Freeze-dried rabies vaccine for human use and preparation method thereof
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A rabies vaccine and freeze-drying technology, which is applied in the direction of freeze-drying transportation, medical preparations containing active ingredients, antiviral agents, etc., can solve the problems of unstable product quality and short validity period of liquid dosage forms, and achieve thermal stability and Effect of Potency, Good Thermal Stability and Potency
Inactive Publication Date: 2014-04-02
DALIAN HISSEN BIO-PHARM CO LTD
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Problems solved by technology
The liquid dosage form has a short validity period of only 12 months, and the product quality is not stable, and it contains the preservative sodium thimerosal
Method used
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Embodiment 1
[0038] a. Preparation of lyoprotectant
[0039] Add sucrose and dextran 40 to water for injection, stir until completely dissolved, and steam sterilize at 115°C at 0.09 MPa for 45 minutes; add glycine to water for injection at 30°C, stir to dissolve completely, and use a 0.22 μm microporous filter Membrane sterilization filtration;
[0040] b. Preparation of semi-finished products
[0041] According to the determined protein content or antigen content of the pre-vaccine stock solution, the total protein content is not higher than 80 μg / dose for preparation, adding sucrose, dextran 40, and glycine, which is a semi-finished product;
[0042] c. Preparation of finished product
[0043] 3.1 Divide the semi-finished product and put it into the freeze-dryer box, set the freeze-drying parameters, and carry out freeze-drying;
[0044] 3.2 Pre-freezing stage: cool down until the sample temperature is below -45°C, and keep warm for 2 to 4 hours;
[0045] 3.3 Vacuum pumping stage: wh...
Embodiment 9
[0052] a. Preparation of lyoprotectant
[0053] Add sucrose and dextran 40 to water for injection, stir until completely dissolved, steam sterilize at 115°C at 0.09-0.10MPa for 45min; add glycine to water for injection at 15-30°C, stir to dissolve completely, use 0.22μm Microporous membrane sterilization filtration;
[0054] b. Preparation of semi-finished products
[0055] According to the determined protein content or antigen content of the pre-vaccine stock solution, the total protein content is not higher than 80 μg / dose for preparation, adding sucrose, dextran 40, and glycine, which is a semi-finished product;
[0056] c. Preparation of finished product
[0057] 3.1 Divide the semi-finished product and put it into the freeze-dryer box, set the freeze-drying parameters, and carry out freeze-drying;
[0058] 3.2 Pre-freezing stage: cool down until the sample temperature is below -45°C, and keep warm for 2 to 4 hours;
[0059] 3.3 Vacuum pumping stage: when the temperatu...
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Abstract
The invention discloses a freeze-dried rabies vaccine for human use and a preparation method thereof. The preparation method comprises the following steps: adding cane sugar and dextran 40 into water for injection respectively, stirring to a fully-dissolved state, and performing steam sterilization at the temperature of 115 DEG C under the pressure of 0.09-0.10 MPa for 45 minutes; adding glycine into water for injection of which the temperature is 15-30 DEG C, stirring to a fully-dissolved state, and degerming and filtering with a microfiltration membrane of 0.22 mu m; preparing a dose of which the total protein content does not surpass 80 mu g according to the measured protein content or antigen content of an early vaccine stock solution, and adding cane sugar of which the final concentration is 4-10 percent by weight, dextran 40 of which the final concentration is 1-4 percent by weight and glycine of which the final concentration is 0.5-2 percent by weight to obtain a semi-finished product; performing split charging on the semi-finished product, semi-plugging, putting into a freezer drier box, setting a freeze drying parameter, and performing freeze drying; performing pre-freezing, vacuum pumping, sublimation, secondary drying and vacuum plugging, and ending freeze drying to obtain the freeze-dried rabies vaccine for human use. Active ingredients in the vaccine disclosed by the invention can be well protected, the vaccine is high in thermal stability, and the period of validity can be at least up to 24 months.
Description
technical field [0001] The invention belongs to the field of vaccine production. In particular, it relates to a human rabies vaccine and a preparation method thereof. Background technique [0002] The existing liquid dosage form of human rabies vaccine (hamster kidney cells) is to inoculate primary hamster kidney cells with rabies virus fixed virus, after culturing, harvesting virus liquid, concentrating, inactivating and purifying, adding suitable stabilizer agent made. It is a colorless clear liquid. The liquid dosage form has a short validity period of only 12 months, and the product quality is also unstable, and contains the preservative sodium thimerosal. Contents of the invention [0003] In order to solve the problems existing in the prior art, the present invention provides a freeze-dried human rabies vaccine that can well maintain the active ingredients of the vaccine, has strong thermal stability, and has a vaccine validity period of at least 24 months and its...
Claims
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