RU2342156C2 - Method for vaccine injection - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention can be applied for subcutaneous fat post-injection injury preventing during subcutaneous injections of vaccine. To meet this object, the spot is anesthetised prior injection. Sodium chloride 0.9% solution is added to single dose of vaccine in proportion 1:5. Vaccine injection is implemented by manifold pricking around injection spot. Pricks are done at least 6 mm from each other, no more than 0.2 ml vaccine is injected at a time.

EFFECT: subcutaneous fat post-injection injury preventing due to reducing vaccine irritant components level below critical value in each point of the tissue.

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Description

The invention relates to medicine, in particular to therapy and clinical pharmacology, and can be used for subcutaneous injections of influenza vaccines.

There is a method of subcutaneous injection of 0.25 or 0.5 ml of GRIPPOL - a flu-free trivalent polymer-subunit liquid vaccine by wiping the ampoule knife and the neck of the ampoule with cotton dampened with 70% ethyl alcohol, opening the ampoule, vaccine kit in a disposable syringe, removing from the syringe excess air, rubbing the skin at the injection site with alcohol, piercing it and injecting it under the skin (GRIPPOL Instructions for Use - Trivalent influenza polymer subunit liquid vaccines, solution for intramuscular and subcutaneous administration. con firmed by the chief sanitary doctor of the Russian Federation of 27.09.2004 G.G.Onischenko).

The disadvantage of this method is the low safety of protection of subcutaneous fat from post-injection damage. The fact is that the introduction of the GRIPPOL vaccine solution from the ampoule into the subcutaneous fat causes the physico-chemical damage caused by hypoosmosis (GRIPPOL has an osmotic activity of about 10 mOsm / l of water) and the presence of a high molecular weight colloidal protein medium with a surface activity due to the content of surface glycoproteins (hemagglutinin and neuraminidase) in combination with a water-soluble high molecular weight N-oxidized derivative of poly-1,4-ethylene piperazine (polyoxidonium) and in combination with a preservative thiolate. Excessive hypoosmoticity causes water damage to the cells, and the presence in the aqueous solution of a water-soluble complex of glycoproteins with high molecular weight protein components gives colloidal properties and increases the viscosity of the vaccine, which complicates the diffusion of high molecular weight components in the subcutaneous fat, contributing to their delay and concentration at the injection site from injection due to the loss of water due to its easier diffusion. In this case, water and low molecular weight compounds easily and quickly leak through the tissue of the subcutaneous fat from the place of direct outflow from the end of the needle, and high molecular weight compounds do not leak through the tissue of the subcutaneous fat. There is a mechanical separation of the media into two components: one is water and low molecular weight components, which quickly impregnate a significant part of the subcutaneous fat, infiltrating it and forming the bulk of drug infiltrate, the other is a complex of surface glycoproteins with high molecular weight polyoxidonium and a preservative that melt lingers in the subcutaneous fat near the end of the needle as on an appropriate filter, through the pores of which it is not able to penetrate. The delay of these compounds during the injection and separation of the media into two fractions, one of which is removed from the injection site and the other remains in it, leads to the fact that in this place all the “stuck” components of the vaccine are concentrated to excessive values. An excessively high concentration of these components causes tissue damage in the central part of the drug infiltrate, manifested in soreness, swelling, hyperemia, hyperthermia and impaired function.

The purpose of the invention is the prevention of post-injection damage to the subcutaneous fat.

The essence of the proposed method for the injection of the GRIPPOL vaccine, which includes a set of the average therapeutic dose of the vaccine into the syringe, followed by its introduction into the subcutaneous fat, is that the injection area is pre-anesthetized, a five-fold volume of 0.9% sodium chloride solution (physiological sodium chloride solution), and the vaccine solution is administered by repeatedly chipping the injection area, making punctures no closer than 6 mm from each other and injecting no more than 0.2 m each time l

In the proposed method, preliminary anesthesia of the injection area deprives it of sensitivity to all irritating agents, which excludes the development of reactive tissue inflammation in response to mechanical irritation when they are punctured with an injection needle and in response to physico-chemical irritation when a high molecular weight protein colloid medium appears in the tissues, which prevents the development of post-injection damage to the subcutaneous fat due to its excessive reactive inflammation.

The introduction of a solution of 0.9% sodium chloride in a five-fold volume to the average therapeutic dose of GRIPPOL ensures the preservation of the therapeutic effectiveness of this influenza vaccine by using the effective average therapeutic single dose of GRIPPOL and reducing the irritating effect of the diluted vaccine on subcutaneous fat due to the use of a less concentrated vaccine. Supplementing the average therapeutic single dose of the vaccine with a 5-fold volume of a solution of 0.9% sodium chloride provides the optimal degree of dilution of the vaccine, the optimal level of its osmotic activity and an increase in volume within safe limits.

Dilution of the GRIPPOL vaccine with a 5-fold solution volume of 0.9% sodium chloride provides, on the one hand, a decrease in the concentration of high molecular weight protein components of the vaccine to a safe level (to safe values), and on the other hand, eliminates the introduction of excessively large volumes of 0.9% solution sodium chloride and the creation of an excessively large volume of diluted vaccine. Moreover, due to the isoosmoticity of the solution of 0.9% sodium chloride, the level of isoosmoticity of the vaccine diluted by it is ensured.

