RU2156131C1 - Semifinished product for preparing drug base, drug base made of this semifinished product (variants) and drug based on this base (variants) - Google Patents

Abstract

FIELD: medicine, cosmetology, veterinary science, pharmacy. SUBSTANCE: invention relates to the prepared semifinished product for preparing drug base containing placental material, drug base made of this semifinished product containing milled semifinished product prepared of placental material and special addition mixed with the base. Placental material forms mass exhibiting the novel structural properties that is treated with additions that retain its parent state and/or promoting the penetration of its biologically active substances through skin into human body and animal. Invention ensures to develop wasteless production of drugs, obtain semifinished product and the bases that retain biologically active substances in native state for a long time. EFFECT: semifinished product indicated above, wasteless production. 20 cl, 3 tbl, 11 ex

Description

 The present inventions relate to medicine, namely to therapy, and can serve, on the one hand, as starting material for the preparation of various bases of various drugs and for the preparation of many drugs, for example, affecting tissue metabolism, and on the other hand, for direct treatment inflammations of various origins, with injuries, post-traumatic complications, wounds, burns, skin diseases and other diseases. In addition, the invention can be used in veterinary medicine for the treatment of various diseases in animals, and can also be used in cosmetology, for example, for cryomassage with biologically active substances, and can also be used as prophylactic therapeutic agents for external use.

A semi-finished product is known containing placental material obtained from a healthy woman in labor and tested for the absence of AIDS, hepatitis, syphilis, as well as repeatedly washed from the blood contained in it and kept at a temperature of +2 to +4 ^o C (see, for example, B .P. Filatov, "Tissue Therapy", M.: Knowledge, 1955, pp. 16-17).

A well-known drug base obtained from the previously specified semi-finished product, which contains solid particles of crushed and ground in a mortar semi-finished product from placental material, (see ibid.) Physiological solution of sodium chloride in a 10-fold volume, while the suspension is aged, filtered by heating to +70 ÷ +80 ^o C and sterilized at a temperature above + 100 ^o C (see ibid.). However, the known semi-finished product from placental material cannot be used to obtain a large number of various biologically active bases of various drugs, in particular for external use for the following reasons:
- the material of the known semi-finished product contains few biologically active substances, since most of them are lost in the manufacture of the semi-finished product, in particular, during repeated washing of the starting material;
- the source material of the specified semi-finished product is unprotected in the open air. In this case, it is seeded with microflora, which is not always indifferent to a living organism, because, as a rule, strains of pathogenic human organisms such as staphylococcus, streptococcus and others accumulate under hospital conditions, which always contributes to the loss of the native state by placental material beyond due to the decomposition of tissue under the action of microorganisms and the activation of endogenous proteases in such conditions.

 The known drug base obtained from the considered known semi-finished product cannot be used as starting material for the manufacture of a medicinal product for external use for the treatment of wound surfaces of the skin, treatment, for example, diseases of the musculoskeletal system or psoriasis, as well as a cosmetic product for skin rejuvenation .

 This is due to the fact that the known base contains solid particles of crushed semi-finished product from a placental material that does not have biologically active substances in their native state. In addition, its particles have a poorly developed surface. This complicates their interaction with a large number of target additives, and during storage, the base is caked, crumpled due to its acquired state, and when introduced into the solution it exfoliates from the liquid phase and precipitates, disrupting the balance of biologically active substances in the drug.

 A well-known drug on this well-known basis cannot be used as a medicinal product for external use, both due to the loss by the material of its solid particles of its native state during the preparation of the drug, for example, during sterilization of the solution, and because of the presence of solid particles, which contact with the wound surface of the skin causes severe pain in the patient.

 Dimelsulfoxide (synonyms: dimexide, DMSO) is known as a liquid with the properties of a solvent and preservative, as well as a drug. It is used in the treatment of bruises, sprains, inflammatory edema, purulent wounds and so on (Mashkovsky M.D., "Medicines", a guide to pharmacotherapy for doctors, edition 10, M .: Medicine, 1985, volume 1, p. 202). Applied as an external agent.

 However, it cannot serve as the basis for the preparation of drugs with a therapeutic effect, since the liquid is volatile by nature, that is, it evaporates quickly, losing its therapeutic agents, and when used as an independent drug, it causes side effects (itching dermatitis, nausea, in isolated cases bronchospasm is possible) and has contraindications (including for angina pectoris, atherosclerosis, glaucoma, cataracts, pregnancy), which are not removed with the introduction of other target additives.

 Known therapeutic ointment, for example, liniment synthomycin, which is a liquid mass, in particular, in a creamy state (see Mashkovsky MD, Medicines. Pharmacotherapy manual for doctors. Part 2. Vilnius, 1993, publishing house ZAO Gamta, p. 224).

 This ointment is intended for external use in the treatment of the patient, as it exhibits the properties of a thick therapeutic emulsion. However, it under the action of heat quickly stratifies into two opposite phases: solid and liquid, which leads to a loss of the therapeutic effect of the ointment and therefore it cannot be used as the basis for the preparation of a wide class of drugs.

The most widely used semi-finished product for producing a medicinal product is known, which contains placental material obtained from a healthy woman in labor and tested for AIDS, hepatitis and syphilis, as well as repeatedly washed from the blood contained in it and kept in the cold (see, for example, Mashkovsky MD, Medicines, Pharmacotherapy Manual for Doctors, Part 2, Vilnius, 1993, Gamta Publishing House, p. 136)
A known drug base obtained from this known prefabricated product, which contains solid particles of the prefabricated placental material obtained after fine grinding (see ibid.).

 This known prefabricated placental material and the known drug base derived from it have the same disadvantages that were noted when considering the first analogue of the present invention.

 For example, the base contains solid particles of crushed semi-finished product from the placental material and biologically active substances that have lost their nativeness in the preparation of the semi-finished product and base and, therefore, this base cannot be used for the preparation of a large number of different drugs with therapeutic effect, especially for external application.

 A drug is known, for example, affecting tissue metabolism, containing a base in the form of solid particles of finely ground semi-finished product from placental material and a target additive mixed with it, which is used as an isotonic solution (Mashkovsky MD Medicines. Pharmacotherapy manual for doctors , edition 10, M .: Medicine, 1985, volume 2, p. 154).

This product contains a base made of placental material in the form of particles of fine placental material crushed by grinding by trituration, and an isotonic sodium chloride solution is used as the target additive. In the manufacture of this known product, the components are mixed, the resulting suspension is poured into ampoules and sterilized at a temperature of +120 ^o C for one hour. Before use, the ampoules are shaken so that the particles of the known base are evenly distributed in the solution.

 The tool is used as a biogenic stimulant for various eye diseases (myopia, keratitis, clouding of the cornea, etc.) and other indications of the use of biogenic stimulants. Assign in the form of injections under the skin in 2 ml (pre-injected with a 0.5% solution of novocaine) once every 7-10 days; on a course of 3 to 4 injections. The course can be repeated after 2 to 3 months.

 However, this tool can not be used externally, since it is intended for injection, and also because of the separation of solid particles of the base from the liquid phase of the solution. In addition, this agent has a low biological activity, which is due to the prolonged high-temperature sterilization of the agent and the fact that prior to use, a preliminary injection of novocaine is necessary to relieve pain.

 Analysis of the known prefabricated product for the production of a drug, the basis of a drug from this semi-finished product, a drug based on this basis shows that the state of the initial placental material from which the known prefabricated material is made, and then everything else, does not allow their use for treatment, for example, by the application method , many diseases, since they have low biological activity. This medicine is for injection only.

 The first objective of the present inventions is the creation of a semi-finished product for the manufacture of essential drugs, having the material in such a state or with such a structure that would ensure that it contains a large number of biologically active substances, as well as coordination with many components used to obtain different essentials of the drug. In addition, it could be stored, transported and processed quickly for a long time without losing its biologically active substances.

 The second objective of the present inventions is to create the basics of a medicinal product from the aforementioned semi-finished product having such a condition, and their material and structure, which would ensure the content of a large number of biologically active substances and coordination with various target additives when preparing medicines for various purposes on their basis and applications, and also could be independent medicines for internal and external use.

 The third objective of the present invention is the creation of medicines on the above bases, having a state, and their material structure, and targeted additives that provide the tool with a high therapeutic effect and internal or external use for the treatment of various diseases, including psoriasis, osteochondrosis, diseases of the musculoskeletal system motor apparatus.

 The first problem is solved in that in the known semi-finished product for obtaining the basis of a medicinal product containing placental material, according to the present invention, the placental material is in the native state.

There are development options for this solution, namely:
- the placental material is mixed with a cryoprotectant, preserving its native state, for example, glycerin, and frozen, and the amount of glycerol is up to three percent of the mass of the said material;
- placental material is treated with a preservative in an amount up to 10% of the total mass, with dimethyl sulfoxide or 6-10% acetic acid being used as a preservative;
- as a placental material, a part is used, separated from its amniotic membrane.

 The proposed semi-finished product for obtaining the drug base differs from the known one in that it has a native state containing the maximum number and quantity of biologically active substances determined by the nature of the creation of its material. This dramatically expands the range of the drug bases obtained from it having a therapeutic effect.

 The effect is due to the fact that the placental material is in its native state when the blood has not yet coagulated. Therefore, it contains a maximum of substances with a native structure.

