CN1116898C - Oral immune globulin preparation and its preparing process - Google Patents
Oral immune globulin preparation and its preparing process Download PDFInfo
- Publication number
- CN1116898C CN1116898C CN 00114378 CN00114378A CN1116898C CN 1116898 C CN1116898 C CN 1116898C CN 00114378 CN00114378 CN 00114378 CN 00114378 A CN00114378 A CN 00114378A CN 1116898 C CN1116898 C CN 1116898C
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- preparation
- immunoglobulin
- formulation
- cattle colostrums
- immune globulin
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- Expired - Lifetime
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- 108060003951 Immunoglobulin Proteins 0.000 title claims abstract description 33
- 102000018358 immunoglobulin Human genes 0.000 title claims abstract description 33
- 238000002360 preparation method Methods 0.000 title claims abstract description 27
- 238000000034 method Methods 0.000 title description 5
- 239000000843 powder Substances 0.000 claims abstract description 12
- 238000000108 ultra-filtration Methods 0.000 claims abstract description 9
- 239000002994 raw material Substances 0.000 claims abstract description 6
- 238000005238 degreasing Methods 0.000 claims abstract description 5
- 238000001035 drying Methods 0.000 claims abstract description 4
- 241000283690 Bos taurus Species 0.000 claims description 27
- 210000003022 colostrum Anatomy 0.000 claims description 23
- 235000021277 colostrum Nutrition 0.000 claims description 23
- 239000002775 capsule Substances 0.000 claims description 5
- 241001591005 Siga Species 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 4
- 238000004108 freeze drying Methods 0.000 claims description 3
- 238000007710 freezing Methods 0.000 claims description 3
- 230000000844 anti-bacterial effect Effects 0.000 claims description 2
- 230000018044 dehydration Effects 0.000 claims description 2
- 238000006297 dehydration reaction Methods 0.000 claims description 2
- 238000001914 filtration Methods 0.000 claims description 2
- 230000008014 freezing Effects 0.000 claims description 2
- 239000012535 impurity Substances 0.000 claims description 2
- 230000008520 organization Effects 0.000 claims description 2
- 239000012905 visible particle Substances 0.000 claims description 2
- 239000000203 mixture Substances 0.000 abstract description 8
- 238000010521 absorption reaction Methods 0.000 abstract description 3
- 235000013336 milk Nutrition 0.000 abstract description 3
- 239000008267 milk Substances 0.000 abstract description 3
- 210000004080 milk Anatomy 0.000 abstract description 3
- 230000001900 immune effect Effects 0.000 abstract description 2
- 230000036737 immune function Effects 0.000 abstract description 2
- 230000032696 parturition Effects 0.000 abstract description 2
- 238000009472 formulation Methods 0.000 abstract 7
- 208000035240 Disease Resistance Diseases 0.000 abstract 1
- 235000020243 first infant milk formula Nutrition 0.000 abstract 1
- 230000002265 prevention Effects 0.000 abstract 1
- 238000009777 vacuum freeze-drying Methods 0.000 abstract 1
- 201000010099 disease Diseases 0.000 description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 5
- 239000000706 filtrate Substances 0.000 description 4
- 210000004027 cell Anatomy 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 244000005700 microbiome Species 0.000 description 3
- 239000011148 porous material Substances 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 241000725303 Human immunodeficiency virus Species 0.000 description 2
- 206010042566 Superinfection Diseases 0.000 description 2
- 241000700605 Viruses Species 0.000 description 2
- 230000004071 biological effect Effects 0.000 description 2
- 239000000284 extract Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 238000012856 packing Methods 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- OTLLEIBWKHEHGU-UHFFFAOYSA-N 2-[5-[[5-(6-aminopurin-9-yl)-3,4-dihydroxyoxolan-2-yl]methoxy]-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-3,5-dihydroxy-4-phosphonooxyhexanedioic acid Chemical compound C1=NC=2C(N)=NC=NC=2N1C(C(C1O)O)OC1COC1C(CO)OC(OC(C(O)C(OP(O)(O)=O)C(O)C(O)=O)C(O)=O)C(O)C1O OTLLEIBWKHEHGU-UHFFFAOYSA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 102000002322 Egg Proteins Human genes 0.000 description 1
- 108010000912 Egg Proteins Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000006395 Globulins Human genes 0.000 description 1
- 108010044091 Globulins Proteins 0.000 description 1
- 239000011149 active material Substances 0.000 description 1
- 235000020244 animal milk Nutrition 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 102000038379 digestive enzymes Human genes 0.000 description 1
- 108091007734 digestive enzymes Proteins 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 239000002095 exotoxin Substances 0.000 description 1
- 231100000776 exotoxin Toxicity 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 108010074605 gamma-Globulins Proteins 0.000 description 1
- 210000004211 gastric acid Anatomy 0.000 description 1
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- 238000000227 grinding Methods 0.000 description 1
- 208000005252 hepatitis A Diseases 0.000 description 1
- 208000002672 hepatitis B Diseases 0.000 description 1
- 235000020256 human milk Nutrition 0.000 description 1
- 210000004251 human milk Anatomy 0.000 description 1
- 208000026278 immune system disease Diseases 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 229960001438 immunostimulant agent Drugs 0.000 description 1
- 239000003022 immunostimulating agent Substances 0.000 description 1
- 230000003308 immunostimulating effect Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 210000004681 ovum Anatomy 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 244000052769 pathogen Species 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 210000002826 placenta Anatomy 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 230000000392 somatic effect Effects 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 210000003684 theca cell Anatomy 0.000 description 1
- 210000004881 tumor cell Anatomy 0.000 description 1
- 238000001291 vacuum drying Methods 0.000 description 1
Landscapes
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
The present invention relates to an oral immunoglobulin formulation and a preparation method thereof. The oral immunoglobulin formulation uses cow first milk in 1 to 3 says after the parturition of a healthy milk cow as a raw material which is manufactured into drying solute powder through the steps of centrifugal degreasing, ultrafiltration and vacuum freeze drying treatment under the aseptic condition of low temperature, wherein the content of immunoglobulin is 10 to 36% of the weight of the whole formulation. The present invention has the advantages of abundant resources, powerful immunological regulation functions, high content of the immunoglobulin in the formulation, easy absorption by human bodies, oral formulation, convenient operation, safety and availableness; further, the formulation can be taken by both children and adults, and the oral immunoglobulin formulation has the better efficiency of human body immunological function enhancement and human body disease resistance and prevention capability promotion.
Description
Technical field
The present invention relates to a kind of oral immune globulin preparation and preparation method thereof, belong to the biological health product technique field.
Background technology
Immunoglobulin is called for short Ig, it can in and the bacterial exotoxin and the particle that causes a disease, and make the virus forfeiture continue the somatic ability of infected person, it can also suppress the procreation of source of disease microorganism, blocking-up source of disease microorganism and theca cell are bonding, to reduce the infection of alien bacteria to human body.When Ig content in the body descended or is not enough, then the chance that can cause procreation for harmful microorganisms such as external virus, cell caused the generation of various diseases.Ig has the supervision effect to senile cell and the tumor cell that occurs in the human body, thereby makes the people keep the physiological equilibrium.If immune dysfunction, human body will produce a series of disease, and therefore, since nearly half a century, immunoglobulin has obtained using widely as the immunostimulant goods.
Immunoglobulin (also claiming gamma globulin) commonly used at present extracts from human plasma and Placenta Hominis usually, using method adopts intramuscular injection and two kinds of forms of intravenous injection, because the superinfection in few valency height of raw material resources limit amount and the serum product, as the potential danger of hepatitis A, hepatitis B, HIV (human immunodeficiency virus), the application of this based article is subjected to certain limitation.Some researchs in recent years are raw material with the egg, adopt various biotechnology to attempt to develop the ovum immunoglobulin, but its biological value are too low, and the oral absorption rate is not high yet, and also have quite long process from suitability for industrialized production.Latest report vaccinate on jenny makes its breast milk of giving birth to contain immunologic active material both at home and abroad, but because of animal milk can not directly eat, needs heat treated, and its biological activity can not guarantee, thereby research is not succeedd as yet.
Summary of the invention
Purpose of the present invention aims to provide that a kind of raw material sources are abundant, immunoglobulin content is high, be convenient to take and be easy to safe oral immune globulin preparation of absorption of human body and preparation method thereof.
Oral immune globulin preparation of the present invention is realized by following technical scheme: the cattle colostrums that divided puerperium 1-3 days with healthy cow is a raw material, under the cryogenic sterile condition, through centrifugal degreasing, ultrafiltration, vacuum lyophilization is handled and is made solute dry powder, and wherein the content of immunoglobulin is the 10-36% of whole preparation by weight.
