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Combined attenuated live vaccine for measles, mumps and encephalitis B and preparation method thereof

A technology of attenuated live vaccines and Japanese encephalitis, applied in antiviral agents, pharmaceutical formulas, medical preparations containing active ingredients, etc. It is suitable for large-scale production, can not meet the requirements of unit price seedlings, etc., and achieves the effect of simple preparation process and guaranteed stability

Active Publication Date: 2010-01-06
WUHAN INST OF BIOLOGICAL PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In 2002 and 2005, the applicant for the patent of the present invention carried out a pilot test of 20,000 tubes / batch, a total of 4 batches of measles, mumps, Japanese encephalitis combined live attenuated vaccine according to the above small-scale trial production plan. When the two key indicators of titer and thermal stability were tested, it was found that not only the two indicators of virus titer and thermal stability fluctuated greatly, but also failed to meet the requirements of each unit price seedling, see Table 3
It shows that the key quality indicators of the combined vaccine prepared by the original method are unstable, and the technical scheme of the original measles, mumps, Japanese encephalitis combined live attenuated vaccine is not suitable for the large-scale production of the pilot test and above

Method used

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  • Combined attenuated live vaccine for measles, mumps and encephalitis B and preparation method thereof
  • Combined attenuated live vaccine for measles, mumps and encephalitis B and preparation method thereof
  • Combined attenuated live vaccine for measles, mumps and encephalitis B and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0055] The preparation method of the measles mumps Japanese encephalitis joint attenuated live vaccine provided by the invention is as follows:

[0056] 1. Preparation of three kinds of monovalent vaccine stock solutions: in the vaccine production workshop of Wuhan Institute of Biological Products, which has passed the national GMP certification, according to the requirements of the three parts of the 2005 edition of the "Pharmacopoeia of the People's Republic of China", respectively

[0057] 1.1 According to the 2005 edition of the "Pharmacopoeia of the People's Republic of China" Part III, P98-99, the primary chicken embryo cells were inoculated with the measles Shanghai 191 vaccine strain, and the virus titer was prepared at 5.0 lgCCID 50 / ml~6.0lgCCID 50 / ml of measles vaccine stock solution;

[0058] 1.2 According to the requirements of the 2005 edition of "The Pharmacopoeia of the People's Republic of China", three volumes, P107-108, use mumps Wm 84 The vaccine strain ...

Embodiment 2

[0082] Preparation of combined vaccine of the present invention

[0083] It is operated in a vaccine production workshop certified by the national GMP.

[0084] First prepare virus titer at 5.0lgCCID by the step 1 of embodiment 1 50 / ml of measles vaccine stock solution, the prepared virus titer is at 6.0lgCCID 50 The mumps vaccine stoste of / ml prepares the Japanese encephalitis vaccine stoste of virus titer at 7.0lgPFU / ml; Then prepare the vaccine protective agent according to the step 2 of embodiment 1; then press the 8% gelatin prepared in the step 2 of embodiment 1 Add 8600ml of the prepared measles vaccine stock solution to 1000ml of 40% sucrose protective agent, mix well, then add 400ml 20% human serum albumin, mix well. At this point, a monovalent measles vaccine solution with a volume of 10,000 ml has been prepared, containing a final concentration of 0.8% gelatin, 4% sucrose, and 0.8% human albumin. Prepare the monovalent mumps vaccine liquid of volume 10000ml and...

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Abstract

The invention relates to a method for preparing a combined attenuated live vaccine for measles, mumps and encephalitis B, which comprises the following steps: (1) preparing measles stock vaccine solution, mumps stock vaccine solution and encephalitis B stock vaccine solution respectively; (2) mixing the three types of univalent stock solution with gelatin and sucrose as vaccine protective agents and human serum albumin respectively to obtain measles univalent vaccine solution, mumps univalent vaccine solution and encephalitis B univalent vaccine solution; and (3) mixing the three types of univalent solution according to the volume ratio of the measles univalent vaccine solution to the mumps univalent vaccine solution to the encephalitis B univalent vaccine solution of 1-3:1-5:2-7, packaging the mixture, freezing-drying the packaged mixture to obtain the combined attenuated live vaccine for the measles, the mumps and the encephalitis B. The method preparing the combined attenuated livevaccine for the measles, the mumps and the encephalitis B makes great improvement and regulation for four key processes including the mixing time of the univalent vaccines and the vaccine protective agents, the mixing proportion of the univalent vaccines, the preparation sequence of the combined vaccine and the vaccine protective agents in the prior art. Compared with the prior art, the method for preparing the combined attenuated live vaccine for the measles, the mumps and the encephalitis B has the advantages of simple preparation process, stable vaccine valence, low cost, suitability for large-scale production and the like.

Description

technical field [0001] The invention relates to a vaccine for disease prevention, in particular to combined vaccine technology, in particular to a combined attenuated live vaccine against measles, mumps and Japanese encephalitis. Background technique [0002] With the rapid development of various new vaccines, more and more vaccines are being vaccinated, and the types of vaccines included in the children's planned immunization (EPI) are increasing, and the number of vaccinations for infants and young children is also increasing. There are as many as 22 to 26 vaccines, which not only greatly increases the immunization burden of the epidemic prevention department and children, increases the cost, but also increases the chance of cross-infection. In order to reduce the cost of vaccination, reduce the number of vaccinations for children, increase the coverage rate of immunization, and accelerate the realization of the vaccine's disease prevention and eradication effect, it is ur...

Claims

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Application Information

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IPC IPC(8): A61K39/295A61P31/14
CPCY02A50/30
Inventor 李萍萍贾丽丽杨晓明方志正董关木孙凌聪易玲桂金柱吕文利岳广智刘晓娜夏莉莉刘钢胡德祥胡志雄王志伟徐宏山刘欣玉
Owner WUHAN INST OF BIOLOGICAL PROD CO LTD
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