 For long-term storage, transportation, it is advisable to freeze this semi-finished product.

However, during the usual freezing of the placental material to -20 ^o C, the material retains cold-resistant microorganisms, which continue to affect the biologically active material, destroying it.

If you freeze this material at lower temperatures, for example, to -30 -40 ^o C, then freezing of water occurs, which leads to a decrease in the nativeness of the frozen material and loss of biological activity.

 The addition of glycerin usually up to 3% by weight of the material protects the material from freezing, i.e. preserves intracellular structures, thereby preserving the initial native state of the placental material.

 An addition of glycerol above 3% translates it into the composition of the target drug supplement.

 In the case when the placental material is treated with dimethyl sulfoxide or acetic acid, the latter serve as a solvent and preservative and allow to increase the shelf life of the semi-finished product while maintaining its native state material, as well as to provide preliminary preparation for obtaining highly effective drug bases from it. Moreover, if we take a larger percentage of the preservative of the total mass, then the consistency changes and the semi-finished product becomes a saturated liquid preservative, which is not economically feasible for the task.

 In the case when placental material is used, separated from its amniotic membrane, this is not the best version of the semi-finished product, because part of it having a native structure is lost, but in such a semi-finished product its material has biologically active substances uniformly distributed over the volume.

 In addition, this option for the manufacture of the semi-finished product allows you to get waste-free production in the manufacture of the basis of the drug on the basis of the amniotic shell.

 The second problem is solved by the fact that in a known base containing a semi-finished product from the placental material according to the present invention, an amniotic membrane is used as a semi-finished product, isolated from the said material in its native state, formed by a 0.5 molar solution of sodium chloride, impregnated with glycerol and frozen .

 This new drug base differs from the known one in that it is formed from a material having a different physical state, a different shape, a different design, which is able to make best use of its properties, especially when it is necessary to stimulate skin regeneration, because it is basically collagen in its native form. A 0.5 molar solution of sodium chloride serves as a collagen stabilizer. Glycerin is a cryoprotectant that protects the material from freezing during storage in a frozen state.

 There is an option for solving this problem, when, in a known manner, a medicinal product containing a crushed semi-finished product from a placental material according to the present invention, the crushed semi-finished material is in its native state.

There are development options for this solution, namely:
- the crushed material of the semi-finished product, which is in the native state, is impregnated with glycerin and frozen;
- the crushed semi-finished product has a placental material mixed with dimethyl sulfoxide in the amount and proportions forming a liquid-like mass with a homogeneous structure and in a native state;
- the liquid-like mass is in a creamy and / or jelly-like state;
- the liquid mass is impregnated with glycerin and frozen.

 The proposed drug base differs from the known ones in that it contains ground placental material, in which the particles have a material that is in a different physical state than the traditional one, which expands the class of created drugs with a therapeutic effect.

 In the case when the crushed material of the semi-finished product, which is in its native state, is impregnated with glycerin and frozen, it can be stored for a long time in this state.

 In the case when the liquid-like mass is treated with dimethyl sulfoxide, the latter acts as a solvent and preservative, and is also a component that provides deep penetration into the tissues of biologically active substances contained in the placental material, their uniform distribution over the material, and with its own antimicrobial, anti-inflammatory and analgesic effects with which it does not overlap the properties of the placental material.

 In the case of the case when the liquid-like mass of the placental material is in a creamy state, then the proposed base undergoes delamination and is close in structure to disperse-gel structures. As a result, the effect of prolonging the therapeutic effect without the use of special additives arises. In addition, in the presence of solid particles of placental material in it, they serve as additional concentrators of biologically active substances, providing them to the periphery of the mass, and the presence of a liquid phase, which is impregnated with the crushed material of the semi-finished product, allows you to evenly distribute them throughout the volume, especially when the mass has homogeneous structure.

 If the proposed base is in the form of jelly, then the properties and mechanism of its formation are similar to the above. The base has a high biological activity due to the native state of the material, saturated with biologically active substances, and long retains the unique properties of the placental material.

 Thus, for the first time for the manufacture of drugs based on placental material, it is possible to use simultaneously or separately components of therapeutic drugs in the form of targeted additives of three physical conditions: liquid, solid, and gas, which in the analogues and prototype was difficult to carry out without replacing the basis of the drug with other stuff. If a similar known material is used as a base, then it always turns out to be with the wrong concentration of biologically active substances, since their maximum number and maximum activity occur only with one state of the base material - native.

 Another solution to this problem, when in the known basis of the drug containing solid particles of the crushed semi-finished product from the placental material according to the present invention, each solid particle of the crushed semi-finished product has at least pores on its surface formed by the liquid phase of the material mixed with dimethyl sulfoxide, and native structure.

