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Acyclovir lyophilized formulation for injection and preparation method acyclovir lyophilized formulation

A technology for freeze-dried preparations and injections, which is applied in the direction of freeze-dried transportation, medical preparations of non-active ingredients, antiviral agents, etc. It can solve problems such as difficulty in ensuring long-term stability, achieve good clarity, low impurity content, Quality Controlled Effects

Inactive Publication Date: 2015-02-18
湖北潜龙药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is difficult to ensure long-term stability of products made by conventional processes
[0005] Therefore, the present freeze-dried preparation of acyclovir for injection still needs to be improved

Method used

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  • Acyclovir lyophilized formulation for injection and preparation method acyclovir lyophilized formulation
  • Acyclovir lyophilized formulation for injection and preparation method acyclovir lyophilized formulation
  • Acyclovir lyophilized formulation for injection and preparation method acyclovir lyophilized formulation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1 Preparation of acyclovir freeze-dried preparation for injection

[0036]

[0037] Mix acyclovir and mannitol, add water for injection, add sodium hydroxide, stir until completely dissolved, add 1.5% ethanol by volume, and adjust the pH value to 11.0 with sodium acetate, add activated carbon for needles 0.01g / 100ml, stir , filtered and decarbonized, the medicinal solution is finely filtered with a 0.22-micron sterile microporous membrane to obtain acyclovir sterile medicinal solution, which is then subpackaged, semi-stoppered, freeze-dried, plugged, and capped to obtain freeze-dried Finished preparations.

[0038] Wherein, freeze-drying step is:

[0039] (1) Pre-freezing: Vacuumize the cabinet to 15 Pa, lower the temperature of the acyclovir sterile medicinal solution to -15 degrees Celsius under vacuum conditions, and freeze for 15 minutes; remove the vacuum, then cool down to -40 degrees Celsius, and freeze for 40 minutes. minute;

[0040](2) Sublimatio...

Embodiment 2

[0042] Example 2 Preparation of acyclovir freeze-dried preparation for injection

[0043]

[0044] Mix acyclovir and mannitol, add water for injection, add sodium hydroxide, stir until completely dissolved, add 2.0% ethanol by volume, and adjust the pH value to 11.2 with sodium phosphate, add 0.02g / 100ml of activated carbon for needles, and stir , filtered and decarbonized, the medicinal solution is finely filtered with a 0.22-micron sterile microporous membrane to obtain acyclovir sterile medicinal solution, which is then subpackaged, semi-stoppered, freeze-dried, plugged, and capped to obtain freeze-dried Finished preparations.

[0045] Wherein, freeze-drying step is:

[0046] (1) Pre-freezing: Vacuumize the cabinet to 10 Pa, lower the temperature of the sterile acyclovir liquid to -20 degrees Celsius under vacuum conditions, and freeze for 15 minutes; remove the vacuum, then cool down to -40 degrees Celsius, and freeze for 60 minute;

[0047] (2) Sublimation drying: v...

Embodiment 3

[0049] Example 3 Preparation of Acyclovir Lyophilized Formulation for Injection

[0050]

[0051] Mix acyclovir and mannitol, add water for injection, add sodium hydroxide, stir until completely dissolved, add 1.5% ethanol by volume, and adjust the pH value to 11.5 with sodium dihydrogen phosphate, add 0.02g / 100ml of activated carbon for needles , stirred, filtered and decarbonized, and the medicinal liquid was finely filtered with a 0.22 micron sterilizing microporous membrane to obtain acyclovir sterile medicinal liquid, which was then subpackaged, semi-stoppered, freeze-dried, plugged, and capped to obtain The finished freeze-dried preparation.

[0052] Wherein, freeze-drying step is:

[0053] (1) Pre-freezing: Vacuumize the cabinet to 15 Pa, lower the temperature of the sterile acyclovir liquid to -18 degrees Celsius under vacuum conditions, and freeze for 12 minutes; remove the vacuum, then cool down to -40 degrees Celsius, and freeze for 40 minutes. minute;

[0054...

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PUM

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Abstract

The invention relates to an acyclovir lyophilized formulation for injection and a preparation method of the acyclovir lyophilized formulation. The acyclovir lyophilized formulation for injection comprises acyclovir, sodium hydroxide, mannitol and a pH value stabilizing agent, wherein the weight ratio of the acyclovir to the mannitol is 1;(1-10). The acyclovir lyophilized formulation is advanced in prescription and good in product formability; the solution before being frozen is clear in appearance; the lyophilized product is good in solubility; and the re-dissolved solution is good in clarity, low in impurity content, good in stability and controllable in quality.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular, the invention relates to a freeze-dried preparation of acyclovir for injection and a preparation method thereof. Background technique [0002] The main component of acyclovir for injection is acyclovir (chemical name: 9-(2-hydroxyethoxymethyl)guanine, compound shown in formula 1). It is a purine nucleoside analog, which is a highly efficient and broad-spectrum antiviral drug, and has a large market demand. It is mainly used for various infections caused by herpes simplex virus (HSV), and can be used for initial or recurrent skin, mucous membrane, external genital infection and HSV infection in immunocompromised persons. It is the drug of choice for the treatment of HSV encephalitis, and it is superior to adenosine vidarabine in reducing morbidity and mortality. It can also be used for herpes zoster, human herpes virus type 4 (Epstein-Barr virus), and immunodeficiency pa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/522A61K47/10A61P31/12
Inventor 姜建国刘志刚钱丽娜左艳鹏
Owner 湖北潜龙药业有限公司
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