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A vaccine and influenza technology, applied in the field of bioengineering, can solve problems such as stimulating secretory antibodies, and achieve the effects of cost reduction, convenient use, and low cost
Active Publication Date: 2009-09-09
CHENGDU KANGHUA BIOLOGICAL PROD
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Problems solved by technology
Current vaccines do not elicit secretory antibodies (sIgA) at this mucosal surface or the cell-mediated immune response required for recovery from infection, which is typical of the host response to infection and should ideally be elicited by the vaccine
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Embodiment 1
[0037] The oral influenza vaccine buccal tablet involved in the present invention comprises three kinds of existing influenza whole virus inactivated vaccines, split vaccines and subunit vaccines, and its preparation process is as follows:
[0038] (1) Preparation of vaccine seed bank: Like other influenza vaccines of various dosage forms, a three-level seed bank of primary generation, main generation, and working generation should be established. The three-level seed bank must be verified: hemagglutination titer, virus titer , Sterility test, mycoplasma, identification test, exogenous factors (avian adenovirus, leukemia virus detection) and other items.
[0039] (2) Preparation of virus liquid: inoculate chicken embryos with working seeds, inactivate after cultivating, harvesting virus liquid, clarifying and filtering, and make whole virus liquid, subject to verification: hemagglutination titer, sterility test, inactivation Tests, identification tests, etc. Then proceed to l...
Embodiment 2
[0065] Prepare the oral vaccine core of freeze-drying, first the influenza vaccine liquid (whole virus inactivation liquid, lysate or subunit vaccine liquid) that reaches vaccine testing requirements is added adjuvant or antacid, choose calcium carbonate in this example, make it The final concentration reaches 60-80 mg / dose; then add a lyophilized stabilizer to properly dilute the vaccine stock solution, for example, to 30-40 μg / dose or 0.3-0.4ml / dose. Available stabilizers include sucrose, dextran or 4% The amino acid is transferred to the blister-like hole of the plastic according to the dosage of 0.5-0.6ml by aseptic filling operation, and after the composition is freeze-dried, the blister-like hole is sealed by a heat sealing method. In addition to the above-mentioned reagents, the lyophilized preparation can also include the following standard components to achieve the purpose of rapid dissolution in the mouth, including: magnesium stearate, carboxymethyl cellulose, hydrox...
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Abstract
The invention provides high-efficiency low-cost influenza oral tablet vaccine and influenza oral slow-release vaccine which can be produced in large amount and preparation methods thereof, relating to a novel influenza oral tablet or oral slow-release vaccine preparation suitable for oral administration and preparation processes thereof and comprising preparation of virus seed banks, production and preparation of vaccine stock solution, addition and freeze-drying of protective agents and excipients, ingredients of the oral tablet or oral slow-release preparation, forming processes and the like. The preparation method refers to that of whole-virus inactivated vaccines, split vaccines and subunit vaccines. The influenza oral vaccine can avoid pains and discomfort caused by injection, imitate route of natural infection, ensure that most surface areas of the mucosa contact the vaccine and arouse mucosal immune response and systemic immune response. As the vaccines are unnecessary to be produced under extremely strict conditions, the cost is lowered, thus relatively reducing the expenses needed due to increase of the amount of required antigens. The oral vaccine is convenient in use and does not need special personnel for inoculation and is convenient for storage and transportation.
Description
technical field [0001] The invention relates to the field of bioengineering, in particular to the preparation of oral buccal tablets or oral slow-release preparations for influenza comprising whole virus inactivated vaccines, split vaccines and subunit vaccines. Background technique [0002] Influenza is called influenza for short, and is an acute respiratory infectious disease caused by three types of influenza virus (influenza virus) of A, B, and C respectively. The prevalence of influenza A usually causes a worldwide influenza pandemic and can cause influenza epidemics in livestock and poultry; Type B often causes local outbreaks of influenza, but does not cause a worldwide influenza pandemic; Type C appears in the form of sporadic cases , mainly attack infants and young children, and generally do not cause influenza epidemics. The epidemiological characteristics of influenza are sudden outbreak, rapid spread, wide spread, high morbidity rate, and high mortality rate in ...
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