Local hemostatic agent

FIELD: chemistry.

SUBSTANCE: agent further contains aluminium and/or magnesium oxides and satisfies the formula: CaO·(SiO2)m·(M)n·(H2O)k, where M is Al2O3 and/or MgO; m=0.5-3.0; n=0.01-0.05; k=0.2-1.2.

EFFECT: shorter time for onset of hemostasis and low exothermic effect during interaction with blood.

2 tbl, 9 ex

 

The invention relates to medicine, specifically to the means used to stop the massive bleeding, and can be used as a local hemostatic agents to protect the lives and health of people exposed to extreme factors.

Known drug to stop arterial bleeding from a mixture of fine calcium carbonate, boehmite nanoparticles (metagalaxies aluminum) and polysaccharide (EN 2333002), which does not cause pain and chemical burns of exposed tissues, allowing you to reduce the exothermic effect of hydration and thus the heat transferred to the wound. In addition it does not contain substances which are able to give a solidified mass which causes injury to the edges of wounds. The disadvantage of this drug is its low hemostatic efficacy.

Known composition based on mineral powders, consisting of a mixture of clay materials bentonite, montmorillonite, kaolin, kaolinite, with the specified particle sizes (US 20080319476), providing 100%survival of laboratory animals with arterial bleeding. However, the use of such a composition is not safe due to the potential for embolism vessels by entering into the circulatory system subdesertic particles smatovich clays (Journal of Trauma-Injury Infection and Criticl Care. Kheirabadi BS, MR Scherer, Estep JS, Dubick MA, Holcomb JB. Determination of efficacy of new hemostatic dressings in a model of extremity arterial hemorrhage in swine. 2009; 67(3): 459-459).

It is also known local hemostatic agent to stop intensive arterio-venous bleeding (EN 2414225), including a mix of synthetic zeolites

type CAA formula mCaO·nNa2O·2SiO2·Al2O3·0,5H2O and

type Sakh formula mCaO·nNa2O·2.5SiO2·Al2O3·0,5H2O,

the crystal lattice which contain cations of calcium in the amount of 8÷10 wt.% when the ratio of these components, wt.%:

synthetic zeolite mCaO·nNa2O·2SiO2·Al2O3·0,5H2O- 70÷80,
synthetic zeolite mCaO·nNa2O·2.5SiO2·Al2O3·0,5H2O- 30÷20,

and when the ratio n:m, equal 0,13÷0,22.

The solution that is closest to the claimed invention taken as a prototype.

The disadvantage of the invention of the prototype is high, up to 85°C, the temperature during contact of the zeolite material with blood, resulting in thermal burn tissues caused by heat generation at the contact of the zeolite with the aqueous environment of the blood plasma due to the high value of the heat of hydration. Another disadvantage of the invention is a high-cost multi-stage method for the synthesis of the target product.

The technical task of the invention is to develop an effective hemostatic local actions, not giving a high exothermic effect when interacting with the blood produced from inexpensive commercially available raw material, which is important in organizing and providing first and primary health care to stop parenchymal venous and arterial bleeding.

The invention is aimed at finding local hemostatic agents in a series of inorganic sorbents with high absorbent capacity of the blood, characterized by a short time of the onset of hemostasis, not giving a high exothermic effect when interacting with the blood produced from inexpensive commercially available raw materials.

The technical result of the claimed invention is achieved by the fact that the proposed local hemostatic agent based on synthetic calcium hydrosilicate, characterized by short time of the onset of hemostasis and low exothermic effect in the interaction with blood which further comprises oxides of aluminum and/or magnesium and is responsible formula unit:

CaO·(SiO2) m·(M)n·(H2O)kwhere

M-Al2O3and/or MgO;

m=0,5÷3,0; n=0,01÷0,05; k=0,2÷1,2.

The stated number of moles of silicon oxide (m) is determined by the conditions of synthesis of calcium hydrosilicate with the formation of macropores.

The number of moles of aluminum oxide and/or magnesium oxide is selected to ensure optimal micro porosity of the final product, which occurs in the process of its synthesis at the expense of hydrogen by the reaction of the powders of aluminum and/or magnesium introduced into the reaction mixture with water with the formation of oxides of aluminum and/or magnesium. When the value of n is less than 0.01 the obtained calcium hydrosilicate loses the ability to hemostasis due to the low micro porosity and, as a consequence, the decrease in the sorption capacity of the product in the blood. When the n value is more than 0.05 obtained calcium hydrosilicate loses mechanical strength due to the high porosity, which leads to its destruction by contact with blood.

