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Fenoldopam methylsulfonate injection and preparation method thereof

A technology for fenoldopam mesylate and injection, applied in the field of medicine, can solve the problems of difficult control of process parameters, complicated freeze-drying equipment, many process steps, etc., and achieves easy operation, simple preparation method steps, and low solubility. Effect

Active Publication Date: 2015-10-14
YANGTZE RIVER PHARM GRP GUANGZHOU HAIRUI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to overcome the disadvantages of the prior art fenoldopam mesylate freeze-dried powder injection that there are many process steps, difficult control of process parameters, complicated freeze-drying equipment and high cost, the purpose of the present invention is to provide a kind of fenoldopam mesylate Pan injection and preparation method thereof, to solve the above problems

Method used

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  • Fenoldopam methylsulfonate injection and preparation method thereof
  • Fenoldopam methylsulfonate injection and preparation method thereof
  • Fenoldopam methylsulfonate injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1, Fenoldopam Mesylate Injection

[0029] Components of Fenoldopam Mesylate Injection:

[0030] Fenoldopam mesylate 8g, propylene glycol 80g, citric acid 0.8g, sodium metabisulfite 2.4g, sodium dihydrogen phosphate 0.8g,

[0031] Add 0.9% sodium chloride solution to 1000ml, make 1ml specification, and make 1000 sticks in total. The particle size of the fenoldopam mesylate is 10μm~100μm.

[0032] Its preparation method comprises the following steps:

[0033] Weigh 8 g of fenoldopam mesylate in the prescribed amount and suspend it in 500 ml of 0.9% sodium chloride solution, then add 80 g of propylene glycol, stir to dissolve it completely, then add 0.8 g of citric acid and sodium metabisulfite in the prescribed amount respectively 2.4g, 0.6g sodium dihydrogen phosphate, add 0.9% sodium chloride solution to 1000ml, continue to stir until dissolved, add an appropriate amount of activated carbon, stir for 20min, decarburize with a 0.45um filter membrane, fil...

Embodiment 2

[0034] Embodiment 2, Fenoldopam Mesylate Injection

[0035] Components of Fenoldopam Mesylate Injection:

[0036] Fenoldopam mesylate 10g, propylene glycol 150g, malic acid 2g, sodium bisulfite 4g, sodium malate 3g, add 5% glucose solution to 1000ml, make 1ml specification, make a total of 1000 tubes, the said methanesulfonate The particle size of fenoldopam is 10μm~100μm.

[0037] Its preparation method comprises the following steps:

[0038] Weigh 10 g of fenoldopam mesylate and suspend in 500 ml of 5% glucose solution, then add 150 g of propylene glycol, stir to dissolve completely, then add 0.8 g of malic acid, 4 g of sodium sulfite, and malic acid respectively. Sodium 0.8g, add 5% glucose solution to 1000ml, continue to stir until dissolved, add appropriate amount of activated carbon, stir for 20min, decarburize with 0.45um filter membrane, fill, 1ml / cartridge, seal with nitrogen gas, sterilize, leak check , Light inspection, that is.

Embodiment 3

[0039] Embodiment 3, Fenoldopam Mesylate Injection

[0040] Components of Fenoldopam Mesylate Injection:

[0041] Fenoldopam mesylate 120g, propylene glycol 2400g, citric acid 36g, sodium metabisulfite 60g, sodium malate 24g,

[0042] Add 0.9% sodium chloride solution to 1000ml, make it into 1ml size, and make 1000 sticks in total. The particle size of the fenoldopam mesylate is 10μm~100μm.

[0043] Its preparation method comprises the following steps:

[0044]Weigh 120g of fenoldopam mesylate in prescription quantity and suspend in 500ml 0.9% sodium chloride solution, then add 2400g of propylene glycol, stir to make it dissolve completely, then add prescription quantity of citric acid 36g, sodium metabisulfite 60g, apple Sodium chloride 8g, add 0.9% sodium chloride solution to 1000ml, continue to stir until dissolved, add an appropriate amount of activated carbon, stir for 20min, decarburize with 0.45um filter membrane, fill, 1ml / cartridge, seal with nitrogen gas, sterili...

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Abstract

The invention belongs to the technical field of medicine, and particularly relates to a fenoldopam methylsulfonate injection and a preparation method of the injection. The injection is mainly composed of 8-12 parts of fenoldopam methylsulfonate, 120-240 parts of propylene glycol, 0.8-3.6 parts of organic acid, 2.4-6 parts of an anti-oxidant, and 0.8-3.6 parts of a pH conditioning agent, with the balance being a diluent which is added to a total amount of 1000 parts. Fenoldopam methylsulfonate has a particle size of 10-100 [mu]m. Fenoldopam methylsulfonate in the fenoldopam methylsulfonate injection is high in solubility and stable in quality, and the efficacy of fenoldopam methylsulfonate can be fully developed. The injection is high in stability and beneficial for storage, and is an ideal injection for treating a serious hypertension disease.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a fenoldopam mesylate injection and a preparation method thereof. Background technique [0002] Hypertension is one of the most common cardiovascular diseases in the world, and it is also the disease with the largest number of patients. Generally, the blood pressure measurement value is higher than 140 / 90 mm Hg, which is considered high blood pressure. According to the latest research report, the number of hypertensive patients in the world has exceeded 1 billion. It is estimated that by 2025, 1.56 billion people worldwide will suffer from this disease. a disease. At present, the prevalence of hypertension among adults in my country has reached 33.5%, and the number of hypertensive patients has exceeded 330 million, that is, one out of every three adults suffers from high blood pressure. Therefore, it is of great social and clinical significance to research and de...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/55A61P9/08A61P9/12
Inventor 施猛夏春森任亚东刘恩桂付美琴
Owner YANGTZE RIVER PHARM GRP GUANGZHOU HAIRUI PHARM CO LTD
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