CN104224698A - Preparation method of glutamine injection - Google Patents

Abstract

The invention discloses a preparation method of a glutamine injection. The method comprises the following steps: 1 adding injection water which is 50% of preparation amount to a preparation tank, adding glutamine, continuously stirring for dissolving, and then adding 5M sodium hydroxide solution; 2 adding 0.05% of medicinal carbon to stir evenly, heating, boiling for 5 minutes, quickly cooling to 50 DEG C, then adding 0.05% of medicinal carbon to stir evenly, filtering by a Suzhou sand rod until the solution is clear, and filtering into another preparation barrel; 3 adding injection water to 90% of the preparation amount, and adding 0.05% of medicinal carbon to stir; 4 adding injection water to the preparation amount; 5 filtering by a Suzhou sand rod and a folding polysulfone filter of 0.42 microns until the solution is clear; and 6 sampling and detecting visible particles, simultaneously conveying the sample to a testing center to test the intermediate content, the related substances and the pH value, after all indicators are qualified, filtering the liquid medicine into a liquid storage tank, and introducing nitrogen. According to the preparation method, the related substances can be reduced.

Description

The manufacture method of glutamine injection

Technical field

The present invention relates to a kind of glutamine injection, particularly relate to a kind of manufacture method of glutamine injection.

Background technology

Glutamine is a kind of conditionally essential amino acid.Glutamine can cause intestinal function and immunologic function etc. impaired when lacking, and increases the weight of the state of an illness, even causes death.The related substance that glutamine injection exists is the main cause that possible cause untoward reaction.

Summary of the invention

Technical problem to be solved by this invention is to provide a kind of manufacture method of glutamine injection, and it can reduce related substance.

The present invention solves above-mentioned technical problem by following technical proposals: a kind of manufacture method of glutamine injection, and it is characterized in that, it comprises the following steps:

Step one, adds the water for injection of amount of preparation 50%, adds glutamine in preparing tank, continuous stirring and dissolving; Add 5M sodium hydroxide solution again;

Step 2, adds 0.05% medicinal charcoal and stirs, heating, after boiling 5 minutes, and fast cooling to 50 DEG C; Add 0.05% medicinal charcoal again to stir, clear and bright through time filter of Suzhou sand rod, filter into another preparation bucket;

Step 3, adds water for injection to 90% of amount of preparation, adds 0.05% medicinal charcoal and stirs, and returns filter to clear and bright, filter into another preparing tank with Suzhou sand rod;

Step 4, adds water for injection to amount of preparation, stirs 15 minutes, makes it even;

Step 5, is filtered to clear and bright through Suzhou sand rod, 0.42 μm of folding polysulfone filter;

Step 6, visible foreign matters inspection is done in sampling, samples content, related substance, pH value that censorship measured center surveys intermediate simultaneously, every all qualified, is filtered by medicinal liquid into receiver, passes into nitrogen.

Positive progressive effect of the present invention is: the manufacture method of glutamine injection of the present invention can reduce related substance.

Detailed description of the invention

The manufacture method of glutamine injection of the present invention comprises the following steps:

Step one, adds the water for injection of amount of preparation 50%, adds glutamine in preparing tank, continuous stirring and dissolving; Add 5M sodium hydroxide solution again, regulate about PH to 5.6.Principal agent feeds intake by 105%, guarantees the number of dropouts in technological process.5M sodium hydroxide solution adjust pH to 5.67 ~ 5.77(solution temperature: 25 DEG C), because related substance has a significant effect to its soda acid, control soda acid scope so strict, control related substance and increase.

Step 2, adds 0.05% medicinal charcoal and stirs, heating, after boiling 5 minutes, and fast cooling to 50 DEG C; Add 0.05% medicinal charcoal again to stir, clear and bright through time filter of Suzhou sand rod, filter into another preparation bucket.Active carbon adds at twice, and each 1/2, guarantee that absorption is fully.After adding active carbon, be rapidly heated to micro-and boil, cool fast, control related substance and increase;

Step 3, adds water for injection to 90% of amount of preparation, adds 0.05% medicinal charcoal and stirs, and returns filter to clear and bright, filter into another preparing tank with Suzhou sand rod;

Step 4, adds water for injection to amount of preparation, stirs 15 minutes, makes it even;

Step 5, is filtered to clear and bright through Suzhou sand rod, 0.42 μm of folding polysulfone filter;

Step 6, visible foreign matters inspection is done in sampling, samples content, related substance, pH value that censorship measured center surveys intermediate simultaneously, every all qualified, is filtered by medicinal liquid into receiver, passes into nitrogen.

Prove that indices is all in acceptability limit after glutamine injection before changing by experiment.The manufacture method of glutamine injection of the present invention can reduce related substance.

Although the foregoing describe the specific embodiment of the present invention, it will be understood by those of skill in the art that these only illustrate, under the prerequisite not deviating from principle of the present invention and essence, various changes or modifications can be made to these embodiments.Therefore, protection scope of the present invention is defined by the appended claims.

Claims (1)

1. a manufacture method for glutamine injection, is characterized in that, it comprises the following steps:

Step one, adds the water for injection of amount of preparation 50%, adds glutamine in preparing tank, continuous stirring and dissolving; Add 5M sodium hydroxide solution again;

Step 2, adds 0.05% medicinal charcoal and stirs, heating, after boiling 5 minutes, and fast cooling to 50 DEG C; Add 0.05% medicinal charcoal again to stir, clear and bright through time filter of Suzhou sand rod, filter into another preparation bucket;

Step 3, adds water for injection to 90% of amount of preparation, adds 0.05% medicinal charcoal and stirs, and returns filter to clear and bright, filter into another preparing tank with Suzhou sand rod;

Step 4, adds water for injection to amount of preparation, stirs 15 minutes, makes it even;

Step 5, is filtered to clear and bright through Suzhou sand rod, 0.42 μm of folding polysulfone filter;

Step 6, visible foreign matters inspection is done in sampling, samples content, related substance, pH value that censorship measured center surveys intermediate simultaneously, every all qualified, is filtered by medicinal liquid into receiver, passes into nitrogen.