High-titer human tetanus immunological blood plasma and preparation process thereof

Abstract

The invention relates to a high-titer human tetanus immunological blood plasma and a preparation process of the high-titer human tetanus immunological blood plasma. The blood plasma is obtained by the following steps: immunizing a health blood donor with tetanus toxoid; when the antibody in the blood donor is more than 12 international units per mL, collecting the blood plasma of the blood donor alone; and freezing and preserving the collected immunological blood plasma after being detected regularly. The immunological blood plasma obtained by the method of the invention has the advantages of high titer, high specificity, high safety, long durable time in the body and so on, prolongs protected period of a wounded person and enhances immunity preventive effect.

Description

technical field [0001] The invention relates to a blood product raw material and a preparation method thereof. It specifically relates to a high-titer human tetanus immune plasma and a preparation process thereof. Background technique [0002] Tetanus is mainly caused by bacillus tetanus invading the human body through damaged skin and mucous membranes (such as wounds, fractures, burns, wood thorns or rust needles, etc.), and grows and reproduces in the deep anoxic environment of the wound, resulting in a large amount of tetanus. Bacillus exotoxin acts on the nervous system, causing systemic specific infection. This type of tetanus is also called post-injury tetanus, and its incubation period is irregular, generally 5-10 days, and some can reach more than 20 days. Usually, the closer the trauma site is to the nerve center, the shorter the incubation period and the more serious the condition is. Tetanus is caused by the broken umbilicus of newborns, commonly known as umbili...

AI Technical Summary

Problems solved by technology

Due to reasons such as unreasonable immunization procedures, backward virus inactivation technology, and unguaranteed blood source safety, most domestic tetanus immune plasma has many shortcomings such as low potency and difficult to guarantee safety. High-quality tetanus immune plasma The production capacity is very limited, which has become the main bottleneck restricting the production of tetanus human immunoglobulin

[0007] In terms of plasma virus inactivation, most domestic blood product manufacturers currently use the following methods, but a single inactivation method cannot achieve satisfactory results: for example, the BMM membrane method can effectively remove most viruses, but it is not effective in processing large Molecular weight samples are easy to block, and cannot completely remove the B19 virus, lack of economical practicability; dry heat treatment can effectively inactivate lipid-enveloped and non-lipid-enveloped viruses, but it is ineffective for B19 viruses, and there is a problem with temperature control and product quality. There are very high requirements; the acid incubation method is only suitable for gamma globulin

The S / D method is very effective for the inactivation of lipid-enveloped viruses. Relatively speaking, the effect of inactivating the virus is more thorough. However, in recent years, it has been reported that only the S / D method is used for virus inactivation treatment and blood products can transmit hepatitis A, because This method is not effective for non-enveloped viruses