 In fact, the initial native state of the liquid-like material of the placental material passed into the structure of its solid particles.

 This base of the drug differs from the known similar base in another embodiment of the particles of ground semifinished product from the placental material, pores formed at least on the surface of the particles and the structure of its material. However, drug powders are known in which the particles have a porous structure, in particular, this is observed in activated carbon, which is an adsorbent. In our case, in addition to adsorption properties, the porous structure of a solid powder particle from placental material performs the function of a concentrate of biologically active substances and at the same time is a prolongator of therapeutic effects on the body. In addition, the presence of pores allows two opposite processes to occur simultaneously: sorption and resorption. Sorption of toxins, and resorption of biologically active substances, which suggests the creation of a natural ion exchanger of biological substances with a wide spectrum of action, for example, from trace elements to large protein structures.

 In addition, the base proposed in this embodiment has a form and condition that do not correspond to the known ones. For example, in suspension, the particles stick together, since their size is commensurate with the pore size and the particles are obtained as a result of fine grinding of dry placental material. In our case, this is not, since the pore sizes are smaller than the particle size of the powder of the placental material, since they are formed by dimethyl sulfoxide vapors. Moreover, in some cases, such powder particles can have pores through, which enhances their influence on the creation of a highly efficient natural ion exchanger of biological substances with a wide spectrum of action, in particular, due to the formation of a channel between the media.

 And yet, in the known powdery bases, the material of their particles does not have a native structure, which dramatically reduces the therapeutic effect of the known bases. In the proposed basis, the particles have the material in the native state.

 The third problem is solved in that in a known drug containing a base of ground placental material and a target additive mixed with it, according to the present invention, a liquid-like mass of placental material is used as a base, which has a homogeneous structure and is in a creamy state, and its placental the material is in its native state, impregnated with glycerin and treated with dimethyl sulfoxide in an amount of up to 10% of the total mass, while the target additive is formed from vegetable oil ethanol in amounts and in proportions which give the appearance-based emulsion and ensure the safety of the material in its native state.

 This embodiment of the drug allows, due to emulsion properties, to maintain the native state of the placental base material for a long time, to provide good application with a uniform distribution of the biologically active substances of the base throughout the volume and surface, which significantly distinguishes the proposed base from the placental material from the known base obtained from a similar material.

There is another solution to this problem. When in a known medicinal product containing a base of ground placental material and a target additive mixed with it, according to the present invention, a liquid-like mass of placental material is used as a base, which has a homogeneous structure, and its material is impregnated with glycerin, is in its native state and treated with dimethyl sulfoxide in an amount up to 10% of the total mass, while dimethyl sulfoxide was used as the target additive in the following ratio of components, wt.%:
Base - 10-90
Target Supplement - Else
Distinctive features are the use of a base made of placental material, which is a liquid-like mass, for example, in a creamy state, i.e. one of the components of the composition has different physicochemical characteristics than the known bases, and the use of dimethyl sulfoxide as a target additive at a certain ratio of components.

 In the claimed agent, dimethyl sulfoxide is used as a solvent, preservative, as a component that provides deep penetration into the tissue of biologically active substances contained in the placental material, which is in its native state, and also as a component with its own antimicrobial, anti-inflammatory and analgesic effects.

 The physicochemical properties of the obtained product are largely determined by the homogeneous mass structure with the consistency of a red-brown liniment with a specific odor. The drug retains its properties when stored in a cool, dry place in dark glass bottles for three years.

 The choice of the ratio of the components is due to their properties and requirements for the finished product.

 The minimum content of the base and placental material in the finished product was selected in an amount of 10 wt.%, Since with a lower content there is practically no synergistic effect and the properties of the composition almost completely repeat the properties of the second component - dimethyl sulfoxide, i.e. there are also noticeable side effects inherent in this drug, which reduce the effectiveness of the drug. In addition, the content in the finished product of less than 10% of the base of the placental material and, accordingly, more than 90 wt.% Dimethyl sulfoxide changes the consistency of the product, making it too liquid, which leads to an uneven distribution of particles of the placental material when applying the product on the skin, because its homogeneous structure is violated.

 The maximum content of the base from the placental material in the finished product is selected in the amount of 90 wt.%, Because with its greater content in the finished product, the synergistic effect is also lost, and dimethyl sulfoxide in an amount of less than 10 wt.% does not ensure the complete delivery of biologically active substances contained in the placenta deep into the tissue, and there is no further enhancement of the biological effect. In addition, an insufficient amount of dimethyl sulfoxide (less than 10 wt.%) Leads to quick drying of the product applied to the skin, the formation of a crust, a reduction in the time of biological exposure, and also contributes to the rapid disruption of the homogeneous structure of the material.

