Medical glue

FIELD: medicine.

SUBSTANCE: medical glue "Neosulphacrylate" contains, wt.p.: ethyl-α-cyanacrylate 76.5-85.0, 3-methacrylcarboxysulpholane 9.0-12.5, decylmetacrylate 6.0-11.0.

EFFECT: glue extends an assortment of compositions of the stated purpose, possesses improved organoleptic properties, increased adhesion and reduced neurotoxicity in tissue gluing, provides an increase of anti-inflammatory action with preservation of such physic-chemical characteristics as rupture strength and elasticity at the level of its prototype.

2 tbl, 6 ex

 

The invention relates to medicine, namely to the development of surgical adhesives of the new generation, which has anti-inflammatory action, improved organoleptic qualities, as well as the ability to provide reliable hemostasis and sealing of the wound surfaces when performing surgical procedures, and can be used for sealing joints in abdominal, thoracic, vascular, maxillofacial and neurosurgery.

The use of adhesive materials, prepared on the basis of esters of 2-cyanacrylate acid, allowed to develop new technologies surgical interventions (see M. R. Shapiro, Cyanocrylate adhesives in traumatology and orthopedics, M, Medicine, 1976). In surgical practice, using such adhesive materials based on alkyl-2-cyanacrylate as dermatan (ETHICON, USA), history and Intersil (UK), "Histacol T-110" (Germany), "Athos-2" and cyanosed (Japan).

In Russia experimental and clinical testing have been adhesives MK-2, MK-6, MK-8, MK-9, MK-14", "Zanocin WITH 4 and the Propeller EA (TU 6-09-30-76).

Closest to the proposed invention is adopted for the prototype medical adhesive Sulfacrylate by the patent RF №2156140 (publ. 20.09.2000), containing as an adhesive component ethyl ester 2-cyanacrylate acid (ethyl-α-cyanacrylate, as an anti-inflammatory component 1,1-dioxotetrahydrofuran-1λ6-thiophene-3-silt methacrylic acid (3-methacryloyloxyethyl-Folan) and a plasticizing component.

Medical adhesive Sulfacrylate shows in the clinic such advantages over the known compositions of Russian and foreign production, as:

- the absence of an inflammatory reaction in the joints tissues;

- autostability;

- increased flexibility of the adhesive film, while ensuring the tightness of connections and the lack of post-traumatic keloid scars.

Sulfacrylate provides a highly malotravmaticheskaya connection and hemostasis of tissue parenchymal organs and intestines during surgery, which allows you to perform reconstructive surgery associated with a high risk of postoperative bleeding and septic complications in emergency and planned surgery on the abdominal and thoracic cavity, brain, ophthalmology (RF Patent №2156140,publ. 20.09.2000, bull. No. 26; Marchenko V.T., skorupi VA Morphological features of reparative regeneration of organs and tissues by applying sulfacrylate new generation // bull. the experts. Biol. and the honey. 2004, No. 2, S-236; Marchenko V.T., Potovyh NN. The use of adhesive technology in de is tion surgery // Bulletin of new medical technologies. 2003, Vol.10, No. 4, P.84-86).

For all its merits, the composition of the prototype has a low organoleptic quality, due to the sharp odor of plasticizer, and not enough high anti-inflammatory effect and increased neurotoxicity when gluing tissue.

Object of the present invention is to provide formulations of medical glue "Poulfelt"extending the range of compositions for this purpose, improving the organoleptic properties of the adhesive, increasing its adhesion and reduce the neurotoxicity for bonding fabrics, as well as providing a high anti-inflammatory effect by increasing the bioavailability and activity of anti-inflammatory component while maintaining the level of a prototype of such physico-chemical characteristics as tensile strength and elasticity.

