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Compound glycyrrhizin medicinal composition for injection and preparation method thereof

A compound glycyrrhizin and glycyrrhizin technology are applied in the compound glycyrrhizin pharmaceutical composition for injection and preparation thereof, and the field of pharmaceutical composition for injection and preparation thereof, can solve the problems of limited solubilization effect and the like, and achieve safety Enhanced, rapid reconstitution, sustained stability, high physiological tolerance

Active Publication Date: 2015-04-01
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Sodium hydroxide is used as a cosolvent in this prescription, but sodium hydroxide is often used as a pH regulator, and its solubilizing effect as a solubilizer is limited

Method used

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  • Compound glycyrrhizin medicinal composition for injection and preparation method thereof
  • Compound glycyrrhizin medicinal composition for injection and preparation method thereof
  • Compound glycyrrhizin medicinal composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Prescription of Compound Glycyrrhizin for Injection (in 1000 sticks, unit: g)

[0037] Glycyrrhizin

[0038]Preparation process: Add 700ml of water for injection into a stainless steel container, control the temperature of the water for injection at 45°C to 60°C, add 8g of sodium sulfite, 50g of polyethylene glycol 15-hydroxystearate in turn, stir to dissolve completely; add 20g of licorice Add 200g glycine, stir to dissolve completely; add 10g L-cysteine ​​hydrochloride, stir to dissolve completely; measure the pH value of the solution, adjust the pH value to 6.2 with 10% sodium hydroxide solution ~6.4; add medicinal charcoal with a liquid dosage of 0.1% (w / v), heat and absorb at 45°C~60°C for 15 minutes, stir, and decarbonize by coarse filtration while hot; add water for injection to the full amount, stir evenly, and measure the pH The value range is controlled between 6.0 and 7.5, fine filtration, filling, half-tamping, freeze-drying, capping, lig...

Embodiment 2

[0039] Example 2 Prescription of compound glycyrrhizin for injection (in 1000 sticks, unit: g)

[0040] Glycyrrhizin

[0041] Preparation process: Add 700ml of water for injection into a stainless steel container, control the temperature of the water for injection at 45°C to 60°C, add 8g of sodium sulfite, 250g of polyethylene glycol 15-hydroxystearate in turn, stir to dissolve completely; add 20g of licorice Add 200g glycine, stir to dissolve completely; add 10g L-cysteine ​​hydrochloride, stir to dissolve completely; measure the pH value of the solution, adjust the pH value to 6.2 with 10% sodium hydroxide solution ~6.4; add medicinal charcoal with a liquid dosage of 0.1% (w / v), heat and absorb at 45°C~60°C for 15 minutes, stir, and decarbonize by coarse filtration while hot; add water for injection to the full amount, stir evenly, and measure the pH The value range is controlled between 6.0 and 7.5, fine filtration, filling, half-tamping, freeze-drying, capping, l...

Embodiment 3

[0042] Example 3 Prescription of Compound Glycyrrhizin for Injection (in 1000 sticks, unit: g)

[0043] Glycyrrhizin

[0044] Preparation process: Add 700ml of water for injection into a stainless steel container, control the temperature of the water for injection at 45°C to 60°C, add 40g of sodium sulfite, 50g of polyethylene glycol 15-hydroxystearate in turn, stir to dissolve completely; add 20g of licorice Add 200g glycine, stir to dissolve completely; add 10g L-cysteine ​​hydrochloride, stir to dissolve completely; measure the pH value of the solution, adjust the pH value to 6.2 with 10% sodium hydroxide solution ~6.4; add medicinal charcoal with a liquid dosage of 0.1% (w / v), heat and absorb at 45°C~60°C for 15 minutes, stir, and decarbonize by coarse filtration while hot; add water for injection to the full amount, stir evenly, and measure the pH The value range is controlled between 6.0 and 7.5, fine filtration, filling, half-tamping, freeze-drying, capping, l...

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Abstract

The invention relates to a compound glycyrrhizin medicinal composition for injection and a preparation method thereof, and belongs to the technical field of medicines. The compound glycyrrhizin medicinal composition for injection, which is prepared by adopting the formula and the process, has a simple formula and does not contain a lyophilized excipient, the prepared product is full in appearance and is a white loose block, the technical biases that the product appearance is maintained by adding dextran and other excipients in the prior art can be overcome, the safety risk caused by adding dextran and other excipients can be reduced, and the safety can be greatly improved; 15-hydroxystearate polyglycol ester is used as a solubilizer, and users unexpectedly discover a higher physiological tolerance, no hemolysis or irritation phenomena and strong solubilizing power of the 15-hydroxystearate polyglycol ester, so that the use safety is improved while the medicine dissolution is guaranteed.

Description

technical field [0001] The invention relates to a pharmaceutical composition for injection and a preparation process thereof, in particular to a compound glycyrrhizin pharmaceutical composition for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Compound Glycyrrhizin Injection was first developed and produced in Japan, and the trade name of the imported drug is "Meineng". In practical application, it is found that the compound glycyrrhizic acid injection is easy to crystallize out, resulting in poor stability of the injection, so it is made into a powder injection preparation to improve the stability of the preparation. [0003] The Chinese patent application number 200810115716.0 discloses a compound glycyrrhizin powder injection and its preparation method. The patent prescription contains glycyrrhizin (or glycyrrhizin monoammonium salt), glycine, cysteine ​​hydrochloride, dextran , Anhydrous Sodium Su...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/34A61K31/704
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD