CN1098315A - Hepatitis B gene vaccine transfer factor and immune ribonucleic acid and process - Google Patents
Hepatitis B gene vaccine transfer factor and immune ribonucleic acid and process Download PDFInfo
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- CN1098315A CN1098315A CN93111640A CN93111640A CN1098315A CN 1098315 A CN1098315 A CN 1098315A CN 93111640 A CN93111640 A CN 93111640A CN 93111640 A CN93111640 A CN 93111640A CN 1098315 A CN1098315 A CN 1098315A
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- Prior art keywords
- hepatitis
- immune
- irna
- vaccine
- ribonucleic acid
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- 208000002672 hepatitis B Diseases 0.000 title claims abstract description 22
- 229960005486 vaccine Drugs 0.000 title claims abstract description 16
- 229920002477 rna polymer Polymers 0.000 title claims abstract description 9
- 108010074506 Transfer Factor Proteins 0.000 title claims abstract description 8
- 238000000034 method Methods 0.000 title claims abstract description 7
- 101150076489 B gene Proteins 0.000 title description 2
- 108090000623 proteins and genes Proteins 0.000 claims abstract description 5
- 230000002265 prevention Effects 0.000 claims abstract description 3
- 238000004519 manufacturing process Methods 0.000 claims description 14
- 241001465754 Metazoa Species 0.000 claims description 7
- 241000700721 Hepatitis B virus Species 0.000 claims description 5
- 239000000427 antigen Substances 0.000 claims description 5
- 108091007433 antigens Proteins 0.000 claims description 5
- 102000036639 antigens Human genes 0.000 claims description 5
- 239000008280 blood Substances 0.000 claims description 5
- 210000004369 blood Anatomy 0.000 claims description 5
- 229940124872 Hepatitis B virus vaccine Drugs 0.000 claims description 4
- 238000010521 absorption reaction Methods 0.000 claims description 4
- 210000004027 cell Anatomy 0.000 claims description 4
- 239000007788 liquid Substances 0.000 claims description 4
- 238000009738 saturating Methods 0.000 claims description 4
- 238000002604 ultrasonography Methods 0.000 claims description 4
- 230000003449 preventive effect Effects 0.000 claims description 3
- 241000283690 Bos taurus Species 0.000 claims description 2
- 241000282693 Cercopithecidae Species 0.000 claims description 2
- 241001494479 Pecora Species 0.000 claims description 2
- 241000282898 Sus scrofa Species 0.000 claims description 2
- 230000002401 inhibitory effect Effects 0.000 claims description 2
- 210000003563 lymphoid tissue Anatomy 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims description 2
- 210000000633 nuclear envelope Anatomy 0.000 claims description 2
- 239000002994 raw material Substances 0.000 claims description 2
- 210000000952 spleen Anatomy 0.000 claims description 2
- 239000004094 surface-active agent Substances 0.000 claims description 2
- 238000000108 ultra-filtration Methods 0.000 claims description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 2
- 108010008038 Synthetic Vaccines Proteins 0.000 claims 5
- 229940124551 recombinant vaccine Drugs 0.000 claims 5
- 210000000805 cytoplasm Anatomy 0.000 claims 1
- 230000009261 transgenic effect Effects 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 7
- 230000000694 effects Effects 0.000 abstract description 4
- 208000035473 Communicable disease Diseases 0.000 abstract description 2
- 206010019799 Hepatitis viral Diseases 0.000 abstract description 2
- 230000001684 chronic effect Effects 0.000 abstract description 2
- 208000015181 infectious disease Diseases 0.000 abstract description 2
- 238000002360 preparation method Methods 0.000 abstract description 2
- 201000001862 viral hepatitis Diseases 0.000 abstract description 2
- 206010016654 Fibrosis Diseases 0.000 abstract 1
- 210000001557 animal structure Anatomy 0.000 abstract 1
- 239000000969 carrier Substances 0.000 abstract 1
- 230000007882 cirrhosis Effects 0.000 abstract 1
- 208000019425 cirrhosis of liver Diseases 0.000 abstract 1
- 230000007547 defect Effects 0.000 abstract 1
- 201000007270 liver cancer Diseases 0.000 abstract 1
- 208000014018 liver neoplasm Diseases 0.000 abstract 1
- SPSXSWRZQFPVTJ-ZQQKUFEYSA-N hepatitis b vaccine Chemical compound C([C@H](NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](N)CCSC)C(=O)N[C@@H](CC1N=CN=C1)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C(C)C)C(=O)OC(=O)CNC(=O)CNC(=O)[C@H](C)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CC(C)C)NC(=O)CNC(=O)[C@@H](N)CCCNC(N)=N)C1=CC=CC=C1 SPSXSWRZQFPVTJ-ZQQKUFEYSA-N 0.000 description 3
- 229940124736 hepatitis-B vaccine Drugs 0.000 description 3
- 230000036039 immunity Effects 0.000 description 2
- 230000005847 immunogenicity Effects 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- 206010011968 Decreased immune responsiveness Diseases 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000002068 genetic effect Effects 0.000 description 1
- 208000006454 hepatitis Diseases 0.000 description 1
- 231100000283 hepatitis Toxicity 0.000 description 1
- 238000002649 immunization Methods 0.000 description 1
- 230000003053 immunization Effects 0.000 description 1
- 238000009169 immunotherapy Methods 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 230000001394 metastastic effect Effects 0.000 description 1
- 206010061289 metastatic neoplasm Diseases 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
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- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention relates to a gene engineering vaccine made factor for preventing and curing hepatitis B transfer and immune ribonucleic acid and its preparation process.
Hepatitis B is a very serious infectious disease in viral hepatitis, more than 3 hundred million chronic carriers exist in the world at present, and more than 1 hundred million people exist in China. Many patients develop cirrhosis or liver cancer. Although the existing anti-hepatitis B transfer factor and immune ribonucleic acid have better prevention and treatment effects, the traditional anti-hepatitis B transfer factor and immune ribonucleic acid have limited sources, complex process, high price and low activity and success rate, and high-tech products are adopted to overcome the defects, so that the new immune medicine and the process are designed, and the new immune medicine is prepared by treating animal organs at one time by adopting a combined new process and becomes a second-generation anti-hepatitis B medicine.
Description
The invention belongs to a kind of specific immune medicine and technology of preventing and treating hepatitis.
Hepatitis B (HB) is a global infectious disease, and the whole world has hepatitis B virus surface antigen (HB now
BAg) chronic carrier is more than 300,000,000, China surpasses 100,000,000, therefore all pay much attention to the control of hepatitis B both at home and abroad, develop multiple vaccine and be used for the prevention of hepatitis B, and obtain preventive effect preferably, aspect treatment, since so far still needleless to the specific medicament of hepatitis B virus, immunization therapy has become one of main Therapeutic Method of hepatitis B, immune ribonucleic acid of Shi Yonging and transfer factor in the past, it is a kind of non-specific immunotherapy medicaments, the usefulness vaccine from blood immune animal of developing in recent years prepares, and can be used for the clinical curative effect preferably that obtained at the specific immune ribonucleic acid (HB-IRNA) and the transfer factor (HB-TF) of hepatitis B virus, but this medicine is at raw material sources, manufacturing process, also there are many shortcomings in aspects such as effective utilization, and for overcoming these shortcomings, we adopt new high-tech product, novel anti-hepatitis B immune new drug---dna gene vaccine ribonucleic acid and transfer factor have been developed, (G.HB-IRNA and G.HB-TF).And designed and united the manufacturing new technology.
G.HB-IRNA and G.HB-TF combined manufacturing process are as follows:
A), with metastatic gene cell B
4aThe purified recombiant vaccine of making of excretory hepatitis B virus surface antigen master albumen, or mix with other efficient gene engineering Hepatitis B virus vaccine or with vaccine from blood, 5-60ug/ immune swine, monkey, sheep, cattle pressed;
B), in the animal's antibody peak period, cut open extremely animal and take out spleen and lymphoid tissue, smash to pieces and grind to form homogenate;
C), multigelation, (35-60 kilohertz) broken cell film under ultrasound condition;
D), putting into bag filter dialyses to water (D.W) or puts into ultrafilter and carry out ultrafiltration;
E), saturating outer liquid or super following liquid are crossed HB antigen or antibody column absorption inhibitive factor;
F), absorption afterwards by existing TF manufacturing technology, is finally made G.HB-TF;
G), the saturating interior or super last homogenate that stays adds logical * 100 surfactants in the 0.1-0.8% song, after under ultrasound condition, further destroying nuclear membrane,, finally make G.HB-IRNA by existing IRNA manufacturing technology, by time processing, can obtain two products simultaneously like this.
This G.HB-TF and G.HB-IRNA and the HB-TF and the HB-IRNA that use at present relatively have following advantage:
1, use HB-TF and HB-IRNA to use human serum in the past, the haematogenous HB vaccine immunity animal of making is made, thereby it is limited to originate, preparation process complexity in addition, the cost height costs an arm and a leg, be difficult to satisfy the demand, and G.HB-TF that the present invention makes and G.HB-IRNA adopt high-tech product, and recombinant hepatitis b vaccine is made, the manufacturing that it can be endless, the source is abundant, easily manufactured, cost is low, low price.
2, the past is to adopt single explained hereafter, once can only go out a product, and the present invention adopts the process integration time processing to form, and once can produce two products of G.HB-TF and G.HB-IRNA, can further improve work efficiency like this, reduces cost.
3, use new high-tech product, HB-TF and HB-IRNA that G.HB-TF that recombinant hepatitis b vaccine is made and the success rate of G.HB-IRNA are made apparently higher than vaccine from blood.
4, because the present invention has selected for use the high-performance recombinant hepatitis b vaccine to make TF and its activity of IRNA will be higher than HB-TF and HB-IRNA in the past, this is existing evidence " the more single hypotype person's immunogenicity of vaccine that contains two hypotypes strengthens; the proteic vaccine of S1.2 can strengthen the immunogenicity of HBsAg and reduce anergy before containing; immunne response is occurred early; antibody titer height, longer duration " from the data of the 7th the international viral hepatitis meeting in 90 years.The data in 91 years of China further proves " the positive occurrence rate of genetic vaccine is apparently higher than vaccine from blood; immunity is after one month; the former geometric mean titer (GMT) is 429.7mIU; and the latter only has 207.4mIU; the former can reach 628mIU after 6 months, and the negative antibody rate is up to 100% ".
If 5 with G.HB-TF and G.HB-IRNA and the collaborative use of Hepatitis B virus vaccine, will produce better preventive effect.
Above-mentioned advantage fully shows, the appearance of enforcement of the present invention and G.HB-TF and G.HB-IRNA will provide a kind of effective, production is easy, cost is low novel immuning agent for the control of hepatitis B, and it will become the anti-hepatitis B immune new drug of the second filial generation.
Claims (3)
1, a kind of transfer factor that prevents and treats hepatitis B with the recombinant vaccine manufacturing
(G.HB-TF) and immune ribonucleic acid (G.HB-IRNA) it is characterized in that, recombinant vaccine immune animal with new and high technology production, process with the new technology of uniting manufacturing, its raw material can endlessly be produced, easy to process, morning, longer duration appear in this pharmaceutically active height simultaneously, antibody geometric mean titer (GMT) is 492.7mIU after immune one month, reaches the 628mIU positive rate up to 100% in six months.
2, a kind of with the G.HB-TF of recombinant vaccine manufacturing and the manufacturing process of G.HB-IRNA, it is to be present in Cytoplasm and IRNA is present in nuclear characteristics and utilizes new high-tech product according to TF, the associating new technology that the recombinant vaccine design is set up is characterized in that:
A), use transgenic cell B
4aThe purified recombiant vaccine of making of excretory hepatitis B virus surface antigen master albumen, or mix with other efficient gene engineering Hepatitis B virus vaccine or with vaccine from blood, 5-60ug/ immune swine, monkey, sheep, cattle pressed;
B), in the animal's antibody peak period, cut open extremely animal and take out spleen and lymphoid tissue, smash to pieces and grind to form homogenate;
C), multigelation, (35-60 kilohertz) broken cell film under ultrasound condition;
D), putting into bag filter dialyses to water (D.W) or puts into ultrafilter and carry out ultrafiltration;
E), saturating outer liquid or super following liquid are crossed HB antigen or antibody column absorption inhibitive factor;
F), absorption afterwards by existing TF manufacturing technology, is finally made G.HB-TF;
G), the saturating interior or super last homogenate that stays adds logical * 100 surfactants in the 0.1-0.8% song, after under ultrasound condition, further destroying nuclear membrane,, finally make G.HB-IRNA by existing IRNA manufacturing technology, by time processing, can obtain two products simultaneously like this.
3, a kind of G.HB-TF of the control hepatitis B made from recombinant vaccine and the purposes of G.HB-IRNA, it is characterized in that: decapacitation is used for outside the treatment of hepatitis B, and can also be used for the prevention of hepatitis B, particularly with Hepatitis B virus vaccine, the collaborative preventive effect of using is better.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN93111640A CN1098315A (en) | 1993-08-04 | 1993-08-04 | Hepatitis B gene vaccine transfer factor and immune ribonucleic acid and process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN93111640A CN1098315A (en) | 1993-08-04 | 1993-08-04 | Hepatitis B gene vaccine transfer factor and immune ribonucleic acid and process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1098315A true CN1098315A (en) | 1995-02-08 |
Family
ID=4989405
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN93111640A Pending CN1098315A (en) | 1993-08-04 | 1993-08-04 | Hepatitis B gene vaccine transfer factor and immune ribonucleic acid and process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1098315A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004106523A1 (en) * | 2003-05-28 | 2004-12-09 | The University Of Hong Kong | Compositions and methods for preventing and treating liver cirrhosis |
-
1993
- 1993-08-04 CN CN93111640A patent/CN1098315A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004106523A1 (en) * | 2003-05-28 | 2004-12-09 | The University Of Hong Kong | Compositions and methods for preventing and treating liver cirrhosis |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C01 | Deemed withdrawal of patent application (patent law 1993) | ||
| WD01 | Invention patent application deemed withdrawn after publication |