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Valacyclovir hydrochloride freeze dried preparation and its preparation method

A technology of valacyclovir hydrochloride and freeze-dried preparations, which is applied in the field of freeze-dried preparations and its preparation, can solve the problems of no injections and less valacyclovir hydrochloride, etc., and achieve increased preparation diversification, excellent appearance, and improved biological The effect of utilization

Inactive Publication Date: 2005-10-26
NANJING QINUO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there are few reports on the preparation of valacyclovir hydrochloride, and there are no related patent literature reports in China, and there are only oral preparations at home and abroad, and there are no reports about injections. In order to improve the curative effect, more choices are provided for doctors, especially To provide more options for the prevention and treatment of acute diseases, it is necessary to invent an injection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Take 100mg of valacyclovir hydrochloride and 50mg of mannitol, add it to 1ML water for injection, stir to dissolve it, add activated carbon according to the dosage of 0.5% (w / v), stir at 20°C for 40 minutes, decarbonize and filter, add hydroxide The pH value of the solution was adjusted to 8.5 with sodium, and the obtained filtrate was sterilized by filtration with a 0.22 μm microporous membrane, and the content was determined. Gained solution is packed in the vial under aseptic condition, put in the lyophilizer and freeze-dry after 20 hours, crimp the cap, take out the case, pack and obtain the valacyclovir hydrochloride freeze-dried preparation of the present invention.

[0021] In order to investigate the adaptability and stability of the freeze-dried preparation formulation process of the present invention, the above-mentioned freeze-dried preparation has been carried out strong light (4500 ± 500Lx), high temperature (60 ℃), high humidity (relative humidity 90 ± 5%) ...

Embodiment 2

[0025] Take 200mg of valacyclovir hydrochloride and 75mg of sorbitol, add it to 2ML water for injection, stir to dissolve it, add activated carbon according to the dosage of 0.5% (w / v), stir at 30°C for 30 minutes, decarbonize and filter, add hydroxide The pH value of the solution was adjusted to 8.0 with potassium, and the obtained filtrate was sterilized by filtration with a 0.22 μm microporous membrane, and the content was determined. Put the obtained solution into a vial under aseptic conditions, put it into a freeze-drying box with a temperature of -20°C for pre-freezing, then raise the vacuum in the freeze-drying box to below 13.33Pa and turn off the freezer, pass through the shelf plate The heating system below heats up slowly to supply the heat required by the sample during the sublimation and drying process, so that the temperature of the frozen sample gradually rises to about -20°C, and the water in the liquid can be sublimated, and the sublimation and drying are cont...

Embodiment 3

[0027] Take 500mg of valacyclovir hydrochloride, 150mg of sodium chloride, 100mg of glucose, 200mg of sucrose, and 50mg of lactose, add them to 3ML water for injection, stir to dissolve, add activated carbon according to the dosage of 1.0% (w / v), and stir at 40°C After 20 minutes, decarbonize and filter, add phosphate buffer to adjust the pH value of the solution to 5.0, and filter the obtained filtrate to sterilize with a 0.22 μm microporous membrane, and measure the content. Put the obtained solution into a vial under aseptic conditions, put it into a freeze-drying box with a temperature of -25°C for pre-freezing, then raise the vacuum in the freeze-drying box to below 13.33Pa and turn off the freezer, pass through the shelf plate The heating system below heats up slowly to supply the heat required by the sample during the sublimation and drying process, so that the temperature of the frozen sample gradually rises to about -20°C, and the water in the liquid can be sublimated,...

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PUM

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Abstract

A freeze-dried composite medicine is proportionally prepared from valacyclovir hydrochlorine and pharmacologicaly acceptable excipient through proportional mixing.

Description

technical field [0001] The invention relates to a lyophilized preparation and a preparation method thereof, in particular to a valacyclovir hydrochloride lyophilized preparation and a preparation method thereof. Background technique [0002] Valacyclovir hydrochloride is the prodrug of acyclovir, and it is the hydrochloride salt of ester of acyclovir and valine. The molecular formula is: C 13 h 20 N 6 o 4 HCL, valacyclovir hydrochloride is rapidly converted to acyclovir after oral administration. In the virus-infected cells, it is activated by deoxyglycoside kinase and further phosphorylated into triphosphate, which inhibits DNA polymerase and acts on DNA polymerase. Under this condition, it combines with the growing DNA to terminate the replication of the virus, thus achieving the antiviral effect. Clinically used for the treatment of herpes zoster, genital herpes, hepatitis B, condyloma acuminatum, etc., and widely used for the treatment of other herpes virus infection...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/522
Inventor 何淑旺郑黎李小军杨迎庆
Owner NANJING QINUO PHARMA
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