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Rabies vaccine freeze drying preparation

A technology for rabies vaccine and freeze-dried preparations, which can be applied in the directions of antiviral agents, freeze-dried delivery, medical preparations of inactive ingredients, etc. simple effect

Active Publication Date: 2018-08-24
广州瑞贝斯药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the process of preparing freeze-dried human rabies vaccine, in addition to the above-mentioned excipients, gelatin, trehalose and surfactants need to be added to enhance the protective effect during freeze-drying and storage and reduce the loss rate of vaccine potency , but the ingredients introduced thereby will have a greater impact on the safety of the product

Method used

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  • Rabies vaccine freeze drying preparation
  • Rabies vaccine freeze drying preparation
  • Rabies vaccine freeze drying preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] 1.1 Prepare the vaccine semi-finished product according to the following formula, and test its freeze-drying effect:

[0026] Human serum albumin 1.5(w / w)%;

[0027] Sucrose 5.0(w / w)%;

[0028] Rabies virus antigen stock solution 50mL;

[0029] Supplement the pH7.2~8.0 phosphate buffer to 100mL.

[0030] 1.2 Preparation method of rabies vaccine

[0031] The purified rabies virus antigen stock solution is prepared into a semi-finished product according to the above formula;

[0032] The semi-finished product is divided into 2ml vials, 0.5ml per tube, and placed in a small lyophilizer for freeze-drying.

[0033] 1.3 Vaccine testing method

[0034] Potency determination: according to the "Chinese Pharmacopoeia" 2015 edition three general rules 3503 method;

[0035] Moisture: Measured according to the 0832 method of the three general rules of the "Chinese Pharmacopoeia" 2015 edition;

[0036] Abnormal toxicity test: determined according to the method 1141 of the thre...

Embodiment 2

[0060] 2.1. Effect of different sucrose dosages on vaccine preparations

[0061] Set the human serum albumin concentration in the vaccine semi-finished product to 1.5%, and adjust the sucrose concentration therein, and observe the influence of the sucrose concentration on the freeze-drying effect of the vaccine. The specific comparison results are shown in Table 5:

[0062] The impact of different sucrose concentrations in table 5 on freeze-drying effect

[0063]

[0064] The data in Table 5 shows that in the range of 1 to 10% sucrose concentration, the appearance, reconstitution time and water content all meet the relevant requirements of "Chinese Pharmacopoeia" three (2015 editions) for freeze-dried human rabies vaccine, but in 3 Both the appearance and the reconstitution time were optimal in the range of ~6% sucrose concentration.

[0065] 2.2 Effects of different dosages of human serum albumin on vaccine preparations

[0066] Set the sucrose concentration in the semi...

Embodiment 3

[0070] The impact of the vaccine stabilizer of embodiment 3 different combinations on the vaccine preparation

[0071]

[0072] The above experiments show that the vaccine stabilizer of the present invention effectively controls the loss rate of vaccine activity in the freeze-drying process.

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Abstract

The invention discloses a rabies vaccine freeze drying preparation, which contains a rabies vaccine raw liquid and a vaccine stabilizer, wherein the vaccine stabilizer comprises human serum albumin and sucrose. According to the present invention, the auxiliary material comprises the simple components and does not contain the component derived from the animal source, such that the risk is low; theloss of the vaccine activity during the freeze drying is effectively controlled; and (3) after the finished product is prepared from the preparation, the stability research results show that the product has good stability.

Description

technical field [0001] The invention belongs to the technical field of virus biology, in particular to a freeze-dried preparation of rabies vaccine. Background technique [0002] Rabies is a highly fatal disease and death is almost inevitable once exposure to the virus has reached its morbid stage. Vaccination of humans, dogs and other sensitive host animals with frequent contact with humans is the only effective measure to control the occurrence and prevalence of rabies. [0003] Inactivated whole virus vaccine products are usually administered subcutaneously or intramuscularly, using the abundant immune cells in these parts, especially antigen presenting cells (Antigen Presenting cells, APCs) and recruiting immune cells and immune-related cytokines in other parts The ability to reach these sites induces a rapid protective immune response in the body. Therefore, this type of vaccine product is usually prepared by injection, including water injection and freeze-dried powde...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/42A61K47/26A61K39/205A61P31/14
CPCA61K9/19A61K39/12A61K47/26A61K47/42C12N2760/20134
Inventor 沈名锋艾譞伍磊健艾文
Owner 广州瑞贝斯药业有限公司