The problem is solved by the claimed formulation medical glue "Poulfelt", which contains as an adhesive component ethyl-α-cyanacrylate, as an anti-inflammatory component 3-methacryloyloxyethyl and plasticizing component. The peculiarity lies in the fact that the composition as a plasticizing component contains decylmethacrylate in the following ratio, wt. Dol.:

ethyl-α-cyanacrylate
76,5-85,0
3-methacryloyloxyethyl9,0-12,5
decylmethacrylate6,0-11,0

The inventive component adhesive composition differs from the prototype in any other plasticizer - decylmethacrylate (prototype - butyl or hexyl ester of acrylic acid) to give the target product improved organoleptic evaluation. In combination with an adhesive component specified plasticizer improves the adhesion of the target product, and in combination with anti-inflammatory component increases protivovospalitelnoe action, ensuring a higher bioavailability and activity.

Going beyond the proposed limits of the weight fractions of the components of glue is impractical, because the ratio of the components in the composition is optimal and are chosen from considerations of providing the required level of the entire complex properties of the adhesive.

The technology of manufacture is simple: medical adhesive is prepared by mixing at room temperature of all the above components to dissolve 3-methacryloyloxyethyl.

Study of anti-inflammatory activity was carried out on outbred mice weighing 20-25 g, were obtained from the vivarium of the Institute of Cytology and genetics SB RA is.

The experiments were conducted on two models of inflammation induced by 1,0%solution carragenine and 3.0%formalin solution, which was introduced in the aponeurosis of the foot mouse in a volume of 0.05 ml

Glue was applied as healthy and reproduced with inflammation of the skin of the feet in the form of application.

Anti-inflammatory effect of the claimed adhesive was compared with the activity of standard antiphlogistic - voltaren. It is shown that the anti-inflammatory effect of glue similar to the benchmark comparison voltaren, but superior to the prototype.

The influence of the medical glue to conduct nerve impulses in the sciatic nerve was studied in frogs. Analysis of the amplitude-time characteristics showed that after application of the adhesive conductive function of the peripheral nervous system is stored within 48,7±4,3 min (P - significance by student's criterion - <0,05).

The shelf life of the adhesive 18 months at a temperature of 7°C. the Evaluation of the organoleptic properties of the adhesive showed a significant reduction of sharp odor compared to the prototype.

All of the above is confirmed by the following examples.

Example 1. Obtaining A composition of glue "Poulfelt".

To 76,5 weight. the fractions of ethyl-α-cyanacrylate add 11 weight. the Dol. decylmethacrylate and 12.5 weight. the Dol. 3-methacryloyloxyethyl, the mixture is stirred until complete dissolution of the components of the clients.

Elongation of 130%, the tensile shear specimen from duralumin D-16 125 kg/cm2.

Example 2. A composition B glue "Poulfelt".

To 80,0 weight. the fractions of ethyl-α-cyanacrylate add 10.0 weight. the Dol. decylmethacrylate and 10.0 weight. the Dol. 3-methacryloyloxyethyl, the mixture is stirred until complete dissolution of the components.

Elongation of 120%, the tensile shear specimen from duralumin D-16 127 kg/cm2.

Example 3. The study of anti-inflammatory activity of the composition And glue "Poulfelt" carragenine and formalin models.

Study of anti-inflammatory activity was carried out on models of inflammatory edema induced in mice by the introduction of the aponeurosis of the hind legs of an aqueous solution of logogen (1,5% carrageenin and 3.0% formalin) in a volume of 0.05 ml of Glue was applied as healthy and reproduced by inflammation of the skin of the feet in the form of application.

The reference drug was the substance of diclofenac sodium ("Fluka") in the dose of 10 mg/kg Control animals were injected with an equivalent amount of water with the twin. After 5 h after injection of logogen dogs were killed by the cranio-cervical dislocation and determined the mass of both of the rear legs below the ankle with swelling and without it. Indexes of inflammation was calculated as the ratio of the difference between healthy and inflamed paws to mass is Gorovoy, expressed as a percentage. Anti-inflammatory effect was evaluated by the difference between the relative index values of edema in the control and experimental groups. The results are shown in table 1.

Table 1.
Adhesive compositionAverage % increase swelling caused
Formalin 3%Carragenine 1,5%

Composition And glue "Poulfelt: ethyl-α-cyanacrylate - 76,5 weight. dollars., decylmethacrylate - 11 weight. dollars., 3-methacrylate carboxymaltose to 12.5 weight. dollars.41,5±2,40∗42,3±2,20∗
Voltaren 10 mg/kg45,8±1,65∗49,6±1,5∗
Sulfacrylate (prototype)55,25±2,9048,6±2,5∗
Control69,6±3,4566,0±2,7
∗P<0,001 - in relation to the control

It is shown that the composition And exhibits on the 2 models is asplenia similar to the reference drug voltaren anti-inflammatory activity, but surpassing the prototype.