 The inclusion in the composition of the claimed means of the base, representing a liquid-like mass of placental material, having a homogeneous structure and material in the native state, allows you to concentrate a large number of biologically active substances in the tool and to predetermine the technology for the preparation of the drug. The introduction of dimethyl sulfoxide as a solvent, as a preservative, as a component that ensures the deep penetration of biologically active substances contained in the base into the body tissue and has its own antimicrobial, anti-inflammatory and analgesic effect, enhances the useful properties of the finished product, namely high biological activity, long shelf life, external use of the drug on this basis. The placental material, impregnated with glycerin, retains its native state longer and is not afraid of freezing when stored in the frozen state.

Another option for solving the third problem, when in a known medicinal product containing a base of crushed placental material and a target additive mixed with it, according to the present invention, a liquid-like mass of placental material is used as a base, which has a homogeneous structure, and its material is in native condition and treated with dimethyl sulfoxide in an amount up to 10% of the total mass, while a water-oil-alcohol emulsion is used as the target additive in the following ratios of comp onents wt.%:
Base - 30-70
Target Supplement - Else
There is a development option for this solution, namely:
- in the water-oil-alcohol emulsion, vegetable oil (castor oil) was used as the oil fraction, and ethanol was used as the alcohol fraction with the ratio of the components of the emulsion 1: 1: 1.

 Distinctive features are the use of a liquid-like mass of placental material with a homogeneous structure, and its material is in its native state and treated with dimethyl sulfoxide and a composition having different physicochemical characteristics, as well as the use of a water-oil-alcohol emulsion as a target additive with a certain ratio of components .

 Water-oil-alcohol emulsion is used in the inventive tool as a solvent for biologically active substances contained in the base material (including water, fat and alcohol soluble). In addition, the alcohol contained in the emulsion is a preservative, and also has a partial denaturing effect on some large protein molecules, which eliminates the possibility of allergic reactions, and the oil component of the emulsion protects the skin surface from the tanning effect of alcohol, which prevents the penetration of biologically active substances deep into the tissue.

 The ratio of the components of the emulsion 1: 1: 1 is convenient for its preparation, however, it can be changed depending on the requirements for the drug on this basis.

 The water-oil-alcohol emulsion is non-toxic and is well tolerated by patients when applied to the skin.

 According to the physicochemical properties, the obtained agent (means for regulating tissue metabolism) is a homogeneous mass with the consistency of a red-brown liniment with a specific odor. The drug retains its properties when stored in a cool, dry place in dark glass bottles for three years.

 The choice of the ratio of the components is due to their properties and requirements for the finished product.

 The minimum content of the base from the placental material in the finished product is selected in an amount of 30 wt.%, Because with a lower content, the biological activity of the agent is much weaker, the analgesic effect is sharply reduced, and the properties of the composition almost completely repeat the properties of the second component - a water-oil-alcohol emulsion.

 The maximum content of the base from the placental material in the finished product is selected in the amount of 70 wt.%, Because with its greater content, not all biologically active substances are extracted with a solvent, irrational use of placental material occurs without enhancing the therapeutic effect. In addition, when the content of water-oil-alcohol emulsion in an amount of less than 30 wt.% Decreases the shelf life of the finished product due to the insufficient amount of alcohol.

 In addition, in this medicinal product, the basis is the liquid-like mass of the placental material in the native state, obtained from the semi-finished product proposed by the present invention, and which is formed from the placental material without first washing it repeatedly, prolonged sterilization at high temperatures and with a clearly defined state of the material , which leads to a high biological activity of the product, good repeatability of its characteristics, which are known drugs Vases based on placental material are sharply reduced and difficult to repeat.

 The introduction of a water-oil-alcohol emulsion into the composition of this product as a solvent, preservative, and as a component ensuring slow drying of the product applied to the skin enhances the useful properties of the finished product - high biological activity, long shelf life, and external use.

 Another solution to the third problem, when in a known medicinal product containing a base of crushed placental material and a target additive mixed with it, according to the present invention, a liquid-like mass of placental material is used as a base, which has a homogeneous structure and is in a creamy state, and its placental material is in its native state and treated with 6-10% acetic acid in an amount of up to 10% of the total mass, while 6-10% acetic acid was used as the target additive I acid in an amount equal to or greater than the amount of base material.

 A distinctive feature of this well-known drug is an unusual combination of a liquid-like mass of placental material in its native state with the target additive, acetic acid, which made it possible to obtain a drug for internal use, which in known drugs is based on that obtained from a known semi-finished product from placental material cannot be reached.

 The choice of the amount of acetic acid in the equal mass of the placental material is due to the need to obtain the dissolution of biologically active substances, which is achieved by the ratio of the volumes of liquid and solid phases contained in the material, and therefore, the amount of acetic acid must be used and more than the mass of placental material, achieving a more complete dissolution of the biological material .

