Monoammonium Glycyrrhizinate (equivalent to Glycyrrhizin 40g) 53g

[0062] Glycine 400g

[0063] Cysteine ​​Hydrochloride 20g

[0064] Sodium bisulfite 16g

[0065] Edetate Calcium Sodium 1g

[0066] Appropriate amount of sodium hydroxide

[0067] Add water for injection to 20000ml

[0068]

[0069] Make 1000 pieces, each 20ml

[0070] Preparation process: Weigh the prescribed amount of monoammonium glycyrrhizinate, glycine, and cysteine ​​hydrochloride, put them in a sterilized container, add 2000ml of water for injection, stir to dissolve in a water bath at 37°C, and then add sodium bisulfite 1. Calcium and sodium edetate, stir to dissolve, add water to 2500ml, adjust the pH value to about 7.2 with 1.0mol / L sodium hydroxide solution, add the prescribed amount of activated carbon, keep stirring at 80°C for 40 minutes, and use aseptic pumping Decarburize by filtering with a filter device, add 20,000 ml o...

Embodiment 3

[0072] Prescription: Monoammonium Glycyrrhizinate (equivalent to Glycyrrhizin 40g) 53g

[0073] Glycine 400g

[0074] Cysteine ​​Hydrochloride 20g

[0075] L-Arginine 35g

[0076] Disodium hydrogen phosphate-2H 2 O 712.2g

[0077] Sodium dihydrogen phosphate-2H 2 O 624.2g

[0078] Sodium chloride 170.8

[0079] Add water for injection to 20000ml

[0080]

[0081] Make 1000 pieces, each 20ml

[0082] Preparation process: Weigh monoammonium glycyrrhizinate, glycine, cysteine ​​hydrochloride, L-arginine, sodium dihydrogen phosphate, disodium hydrogen phosphate, and sodium chloride in a sterilized container, add Water for injection 5000ml, in a water bath at 40±5°C, stir to dissolve it, then add activated carbon for injection, keep stirring at 60±1°C for about 30 minutes, filter, filter the filtrate with a 0.22um microporous membrane, and replenish water for injection To the prescribed amount, sub-package, circulation steam steriliza...

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Abstract

The invention relates to a compound glycyrrhizin injection preparation which is prepared by glycyrrhizin (or monoammonium glycyrrhizinate), glycine, cysteine hydrochloride, basic amino acid, a pH buffer system and an isotonic regulator. The injection prepared by the prescription has the advantages of stable quality and high safety and can avoid the use of sodium bisulfite and other substances which are easy to produce potential safety hazard.

Description

technical field [0001] The invention relates to a highly stable compound glycyrrhizin injection preparation, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] Compound Glycyrrhizin Injection was first produced by Japan’s Mino Fayuan Pharmaceutical Company (Compound Glycyrrhizin Injection, (Compound Glycyrrhizin Injection), which has been imported to China, and the trade name is “Meineng”. There is Compound Glycyrrhizin Monoammonium Injection in China. Listed, the composition of the main drug is the same as it, but the ratio is different. Compound glycyrrhizin injection includes compound glycyrrhizin injection, compound monoammonium glycyrrhizinate injection, compound ammonium glycyrrhizinate injection, etc. Among them, compound glycyrrhizin injection is also The name is compound glycyrrhizin injection. Compound glycyrrhizin injection powder injection is an improvement of water injection, especially compared to glycine, because...

Claims

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Application Information

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IPC IPC(8): A61K31/704A61K31/198A61K47/18A61K9/08A61K9/19
Inventor 张春丽齐平熊国裕黄俊韩智冲
Owner BEIJING KAWIN TECH SHARE HLDG
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