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Fast detection method of intermediate mannitol content of compound mannitol injection

A detection method, the technology of mannitol, which is applied in the field of medicine, can solve the problems of low detection efficiency, inaccurate detection results, and inability to continuously fill the production line, etc., and achieve high accuracy, good repeatability, and good intermediate precision.

Inactive Publication Date: 2018-09-28
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] The present invention overcomes the deficiencies of the prior art, and provides a rapid detection method for the mannitol content of the compound mannitol injection intermediate, in order to solve the problem that the production line of the compound mannitol injection has low detection efficiency and cannot be filled continuously, and The problem of inaccurate test results leading to substandard drugs

Method used

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  • Fast detection method of intermediate mannitol content of compound mannitol injection
  • Fast detection method of intermediate mannitol content of compound mannitol injection
  • Fast detection method of intermediate mannitol content of compound mannitol injection

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Effect test

Embodiment 1

[0018] Precisely draw 5ml of the first batch of sample solution to be tested, put it in a 100ml measuring bottle, add 0.2ml of ammonia test solution with a solute mass fraction of 40%, add water to the mark, shake well, let stand for 10min, and then use a 1dm measuring tube to measure the wavelength Measure the optical rotation α under the condition of 589nm sodium lamp D line as the light source and the measurement temperature of 20±0.5°C 1 =0.109; Precisely draw 5ml of the sample solution to be tested, place it in a 100ml brown measuring bottle, add 60ml of ammonium molybdate solution with a solute mass fraction of 5% and 4ml of a sulfuric acid solution with a solute mass fraction of 10%, add water to the mark, shake well, Stand still for 10 minutes, use a 1dm measuring tube to measure the optical rotation α under the conditions of a 589nm sodium lamp D line as the light source and a measuring temperature of 20±0.5°C 2 =1.169; the optical rotation α 1 and optical rotation α...

Embodiment 2

[0023] Precisely draw 5ml of the second batch of sample solution to be tested, put it in a 100ml measuring bottle, add 0.2ml of ammonia test solution with a solute mass fraction of 40%, add water to the mark, shake well, let it stand for 10min, and then use a 1dm measuring tube to measure the wavelength Measure the optical rotation α under the condition of 589nm sodium lamp D line as the light source and the measurement temperature of 20±0.5°C 1 =0.108; Precisely draw 5ml of the sample solution to be tested, place it in a 100ml brown measuring bottle, add 60ml of ammonium molybdate solution with a solute mass fraction of 5% and 4ml of a sulfuric acid solution with a solute mass fraction of 10%, add water to the mark, shake well, Stand still for 10 minutes, use a 1dm measuring tube to measure the optical rotation α under the conditions of a 589nm sodium lamp D line as the light source and a measuring temperature of 20±0.5°C 2 =1.171; the optical rotation α 1 and optical rotati...

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Abstract

The invention discloses a fast detection method of the intermediate mannitol content of a compound mannitol injection. Firstly, the optical rotation alpha 1 of glucose in the compound mannitol injection is measured under the conditions of using sodium lamp D rays with the wavelength being 589 nm as a light source and the measuring temperature being 20+ / -0.5 DEG C; then, the total optical rotationalpha 2 of glucose and mannitol in the compound mannitol injection is measured under the same conditions; the mannitol content in the compound mannitol injection is calculated by using a differentialrotation method. The detection method provided by the invention has the advantages that the interference of the glucose on the mannitol detection result is avoided; the differential rotation method isused, so that the content of the mannitol can be accurately obtained; ammonium molybdate is used as a rotation increasing agent, so that the optical rotation performance of a solution to be tested can be obviously increased, and the detection result is more accurate. The detection method has the advantages of strong specificity, high accuracy, good middle precision and good repeatability. The method has the advantages that the practicability is high; the detection environment temperature and the sample standing time do not have obvious influence on the detection result.

Description

technical field [0001] The invention relates to the field of medicine, more specifically, the invention relates to a rapid detection method for the content of mannitol in the intermediate of compound mannitol injection. Background technique [0002] The compound mannitol injection contains mannitol, glucose and sodium chloride, which has a good clinical effect of lowering blood pressure and dehydration. At the same time, it solves the problem of unilateral mannitol crystallization when it is cold, and reduces side effects. Compared with mannitol alone, it has greater advantages in efficacy and pharmacology. [0003] From 2007 to 2013, the national standard stipulated that the detection method of mannitol content in compound mannitol injection was the iodometric method, which was changed to the HPLC method after 2013. Both the iodometric method and the HPLC method took a long time and could not meet the requirements of production. For example, in the national standard "YBH12...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/84
CPCG01N21/84
Inventor 黄燕王惠刘思川谭鸿波葛均友郭晓英刘文军罗成鑫王昌斌熊群王新强
Owner SICHUAN KELUN PHARMA CO LTD
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