Example 4. The influence of composition And glue "Poulfelt" on neurotoxicity.

The amplitude caused by the total action potential (conductive function of the peripheral nervous system) were studied during application of the composition And the adhesive on the sciatic nerve of a frog in an amount of 5 μl for 1.5 see

As a result of researches it is established that the amplitude caused by the total action potential drops to zero within 48,7±4,3 min (P<0,05).

Example 5. The study of anti-inflammatory activity of the composition B glue "Poulfelt" carragenine and formalin models.

Study of anti-inflammatory activity was carried out on models of inflammatory edema induced in mice by the introduction of the aponeurosis of the hind legs of an aqueous solution of logogen (1,5% carrageenin and 3.0% formalin) in a volume of 0.05 ml of Glue was applied as healthy and reproduced by inflammation of the skin of the feet in the form of application.

The reference drug was the substance of diclofenac sodium ("Fluka") in the dose of 10 mg/kg Control animals were injected with an equivalent amount of water with the twin. After 5 h after injection of logogen dogs were killed by the cranio-cervical dislocation and determined the mass of both of the rear legs below the ankle with swelling and without it. Indices of inflammation were calculated cacotheline the difference between healthy and inflamed paws to weight healthy expressed in percentage. Anti-inflammatory effect was evaluated by the difference between the relative index values of edema in the control and experimental groups. The results are shown in table 2.

Table 2.
Adhesive compositionAverage % increase swelling caused
Formalin 3%Carragenine 1,5%
Composition B glue "Poulfelt: ethyl-α-cyanacrylate - 80,0 vestal., decylmethacrylate - 10.0 weight. the Dol. 3-methacryloyloxyethyl - 10.0 weight. dollars.42,3±2,10∗42,5±2,30∗
Voltaren 10 mg/kg45,8±1,.65∗49,6±1,5∗
Sulfacrylate (prototype)55,25±2,.9048,6±2,5∗
Control69,6±3,4566,0±2,7
∗P<0,001 - in relation to the control

It is shown that composition B shows 2 models of inflammation similar pattern is th drug voltaren anti-inflammatory activity, but surpassing the prototype.

Example 6. The influence of composition B glue "Poulfelt" on neurotoxicity.

The amplitude caused by the total action potential (conductive function of the peripheral nervous system) were studied during application of the composition B of glue on the sciatic nerve of a frog in an amount of 5 μl for 1.5 see

As a result of researches it is established that the amplitude caused by the total action potential drops to zero within 48,7±4,3 min (P<0,05).

In a separate series of experiments on rats to both songs glue "Poulfelt" studies have been conducted to identify toxic effects with a long introduction (30 days).

As a result of the studies have shown that intraperitoneal implantation compositions glue "Poulfelt" did not reveal violations of the dynamics of body weight, peripheral blood, the General reactivity of the organism, the state of the Central nervous system, liver and kidneys. When macroscopic examination of the terms 7-14, 21-30 days, shows a gradual destruction of glue at the injection site without the expressed inflammatory reaction. After 2 months on the injection fragments glue and no pathological differences in tissue reaction was not found.

For both compositions a and B glue "Poulfelt" was shown on the absence of a sharp odor, i.e. organoleptic index significantly improved.

Studies show that the proposed solution is feasible, the claimed medical adhesive composition possesses advantages in comparison with the prototype, allows to satisfy a long existing need in the task.

Medical adhesive containing as an adhesive component ethyl-α-cyanacrylate, as an anti-inflammatory component 3-methacryloyloxyethyl and a plasticizing component, characterized in that the plasticizing component contains decylmethacrylate in the following ratio, wt. Dol.:

ethyl-α-cyanacrylate76,5-85,0
3-methacryloyloxyethyl9,0-12,5
decylmethacrylate6,0-11,0



 

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