Fractional administration of a single dose of the vaccine by repeated chipping of the injection field ensures the safety of the injection by reducing the amount of high molecular weight components of the vaccine in each individual area of subcutaneous fat, which are potentially dangerous by physicochemical irritant effect. Moreover, a fractional injection under the skin of the GRIPPOL vaccine, diluted 5 times, in a volume of not more than 0.2 ml with each of its multiple punctures provides a decrease in the content of the irritating components of the vaccine in each individual area of subcutaneous fat below a critical value, which eliminates the appearance of in the local area of subcutaneous fat of such a quantity of vaccine that would contain an excessive amount of high molecular weight compounds, which, in the end, prevents post-injection damage to the subcutaneous fat fiber howl.

Repeated chipping of the injection field with punctures carried out no closer than 6 mm from each other eliminates the accidental increase in the number of high molecular weight compounds to an excessive level that can occur with closer punctures. The fact is that with punctures and injections carried out no closer than 6 mm from each other, the contact and overlapping of the central zones of neighboring drug infiltrates enriched with high molecular weight compounds are excluded, which eliminates the summation of their quantities and exceeding the critical level at the confluence of individual central zones of post-injection drugs subcutaneous fat infiltrates, which, in turn, prevents the development of post-injection damage to the subcutaneous fat.

Example. Patient L., in connection with immunodeficiency, was given a double injection under the skin of the influenza vaccine GRIPPOL 0.5 ml with an interval of 4 weeks. The first injection was made under the skin of the upper third of the outer surface of the right shoulder. To do this, wipe the ampoule knife and the neck of the ampoule with a cotton moistened with 70% ethyl alcohol, open the GRIPPOL ampoule (FSUE NPO Mikrogen, Ministry of Health of the Russian Federation, Ufa, series No. S-27), and take 0.5 ml of the vaccine into a disposable syringe application, removed excess air from the syringe, rubbed the skin at the injection site with alcohol, punctured and injected a vaccine under the skin. Almost immediately, a light pink drug infiltrate with a diameter of about 16 mm was formed with a rounded zone of white-gray color with a diameter of 6 mm in the central region around the puncture site. A swelling formed in the area of the entire infiltrate, the half-life of which was 10 minutes. Simultaneously with the swelling, a feeling of irritation appeared in the central zone of the infiltrate, and after 2 minutes the central zone began to turn red, after 4 minutes it turned bright red, the feeling of irritation transformed into a feeling of pain, hyperthermia appeared (the temperature in the hyperemia zone rose from 29 up to 33 ° C). At the same time, the intensity of hyperemia, hyperthermia, swelling and pain in the central zone of infiltrate with a diameter of 6 mm began to increase and reached a maximum by 15 minutes, remaining at this level for another 10 minutes. In this regard, the patient was injected with 1 ml of a solution of 1% diphenhydramine, after which (from the 25th minute after the injection) the phenomena of inflammation of the skin and subcutaneous fat began to decrease. So, by the 35th minute after the injection, the central zone of tissue damage (in the form of a swollen, painful and hyperemic area) decreased in diameter from 6 to 5 mm. However, tissue damage persisted and continued to manifest itself as swelling, hyperemia, hyperthermia, and soreness for several hours until the next day.

After 4 weeks, the same patient was again introduced the GRIPPOL vaccine in a dose of 0.5 ml under the skin of the upper third of the outer surface of the left shoulder. To prevent damage to the subcutaneous fat, the injection area was anesthetized by cooling it with chloroethyl, then with a cotton swab moistened with 70% ethyl alcohol, the ampoule knife and the neck of the GRIPPOL ampoule were rubbed (FSUE NPO Microgen, Ministry of Health of the Russian Federation, Ufa, series No. C-27) and the neck of the ampoule of a solution of 0.9% isotonic sodium chloride for injection (OJSC Biosynthesis, Penza), scored 0.5 ml of the vaccine in a syringe, 2.5 ml of a solution of 0.9% isotonic sodium chloride was added to it, rubbed an alcohol injection field, after which 13 skin punctures were made in and injection field at a distance of 7 mm from each other and injected 12 times under the skin of 0.2 ml and once 0.1 ml of diluted vaccine. As a result of fractional administration of the diluted vaccine in the injection area, an oval-shaped drug infiltrate of light pink color with a size of 3 × 4 cm was formed without separate damage zones (without areas of increased hyperemia, hyperthermia, soreness and swelling of the skin and subcutaneous fat at the puncture sites), which completely resolved 55 minutes after the injection. The audit performed using ultrasound revealed a complete absence of drug infiltrate in the injection area.

Claims (1)

A method of injecting the influenza vaccine into subcutaneous fat, characterized in that the injection area is pre-anesthetized, an additional 0.9% sodium chloride solution is added to the syringe with the vaccine five times the volume of the vaccine, and the vaccine is administered by repeatedly chipping the injection area, making punctures no closer than 6 mm from each other and injecting no more than 0.2 ml each time.