 Another solution to the problem, when in a known medicinal product containing a base of crushed placental material and a target additive mixed with it, according to the present invention, the base with the target additive mixed with it is in a foam mass, in which a liquid-like placental mass is used as the base a material having a homogeneous structure, and its material treated with dimethyl sulfoxide in an amount of up to 10% of the total mass is a native state, with earinovaya acid or soap in the amount and ratios of forming a foamed mass. A distinctive feature of this variant of the drug is the creation of a foamed mass of placental material, which, for example, is absent in the known means prepared on the placental material. As a result, this tool is effectively used to treat various skin inflammations.

 The foam structure allows you to gently apply the drug to the damaged tissue, which is reflected in the absence of pain from the patient.

 The problem is solved in that in the known medicinal product containing a placental base material and a target additive according to the present invention, an amniotic membrane is used as the base, separated from the placental material in the native state, and dimethyl sulfoxide and / or as the target additive an antibiotic or ethanol in the amount and proportions synergistically enhancing the therapeutic effect of the base material, while the amniotic membrane is treated with a 0.5 molar chloride solution sodium and has a native structure.

There is a development option for this solution, namely:
- the amniotic membrane is processed with glycerin and frozen.

 A distinctive feature of this tool is the use of an amniotic membrane with the appropriate structure and separated from the placental material, which is in its native state, in combination with the corresponding target additive, which allows the use of this tool as a therapeutic and prophylactic, for example, removing irritation from the skin, t. to. used organic material with the nature of biological activity characteristic of humans, which is extremely important when providing first aid without a doctor, without fear of causing harmful side effects in the patient.

 In addition, a distinctive feature is the type of drug - a thin amniotic membrane.

 Interestingly, this drug allows combination with targeted additives, some of which penetrate into its structure, like dimethyl sulfoxide, and with its help enhance the flow of their biologically active substances into the patient’s tissues, others only remain on the surface, for example, a powdered antibiotic as a component, having an initial effect on the patient’s tissue, and already on it or in it is combined with biologically active substances secreted by the amniotic membrane. Everything is determined by the requirements for the treatment of the disease.

 In the frozen state, the amniotic shell with target additives is not only convenient to use for application, but also to transport, store and divide it into parts.

 And another solution to the same problem, when in a known medicinal product containing a base of ground placental material and a target additive mixed with it, according to the present invention, the base with the target additive mixed with it is in a liquid state with a melt liquid structure isolated from a liquid-like placental material treated with the target additive, which is used dimethyl sulfoxide, taken in an amount of more than 10% by weight of the mentioned material.

 A distinctive feature of this drug is the use as a base of liquid mixed with the target additive isolated from the crushed placental material in its native state, as well as its state as a thawed liquid, in which the physicochemical structure is changed, i.e. from an amorphous structure passes through a structure similar to ice to the structure of melt liquid with a corresponding increase in its biological activity and with a uniform distribution by weight and volume of biological active substances ki of placental material and to form a uniform base.

Embodiment
Immediately after birth, placental material is taken from healthy women in labor. They check it for the absence of external signs of decomposition on it: musty, decomposition of the material. If they are not, then the placental material is considered to be in the native state. Then they check it for the absence of infections: AIDS, hepatitis, syphilis. With a positive result, blood is washed off the surface of the material, i.e. they cleanse its appearance, for example, with distilled water and recognize it as a ready-made semi-finished product from the placental material in its native state.

To ensure long-term storage, the placental material is mixed with a cryoprotectant preserving its native state, for example, glycerin, the amount of which is usually taken up to 3% by weight of the material, and then frozen at a temperature of 30 to 40 ^o C.

 Glycerin keeps intracellular structures of the material in its frozen state, because the hygroscopicity of glycerol prevents the freezing of water from the material and thereby preserves the original native state of the placental material.

 It is possible to manufacture a semi-finished product from a part of the placental material, which is separated from the amniotic membrane of the said material. In this case, the semi-finished product has a material that is in its native state, but with a reduced number of biologically active substances, because the amniotic membrane, which forms another part of the placental material and is basically collagen in its native form, has been removed. But then the material of the semi-finished product is homogeneous, which is an extremely important circumstance.

 The best option for the semi-finished product is the semi-finished product, in which the placental material is in its native state and processed with a preservative in an amount of up to 10% of the total mass. As a preservative, dimethyl sulfoxide or 6-10% acetic acid is used.

 As a result, the preservative penetrates the placental material and contributes not only to its preservation, but also to the uniform distribution of its biologically active substances in the volume of the material, due to which the semi-finished product is prepared for the process of obtaining the corresponding drug base.