The number of moles of water is determined on the basis of laboratory test results, according to which when the value of k is less than 0.2 mol of the obtained calcium hydrosilicate loses the ability to hemostasis, as destroyed the porous structure of the product, which is more than 80% is converted to inert with respect to blood calcium salt of metasilicic acid CaSiO3and when the value of k b is more 1,2 there is a significant reduction of hemostasis due to the decrease in the sorption capacity of the product in the blood.

The invention consists in that the refined composition of the synthetic calcium hydrosilicate with the inclusion of oxides of aluminum and/or magnesium that have the property to stop the massive bleeding, not giving a high exothermic effect in the interaction with blood and made from inexpensive commercially available raw materials.

Below are the best examples of embodiments of the invention from the point of view of the sorption ability of the proposed drug. The invention is implemented as follows.

The mixture of powders 56 kg of calcium hydroxide mark "h" according to GOST 9262-77, 72 kg of Aerosil (colloidal silicon dioxide (SiO2)) brand ASKO-175 according to TU U 2101-31695418-002-2003 and 1 kg of a powdered aluminum grade PAP-1 or 0.5 kg of magnesium powder brand MPF-4 according to GOST 6001-73 shut in 100 l of water. The resulting dough is loaded into the form of stainless steel that are placed on the shelves of the autoclave type 2 H. Zatvorenog the mixture is treated with saturated steam with temperature (175÷200°C under pressure (0,9÷1,6) MPa for 6 hours. At the end of the process of steaming produce steam release into the atmosphere, cooling the autoclave and unloading forms. The result is calcium hydrosilicate, saturated with macropores formed during crystallization and evaporation of water, and the micropores formed stand out bodoro the om by the reaction of the powders of aluminum or magnesium with water, accompanied by the formation of oxides of aluminum and/or magnesium.

The briquettes obtained porous synthetic calcium hydrosilicate are extracted from the molds and passed through a jaw crusher. The resulting powder was classified into fractions of 0.1÷0.3 mm, 0,25÷1.25 mm 0,3÷5,0 mm 5,0÷10,0 mm

To increase the absorbent capacity of the obtained synthetic calcium hydrosilicate blood spend his subsequent annealing at 200°C for 1 hour or contactless heating in the electromagnetic field of the microwave radiation at power microwave 1000 W at a frequency of 2450 MHz radiation for 30 minutes under the conditions of this treatment, the evaporation of molecular water and removing a portion of the absorbed water from the micropores of the product. Get either Cao·1,2SiO2·0,025Al2O3·0,7H2O or Cao·1,2SiO2·0,04MgO·0,2H2O, are shown in Table 2, examples 5 and 6.

The finished product is heated to a temperature of 80÷90°C, Packed in sealed packs of combined packaging material type Teratol and subjected to radiation sterilization.

General physic-chemical properties of the drug are presented in Table 1.

Table 1
№№ p/pIndex Value
1Fractional composition: wt.%,
the number of grains less than 0.3 mm and not more than3
the number of grains more than 5.0 mm, max3
2Specific surface area by BET, m2/g, not less than40
3The total porosity, ml/g, not less than4·10-2
4Sorption capacity, g/g
- water fluid., not less than,1,0
by blood, not less,1,2
5the pH of aqueous extract7,0-9,5
6The temperature increase in the interaction with blood, hail. With, not above45

The values of porosity and sorption ability of calcium hydrosilicate, optionally containing oxides of aluminum and/or magnesium, if p is the applicatio provide a stop massive bleeding due to the implementation of hygroscopic mechanism of hemostasis, leading to the binding of water and solutes in the area of defect vessels and the local concentration of cellular and major protein components of the blood (including clotting factors). This, in turn, induces the formation of a blood convolution. The effect of stopping the bleeding increases due to the high calcium content in the product, which is a cofactor in many parts of the coagulation cascade, but also due to the surface potential of crystals of calcium hydrosilicate, contributing to the activation of factor XII clotting and platelets.

Below are examples of the results of laboratory tests of funds committed by known methods (patent RU 2127428, THE 9393-001-18152288-2009), are summarized in Table 2: "the timing of hemostasis and the sorption capacity of the blood of the inventive hemostatic agents".

