Preparation method of virus lyophilized preparation

A technology for freeze-dried preparations and viruses, which is applied to antiviral agents, viral antigen components, medical raw materials derived from viruses/phages, etc. Viral activity, prolonging the storage time, the effect of good viral activity

Inactive Publication Date: 2013-02-06
TIANJIN JIMINGSHENG BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] There are following problems in the process of producing freeze-dried preparations by the above method: 1. The shelf life of freeze-dried preparations is short; 2. The biological activity of freeze-dried preparations is unstable.

Method used

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  • Preparation method of virus lyophilized preparation
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  • Preparation method of virus lyophilized preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1, produce freeze-dried preparation of the present invention

[0025] The production of Newcastle disease virus freeze-dried preparation of the present invention comprises the following steps:

[0026] 1. The seed virus used for production is clone30 strains;

[0027] 2. Incubation: take the fertilized eggs and incubate for 10 days at 37° C. according to the method in the "Quality Standards for Biological Products of the People's Republic of China" (hereinafter referred to as "Standards"). Dilute the seed virus with normal saline to make the virus titer 9log2, inoculate 0.1ml of the seed virus into the allantoic cavity of each chicken embryo, and incubate at 36°C for 72 hours;

[0028] 3. Harvest the stock solution: discard the chicken embryos that died 24 hours ago, and refrigerate the remaining chicken embryos at 4°C overnight. Draw the allantoic fluid under sterile conditions, mix and filter, and store in airtight;

[0029] 4. Filter the harvested stock...

Embodiment 2

[0038] Example 2, the shelf life of the freeze-dried preparation of the present invention under the storage condition of 2-8°C

[0039] Under the condition of 2~8 ℃, measured respectively the half infection rate (EID 50 ), the results are shown in Table 1:

[0040] Table 1: EID of lyophilized formulations stored at 2-8°C 50

[0041]

[0042] Table 2: Virus titers of freeze-dried preparations stored at 2-8°C

[0043]

[0044] It can be seen from the results in the table that the freeze-dried preparation of the present invention can be stored for at least 14 months at 2-8°C.

Embodiment 3

[0045] Embodiment 3, the shelf life of freeze-dried preparation under high temperature, high humidity conditions

[0046] Observe the EID of freeze-dried preparations in different storage periods under the conditions of 37°C and 75% relative humidity 50 , the results are shown in Table 3.

[0047] Table 3: EID of lyophilized formulations stored at 37°C and 75% relative humidity 50

[0048]

[0049] As can be seen from the results in the table, the thermal stability of the freeze-dried preparation of the present invention meets the relevant regulations of the U.S. Food and Drug Administration on the stability assessment standard (FDA) of live Newcastle disease virus freeze-dried preparations.

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PUM

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Abstract

The invention discloses a preparation method of a virus lyophilized preparation, and belongs to the field of virus lyophilized preparations and preparation methods thereof. The invention aims at providing a virus lyophilized preparation. A technical scheme of the invention is that: the virus lyophilized preparation comprises a Newcastle disease virus stock solution and a lyophilization additive; and the lyophilization additive is substantially composed of human serum albumin and hydroxyethyl starch. The method for producing the virus lyophilized preparation comprises the steps that: (1) the virus stock solution and the lyophilization additive are well mixed; the mixture is subjected to sterile filtration; and the mixture is sub-packaged into vials; (2) the vials are placed into a lyophilizing device, and are respectively equilibrated for 1h under temperatures of 5 DEG C, 0 DEG C, and -6 DEG C; (3) rapid freezing is carried out, wherein a product temperature is reduced to -50 DEG C, and the temperature is maintained for 3h; (4) vacuum drying is carried out; (5) heating drying is carried out, wherein a temperature is maintained for 3h when the product temperature reaches 30 DEG C; and (6) the products are plugged and sealed.

Description

technical field [0001] The invention relates to a preparation method of a virus freeze-dried preparation, in particular to a preparation method of a Newcastle disease virus freeze-dried preparation. Background technique [0002] Newcastle disease virus belongs to animal paramyxoviruses. The current method for producing ND virus freeze-dried preparations is to inoculate standard virus liquids such as Newcastle disease virus La Sota strain, clone30 strain, HBi strain, F strain or N79 strain in 10-day-old In the allantoic cavity of chicken embryos, hatch and reproduce at 37°C. Qualified chicken embryo allantoic fluid is regularly collected, mixed evenly with an appropriate amount of freeze-drying additives, quantitatively dispensed into sterile vials, and pre-frozen and vacuum-heated to make a freeze-dried preparation. [0003] The following problems exist in the process of producing the freeze-dried preparation by the above method: 1. The shelf life of the freeze-dried prepar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/76A61K39/17A61K47/42A61P31/14A61K47/36A61K47/22A61K47/16
Inventor 沈丽丽
Owner TIANJIN JIMINGSHENG BIOLOGICAL TECH
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