CN101214377A - Pig immunoglobulinlg oral liquid and preparation thereof - Google Patents
Pig immunoglobulinlg oral liquid and preparation thereof Download PDFInfo
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- CN101214377A CN101214377A CNA2008100001117A CN200810000111A CN101214377A CN 101214377 A CN101214377 A CN 101214377A CN A2008100001117 A CNA2008100001117 A CN A2008100001117A CN 200810000111 A CN200810000111 A CN 200810000111A CN 101214377 A CN101214377 A CN 101214377A
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- serum
- oral liquid
- immune globulin
- pig immune
- filtration
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Abstract
The invention is to provide an immunoglobulin oral solution with rich raw material sources, high content of immunoglobulin, being easy to be taken and absorbed by the human body, and a method of preparing the oral solution. The invention is an oral aseptic solution prepared in the following processes: fresh and healthy pig blood is collected; serapheresis is conducted on the pig blood through a conventional method and the prior art under the low temperature and aseptic conditions; hybridprotein in the serum is removed through a Rivanol method, ultra-filtration and other conventional methods as well as the prior art; any potential virus in the pig blood is removed through a conventional virus inactivation method and the prior method; sterilization by filtration, aseptic packaging, etc.
Description
Technical field
What the present invention relates to is a kind of utilization oral liquid of extracting pig immune globulin preparation from Sanguis sus domestica and preparation method thereof, be used for effectively treatment and prevention bacterial infection and viral disease, especially the viral diarrhea that rotavirus infection causes had significant curative effect.The invention belongs to biological health goods field.
Background technology
At present, the medicine of treatment bacterial infection and viral disease is mainly antibiotics, though antibiotics can effectively be treated above-mentioned disease, but easily develop immunity to drugs, and because patient's body constitution difference, situation hypersensitive, serious antibiotic medicine allergy even entail dangers to life often appear.
Immunoglobulin is called for short Ig, is the indispensable composition of health, when human body Ig component content descends or be not enough, then can't suppress virus and antibacterial, suffer from bacterial infection and viral disease easily, therefore, the immunoglobulin medicine is widely used in human medical treatment and healthcare field.Immunoglobulin at present commonly used mainly extracts from human plasma and Placenta Hominis, and the shortcoming of this mode is that raw material is few, and price is high and because serum product may hide the danger that hepatitis A, hepatitis B, HIV (human immunodeficiency virus) are arranged, and the possibility of superinfection is arranged.
Summary of the invention
It is abundant to the purpose of this invention is to provide a kind of raw material sources, and the immunoglobulin content height is convenient to take and be easy to pig immune globulin oral liquid of absorption of human body and preparation method thereof.
It is raw material that the present invention adopts Sanguis sus domestica, uses known technology and conventional method to extract pig immune globulin, confirms through DEAE Sephadex G6200 and Sephadex A50 chromatography, contain IgG, IgM, three kinds of globulin of IgA, molecular weight is 160,000～800, between 000 dalton.
Pig immune globulin oral liquor of the present invention is to be realized by following technical scheme: the blood of gathering fresh healthy swine, under the cryogenic sterile condition, the utilization conventional method is carried out serum with known technology to Sanguis sus domestica and is separated, conventional method such as utilization Fan Nuofa, ultrafiltration and known technology are removed the foreign protein in the serum, and according to conventional virus inactivating method and known method, remove any virus that may exist in the Sanguis sus domestica, the more oral sterile solution for preparing by aseptic filtration, process such as aseptic subpackaged.
The concrete technology of preparing scheme of pig immune globulin oral liquid of the present invention is as follows:
Gather the fresh and healthy Sanguis sus domestica through centrifugalize serum, by 1: 0.69 adding distilled water diluting serum, add 3% ethacridine and sad in the serum dilution, stir, transfer PH to 7.0-7.3, remove supernatant, filtration, filter back serum is centrifugal by 1: 0.05 adding 5%Nacl, and removes ethacridine through diatomite adsorption, measure protein content, and be merged into stock solution; With total protein is in the stock solution of 200 grams, add protective agent 80% sorbitol 1000ml (10%), glycerol 400ml (4%), 0.01M4 doubly concentrated phosphoric acid salt buffer 2500ml (25%) and Oleum Caryophylli 33.3ml (0.33%), and be diluted to 10000ml with sterilized water for injection, making the final content of goods protein is 2%, and accent PH is 6.4-7.4; The goods that obtain are placed 60 ℃ of water-baths, 10 hours inactivation of viruses; By strict aseptic manipulation, use asbestos-free medium to clarify and aseptic filtration, and the pig immune globulin oral liquid is made in packing in time.
Pig immune globulin oral liquid raw material sources of the present invention are abundant, be fit to produce in enormous quantities, the immunoglobulin content height that from Sanguis sus domestica, extracts, can effectively treat and prevent bacterial infection and viral disease, especially the viral diarrhea that rotavirus infection is caused has significant curative effect, and the characteristics of oral liquid are to be easy to absorb, and are easy to use, and the growth that improves human body constitution, enhancing resistance of human body and child is had good effect.Pig immune globulin oral liquid preparation process of the present invention is rigorous, and each step is all carried out under sealing, aseptic scientific environment, has guaranteed the composition of oral liquid and has taken safety.
