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Pretreatment of metaraminol bitartrate injection and separation and determination of enantiomer

A technology of metahydroxylamine bitartrate and injection, applied in the field of freeze-drying technology, can solve problems such as the separation of injection isomers, which has not been reported, and achieve the effect of ensuring safety and effectiveness

Inactive Publication Date: 2021-02-05
南京斯泰尔医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, there is only detection of enantiomers of metaraminol bitartrate material in the literature, but there is no report on the separation of isomers of its injection

Method used

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  • Pretreatment of metaraminol bitartrate injection and separation and determination of enantiomer
  • Pretreatment of metaraminol bitartrate injection and separation and determination of enantiomer
  • Pretreatment of metaraminol bitartrate injection and separation and determination of enantiomer

Examples

Experimental program
Comparison scheme
Effect test

experiment example ）

[0027] Separation of enantiomers in metaraminol bitartrate injection by high performance liquid chromatography.

[0028] 1. Reagents.

[0029] n-Hexane, methanol, isopropanol, isopropylamine.

[0030] Second, drug testing.

[0031] Metaraminol tartrate reference substance, enantiomer reference substance.

[0032] 3. Instruments.

[0033] High performance liquid chromatography: Diane, U3000.

[0034] Column CHIRALPAK IA (4.6 × 250mm, 5um).

[0035] 4. Chromatographic conditions.

[0036] Mobile phase: n-hexane: methanol: isopropanol: isopropylamine (85:10:5:0.2).

[0037] Flow rate: 1ml / min.

[0038] Column temperature: 20°C.

[0039] Detection wavelength: 220nm.

[0040] Injection volume: 20ul.

[0041] Five: Experimental steps.

[0042] Blank solvent: methanol.

[0043] Weigh about 1.9mg of enantiomeric reference substance into a 10ml measuring bottle, dissolve in methanol and dilute to the mark as stock solution 1, weigh about 76mg of metaraminol tartrate referen...

Embodiment ）

[0048] 1. Reagents, instruments, and chromatographic conditions.

[0049] Same as the experimental example.

[0050] Second, drug testing.

[0051] Metaraminol Bitartrate Injection, Enantiomer Reference Substance.

[0052] Three: Experimental steps.

[0053] Pre-treatment: (1) Pipette 4ml of metaraminol bitartrate injection (containing about 40 mg of metaraminol), and put it in a rotary evaporator, adjust the temperature of the rotary evaporator to 50°C and the speed of 70r / min, take a sample after 40 minutes, and use methanol Transfer to a 20ml volumetric flask, and take the continued filtrate to obtain the test solution.

[0054] Pre-treatment: (2) Or pipette 4ml of Metaraminol Bitartrate Injection (containing about 40mg of Metaraminol). As for the freeze-drying vial, set the freeze dryer to pre-freeze at -15°C for 2 hours, sublimate and dry at -5°C for time 10h, analyze and dry at 20°C, take a sample after 8h, transfer it to a 20ml volumetric flask with methanol, and ta...

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Abstract

The invention discloses a pretreatment method of two metaraminol bitartrate injections and an enantiomer separation method. Two technologies of freeze-drying and rotary evaporation are mainly adoptedfor pretreatment, and a high performance liquid chromatography is adopted for enantiomers. The method solves the problems ofinterference to isomer separation and damage to a chiral column since the injection liquid is a water solution, and a specific proportion of a mobile phase is obtained, so that the enantiomer of the metaraminol bitartrate injection can be effectively separated. The effectiveness and the safety of the metaraminol bitartrate injection are ensured.

Description

technical field [0001] The invention belongs to the technical field of analytical chemistry and preparation technology, and specifically relates to the pretreatment of metaraminol bitartrate injection and the detection of enantiomers by freeze-drying technology, rotary evaporation technology and high-performance liquid chromatography. Background technique [0002] Metaraminol Bitartrate Injection mainly acts on α-receptors and excites α-receptors, resulting in vasoconstriction and continuous increase of systolic and diastolic blood pressure. This product can prevent acute hypotension that occurs during spinal block anesthesia, and can also be used for hypotension caused by hemorrhage, drug allergy, surgical complications, traumatic brain injury or shock caused by brain tumors. It can treat hypotension due to cardiogenic shock or sepsis. [0003] Due to the presence of two chiral carbon atoms in metaraminol bitartrate, it has four configurations (1R, 2S), (1S, 2R), (1R, 2R),...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/74G01N30/54
CPCG01N30/02G01N30/06G01N30/54G01N30/74G01N2030/027G01N2030/062
Inventor 周国才陈迅
Owner 南京斯泰尔医药科技有限公司
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