Dog interferon freeze-dried product

Abstract

The invention discloses a dog interferon freeze-dried product, and relates to the technical field of freeze-dried biological products.The dog interferon freeze-dried product is prepared by freeze-drying a dog interferon stock solution and a freeze-drying protecting agent, wherein a freeze-drying protecting agent base solution is composed of a pH buffer agent and a protein protecting agent, and the freeze-drying protecting agent comprises a heat-resisting protective agent, a filling agent and a freeze-drying accelerating agent.The prepared dog interferon freeze-dried product can be stored for a long term at 2 DEG C-8 DEG C; due to the fact that the freeze-drying accelerating agent is added, the freeze-drying time of a freeze-drying technological link in large-scale industrialized production is shortened, the freeze-drying efficiency is improved, it is guaranteed that freeze-drying is full, and the stability of products of different batches is guaranteed; through combination of the preferable heat-resisting protective agent and filling agent, the anti-fracture strength of a dog interferon protein chain is improved, the biological activity of the dog interferon freeze-dried product is improved, and the product yield ratio of the dog interferon freeze-dried product is increased.

Description

technical field

[0001] The invention relates to the technical field of freeze-dried biological products, in particular to a freeze-dried product of canine interferon. Background technique

[0002] Canine interferon is a glycoprotein substance produced by normal canine body cells under the action of a suitable inducer. It has broad-spectrum anti-virus, anti-tumor and immune function regulation functions. It has been used clinically. The common clinical preparation is canine interferon lyophilized product, which is a biological product obtained by mixing canine interferon protein and lyoprotectant in proportion and then freeze-drying. This type of product can effectively prolong the storage time of interferon protein, but its thermal stability is poor, and it needs to be stored below -15°C, which brings great difficulties to the storage and transportation of interferon; at the same time, freezing during large-scale production In the drying process, often due to the long freez...

Examples

Embodiment 1

[0020] Prepare the canine interferon freeze-dried product according to the following method, and its characteristics include the following preparation process:

[0021] According to dodecacrystalline water sodium hydrogen phosphate 2.9g / L, sodium dihydrogen phosphate 0.2g / L, polyvinylpyrrolidone 50g / L, mannitol 20g / L, soybean peptone 2.5g / L, tert-butanol 1.8g / L preparation To freeze-dry the stock solution, prepare the formula stock solution, autoclave it, and mix thoroughly; take some canine interferon stock solution, mix the autoclaved formula stock solution and canine interferon stock solution according to the ratio of 5:1, divide Pack it, add a rubber stopper cover, and put it into a freeze dryer for freeze drying; after the freeze drying is completed, press the cover to obtain the canine interferon freeze-dried product.

Embodiment 2

[0023] Prepare the canine interferon freeze-dried product according to the following method, and its characteristics include the following preparation process:

[0024] According to dodecacrystalline water sodium hydrogen phosphate 16.07g / L, sodium dihydrogen phosphate 1.05g / L, polyvinylpyrrolidone 125g / L, mannitol 50g / L, soybean peptone 1.5g / L, tert-butanol 2.25g / L To freeze-dry the stock solution, prepare the formula stock solution, autoclave it, and mix thoroughly; take some canine interferon stock solution, mix the autoclaved formula stock solution and canine interferon stock solution according to the ratio of 5:1, divide Pack it, add a rubber stopper cover, and put it into a freeze dryer for freeze drying; after the freeze drying is completed, press the cover to obtain the canine interferon freeze-dried product.

Embodiment 3

[0026] Prepare the canine interferon freeze-dried product according to the following method, and its characteristics include the following preparation process:

[0027] According to dodecacrystalline water sodium hydrogen phosphate 29.85g / L, sodium dihydrogen phosphate 1.98g / L, polyvinylpyrrolidone 200g / L, mannitol 80g / L, soybean peptone 0.5g / L, tert-butanol 2.7g / L To freeze-dry the stock solution, prepare the formula stock solution, autoclave it, and mix thoroughly; take some canine interferon stock solution, mix the autoclaved formula stock solution and canine interferon stock solution according to the ratio of 5:1, divide Pack it, add a rubber stopper cover, and put it into a freeze dryer for freeze drying; after the freeze drying is completed, press the cover to obtain the canine interferon freeze-dried product.

technical field

[0001] The invention relates to the technical field of freeze-dried biological products, in particular to a freeze-dried product of canine interferon. Background technique

[0002] Canine interferon is a glycoprotein substance produced by normal canine body cells under the action of a suitable inducer. It has broad-spectrum anti-virus, anti-tumor and immune function regulation functions. It has been used clinically. The common clinical preparation is canine interferon lyophilized product, which is a biological product obtained by mixing canine interferon protein and lyoprotectant in proportion and then freeze-drying. This type of product can effectively prolong the storage time of interferon protein, but its thermal stability is poor, and it needs to be stored below -15°C, which brings great difficulties to the storage and transportation of interferon; at the same time, freezing during large-scale production In the drying process, often due to the long freez...

Examples

Embodiment 1

[0020] Prepare the canine interferon freeze-dried product according to the following method, and its characteristics include the following preparation process:

[0021] According to dodecacrystalline water sodium hydrogen phosphate 2.9g / L, sodium dihydrogen phosphate 0.2g / L, polyvinylpyrrolidone 50g / L, mannitol 20g / L, soybean peptone 2.5g / L, tert-butanol 1.8g / L preparation To freeze-dry the stock solution, prepare the formula stock solution, autoclave it, and mix thoroughly; take some canine interferon stock solution, mix the autoclaved formula stock solution and canine interferon stock solution according to the ratio of 5:1, divide Pack it, add a rubber stopper cover, and put it into a freeze dryer for freeze drying; after the freeze drying is completed, press the cover to obtain the canine interferon freeze-dried product.

Embodiment 2

[0023] Prepare the canine interferon freeze-dried product according to the following method, and its characteristics include the following preparation process:

[0024] According to dodecacrystalline water sodium hydrogen phosphate 16.07g / L, sodium dihydrogen phosphate 1.05g / L, polyvinylpyrrolidone 125g / L, mannitol 50g / L, soybean peptone 1.5g / L, tert-butanol 2.25g / L To freeze-dry the stock solution, prepare the formula stock solution, autoclave it, and mix thoroughly; take some canine interferon stock solution, mix the autoclaved formula stock solution and canine interferon stock solution according to the ratio of 5:1, divide Pack it, add a rubber stopper cover, and put it into a freeze dryer for freeze drying; after the freeze drying is completed, press the cover to obtain the canine interferon freeze-dried product.

Embodiment 3

[0026] Prepare the canine interferon freeze-dried product according to the following method, and its characteristics include the following preparation process:

[0027] According to dodecacrystalline water sodium hydrogen phosphate 29.85g / L, sodium dihydrogen phosphate 1.98g / L, polyvinylpyrrolidone 200g / L, mannitol 80g / L, soybean peptone 0.5g / L, tert-butanol 2.7g / L To freeze-dry the stock solution, prepare the formula stock solution, autoclave it, and mix thoroughly; take some canine interferon stock solution, mix the autoclaved formula stock solution and canine interferon stock solution according to the ratio of 5:1, divide Pack it, add a rubber stopper cover, and put it into a freeze dryer for freeze drying; after the freeze drying is completed, press the cover to obtain the canine interferon freeze-dried product.

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