 The proposed semi-finished product can be made both from the placental material of a person, and from various types of animals, for example dogs, cattle (cows) and pigs.

 The manufacturing method is identical to that described, with the only difference being that placental material is taken from animals immediately after birth and frozen, after taking samples for the presence of pathogenic flora, toxins, etc. With a positive result, the semi-finished product is considered suitable.

 The proposed first drug base is made as follows.

Take the semi-finished product from the placental material, the manufacture of which has been described previously. Moreover, if the material of the semi-finished product is frozen, then it is first thawed and the amniotic shell is peeled off from it. Wash it off in a 0.5 molar solution of sodium chloride from the blood and rinse with distilled water. In this case, all actions are performed without violating the native state of the material, which can happen if the ambient temperature is above +20 ^o C. Or, when rinsing the material, they make such sharp and frequent movements of the material that they are washed out, thereby removing biologically active substances from the structure.

 Then it is washed with glycerin and frozen. As a result, a base is obtained from a material having a native structure.

 To prepare a drug on this basis, it is thawed and either impregnated with the target additive or the target additive is applied to the surface of the shell.

 The proposed second drug base is prepared as follows.

 Take the semi-finished product from the placental material, which is in the native state, and grind, for example, in a meat grinder or similar device. Moreover, the speed and effort of grinding is chosen from the conditions of preventing violations of the native state of the placental base material. As a result, the required drug base is obtained.

 In the case when the semi-finished product is taken with frozen placental material, it is crushed in a frozen state, which is preferable for the technology for producing the base.

 In the development of this option, grinding is performed until a liquid-like mass of placental material is formed, which is achieved, for example, by installing a lattice with small holes in a meat grinder and adding dimethyl sulfoxide to the material in an amount and in ratios that form a finely divided mass. Moreover, it is advisable to add dimethyl sulfoxide to the loading device of a meat grinder or similar mechanism so that it is absorbed into the placental material during its grinding. The resulting mass is brought to a homogeneous creamy and / or jelly-like state on a homogenizer or using a disintegrator. If placental material is taken after freezing, then it is crushed in a frozen form and then homogenized. In this case, the material is in its native state. The resulting creamy and / or jelly-like mass of placental material has a reddish-brown color, a specific smell, and a salty taste. Moreover, the structure resembles a dispersed-gel structure. The liquid is from 20 to 90% of the total mass. The specific percentage of the liquid phase in the resulting creamy and / or jelly-like basis from the placental material can be predetermined by the requirements for drugs manufactured on this basis. Moreover, in one case, the liquid phase is expelled from such a mass, and in the other case it can be added, for example, in the form of distilled water. However, the most optimal variant of the present drug base is the presence in the creamy and / or jelly-like mass of the placental material of the liquid phase obtained from it itself during grinding, for example, in a meat grinder, which allows all biologically active components of the feedstock to be based on in their natural state.

 In addition, a creamy and / or jelly-like mass is possible that has been impregnated with glycerol and frozen. In this case, when thawing, it acquires an additional useful property: preserving the crystalline structure of ice, the liquid phase increases its biological activity (acquires the properties of melt water), and is stored for a long time in the frozen state.

 The proposed drug base can be obtained from both the placental material of humans and various species of animals, such as dogs, cattle (cows) and pigs.

The method of obtaining the finished drug base is identical to that described previously, in particular:
after childbirth, the animal takes the placental material, which is immediately impregnated with glycerin and frozen, after having taken all the necessary samples for the presence of pathogenic flora, toxins, etc. This is a semi-finished product in which the material is in its native state. After receiving confirmation of the quality of the material, it is thawed, crushed, obtaining a liquid-like mass, which is then treated with dimethyl sulfoxide.

 The proposed base, in particular creamy mass, is the most complex in structure and composition, has physical and biochemical characteristics illustrated in table. 1 and 2.

 For preservation of the obtained drug base, it is permissible to introduce no more than 5% of the total mass of dimethyl sulfoxide into it.

 The proposed base can be used for the preparation of various medicines. In this case, it is extremely important to coordinate the physicochemical and pharmacobiological properties of the introduced additives with the properties of the base itself.

 Example 1

Prepared according to the previously described technology, in particular, a creamy mass of placental material is thoroughly washed from the blood with saline to obtain a clear liquid and a grayish-white precipitate. Then the washed precipitate is kept at a temperature of +3 - 5 ^o C for 7 days and then a 0.9% solution of sodium chloride is added to it in ten times the initial mass of placental material. Then it is sterilized in an autoclave at a temperature of +120 ^o C. The resulting drug is ready for use, in particular for subcutaneous injection and in its properties, as shown by biochemical studies, is comparable to similar indicators of a traditional placental extract.

