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Compound mannitol injection and preparation method thereof

A technology of mannitol and injection, which is applied in the field of compound mannitol injection and its preparation, can solve the problems of poor stability and easy crystallization, and achieve the effect of mild process conditions and simple operation

Inactive Publication Date: 2013-12-11
蚌埠丰原涂山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to overcome the defects that the existing compound mannitol injection is prone to crystallization and poor stability, the object of the invention is to provide a compound mannitol injection

Method used

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  • Compound mannitol injection and preparation method thereof
  • Compound mannitol injection and preparation method thereof
  • Compound mannitol injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Recipe (by weight):

[0035] D-mannitol: 150 parts;

[0036] Anhydrous glucose: 50 parts;

[0037] Sodium chloride: 4.5 parts;

[0038] Propylene glycol: 0.75 part;

[0039] Water for injection: 1000 parts.

[0040] making process:

[0041] (1) Concentrated blend:

[0042] At a temperature of about 50°C, firstly dissolve the accurately weighed raw material mannitol and propylene glycol with water for injection (the amount of water for injection is enough to dissolve mannitol and propylene glycol), and then dissolve the dissolved solution with 0.22 μm The ultrafilter performs ultrafiltration to obtain the ultrafiltered mannitol solution.

[0043] Heat about 1 / 3 of the volume (relative to the total amount of water for injection) of water for injection to a temperature of about 50°C, pour it into the concentrated preparation tank, start stirring, and add the ultrafiltered mannitol solution, accurately weighed Water glucose and sodium chloride are added to the above-...

Embodiment 2

[0065] Recipe (by weight):

[0066] D-mannitol: 170 parts;

[0067] Anhydrous glucose: 80 parts;

[0068] Sodium chloride: 6.0 parts;

[0069] Propylene glycol: 0.5 parts;

[0070]Water for injection: 1000 parts.

[0071] making process:

[0072] (1) Concentrated blend:

[0073] At a temperature of about 50°C, first dissolve the accurately weighed raw material mannitol and propylene glycol with water for injection, and then perform ultrafiltration on the dissolved solution with a 0.22 μm ultrafiltration machine to obtain an ultrafiltered mannitol solution .

[0074] Heat about 1 / 4 volume (relative to the total amount of water for injection) of water for injection to a temperature of about 50°C, pour it into the concentrated preparation tank, start stirring, and add the ultrafiltered mannitol solution, accurately weighed Water glucose and sodium chloride are added to the above-mentioned concentrated preparation tank, stirred to fully dissolve, and 0.02% activated carbon ...

Embodiment 3

[0084] Recipe (by weight):

[0085] D-mannitol: 120 parts;

[0086] Anhydrous glucose: 40 parts;

[0087] Sodium chloride: 4 parts;

[0088] Propylene glycol: 0.5 part;

[0089] Water for injection: 1000 parts.

[0090] The preparation process is the same as in Example 1.

[0091] Through the data analysis of influencing factor test, accelerated test and long-term test, the mannitol content in the above-mentioned injections is all between 95.0%-105.0%; the glucose content is all between 90.0%-110.0%; the sodium chloride content is all between 95.0% %-105.0%, it can be seen that various detection indicators such as foreign matter are within the qualified range of the "Chinese Pharmacopoeia".

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Abstract

The invention relates to a compound mannitol injection which is added with a small amount of propylene glycol based on a conventional compound mannitol injection. The invention also relates to a preparation method of the compound mannitol injection. The compound mannitol injection provided by the invention is substantially improved in stability, and has no crystallization even after long-term storage, and thus the injection is substantially improved in quality and extremely improved in pharmacy safety. The preparation method provided by the invention is mild in technological conditions and simple in operation, and is suitable for large-scale industrialized application.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a compound mannitol injection and a preparation method thereof. Background technique [0002] The compound mannitol injection is a compound preparation of mannitol, sodium chloride and anhydrous glucose, and the excipient is water for injection. Compound Mannitol Injection can be used clinically as: (1) Tissue dehydration drug, used to treat cerebral edema caused by various reasons, reduce intracranial pressure, and prevent brain herniation. (2) Reduce intraocular pressure, which can effectively reduce intraocular pressure, and is used when other intraocular pressure reduction is ineffective or in preparation for intraocular surgery. (3) Osmotic diuretics are used to identify prerenal diuretic factors or oliguria caused by acute renal failure, and can also be used to prevent acute tubular necrosis caused by various reasons. (4) As an auxiliary diuretic measure to trea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/047A61K47/10A61P7/10A61P27/02A61P39/02
Inventor 陈彬卢德浩赵莉莉
Owner 蚌埠丰原涂山制药有限公司
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