The technical scheme of preparation method of the present invention is: put the cattle colostrums of gathering under the 2-8 ℃ of aseptic condition (1), pours the centrifuge centrifugal degreasing into, ten thousand rev/mins of centrifuge speed 0.6-1.2, and the time is 8-20 minute, removes the fat in the cattle colostrums; (2) under 2-8 ℃ of aseptic condition, it is to carry out ultrafiltration in the 20 μ m ultrafilters that the cattle colostrums of sloughing fat is put the aperture, removes visible particle, macromolecular organization's cell and impurity in the cattle colostrums; (3) under 2-8 ℃ of aseptic condition, will be the filtering cattle colostrums of one-level to place the aperture be that 0.22 μ m filter carries out ultrafiltration, to remove the antibacterial in the cattle colostrums; (4) rapidly the cattle colostrums of degerming place-20～-40 ℃ environment freezing and carry out the vacuum dehydration drying, make it become the solute dry powder that is rich in immunoglobulin.
Good effect of the present invention is: 1, source resource is abundant, is suitable for producing in enormous quantities; 2, from cattle colostrums, extract, the content height of immunoglobulin, to improving the immunocompetence of human body, health invigorating promotes child's generation growth that good effect is all arranged; 3, because of containing the albumen inhibitory enzyme in the cattle colostrums, can protect immunoglobulin not destroyed by the digestive enzyme in gastric acid and the gastrointestinal tract, thereby the present invention can orally use, the characteristics of mouthful ophthalmic preparation are to use conveniently, safe and effective, reduce chance to blood biological product superinfection; 4, immunoglobulin of the present invention is easily absorbed by the body, and test shows that this immunoglobulin can be absorbed by major part at stomach the child, can be absorbed by most of in intestinal the adult; 5, the SigA sIgA that contains 5-10% in the immunoglobulin of the present invention by weight, this globulin A participates in the mucosa local immunity, and pathogen is stoped external, and the human immunologic function is further strengthened; 6, manufacturing process rigorous and scientific of the present invention, whole process is carried out under cryogenic conditions, and adopts the quick-freezing mode to carry out vacuum drying, and its water content is the 3-10% (by weight) of whole preparation, has guaranteed the biological activity in the cattle colostrums composition.
The specific embodiment
Below further describe embodiments of the invention, the 1st day cattle colostrums behind the collection cow birth, in 4 ℃ of aseptic heat-preserving containers, transport to job shop, working environment is 4 ℃, cattle colostrums is poured in the high speed centrifuge, set 10,000 rev/mins of centrifuge speeds, move 12 minutes, the top fat deposit is removed, and it is 20 μ m that the mixed liquor that takes off portion places fine filter ultra-filtration filters aperture, gets filtrate thereafter and places film filter to filter, pore size filter is 0.22 μ m, get filtrate and insert in the freeze dryer of vacuum, cryogenic temperature is-30 ℃, makes the freeze-dried powder of shallow milk yellow finely squamose, grind and then become solute dry powder, its water content is 3-5%, and the content of immunoglobulin is 33% of preparation by weight, and the content of SigA sIgA is 7.5% by weight in immunoglobulin, with this powder preparation, under 4 ℃ of gnotobasiss, incapsulate and pack into packing box or Packaging Bottle in, place the cool place, dry, preserve under the condition of lucifuge or sell.
Second embodiment of the present invention is: the 3rd day cattle colostrums behind the collection cow birth, in aseptic heat-preserving container, transport to job shop, working environment is 4 ℃, cattle colostrums is poured in the high speed centrifuge, set 6800 rev/mins of centrifuge speeds, move 10 minutes, remove the top fat deposit, the mixed liquor that takes off portion places the fine filter ultrafiltration, and pore size filter is 20 μ m, thereafter getting filtrate places film filter to filter, pore size filter is 0.22 μ m, gets filtrate and inserts in the freeze dryer of vacuum, and cryogenic temperature is-40 ℃, make the freeze-dried powder of shallow milk yellow finely squamose, it is 8-10% that grinding then becomes solute dry powder, its water content, and the content of immunoglobulin is 17% of preparation by weight, SigA sIgA content is 7.5% by weight in immunoglobulin, with this powder preparation, under 4 ℃ of gnotobasiss, incapsulate and pack into packing box or Packaging Bottle in, place shady and cool drying, preserve under the condition of lucifuge or sell.
Preparation of the present invention can be pressed into tablet, or makes capsule-type, and capsule is the enteric solubility capsule, takes for the adult, or can be made into powder-type, encapsulates with sealing bag.