Table 2
# exampleThe hemostatic compositionThe timing of hemostasis, sThe sorption capacity of the blood, g/gTemperature interaction hemostatic blood, °C
1 CaO·0,5SiO2·0,01Al2O3·1,2H2O91,244
2CaO·0,5SiO2·0,025Al2O3·0,7H2O81,345
3CaO·0,5SiO2·0,04Al2O3·0,2H2O71,443
4CaO·1,2SiO2·0,01 Al2O3·1,2H2O91,344
5CaO·1,2SiO2·0,025Al2O3·0,7H2O91,445
6CaO·1,2SiO2·0,04MgO·0,2H2O91,245
7CaO·2,9SiO2·0,01 Al2O3·1 2N2About81,544
8 CaO·2,9SiO2·0,025MgO·0,7H2O91,245
9CaO·2,9SiO2·0,04(Al2O3+MgO)·0,2H2O71,243
The proto-typeMixture
75% of CaO·0,1Na2O·2SiO2·Al2O3·0.5H2O100,585
25% CaO·0,2Na2O·2,5SiO2·Al2O3·0.5H2O

To assess the effectiveness of funds conditional name "GameStop-M) experimental studies on the mini-pigs Svetlogorsk breed. The study selected 27 animals, formed into 3 groups: two experimental and one control, 9 animals in each. The objective of the experiment was to study the effectiveness of the drug on the model seriously injured groin damage femoral vascular bundle. In another group of animals was used by local hemostatic tool prototype (code name "GameStop is), which compared the data obtained. In the control group applied a pressure bandage to the wound using a personnel dressing tool PPI-AV. After drawing the wounded and the short period of uncontrolled hemorrhage, the preparation was filled into the wound, then was carried out by manual compression for 7 min, after which assessed the adequacy of hemostasis by the number of recurrent bleeding, survival time and volume of blood loss. The duration of the acute experiment was 180 minutes

"GameStop-M showed significantly high survival rates of 100%, comparable with the local hemostatics "GameStop", whereas in the control group survived only 13% of the animals. The use of local hemostatic agents contributed to the decrease in the volume of blood loss. After treatment in groups where used "GameStop-M" and "GameStop, volume of blood loss averaged 350,62 and 423,12 ml, respectively, compared to control, where animals lost an average of 1522,29 ml in experimental groups was significantly higher than the survival time. In the control group, the average did not exceed of 37.8 minutes parameters are consistent with the rate of recurrent bleeding, which in animals in the experimental groups was significantly less (22,2% 33,3% compared to 71.2 percent control).

Also performed preclinical studies is and the Romanov sheep breed. The similarity of their anatomical and physiological parameters of the cardiovascular system (the caliber of blood vessels, blood pressure, response to stress factors) increased the validity of the experiment, which was attended by 12 animals. Animals were randomized into 3 groups of 4 animals each. As in the previous study assessed the effectiveness of the "GameStop-M" on the model of injured groin. The design of the experiment is similar to the above.

In the group where used "GameStop-M"sustainable primary hemostasis was achieved in 3 cases out of 4 (75.0 per cent). 1 animal after the resumption of bleeding "Gesatop-M was applied again with a positive effect. In the end, all the animals in the 1st experimental group survived to the end of the experiment. Recurrence of bleeding was observed in 1 case after raising systemic blood pressure in response to intravenous infusion. In 1-St and 2-nd experimental groups data on the number of surviving animals and the frequency of recurrence of bleeding reliable and comparable.

In the control group, all animals died prematurely. The frequency of recurrence of bleeding was 100%. When comparing data obtained in both experimental groups, which was used hemostatic agents, differences in the volume of blood loss was not (Mann-Whitney test, p≤0,001), whereas in the experimental group animals were lost on average 1430,12 ml more blood C the experiment.

Mini-pigs Svetlogorsk breed evaluated the effectiveness of the "GameStop-M" on the model of parenchymal bleeding in the injured liver. When comparing two local hemostatics "GameStop-M" and "GameStop" with the control group, in which the bleeding was stopped only by tamponade, it was shown a significant difference in survival rates in experimental animals. In the control group sustained hemostasis was not achieved, all the animals died during the experiment from irreversible blood loss. Whereas in the 1-St and 2-nd experimental groups, the level of survival was equal 88,9 and 78.8%, respectively. When comparing experimental groups with each other, significant differences were not found. Another important characteristic influencing mortality is estimated blood loss. In the performed study defined amount of blood loss before treatment, which in all groups was comparable, as well as blood loss after application of hemostatic and total volume. The average figures indicate significantly higher blood loss in the control animals. It is determined that the effectiveness of the "GameStop-M" and "GameStop" when you stop parenchymal bleeding comparable.

