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Preparation method of vardenafil injection

A technology of vardenafil and injection, which is applied in the field of preparation of vardenafil injection, and can solve the problem that vardenafil injection has not yet been retrieved.

Inactive Publication Date: 2014-01-01
NANJING QIHE MEDICINE SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, no literature or reports on vardenafil injection have been retrieved at home and abroad

Method used

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  • Preparation method of vardenafil injection
  • Preparation method of vardenafil injection
  • Preparation method of vardenafil injection

Examples

Experimental program
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Effect test

Embodiment 1

[0011]

[0012]

[0013] Preparation process: Weigh the raw materials and auxiliary materials of the prescription amount, add water for injection to a sufficient amount, add activated carbon and stir, filter through a 0.22um microporous membrane, divide the filtrate, and sterilize at 121°C for 15 minutes to obtain the product.

Embodiment 2

[0015]

[0016] Preparation process: Weigh the raw materials and auxiliary materials of the prescription amount, add water for injection to a sufficient amount, add activated carbon and stir, filter through a 0.22um microporous membrane, divide the filtrate, and sterilize at 121°C for 15 minutes to obtain the product.

Embodiment 3

[0018] 5-Hydroxymethylfurfural detection method and judgment standard: Take this product as the test sample; take an appropriate amount of 5-Hydroxymethylfurfural reference substance, weigh it accurately, add water to dissolve and dilute to make a solution containing about 10ug per 1ml, As a reference solution. Another appropriate amount of vardenafil impurity I and 5-hydroxymethylfurfural was taken to make a solution containing 10ug per 1ml as a system suitability solution, with octadecylsilane bonded silica gel as filler; 0.05mol / L Potassium dihydrogen phosphate solution (adjust the pH to 3.5 with phosphoric acid)-methanol (80:20) as the mobile phase, and the detection wavelength is 284nm. Take the system suitability sample and inject it into the liquid chromatograph, and the separation degree of 5-hydroxymethylfurfural and vardenafil impurity I should meet the requirements. Get reference substance solution 20ul and inject liquid chromatograph, adjust instrument sensitivity...

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Abstract

The invention discloses a preparation method of a vardenafil injection. In the preparation method, the vardenafil injection is prepared from vardenafil hydrochloride and a pH buffering agent through terminal sterilization. The preparation method of the vardenafil injection is characterized in that the content of 5-hydroxymethyl furfural can be effectively controlled to ensure the safety of clinical use.

Description

technical field [0001] The invention relates to a preparation method of vardenafil injection, in particular to a preparation method of terminal sterilized vardenafil injection. Background technique [0002] Both the European Union and the United States have approved the marketing of Pfizer's sildenafil injection for the treatment of pulmonary hypertension. [0003] Vardenafil, like sildenafil, can be used to treat pulmonary hypertension. However, no literature or reports on vardenafil injection have been retrieved at home and abroad. [0004] Vardenafil is similar to sildenafil, but vardenafil has higher pharmacological activity, lower dosage, and higher safety. [0005] Sildenafil Injection is an isotonic injection containing glucose to adjust osmotic pressure. If glucose is used in vardenafil injection to adjust osmotic pressure, it will bring the possibility of excessive 5-hydroxymethylfurfural content, and the harmfulness of 5-hydroxymethylfurfural is currently certai...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/53A61K47/26A61K47/04A61P9/12
Inventor 毛志英张发成
Owner NANJING QIHE MEDICINE SCI & TECH
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