Oral slow release influenza vaccine and preparation method thereof
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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 reducing costs, low cost, and easy storage and transportation.
Active Publication Date: 2012-11-28
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
[0032] 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:
[0033] (1) Preparation of vaccine seed bank: Like other influenza vaccines of various dosage forms, a three-level seed bank of primary generation, primary 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.
[0034](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...
Embodiment 2
[0058] 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 an oral slow release influenza vaccine and a preparation method thereof. The invention is a divisional application of Chinese patent application 200910103512X, comprises preparation methods for a whole virus inactivated vaccine, a cracking vaccine and a subunit vaccine and relates to a novel influenza oral lozenge or oral slow release vaccine preparation which is suitable to be orally taken and a preparation process thereof. The preparation method comprises preparation of a virus seed bank, production and preparation of vaccine stock solution, addition and freeze-dryingof a protectant and an excipient, composition of the oral lozenge or the oral slow release preparation, a forming process and the like. Through the oral influenza vaccine, pain and discomfort caused by injection can be avoided, a natural infection approach is simulated, the contact of most of mucous membrane surface region and the vaccine can be guaranteed, and immunological reaction of the mucous membrane and immunological reaction of a system are caused; the vaccine is not required to be produced under an extremely strict condition and is low in cost, and the cost required by increase in amount of required antigen can be relatively reduced; and the oral vaccine is convenient to use, is not required to be inoculated by a professional and is convenient to store and transport.
Description
technical field [0001] The invention relates to the field of bioengineering, in particular to an oral oral slow-release vaccine for influenza comprising an inactivated whole virus vaccine, a split vaccine and a subunit vaccine and a preparation method thereof. The present invention is a divisional application of Chinese patent application 200910103512X. 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 ar...
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