CN103585633A - Freeze-drying protective agent for recombinant porcine interferon alpha 1 and preparation method thereof - Google Patents
Freeze-drying protective agent for recombinant porcine interferon alpha 1 and preparation method thereof Download PDFInfo
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- CN103585633A CN103585633A CN201310526190.6A CN201310526190A CN103585633A CN 103585633 A CN103585633 A CN 103585633A CN 201310526190 A CN201310526190 A CN 201310526190A CN 103585633 A CN103585633 A CN 103585633A
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Abstract
The invention discloses a freeze-drying protective agent for recombinant porcine interferon alpha 1 and a preparation method thereof, the composition comprises the following components of sucrose, mannitol and glycerol, and the initial concentrations of the sucrose, the mannitol and the glycerol are respectively 90-300g / L, 300-600g / L and 100-400ml / L. The invention also provides the use of the freeze-drying protective agent in improvement of stability of a rPoIFN alpha 1 product.
Description
Technical field
The present invention relates generally to a kind of freeze drying protectant as Recombinant Swine Interferon α1 and preparation method thereof, especially belongs to therapeutic veterinary biologics technical field of producing.
Background technology
Lyophilization is effective, a method that keeps at present the substance bioactivities such as microorganism, animal tissue, cell and protein.Goods make ice crystal distillation through fully charge and under certain vacuum condition, thereby reach the object of low temperature dewatering, and this process is called lyophilization, is called for short lyophilizing, is freezing and dry combination.
Freeze Drying Technique has and the unrivaled advantage of other drying meanss, and dry at low temperatures, the loss of activity of various compositions, enzyme is few, and rehydration is good, and long shelf-life stores convenient transportation.But, in vacuum lyophilization process, the freezing and dry biologic activity that inevitably can affect protein.For preventing the loss of protein in freeze-drying process; people's normal materials such as sugar, protein, aminoacid that add in freeze-drying process shield; protective agent can change physics, the chemical environment of Frozen Biological when dry; alleviate or prevent lyophilization or the loss of rehydration to protein; keep as far as possible original various physio-biochemical characteristics and biological activity, freeze drying protectant also has influence on the stability of protein between preservation term.The common use of protective agent product of interferon product is albumin at present, and the expensive interferon production cost that causes of albumin improves.The present invention explores a kind of energy by test of many times and can protect Recombinant Swine Interferon α1 activity to avoid the impact of freezing dry process many factors, and the protective agent formula that can reduce costs is again applicable to Recombinant Swine Interferon α1 lyophilizing large-scale production needs very much.
Summary of the invention
The object of the invention is just to provide a kind of as Recombinant Swine Interferon α1 freeze drying protectant and preparation method thereof.
The present invention is achieved by the following technical solutions:
A Recombinant Swine Interferon α1 freeze drying protectant, comprises that following component and the initial concentration when compatibility thereof are: sucrose 90～300g/L, mannitol 300～600g/L and glycerol 100～400ml/L, solvent is water for injection.
The initial concentration of described sucrose in lyophilizing stock solution is 90～300g/L.
The initial concentration of described mannitol in lyophilizing stock solution is 300～600g/L.
The initial concentration of described glycerol in lyophilizing stock solution is 100～400mL/L.
A preparation method for the freeze drying protectant of Recombinant Swine Interferon α1, is characterized in that comprising the following steps:
(1) by each raw material mixed preparing of above-mentioned weight portion, be lyophilizing stock solution;
(2) autoclaving, fully mixes, and obtains described as Recombinant Swine Interferon α1 freeze drying protectant.
Advantage of the present invention is:
First: reduced production cost.The prices of raw and semifnished materials such as sucrose, mannitol and glycerol that freeze drying protectant of the present invention is used are all very cheap.
Second: safety.The raw materials such as sucrose, mannitol and glycerol that the present invention adopts all can pass through high pressure steam sterilization.
The the 3rd: long shelf-life, is easy to store.
The specific embodiment
Embodiment 1
(1) get rPoIFN α 1 stock solution some.
(2) according to sucrose 90～300g/L, mannitol 300～600g/L and glycerol 100～400ml/L, be formulated as lyophilizing stock solution.
(3) after formula stock solution is prepared, autoclaving, fully mixes.
(4) the formula stock solution after autoclaving and rPoIFN α 1 stock solution are mixed according to the ratio of 3:1, packing, has added rubber stopper lid, puts into freeze dryer lyophilizing.
(5), after lyophilizing finishes, gland, turns off freeze dryer.
(6) rPoIFN α 1 dried frozen aquatic products quality inspection
Randomly draw different batches rPoIFN α 1 dried frozen aquatic products and according to following scheme, detect respectively, result shows to adopt rPoIFN α 1 end product quality after the lyophilizing of this frozen-dried protective agent prescription all qualified (as shown in table 1).
Steriling test: undertaken by < < Products in China rules > > general rule < < biological product sterility test rules > > A item;
Safety experiment: with 5 of body weight 18～20g white mice, every lumbar injection 0.5ml(rPoIFN α 1 dried frozen aquatic products is dissolved in 2ml normal saline), observe 7 days, animal should be good for and be deposited, and it is qualified that every body weight increase is judged to;
Outward appearance detects: observe rPoIFN α 1 dried frozen aquatic products whether have collapses, depression, the phenomenon such as damaged, as qualified without being judged to;
Redissolution effect monitoring: get rPoIFN α 1 dried frozen aquatic products and add normal saline 2ml, observe and whether dissolve completely and have or not without naked eyes visible particle after 1min, as qualified without being judged to;
Water content detects, and is to utilize expense Xiu Shi method to measure, and it is qualified lower than 3%, to be judged to.
