Reduced glutathione for injection and pre-freezing method thereof

A technology of glutathione and reduced form, which is applied in the direction of freeze-dried delivery, tripeptide components, and devices for making drugs into special physical or ingestible forms, which can solve the problems of difficulty in guaranteeing freeze-drying residues and high risk of use , to achieve the effect of eliminating product safety risks, stable product quality, and simple process parameters

Inactive Publication Date: 2016-03-30
GUANGZHOU BAIYUNSHAN MINGXING PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

That is to say, if supplementary materials such as mannitol and tert-butanol are added in the production of reduced glutathione freeze-dried powder injection, relevant regulations must be complied with, corresponding safety tests, stability tests, etc. should be carried out and reported t

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The prescription composition of reduced glutathione for injection is:

[0031] Reduced Glutathione 300g

[0032] Sodium hydroxide 39.0g

[0033] Activated carbon 1.0g

[0034] Add water for injection to 1000ml to make 1000 sticks.

[0035] 1. Preparation of Glutathione Solution

[0036] (1) Weigh the prescribed amount of glutathione according to the above formula, put it in a 2000ml beaker, add 40% of the prescribed amount of water, stir in an ice-salt water bath, control the temperature of the suspension at 25°C±2°C, and obtain glutathione Glutathione suspension;

[0037] (2) Weigh NaOH of 105.0% of the prescription amount, put it in a 250ml beaker, add water to dissolve and dilute to make a 3.0mol / L solution, put it in an ice-water bath, and control the temperature of the suspension at 25°C±2°C to obtain a NaOH solution ;

[0038] (3) Add the NaOH solution dropwise to the glutathione suspension at a rate of about 30ml / min, stir while adding, and slowly add the s...

Embodiment 2

[0049]The prescription composition of reduced glutathione for injection is:

[0050] Reduced Glutathione 600g

[0051] Sodium hydroxide 78.0g

[0052] Activated carbon 2.0g

[0053] Add water for injection to 2000ml to make 1000 sticks.

[0054] 1. Preparation of Glutathione Solution

[0055] (1) Weigh the prescribed amount of glutathione according to the above formula, put it in a 3000ml beaker, add 40% of the prescribed amount of water, stir in an ice-salt water bath, and control the temperature of the suspension at 25°C±2°C to obtain glutathione peptide suspension;

[0056] (2) Weigh NaOH of 105.0% of the prescription amount, put it in a 1000ml beaker, add water to dissolve and dilute to make a 2.5mol / L solution, place it in an ice-salt water bath, and control the temperature of the suspension at 25°C±2°C to obtain a NaOH solution ;

[0057] (3) Add the NaOH solution dropwise to the glutathione suspension at a rate of about 40ml / min, stir while adding, and slowly add ...

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PUM

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Abstract

The invention relates to a reduced glutathione for injection and a pre-freezing method thereof. The pre-freezing method includes the following steps that S1, a glutathione solution is prepared and filled; S2, the partition plate temperature of a freeze-drying machine is reduced to be -25 to -35 DEG C; S3, the filled glutathione solution in the step S1 is put on a partition plate of the freeze-drying machine after the step S2 is completed, constant temperature is kept for 2 to 6 hours after the temperature of a product is reduced to be -25 to -35 DEG C, and a reduced glutathione frozen body is obtained, wherein a vacuum pump is started within 0.5 to 1 hour before constant temperature completion in the step S3 to enable the vacuum degree to be smaller than 10 Pa. The reduced glutathione used for injection and prepared by means of the pre-freezing method has the advantages of being high in safety, simple in freeze-drying operation, good in resolubility and stable and reliable in product quality.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to reduced glutathione for injection and a prefreezing method thereof. Background technique [0002] Reduced glutathione (GSH) is a polypeptide naturally synthesized in human cytoplasm, composed of glutamic acid, cysteine ​​and glycine, containing thiol (-SH), widely distributed in various organs of the body, is a biochemical An important antioxidant component of the system, which plays an important role in liver biochemical metabolism. Clinically, it has detoxification and anti-oxidation effects, and is mainly used for the prevention and treatment of chemotherapy and drug-induced liver injury in cancer patients, and the treatment of various hepatitis. Reduced glutathione is sensitive to heat due to the presence of active sulfhydryl groups, and is easily oxidized. It is unstable in aqueous solution and has a high viscosity. It is difficult to sublimate water in the produc...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/06A61P39/02A61P39/06A61P35/00A61P1/16A61J3/02
Inventor 刘连华黎洪高建胜黄子健黄孟秋
Owner GUANGZHOU BAIYUNSHAN MINGXING PHARM CO LTD
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