On models injured groin investigated the security of GameStop-M within the study of thermal effects on tissues. When temperature measurement has been shown that the maximum p is the same rise in the wound does not exceed 45°C, compared with Hemotoma" where the temperature in the wound was 85°C. When using "GameStop-M researchers subjectively did not report excessive heating of the drug in the wound. At the end of the experiment, after removal of hemostatic from the wound, visual inspection revealed no signs of coagulation necrosis of soft tissues. The edges of the skin wound remained intact. Histological examination revealed no signs of necrosis. Post-traumatic changes in an intim vessels, soft tissues were not significantly different from control biopsies.

Thus, the invention opens the possibility to provide first and primary health care to stop parenchymal venous and arterial bleeding effective hemostatic agent local action, not giving a high exothermic effect when interacting with the blood produced from inexpensive commercially available raw materials.

Local hemostatic agent based on synthetic calcium hydrosilicate, characterized by short time of the onset of hemostasis and low exothermic effect in the interaction with blood which further comprises oxides of aluminum and/or magnesium and meets formula one:
CaO·(SiO2)m·(M)n·(H2O)kwhere
M-Al2O3and/or MgO;
m=0,5÷3,0; n=0,01÷0,05; k=0,2÷1,2.



 

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FIELD: medicine, pharmaceutics.

SUBSTANCE: group of inventions refers to medicine, namely to clinical allergology, and may be used for extracorporeal allergen denaturation. That is ensured by treating a surface of objects with an allergen-denaturing composition. The composition contains calcium chloride or calcium acetate and lanthanum chloride or lanthanum nitrate in certain proportions.

EFFECT: combinations of the above metal salts selected in certain proportions provide the effective allergen denaturation ex vivo by a synergistic denaturation action of the given ingredients.

9 cl, 4 tbl

FIELD: medicine.

SUBSTANCE: declared products are presented in the form of suppositories and contain a mechanically active amorphous or amorphocrystalline calcium gluconate as an active substance and additives as a base. One of the declared agents contains hard fat, paraffin, cacao butter and Lutrol F68 as a base in specific proportions. The other agent contains Witepsol W35, Witepsol H15, kollidon CL and Cremophore RH-40 as a base in specific proportions.

EFFECT: invention provides the agents with uniformly released active substances, prolonged action and applicability for unassisted use by the patients; the declared agents provide a wide spectrum of therapeutic activity, particularly the regulation of Ca2+ and phosphate exchange, reduced resorption and higher bone tissue density, Ca2+ replacement, improved Ca2+ intestinal absorption, phosphate renal re-absorption, bone mineralisation, improved blood coagulation, maintained stable cardiac function, and enabled neurotransmission.

2 cl, 5 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine, particularly to paediatrics, namely to otorhinolaryngology, and may be used in treating chronic tonsillitis in children's health centres, in-patient hospitals, polyclinics. The low-power laser light covers projections of palantine tonsils, namely an anterior lateral neck surface below a mandibular angle to the right and to the left. The laser light is generated at wavelength 0.89 mcm, constantly variable frequency 10 to 1,500 Hz by AZOR 2K-02 apparatus in the contact, stable mode. The exposure length is 1 minute per a field at pulse power 2-3 Wt/pulse daily; the therapeutic course is 7-8 procedures in 5-10-year-old children. The exposure takes 2 minutes per a field at pulse power 4-5 Wt/pulse daily within the therapeutic course making 9-10 procedures. Each physiotherapeutic procedure is preceded by tonsillar lacunae irrigation with sterile 0.9% normal saline using a Hartmann cannula. The method is safe by selecting laser light conditions in the children of various age groups.

EFFECT: method enables higher clinical effectiveness in chronic tonsillitis, prolonging remission, reducing a recurrence and complication rate, lowering the need for medical treatment, improving the quality of life in children and adolescents.

2 ex

FIELD: medicine.

SUBSTANCE: material comprises synthesized material having hydroxyapatite structure and additional ytterbium and erbium ions or ytterbium and thulium ions according to known formula. The material is compositionally equivalent to human skeletal bone tissue and biocompatible with it.

EFFECT: wide range of use in investigating tissue behavior in different fields of surgery and traumatic surgery.

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