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Preparation method and use of sodium Penciclovir sodium hydrate

A technology for penciclovir and lovir sodium, which is applied to the preparation and application field of penciclovir sodium-hydrate, can solve the problems of sample decomposition and destruction, long drying time, low product purity and the like, and achieves simple preparation process, The effect of stable quality and high product purity

Inactive Publication Date: 2003-07-16
HUBEI KYLIN BIOLOGICAL SCI & TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Prepare Penciclovir Sodium and its hydrate at present and have method commonly used the method that prepared Penciclovir Sodium aqueous solution is carried out freeze-drying or decompression drying to prepare, but when adopting freeze-drying, not only drying time is longer (normally greater than 2 days), the yield is low, and it also consumes a lot of energy; when using reduced pressure drying, the drying time is also longer, and more expensive instruments are required, and the sample will also be decomposed and destroyed due to long-term heating in the aqueous solution state , resulting in lower purity of the final product
[0004] In addition, it has not been reported that penciclovir sodium monohydrate is prepared into intravenous injections and external preparations as medical raw materials

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1: One of the preparation methods of penciclovir sodium monohydrate

[0022] Take 2 g of penciclovir, add sodium hydroxide solution to dissolve, and adjust the pH of the solution to 11, add 10 times the amount of ethanol under stirring, continue stirring for 10 minutes, leave it for 1 hour, suction filter, add ethanol to wash 3 times (3×5ml), and the obtained precipitate was dried under reduced pressure at 70° C. to constant weight to obtain 2.1 g of white crystalline powder. Elemental analysis results: C40.75%; H5.63%; N21.80%; Na7.88% [Penciclovir sodium-hydrate (C 10 h 14 N 5 o 4 Na.H 2 O) Theoretical value: C40.96%; H5.50%; N21.82%; Na7.84%].

Embodiment 2

[0023] Embodiment 2: The preparation method two of penciclovir sodium monohydrate

[0024] Get Penciclovir 2g, add sodium hydroxide solution to dissolve, and adjust the pH of the solution to be 10, filter to remove insoluble matter, add 10 times the amount of methanol under stirring, continue stirring for 10 minutes, place it for 2 hours, and suction filter, Add methanol to wash 3 times (3×5ml), and dry the resulting precipitate at 80°C under reduced pressure to constant weight to obtain 1.7 g of white crystalline powder.

Embodiment 3

[0025] Embodiment 3: the preparation method three of penciclovir sodium monohydrate

[0026] Take 2 g of penciclovir, add sodium hydroxide solution to dissolve, and adjust the pH of the solution to be 12, add 10 times the amount of propanol under stirring, continue stirring for 10 minutes, leave it for 2 hours, suction filter, add propanol to wash Three times (3×5ml), the obtained precipitate was dried under reduced pressure at 70°C to constant weight to obtain 2.1g of white crystalline powder.

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PUM

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Abstract

A monohydrated Penxiluowei sodium used for preparing injection or exterior-applied medicine is prepared through dissolving Penxiluowei in the solution of sodium hydroxide, regulating pH value, addinginertial organic solvent dissolved with water, stirring, laying aside, filter, washing, and vacuum drying the deposit at 40-90 deg.C. Its advantages are low cost, high purity and high water solubility.

Description

technical field [0001] The present invention relates to a preparation method and application of penciclovir sodium monohydrate, specifically, the hydrate is used as a pharmaceutical preparation (such as injection, external preparation, etc.) Diseases caused by viruses. Background technique [0002] Penciclovir {Penciclovir, the chemical name is 9-[4-Hydroxy-3-(hydroxymethyl)but-1-yl]guanine, and the molecular formula is C 10 h 15 N 5 o 4} is a potent, selective purine antiviral drug. It has obvious activity on herpes simplex virus type I (HSV-1) and hepatitis B virus. It was first invented by Michael R et al. (US patents 4942166, 5075445). [0003] Due to the low solubility of penciclovir itself in water (about 1.7 mg / ml), a certain amount of co-solvent is often added when preparing pharmaceutical preparations, especially water-soluble preparations. If the co-solvent is added too much, it will inevitably increase clinical use. toxic side effects. Therefore, under the ...

Claims

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Application Information

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IPC IPC(8): A61K31/52A61P31/12C07D473/18
Inventor 刘万忠姜建国向江波
Owner HUBEI KYLIN BIOLOGICAL SCI & TECH DEV
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