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Freeze-drying slow-release protective agent used for preparing adenovirus preparation and adenovirus preparation and preparation method thereof

An adenovirus and protective agent technology, applied in the field of adenovirus preparations, can solve the problems of unfavorable long-term storage of viruses, poor resistance to temperature changes, easy inactivation of viruses, etc., achieve human pathogenicity without inducing cancer, prolong storage time, The effect of extending storage time

Inactive Publication Date: 2018-06-19
CHENGDU YUANRUI BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing technology is not suitable for oral administration, the virus is easily inactivated when stored, and has poor resistance to temperature changes. The storage and transportation conditions are harsh and the cost is high. If it is directly taken orally, it is easily affected by gastric acid and reduces the efficacy of the drug
[0003] Adenoviruses have poor long-term storage stability in liquid formulations
If the virus storage process encounters repeated freezing and thawing, the damage to the virus activity will be greater, which is not conducive to the long-term storage of the virus; adenovirus is more sensitive to temperature, and it needs to be transported in a cold chain, and the transportation cost is high

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] The adenovirus preparation suitable for oral administration provided in this embodiment includes: a freeze-dried sustained-release protective agent and a virus liquid containing adenovirus.

[0054] Wherein, the lyophilized sustained-release protective agent includes: a first solution and a second solution.

[0055] The first solution contains sodium alginate, sucrose, lactose and mannitol.

[0056] The second solution contains: calcium chloride; the concentration of calcium chloride is 3% (g / ml, that is, every 100ml of the second solution contains 3g of calcium chloride).

[0057] The content of adenovirus in the virus liquid is: 1×10 7 pfu / mL. The adenovirus is a recombinant adenovirus AdC68-Gp, which contains the rabies virus gp gene. For its preparation method, refer to "A Rabies Vaccine and Its Preparation Method", Patent No. 201310362921.8.

[0058] The preparation method of the adenovirus preparation provided in this embodiment is as follows:

[0059] Take the ...

experiment example 1

[0067] Virus titer detection

[0068] The prepared adenovirus preparation was crushed into fine powder, soaked in 1 ml of pH 7.2 phosphate buffer at room temperature and redissolved for 5 hours, and the precipitate was disintegrated. The adenovirus titer in the solution was detected by the TCID50 method, which is a general method for adenovirus titer detection.

[0069] The results showed that the parallel experiment was compared with the virus liquid prepared without the freeze-dried slow-release protective agent. The mean titer of the virus solution without freeze-dried slow-release protective agent before preparation was 1.50×10 7 pfu / mL, the average titer of the adenovirus preparation after preparation was 1.50×10 7 pfu / mL. After statistical analysis, the t-test showed no significant difference in virus titer before and after preparation (p<0.01), indicating that the preparation method of Example 1 had no significant impact on virus titer.

experiment example 2

[0071] Anti-aging test for different shelf life

[0072] Store the adenovirus preparation sample in Example 1 and the virus solution without the lyophilized slow-release protective agent at 4°C, 25°C, and 37°C, respectively, and the products stored at 4°C and 25°C are sampled every month, and the samples are stored at 37°C Samples of preserved products were taken every 5 days to detect virus titer.

[0073] The result shows, by the sample prepared in embodiment 1, 4 ℃ preserves the sample and keeps at 1.50×10 virus titer in 1 year cycle. 7 There was no change in pfu / mL. Samples stored at 25°C maintained a virus titer of 1.50×10 in the first 6 months 7 No change in pfu / mL, virus titer decreased to 7.00×10 in 7-12 months 6 pfu / mL. Store samples at 37°C for the first 2 weeks at 1.50 x 10 7 pfu / mL, decreased to 5.00×10 after 1 month 6 pfu / mL. The titer of the virus solution without lyophilized sustained-release protective agent decreased to 1.00×10 at 4°C in the first month...

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Abstract

The invention discloses a freeze-drying slow-release protective agent used for preparing an adenovirus preparation and the adenovirus preparation and a preparation method thereof, which relate to thefield of an adenovirus preparation. The freeze-drying slow-release protective agent comprises a first solution containing sodium alginate and a second solution containing calcium chloride, the freeze-drying slow-release protective agent solves the problem of stability of an oral adenovirus preparation, has enteric characteristic, and can protect adenovirus from influence of gastric acid, and the preparation can keep stabilization under low-pH stomach environment, after entering into intestinal tract, the preparation is gradually disintegrated and releases adenovirus, and the adenovirus preparation is suitable for an oral administration mode, which overcomes inconvenience of an injection administration mode. The problem of easy deactivation of preservation of the adenovirus liquid preparation is solved, preservation time of the preparation is prolonged, the requirement of the adenovirus preparation on temperature during preservation and transport processes can be reduced, preparation stability is increased, and economic cost is reduced.

Description

technical field [0001] The invention relates to the field of adenovirus preparations, in particular to a freeze-drying sustained-release protectant for preparing adenovirus preparations, an adenovirus preparation and a preparation method. Background technique [0002] The existing adenovirus vector drug mainly adopts the preparation formula of liquid injection during the preparation process. The existing technology is not suitable for oral administration, the virus is easily inactivated when stored, has poor resistance to temperature changes, and the storage and transportation conditions are harsh and costly. If it is directly orally administered, it is easily affected by gastric acid and reduces the efficacy of the drug. [0003] Adenoviruses have poor long-term storage stability in liquid preparations. If the virus storage process encounters repeated freezing and thawing, the damage to the virus activity will be greater, which is not conducive to the long-term storage of ...

Claims

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Application Information

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IPC IPC(8): A61K35/761A61K9/19A61K47/36A61K47/02A61K47/26A61K39/235A61P31/20
CPCA61K9/0053A61K9/19A61K35/761A61K39/12A61K47/02A61K47/26A61K47/36A61K2039/542C12N2710/10034
Inventor 熊俊梁雯邓飞陈坷帆刘冬梁波
Owner CHENGDU YUANRUI BIOTECH CO LTD
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