34 results about "Japanese encephalitis vaccine" patented technology

The invention discloses a freeze-dried preparation of JE vaccine. The preparation contains JE vaccine stock solution and a vaccine stabilizer, and the vaccine stabilizer is composed of human serum albumin and mannitol. The beneficial effects of the present invention are: (1) The ingredients in the auxiliary materials are simple in composition, without ingredients derived from animal sources, and the risk is lower. (2) The vaccine activity loss rate in the freeze-drying process is effectively controlled. (3) After the preparation is made into a finished product, the product shows good stability through stability research.

The invention provides an adaptive strain of a Japanese encephalitis vaccine strain SA14-14-2 in human diploid cells 2BS and a vaccine of the adaptive strain. The adaptive strain is characterized in that epidemic encephalitis b virus SA14-14-2 is inoculated to a human diploid cell and is subjected to continuous passage by virtue of different methods, so that the virus can propagate in the cell with favorable adaptability and stability, relatively high-titer viruses are obtained, and a three-level virus seed library of viruses is established; by virtue of measuring whole-genome sequence of the virus seed library, the whole-genome sequence thereof is obtained. Effectiveness and safety inspection is performed on the viruses, and the viruses conform to specified standards of Japanese encephalitis vaccines. The Japanese encephalitis strain is relatively high in virus titer, has safety conforming to specification, is favorable in immunogenicity and stable in heredity, conforms to requirements on safety and effectiveness of Japanese encephalitis strains in the third version (2010 edition) of Chinese Pharmacopoeia and is suitable for serving as a strain for producing encephalitis b vaccines.

The invention discloses a Japanese encephalitis vaccine prepared by human embryonic lung fibroblasts and a preparation method thereof, comprising culture and expansion of the human embryonic lung fibroblasts. The method comprises the following steps: Japanese encephalitis virus strain P3, strain SA14-14-2 or strain Nakayama is naturalized and inoculated to fit the human embryonic lung fibroblasts, and the seeds of Japanese encephalitis viruses are prepared on the human embryonic lung fibroblasts; wherein, an inactivated Japanese encephalitis vaccine also comprises the steps of harvesting viruses, inactivating viruses, concentrating, purifying and the like; an attenuated live vaccine also comprises the steps of harvesting viruses, concentrating, purifying and the like. Due to being prepared by healthy human embryonic lung fibroblasts, the two kinds of Japanese encephalitis vaccines do not contain any adventitious pollution agent and tumorigenicity, has high purity after being purified and has the advantages of good immune effect and high security. The preparation method of the invention is suitable for large-scale industrial production and can meet the preparation processes of Japanese encephalitis vaccines required by domestic and abroad markets.

The invention discloses a method for freezing and thawing a single virus harvest liquid, which belongs to the field of vaccine preparation technology. The freezing and thawing method includes the following steps: (1) cryopreservation: freezing a single virus harvest solution; (2) thawing: thawing the single virus harvest solution after freezing in step (1). Freezing and thawing the single virus harvest solution of the live attenuated Japanese encephalitis vaccine under the freeze-thaw method of the present invention can enable the single virus harvest solution to be stored for a long time under the condition of ≤-60°C, and then put into the next step after all the verification items are completed. Use, for the preparation of Japanese encephalitis live attenuated vaccine. By combining the single virus harvest solution of the Japanese encephalitis live attenuated vaccine of the present invention with the freezing-thawing method of the present invention, the storage time can be significantly prolonged, and the loss of virus titer can also be significantly reduced, and there is no need to carry out the risk release of intermediate products. The arrangement is more flexible and controllable, and the risk of a single virus harvest liquid being discarded due to changes in production plans is greatly reduced.

The invention provides Japanese encephalitis (JE) vaccine composition. The JE vaccine composition comprises a JE virus antigen of immunization effective quantity and water based vaccine adjuvant. The invention further provides a preparing method and application of the JE vaccine composition. The vaccine composition has good immunogenicity and immunizing protection. The immune effect of the JE vaccine composition is remarkably superior to that of single pig JE live vaccine and other live vaccine diluted by immunologic adjuvant. The clinical application prospects are good.

The invention provides a vaccine composition, which comprises polymer Carbomer 934P and Japanese encephalitis virus strain SCYA201201 (cell passage attenuated strain) cell culture fluid. Compared with live vaccines, the vaccine composition of the invention can greatly improve the immunogenicity, enhance the body's resistance to porcine Japanese encephalitis virus on the original basis, and provide new technical support for the prevention and control of the disease.

