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Mannitol injection

A technology of mannitol and injection, which is applied in the field of mannitol injection, can solve the problems of nephrotoxicity, inconvenience, crystallization, etc., and achieve the effect of improving drug safety, stability, and injection quality

Active Publication Date: 2014-09-10
安庆回音必制药股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The main problems of the clinically used 20% mannitol injection are: (1) crystallization-20% mannitol is a supersaturated solution, when the temperature drops below 10°C, crystallization often occurs, and once crystallization occurs hard to dissolve
The problem of crystallization brings great inconvenience and trouble to clinicians, and there are great hidden dangers in the safety of medication, which brings inconvenience to rescue patients
(2) Since mannitol mainly removes extracellular fluid through hypertonicity to reduce intracranial pressure, and is excreted from the kidney in the prototype, it has greater nephrotoxicity, and it has been confirmed that patients with acute or chronic renal failure are contraindicated for use
The compound mannitol injection obtained by the existing preparation method is prone to crystallization, resulting in unsafe medication

Method used

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Experimental program
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Embodiment 1

[0026] Mannitol injection has the following components (by weight):

[0027] Mannitol 20%

[0028] Glycine 6%

[0029] Lecithin 2%

[0030] The balance is water for injection.

[0031] Preparation:

[0032] (1) Mix mannitol, glycine and lecithin with 1 / 3 weight of water for injection in proportion, add activated carbon, absorb, filter and decarbonize, and obtain a concentrated solution.

[0033] (2) Mix the above-mentioned concentrated solution with the remaining amount of water for injection, then add activated carbon for secondary adsorption, filter and decarbonize, and obtain a diluted solution.

[0034] (3) Filter the diluted solution in step (2) with a 0.22 μm filter, and fill it.

[0035] (4) Sterilize the injection obtained in step (3) at a temperature of 120-130° C. to obtain the mannitol injection of the present invention.

[0036] The amount of activated carbon added in the above preparation method is 0.02% (w / v), and the carbon removal is filtered with a 0.45 ...

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PUM

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Abstract

The invention relates to the field of pharmaceutical preparations and particularly relates to a mannitol injection. The mannitol injection is prepared from mannitol, glycine, lecithin and water for injection, wherein the weight ratio of mannitol to glycine to lecithin is 10:3:1.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a mannitol injection. Background technique [0002] Intracranial pressure refers to the pressure generated by the contents of the cranial cavity on the wall of the cranial cavity, which is composed of two factors: hydrostatic pressure and vascular dynamic pressure. Since the total volume of the cranial cavity is relatively fixed, the intracranial pressure remains relatively stable. Normal supine intracranial pressure is about 1.33kPa (10mmHg). Intracranial hypertension is called intracranial hypertension when brain tissue swelling; intracranial space-occupying lesions; excessive secretion of cerebrospinal fluid, malabsorption, obstructed circulation, or excessive cerebral blood perfusion lead to intracranial pressure continuously maintained above 2.0kPa (15mmHg). [0003] Mannitol injection is mainly used to treat cerebral edema and reduce intracranial pressure, and i...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/047A61K47/24A61K47/18A61P7/10
Inventor 王大冲翟绪武王建何榕王雪梅吴对荣
Owner 安庆回音必制药股份有限公司
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