Instructions of taking of the present invention is: adult every day 2-3 time, each dosage 0.3-0.6 restrains, and the child reduces by half, and the child can open capsule and stir in other food (≤40 ℃) and take, and also can directly pour in the mouth.
Claims (4)
1, a kind of oral immune globulin preparation, it is characterized in that it divides the cattle colostrums in 1～3 day puerperium with healthy cow is raw material, under the cryogenic sterile condition, through centrifugal degreasing, ultrafiltration, vacuum lyophilization is handled and is made solute dry powder, wherein the content of immunoglobulin is 10～36% of whole preparation by weight, contains 5～10% SigA sIgA in the immunoglobulin of said preparation by weight.
2, by the described oral immune globulin preparation of claim 1, it is characterized in that its water content of solute powder after the lyophilization is 3～10% by weight in the said preparation.
3, by claim 1 or 2 described oral immune globulin preparations, it is characterized in that said preparation makes capsule-type, capsule is the enteric solubility capsule.
4, a kind of preparation method of oral immune globulin preparation is characterized by:
(1) cattle colostrums of gathering is put under 2～8 ℃ of aseptic conditions, poured into the centrifuge centrifugal degreasing, centrifuge speed 0.6～1.2 ten thousand rev/min, the time is 8～20 minutes, removes the fat in the cattle colostrums;
(2) under 2～8 ℃ of aseptic conditions, it is to carry out ultrafiltration in the 20 μ m filters that the cattle colostrums of sloughing fat is put the aperture, removes visible particle, macromolecular organization's cell and impurity in the cattle colostrums;
(3) under 2～8 ℃ of aseptic conditions, will be the filtering cattle colostrums of one-level to place the aperture be that 0.22 μ m filter carries out ultrafiltration, to remove the antibacterial in the cattle colostrums;
(4) rapidly the cattle colostrums of degerming place-20～-40 ℃ environment freezing and carry out the vacuum dehydration drying, make it become the solute dry powder that is rich in immunoglobulin.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00114378 CN1116898C (en) | 2000-02-21 | 2000-02-21 | Oral immune globulin preparation and its preparing process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00114378 CN1116898C (en) | 2000-02-21 | 2000-02-21 | Oral immune globulin preparation and its preparing process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1267549A CN1267549A (en) | 2000-09-27 |
| CN1116898C true CN1116898C (en) | 2003-08-06 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 00114378 Expired - Lifetime CN1116898C (en) | 2000-02-21 | 2000-02-21 | Oral immune globulin preparation and its preparing process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1116898C (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103891900A (en) * | 2014-04-15 | 2014-07-02 | 南京中科集团股份有限公司 | Processing method of bovine colostrum |
| CN109330890A (en) * | 2018-09-27 | 2019-02-15 | 康道生物（南通）有限公司 | A kind of preparation process improving Lyophilized Bovine Colostrums capsule content uniformity |
| CN112106830A (en) * | 2020-09-29 | 2020-12-22 | 黑龙江康普生物科技有限公司 | Method for improving bioactivity of bovine colostrum freeze-dried powder immunoglobulin |
-
2000
- 2000-02-21 CN CN 00114378 patent/CN1116898C/en not_active Expired - Lifetime
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| Publication number | Publication date |
|---|---|
| CN1267549A (en) | 2000-09-27 |
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Assignee: Jiangsu Huaguan Biotechnology Co., Ltd. Assignor: Hubei Chuguan Industry Co., Ltd. Contract record no.: 2011420000255 Denomination of invention: Oral immune globulin preparation and its preparing process Granted publication date: 20030806 License type: Exclusive License Open date: 20000927 Record date: 20111114 |
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| ASS | Succession or assignment of patent right |
Owner name: JIANGSU HUAGUAN BIOTECHNOLOGY CO., LTD. Free format text: FORMER OWNER: HUBEI CHUGUAN INDUSTRY CO., LTD. Effective date: 20120309 |
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Free format text: CORRECT: ADDRESS; FROM: 430070 WUHAN, HUBEI PROVINCE TO: 225300 TAIZHOU, JIANGSU PROVINCE |
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| TR01 | Transfer of patent right |
Effective date of registration: 20120309 Address after: 225300 G11 factory, No. 1 pharmaceutical Avenue, Taizhou economic and Technological Development Zone, Taizhou economic and Technological Development Zone, Jiangsu, China Patentee after: Jiangsu Huaguan Biotechnology Co., Ltd. Address before: 430070 Hubei province Wuhan Wuluo Road No. 586 Jiangtian building Patentee before: Hubei Chuguan Industry Co., Ltd. |
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