The specific embodiment
Below further specify embodiments of the invention:
Gather the fresh and healthy Sanguis sus domestica through centrifugalize serum, by 1: 0.69 adding distilled water diluting serum, add 3% ethacridine and sad in the serum dilution, stir, transfer PH to 7.0-7.3, remove supernatant, filtration, filter back serum is centrifugal by 1: 0.05 adding 5%Nacl, and removes ethacridine through diatomite adsorption, measure protein content, and be merged into stock solution; With total protein is in the stock solution of 200 grams, add protective agent 80% sorbitol 1000ml (10%), glycerol 400ml (4%), 0.01M4 doubly concentrated phosphoric acid salt buffer 2500ml (25%) and Oleum Caryophylli 33.3ml (0.33%), and be diluted to 10000ml with sterilized water for injection, making the final content of goods protein is 2%, and accent PH is 6.4-7.4; The goods that obtain are placed 60 ℃ of water-baths, 10 hours inactivation of viruses; By strict aseptic manipulation, use asbestos-free medium to clarify and aseptic filtration, and the pig immune globulin oral liquid is made in packing in time.
Pharmaceutical biological product assay of the present invention is as follows:
| Inspection item | Standard code | Assay |
| Outward appearance | Greenish orange yellow supernatant liquid should not contain foreign body, floccule and shake the precipitate that does not loose | Up to specification |
| Loading amount | ≥10ml | 11ml |
| PH | 6.4-7.4 | 7.1 |
| Total protein (mg/ bottle) | ≥180 | 288 |
| Total protein and labelled amount are than (%) | ≥90 | 144 |
| Immunoglobulin content (%) | ≥90 | 96 |
| Alpha+beta globulin content (%) | 〉=45 | 49 | |
| Sterility test | Asepsis growth | Up to specification | |
| Abnormal toxicity test (Cavia porcellus) | All be good for and deposit no abnormal reaction, weight increase | Up to specification | |
| Abnormal toxicity test (mice) | All be good for and deposit no abnormal reaction, weight increase | Up to specification | |
| Discrimination test | Produce precipitation line with anti-porcine blood serum, do not produce precipitation line with anti-people and anti-cattle (horse) serum | Up to specification | |
| Anti-rotavirus 1 type NAT | 〉=1: 200 | 1: 320 | |
| Anti-rotavirus 2 type NATs | 〉=1: 200 | 1: 320 | |
| Anti-rotavirus 2 type NATs | 〉=1: 200 | 1: 320 | |
| Anti-rotavirus 2 type NATs | 〉=1: 200 | 1: 320 | |
| Check conclusion | This product is by the check of authorization rules, and the result is up to specification. | ||
Claims (2)
1. a pig immune globulin oral liquid is characterized in that containing pig immune globulin.
2. the preparation method of a pig immune globulin oral liquid, gather the fresh and healthy Sanguis sus domestica through centrifugalize serum, by 1: 0.69 adding distilled water diluting serum, add 3% ethacridine and sad in the serum dilution, stir, transfer PH to 7.0-7.3, remove supernatant, filtration, filter back serum is centrifugal by 1: 0.05 adding 5%Nacl, and remove ethacridine through diatomite adsorption, measure protein content, and be merged into stock solution; With total protein is in the stock solution of 200 grams, add protective agent 80% sorbitol 1000ml (10%), glycerol 400ml (4%), 0.01M4 doubly concentrated phosphoric acid salt buffer 2500ml (25%) and Oleum Caryophylli 33.3ml (0.33%), and be diluted to 10000ml with sterilized water for injection, making the final content of goods protein is 2%, and accent PH is 6.4-7.4; The goods that obtain are placed 60 ℃ of water-baths, 10 hours inactivation of viruses; By strict aseptic manipulation, use asbestos-free medium to clarify and aseptic filtration, and the pig immune globulin oral liquid is made in packing in time.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008100001117A CN101214377A (en) | 2008-01-02 | 2008-01-02 | Pig immunoglobulinlg oral liquid and preparation thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008100001117A CN101214377A (en) | 2008-01-02 | 2008-01-02 | Pig immunoglobulinlg oral liquid and preparation thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101214377A true CN101214377A (en) | 2008-07-09 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2008100001117A Pending CN101214377A (en) | 2008-01-02 | 2008-01-02 | Pig immunoglobulinlg oral liquid and preparation thereof |
Country Status (1)
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| CN (1) | CN101214377A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111166879A (en) * | 2019-12-04 | 2020-05-19 | 昆明白马制药有限公司 | Pig immunoglobulin oral liquid |
-
2008
- 2008-01-02 CN CNA2008100001117A patent/CN101214377A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111166879A (en) * | 2019-12-04 | 2020-05-19 | 昆明白马制药有限公司 | Pig immunoglobulin oral liquid |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20080709 |