The invention provides a vaccine protection agent which is characterized by comprising the following components by weight: 60 to 200 parts of disaccharides, 3 to 10 parts of gelatin, 0.5 to 10 parts of amino acid, 3 to 10 parts of urea, 3 to 10 parts of sorbitol and 2 to 10 parts of human albumin. The invention also provides a combined measles and Japanese encephalitis vaccine and a preparation method thereof. The vaccine protection agent provided in the invention can effectively enhance stability of the combined measles and Japanese encephalitis vaccine and has a high application value.

The invention discloses a mercury-free Japanese encephalitis inactivated vaccine composition, which consists of inactivated Japanese encephalitis virus, phenol red free 199 culture solution and virus protective agent. Through comparison with fungus inspection of a mercury-containing preparation, the composition can achieve the quality standard required by Chinese Pharmacopoeia on sterile products. In the preparation of a Japanese encephalitis vaccine, thiomersalate is not used so as to avoid the adverse effect caused by mercury pollution on users, and ensures body health of the users.

The invention discloses a treatment liquid for desorbing antigens in an aluminum salt adsorption type vaccine. The treatment liquid is a phosphate buffer solution or a citrate buffer solution, wherein the buffer solution contains proteins and at least one acid and / or salts of the acids. The invention further discloses a method using the provided treatment liquid to measure the antigen content of an aluminum salt adsorption type vaccine. The provided method reduces the interference brought by the aluminum adjuvant in Japanese encephalitis vaccine, is capable of rapidly and precisely measuring the antigen content in an adsorption type Japanese encephalitis inactivated vaccine, has the characteristics of good durability, high accuracy, and high precision, and can provide references for quality control of aluminum adjuvant adsorption type Japanese encephalitis inactivated vaccines.

The invention discloses a heat-resistant freeze-drying protective agent for live vaccines and a preparation method thereof. The heat-resistant freeze-drying protective agent for live vaccines is composed of the following raw materials in proportion by weight: 1-10% gelatin, 2-10% sucrose %, Trolox 0.01-0.2%, arginine 0.1-2%, polyvinylpyrrolidone 0.5-8%, and the balance is water for injection. Compared with conventional protective agents, the heat-resistant freeze-dried protective agent of live vaccines provided by the invention can more effectively protect the virus activity in porcine Japanese encephalitis vaccines, and can withstand heat for more than 20 days at 37°C. It can be stored for more than 2 years, which reduces the requirements of vaccines on temperature storage conditions, and facilitates vaccine storage and cold chain transportation. Moreover, the invention improves the immune effect of the vaccine, and the antibody of the immunized pig body is produced faster and lasts longer. The preparation method of the heat-resistant lyoprotectant for live vaccines provided by the invention is simple and suitable for large-scale production.

The invention provides a lyophilized inactivated Japanese encephalitis vaccine, comprising: (a) inactivated Japanese encephalitis totivirus; (b) stabilizer, which comprises maltose, lactose, and optionally mycose, mannite, sorbitol and / or amino acid; and optionally (c) buffer, surfactant, isotonic regulator and / or chelating agent.

The invention relates to a method for removing residual DNA in an encephalitis B vaccine product for human by utilizing a hollow fiber membrane. The method is characterized in that an encephalitis B vaccine obtaining liquid for human is used as a raw material, other proteins and DNA in the encephalitis B vaccine obtaining liquid for human are removed through a hollow fiber membrane microfiltration process, the obtained filtered liquid is collected and is processed by an ultrafilration concentration system to prepare an encephalitis B vaccine concentrate for human, the concentrate is inactivated, and the obtained inactivated encephalitis B vaccine liquid for human is purified by using a molecular sieve chromatography purifying system. A certain proportion of DNA residual in the product is effectively removed through the microfiltration treatment of the virus obtaining liquid by the hollow fiber membrane without influencing the biological activity of the vaccine product, so the residual quantity of DNA in the finished vaccine product reaches a qualified standard.

The present inventors improved methods for inactivating Japanese encephalitis virus vaccines, and assessed the safety of vaccines produced by combining multiple vaccines. The present inventors successfully produced safer Japanese encephalitis vaccines by cell culture, which can be stored more stably over a long period than conventional Japanese encephalitis vaccines. Furthermore, it is also expected that the production methods can be used to produce other viral vaccines with excellent storage stability.

The invention provides a method for proliferation of a Japanese encephalitis virus. The method for proliferation of the Japanese encephalitis virus comprises the steps of culturing cells, inoculating Japanese encephalitis viruses to the cells which are provided with mono-layers in an overgrowing mode, and directly obtaining a virus solution until a rate of a cytopathic effect reaches to 75%-95% after inoculation. The invention further provides a preparation method of Japanese encephalitis vaccines. The method for proliferation of the Japanese encephalitis virus and the preparation method of the Japanese encephalitis vaccines can remarkably improve a Japanese encephalitis virus titer, and meanwhile shorten production periods, and can prepare the Japanese encephalitis vaccines which are better, stable, and good in immunogenicity.