Production and preparation process capable of lowering mannitol injection crystallization

A preparation process and technology of mannitol, which can be used in blood diseases, extracellular fluid diseases, drug delivery, etc., and can solve problems such as unsatisfactory experimental results.

Active Publication Date: 2017-02-15
JIANGXI KELUN MEDICINE IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

But it is not ideal only from the experimental effect

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  • Production and preparation process capable of lowering mannitol injection crystallization
  • Production and preparation process capable of lowering mannitol injection crystallization
  • Production and preparation process capable of lowering mannitol injection crystallization

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Experimental program
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Embodiment 1

[0033] Quality control of raw and auxiliary materials and packaging materials:

[0034] (1) Mannitol, injection grade;

[0035] (2) Activated carbon, pharmaceutical grade;

[0036] (3) Water for injection is made of polyethersulfone and filtered by a super filter element with a pore size of 0.1 μm. The smaller the pore size, the more fine insoluble particles will be retained. The insoluble particles and quantity in the bottle control the formation of crystal nuclei from the source to prevent the induction of crystallization;

[0037] (4) PH regulator (2mol / L hydrochloric acid), pharmaceutical grade;

[0038] (5) Glass infusion bottle, made of strong pharmaceutical grade material, the thickness of the thinnest part (bottle body thickness ≥ 1.5mm, bottle bottom thickness ≥ 2.5mm), smooth inner surface, no stones, no uneven surface;

[0039] (6) Butyl rubber stopper, pharmaceutical grade 22.8;

[0040] (7) Aluminum cover, pharmaceutical grade 22.8 type;

[0041] Preparation ...

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Abstract

The invention relates to a production and preparation process capable of lowering mannitol injection crystallization. The production and preparation process is characterized in that material preparation is operated under Grade-B environment conditions under a background Grade-C, and raw materials are enabled to pass a 200-mesh screen, namely a screen of 75um+ / -4.1um; a super filter element terminal of 0.1um is adopted for filtering; a preparation method of a PH value adjuster includes: weighing 180ml of concentrated hydrochloric acid, adding water for injection to 1000ml, shaking well, and using a filter membrane of 0.1um to perform suction filtering to obtain a hydrochloric acid adjuster of 2mol / L; a PH value adjusting method includes: weighing 2mol / L hydrochloric acid in a needed amount, pouring into a clean measuring cup, linearly adding into a diluting tank while stirring, and stirring well; 90-100 DEG C is determined as using temperature of the water for injection, number of intensive washing times is 10 times of flushing, and water pressure for flushing each time is not lower than 0.15Mpa. By the production and preparation process, proportion of mannitol crystallization during selling is lowered, and high-quality products are provided for clinical medication.

Description

technical field [0001] The invention belongs to the technical field of injection medicine, and in particular relates to a production and preparation process for reducing crystallization of mannitol injection. Background technique [0002] Mannitol injection is widely used clinically to treat cerebral edema caused by various reasons, reduce intracranial pressure, intraocular pressure, prevent brain herniation, treat edema caused by extensive burns, and osmotic diuresis. Through the analysis of the production situation in the past few years and market customer feedback information, the proportion of crystallization of this product during storage is about 5%, which poses potential risks to product quality, and it is difficult to ensure that the quality of mannitol injection is stable and in the best state Therefore, it is particularly necessary to establish a preparation method by improving the production process to reduce the crystallization ratio of the product to ensure the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/047A61P7/10
CPCA61K9/0019A61K9/08A61K31/047
Inventor 艾建高文登攀刘思川万阳浴葛均友
Owner JIANGXI KELUN MEDICINE IND
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