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Production method of compound potassium dihydrogn phosphate

A production method, the technology of potassium hydrogen phosphate, applied in the direction of drug combination, pharmaceutical formula, phosphorus compound active ingredients, etc., can solve the problems of poor stability and inconvenient use of injections, and achieve the effect of ensuring quality and performance

Active Publication Date: 2010-12-29
苏州天马医药集团天吉生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The stability of the injection produced by the existing production method is not very ideal, mainly because crystals will be precipitated in the injection during the placement process before use, especially in winter. However, in a short period of time, especially in a low temperature environment, new crystals will be precipitated soon, which will cause great inconvenience to use

Method used

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  • Production method of compound potassium dihydrogn phosphate

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Comparison scheme
Effect test

Embodiment 1

[0026] A production method of compound potassium hydrogen phosphate injection, comprising the steps of:

[0027] (1), batching: take by weighing potassium dihydrogen phosphate and dipotassium hydrogen phosphate (three crystal water) of recipe quantity, add water for injection, stir and make dissolving completely;

[0028] (2), decolouring: add gac to the solution of step (1), filter after stirring and decolouring, retain the filtrate;

[0029] (3), filling and sealing: the filtrate gained in step (2) is filled into the ampoule bottle cleaned and sealed;

[0030] (4), high temperature (under 121 ℃) sterilization;

[0031] (5) Leak detection: In the sterilizing cabinet under vacuum conditions, inhale 80°C colored water for leak detection. After leak detection, take out the injection and place it at room temperature (about 10°C) to let it drop naturally room temperature;

[0032] (6), light inspection;

[0033] (7), hot bottle: clean the outer surface of the ampoule bottle wi...

Embodiment 2

[0037] A production method of compound potassium hydrogen phosphate injection, comprising the steps of:

[0038] (1), batching: take by weighing potassium dihydrogen phosphate and dipotassium hydrogen phosphate (three crystal water) of recipe quantity, add water for injection, stir and make dissolving completely;

[0039] (2), decolouring: add gac to the solution of step (1), filter after stirring and decolouring, retain the filtrate;

[0040] (3), filling and sealing: the filtrate gained in step (2) is filled into the ampoule bottle cleaned and sealed;

[0041] (4), high temperature sterilization;

[0042] (5) Leak detection: In the sterilizer under vacuum conditions, inhale colored water at room temperature (about 10°C) for leak detection. After leak detection, heat the injection to 80°C in the sterilizer, Then take out the injection solution and let it cool down to room temperature naturally;

[0043] (6), light inspection;

[0044] (7), hot bottle: clean the outer surf...

Embodiment 3

[0048] A production method of compound potassium hydrogen phosphate injection, comprising the steps of:

[0049] (1), batching: take by weighing potassium dihydrogen phosphate and dipotassium hydrogen phosphate (three crystal water) of recipe quantity, add water for injection, stir and make dissolving completely;

[0050] (2), decolouring: add gac to the solution of step (1), filter after stirring and decolouring, retain the filtrate;

[0051] (3), filling and sealing: the filtrate gained in step (2) is filled into the ampoule bottle cleaned and sealed;

[0052] (4), high temperature sterilization;

[0053] (5) Leak detection: in a sterilizing cabinet under vacuum conditions, inhale colored water at room temperature (about 10°C) for leak detection (found crystallization in the injection);

[0054] (6), light inspection;

[0055] (7) Hot bottle: Wash the outer surface of the ampoule bottle with hot water above 80°C to ensure that the temperature of the injection rises above ...

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Abstract

The invention relates to a production method of compound potassium dihydrogn phosphate injection, which comprises the following steps in turn: material preparation, decoloration, encapsulation, sterilization, leakage detection, lamp inspection, bottle boiling, lettering and packaging. The production method also comprises heating-cooling treatment for at least one time after the encapsulation stepand before the packaging step, and the heating-cooling treatment is to heat the injection to 40 to 100 DEG C first and then allows the injection to cool naturally to room temperature. No crystals precipitate from the injection provided by the invention even in a shock cooling environment or in a low-temperature storage environment, so that the quality and the use performance of the product are guaranteed.

Description

technical field [0001] The invention relates to a production method of compound potassium hydrogen phosphate injection. Background technique [0002] Compound Potassium Hydrogen Phosphate Injection is mainly used clinically as a phosphorus supplement in parenteral nutrition therapy, and its main components are dipotassium hydrogen phosphate and potassium dihydrogen phosphate. The common compound potassium hydrogen phosphate injection in the market is a 2ml compound preparation, which contains 413.63-457.17 mg of potassium dihydrogen phosphate and 303.53-335.48 mg of dipotassium hydrogen phosphate (tri-crystal water) in 2 ml of solution. [0003] In the prior art, the production method of compound potassium hydrogen phosphate injection comprises the following steps successively: [0004] (1), batching: take by weighing potassium dihydrogen phosphate and dipotassium hydrogen phosphate (three crystal water) of recipe quantity, add water for injection, stir and make dissolving ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K33/42A61P3/02
Inventor 谢建新欧阳健许强王曦黄林张红郑红
Owner 苏州天马医药集团天吉生物制药有限公司