Method for measuring content of mannitol injection

A determination method and mannitol technology, which are applied in the preparation of test samples, polarization influence characteristics, etc., can solve problems such as increasing human and material resources, and achieve the effects of avoiding pollution, saving costs, and improving economic benefits.

Inactive Publication Date: 2015-12-16
GUANGXI YUYUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0004] The existing method for determining the content of mannitol injection is a statutory standard, and pharmaceutical manufacturers must inspect the products of mannitol injection in accordance with the legal standard. If the company innovates the content determination method, it must apply for approval before implementation, which will increase manpower. material resources

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0027] A method for determining the content of mannitol injection, including the following steps:

[0028] 1. Preparation before measurement

[0029] ⑴ 2.66% ammonium molybdate solution preparation

[0030] Accurately weigh (using a 1 / 10,000 analytical balance) to analyze 26.6g of pure ammonium molybdate, add an appropriate amount of water to dissolve it into 1000ml, shake it, and get it;

[0031] ⑵Preparation of 10% dilute sulfuric acid solution

[0032] Use a pipette to take 10ml of analytically pure sulfuric acid, dilute to 100ml with water, shake well, and get it;

[0033] 2. Preparation of test products

[0034] At 25℃, take 10ml sample at room temperature, put it in a 250ml measuring flask, add 200ml 2.66% ammonium molybdate solution (analytical pure ammonium molybdate 26.6g diluted with water to 1000ml), and then add 5ml 10% dilute sulfuric acid (analysis Dilute 10ml of pure sulfuric acid to 100ml), then dilute to the mark with water, shake well, and get;

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PUM

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Abstract

The invention discloses an improved method for measuring the content of mannitol injection. The content of mannitol injection is measured through an optical rotation measuring method, operation is easy, time is saved, production cost is reduced, economic benefits are improved, medicine is effectively prevented from being contaminated, and safety risks of medicine (intermediate products) are reduced. Compared with the prior measuring art, the method is more suitable for measuring the content of intermediate products in the production process of medicine preparing enterprises.

Description

Technical field [0001] The invention relates to the technical field of drug preparation testing, in particular to a method for determining the content of mannitol injection. Background technique [0002] Mannitol, chemical name: D-mannitol, molecular formula: C 6 H 14 O 6 , Molecular weight: 182.17. Mannitol injection is a sterile aqueous solution of mannitol containing mannitol (C 6 H 14 O 6 ) Should be 95.0-105.0% of the labeled amount, which is a dehydrating medicine. [0003] The 2010 edition of the Chinese Pharmacopoeia published the content determination method of mannitol and mannitol injection. The content determination method of mannitol (raw material) is: take about 0.2g of this product, accurately weigh it, and place it in a 250ml measuring bottle. Dissolve and dilute to the mark, shake well; accurately measure 10ml, put it in an iodine bottle, and accurately add sodium periodate solution (take sulfuric acid solution (1→20) 90ml and sodium periodate solution (2.3→1000) ...

Claims

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Application Information

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IPC IPC(8): G01N21/21G01N1/28
Inventor 庞春林罗世东王亚军陈兴华廖柳艳王敏
Owner GUANGXI YUYUAN PHARMA
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