(7) 37 ℃ of storage stability tests of rPoIFN α 1 dried frozen aquatic products
As shown in table 2: randomly draw each batch of interferon, be positioned in 37 ℃ of incubators, each point in time sampling, adopts WISH cell VSV detection system, with few cells pathological changes, suppresses tiring of method working sample, calculates the reduction percentage rate of tiring, and it is qualified lower than 5%, to be judged to.By testing result, showing to adopt 37 ℃ of rPoIFN α 1 finished products after the lyophilizing of this frozen-dried protective agent prescription to stablize preserves more than 1 month.
(8) 4 ℃ of storage stability tests of rPoIFN α 1 dried frozen aquatic products
As shown in table 3: randomly draw each batch of interferon, be positioned in 4 ℃ of refrigerators, each point in time sampling, adopts WISH cell VSV detection system, with few cells pathological changes, suppresses tiring of method working sample, calculates the reduction percentage rate of tiring, and it is qualified lower than 5%, to be judged to.By testing result, showing to adopt 4 ℃ of rPoIFN α 1 finished products after the lyophilizing of this frozen-dried protective agent prescription to stablize preserves more than 24 months.
Table 1rPoIFN α 1 dried frozen aquatic products quality inspection result
37 ℃ of storage stability tests of table 2rPoIFN α 1 dried frozen aquatic products (tire and reduce percentage rate)
4 ℃ of storage stability tests of table 3rPoIFN α 1 dried frozen aquatic products (tire and reduce percentage rate)
Claims (5)
1. as a freeze drying protectant for Recombinant Swine Interferon α1, it is characterized in that comprising that following component and the initial concentration when compatibility thereof are: sucrose 90 ~ 300g/L, mannitol 300 ~ 600g/L and glycerol 100 ~ 400ml/L, solvent is water for injection.
2. the freeze drying protectant as Recombinant Swine Interferon α1 according to claim 1, is characterized in that the initial concentration of described sucrose in lyophilizing stock solution is 90 ~ 300g/L.
3. according to the freeze drying protectant as Recombinant Swine Interferon α1 claimed in claim 1, it is characterized in that the initial concentration of described mannitol in lyophilizing stock solution is 300 ~ 600g/L.
4. according to the freeze drying protectant as Recombinant Swine Interferon α1 claimed in claim 1, it is characterized in that the initial concentration of described glycerol in lyophilizing stock solution is 100 ~ 400mL/L.
5. a preparation method for the freeze drying protectant as Recombinant Swine Interferon α1 as claimed in claim 1, is characterized in that comprising the following steps:
(1) by each raw material mixed preparing of above-mentioned weight portion, be lyophilizing stock solution;
(2) autoclaving, fully mixes, and obtains described as Recombinant Swine Interferon α1 freeze drying protectant.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310526190.6A CN103585633A (en) | 2013-10-29 | 2013-10-29 | Freeze-drying protective agent for recombinant porcine interferon alpha 1 and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201310526190.6A CN103585633A (en) | 2013-10-29 | 2013-10-29 | Freeze-drying protective agent for recombinant porcine interferon alpha 1 and preparation method thereof |
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| CN103585633A true CN103585633A (en) | 2014-02-19 |
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| CN201310526190.6A Pending CN103585633A (en) | 2013-10-29 | 2013-10-29 | Freeze-drying protective agent for recombinant porcine interferon alpha 1 and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105039474A (en) * | 2015-08-25 | 2015-11-11 | 安徽九川生物科技有限公司 | Preparation method of recombinant chicken interferon-alpha standard substance |
| CN105132497A (en) * | 2015-08-25 | 2015-12-09 | 安徽九川生物科技有限公司 | Preparation process of recombinant poultry interferon alpha product lyophilized preparation |
| CN105801683A (en) * | 2016-03-31 | 2016-07-27 | 天津瑞普生物技术股份有限公司 | Dog interferon freeze-dried product |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1861634A (en) * | 2006-04-06 | 2006-11-15 | 北京江中泽生科技有限责任公司 | Dog interferon alpha, preparation process and use thereof |
| CN1927388A (en) * | 2004-09-10 | 2007-03-14 | 北京金迪克生物技术研究所 | Medicinal composition containing human interferon |
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2013
- 2013-10-29 CN CN201310526190.6A patent/CN103585633A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1927388A (en) * | 2004-09-10 | 2007-03-14 | 北京金迪克生物技术研究所 | Medicinal composition containing human interferon |
| CN1861634A (en) * | 2006-04-06 | 2006-11-15 | 北京江中泽生科技有限责任公司 | Dog interferon alpha, preparation process and use thereof |
Non-Patent Citations (1)
| Title |
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| 张代宝 等: "干扰素制剂冻干技术研究进展", 《中国畜牧兽医》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105039474A (en) * | 2015-08-25 | 2015-11-11 | 安徽九川生物科技有限公司 | Preparation method of recombinant chicken interferon-alpha standard substance |
| CN105132497A (en) * | 2015-08-25 | 2015-12-09 | 安徽九川生物科技有限公司 | Preparation process of recombinant poultry interferon alpha product lyophilized preparation |
| CN105801683A (en) * | 2016-03-31 | 2016-07-27 | 天津瑞普生物技术股份有限公司 | Dog interferon freeze-dried product |
| CN105801683B (en) * | 2016-03-31 | 2019-05-14 | 天津瑞普生物技术股份有限公司 | A kind of dog interferon freeze-dried products |
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