Check patentability & draft patents in minutes with Patsnap Eureka AI!

Human diploid cell cultured rabies vaccine and preparation method thereof

A technology of human diploid cells and rabies vaccine, which is applied in biochemical equipment and methods, medical preparations containing active ingredients, viruses, etc., can solve the problem of high cost of human albumin, high product cost and stable titer. Sexual problems, etc.

Active Publication Date: 2014-04-23
CHENGDU KANGHUA BIOLOGICAL PROD
View PDF4 Cites 1 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] During the freeze-drying process of the semi-finished rabies virus obtained after the amplified and cultured rabies virus stock solution is inactivated and purified, due to the differences in the freeze-drying method and freeze-drying process parameters, the obtained rabies vaccine often has different physical forms, residual moisture content, There are differences in solubility and other properties, which lead to differences in the potency and stability of rabies vaccines
[0005] In addition, during the freeze-drying process of the rabies virus semi-finished product, in order to avoid the reduction of the stability of the potency, it is generally used to add a certain proportion of stabilizers, such as human serum albumin, to the rabies virus semi-finished product; The amount of added human serum albumin is generally 1g or 3g, or more, such as 10g; due to the high cost and price of human serum albumin, if too much is added, the product cost will be high, if too little is added The potency stability of the product is poor

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Human diploid cell cultured rabies vaccine and preparation method thereof
  • Human diploid cell cultured rabies vaccine and preparation method thereof
  • Human diploid cell cultured rabies vaccine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0162] Embodiment 1——The product index determination experiment of comparative example 1-39

[0163] Each control example 1-39 randomly selected 100 vaccine products, and then tested the physical form and color of each finished product according to the current version of "China Biological Products Regulations" ("Chinese Pharmacopoeia" 2010 Edition three p111-113) , residual moisture content, dissolution time and other product indicators, the results of each product indicator obtained are listed in the following table one:

[0164] Table I

[0165]

[0166]

[0167]

[0168] In the test results of the remaining product indicators of the rabies vaccine cultured by human diploid cells in Comparative Example 1-39, the physical form has no collapse cracks, the color is uniform white, and the residual moisture content is between 2.1% and 1.8%.

Embodiment 2

[0169] Embodiment 2——The product thermal stability experiment of comparative example 27-39

[0170] The control examples 27-39 were stored at 37°C for 7d, 14d, and 28d, respectively, and their potency was determined according to the current version of "China Biological Products Regulations" ("Chinese Pharmacopoeia" 2010 edition three p111-113). Not less than 2.5IU / dose is qualified;

[0171] The intervals obtained for each potency are as follows:

[0172] A - 2.51-2.80; B - 2.81-3.10; C - 3.11-3.40; D - 3.41-3.70;

[0173] E——3.71-4.00; F——4.01-4.30; G——4.31-4.60; H——4.61-4.90;

[0174] I——4.91-5.20; J——5.21-5.50; K——5.51-5.80; L——5.81-6.10;

[0175] M——6.11-6.40; N——6.41-6.70; O——6.71-7.00; P——7.01-7.30;

[0176] Q——7.31-7.60; R——7.61-7.90; S——7.91-8.20; T——8.21-8.50;

[0177] U——8.51-8.80; V——8.81-9.10; W——9.11-9.40; X——9.41-9.70;

[0178] Y——9.71-10.0;

[0179] The results obtained are as follows in Table 2:

[0180] Table II

[0181]

Embodiment 3

[0182] Embodiment 3——The titer stability experiment of the product of comparative example 27-39

[0183] The control examples 27-39 were stored at 2-8°C for 2 years, 2.5 years, and 3 years, respectively, and then samples were taken and tested according to the "Chinese Biological Products Regulations" ("Chinese Pharmacopoeia" 2010 edition three p111-113) Valence determination, the obtained results are as follows in Table 3:

[0184] Table three

[0185]

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention discloses a rabies vaccine and a preparation method thereof, and specifically relates to a human diploid cell cultured rabies vaccine and a preparation method thereof. The human diploid cell cultured rabies vaccine contains more than 92.0% of loose body by mass fraction in physical form, and the dissolving time of the human diploid cell cultured rabies vaccine ranges from 95s to 99s. The human diploid cell cultured rabies vaccine is obviously improved in thermal stability and titer stability in contrast with the human diploid cell cultured rabies vaccine which is prepared through the existing freeze-drying process.

Description

technical field [0001] The invention relates to a rabies vaccine and a preparation method thereof, in particular to a rabies vaccine cultured by human diploid cells and a preparation method thereof. Background technique [0002] Rabies vaccine is obtained by amplifying and culturing rabies virus on host cells, followed by inactivation, purification, freeze-drying and other steps, and is used to prevent or treat people who have high-risk contacts with rabies virus or those who have been infected with rabies virus. At present, as the host cell for the preparation of rabies vaccine, it can be the earliest animal cells such as Vero cells, or human diploid cells. Among the aforementioned two kinds of host cells, human diploid cells are derived from human tissues, which is currently known. The host cells that can be used to prepare rabies vaccines; human diploid cells have been studied for decades, and their growth characteristics, genetic stability, exogenous factor contamination...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/205A61K47/42A61K9/19A61P31/14F26B5/06
CPCA61K39/12A61K2039/515A61P31/14C12N2760/20134
Inventor 侯文礼蔡勇张涛
Owner CHENGDU KANGHUA BIOLOGICAL PROD
Features
  • R&D
  • Intellectual Property
  • Life Sciences
  • Materials
  • Tech Scout
Why Patsnap Eureka
  • Unparalleled Data Quality
  • Higher Quality Content
  • 60% Fewer Hallucinations
Social media
Patsnap Eureka Blog
Learn More

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2025 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com