 Example 2

The proposed base, in particular in the form of a creamy mass, is subjected to hydrolysis with hydrochloric acid (10: 1 ratio) and autoclaving (1.5 hours at 1.5 atm, at +120 ^o C). Then the cooled hydrolyzate is filtered and neutralized with sodium hydroxide to a pH of 7.0 and poured, followed by sterilization in an autoclave. Before use, the resulting drug is necessarily bound with an antiseptic and antibiotic.

 Thus obtained drug was also subjected to biological analysis, which showed that this drug is not inferior in its properties to a similar known agent prepared on a different basis.

 Both methods of preparation of the medicinal product on the proposed basis in the form of a creamy mass of placental material allow the maximum removal of the liquid phase from the base, to separate the tissue of the placental material. This makes it possible to accelerate the process of preparation of the drug, while maintaining its inherent pharmacological and biological activity.

 However, the present basis of the drug can be effectively used as an independent drug for therapeutic treatment in the following diseases: arthritis, arthrosis, the consequences of fractures and injuries, and some other diseases of the musculoskeletal system, metabolic disorders.

 This is due to the fact that in a creamy mass of placental material, all biologically active substances are in their most favorable natural state, when the absorption of biologically active substances from the base is sharply accelerated, regenerative processes in the body are accelerated, inflammatory phenomena of various nature are removed; the content of biologically active substances, the adaptive abilities of both individual tissues and the body as a whole increase; the body’s ability to self-regulate improves. All of the above leads the body, ultimately, to a harmonious balance of all physiological and biochemical functions.

 In addition, it is possible to use the proposed framework in frozen form for use as an independent drug for biologically active cryomassage and inhalation according to traditional technology.

For instance:
1. Jelly-like mass - for the treatment and healing of infected wounds in different animals. An acceleration of healing of 1.5-2 times was observed.

 2. Creamy mass - for the treatment of mastitis in goats and dogs. The term of complete cure was 2 days.

 3. Frozen jelly-like and creamy masses were used in beauty parlors for cryomassage, which was carried out according to traditional technology. An accelerated skin rejuvenation process was observed in patients, and also used in the form of masks for various types of skin (dry, oily, mixed).

A proposed other drug base is prepared as follows. Prefabricated material is taken from the placental material in the native state, or placental material in the native state is taken from healthy women in labor with its mandatory check for the absence of infection (AIDS, hepatitis, syphilis). If the result is positive, it is a ready-made semi-finished product, which is then crushed and treated with dimethyl sulfoxide to obtain a liquid-like mass. Then, a liquid phase is separated from it, which is frozen, for example, at -10 ^° C, thawed and a base is obtained in a liquid state.

 The proposed base can be used for the preparation of various medicines with different physical conditions.

 For example, the present base obtained by the previously described method is mixed with distilled water or with a physiological solution of sodium chloride, which, for example, is taken in volume by weight of the base and a drug is obtained having properties similar to the known drug based on placental material.

 Thus obtained drug was subjected to biochemical analysis, which showed that this drug is not inferior in its properties to a similar known agent prepared on a different basis.

 However, the present drug base can be effectively used as an independent drug for therapeutic treatment in the following diseases: arthritis, arthrosis, the consequences of fractures and injuries and some other diseases of the musculoskeletal system, metabolic disorders, psoriasis, for medical and cosmetic purposes and other things.

 This is due to the fact that in the basis, which has the form of melt liquid from the placental material, biologically active substances are in their most favorable natural state, when the absorption of biologically active substances from the base is sharply accelerated, regenerative processes in the body are accelerated, and inflammatory phenomena of various nature; the content of biologically active substances, the adaptive abilities of both individual tissues and the body as a whole increase; the body’s ability to regulate itself improves. All of the above leads the body, ultimately, to a harmonious balance of all physiological and biochemical functions, which improves the quality of the treatment process, in particular, in the treatment of otitis media in dogs and cats with liquid placental material. The term for a complete cure ranged from 2 to 5 days.

 Another proposed drug base is prepared as follows.

From healthy women in labor, placental material is taken, which is in the native state, with a mandatory check for the presence of infection (AIDS, hepatitis, syphilis). Upon receipt of a positive result, this is a ready-made semi-finished product, which is either frozen for storage or crushed, for example, in a meat grinder or similar device. The resulting mass is brought to a homogeneous creamy state on a homogenizer or using a disintegrator. After that, the content of the liquid phase is determined, for example, 82.3%, which is determined by the condition for taking the material and the amount of biologically active liquid. Then, with stirring, dimethyl sulfoxide is introduced, which is distributed throughout the entire volume of the mass evenly and penetrates into the intercellular space and into the cells. For example, 57.5 g of dimethyl sulfoxide were added. Then it is frozen, for example, at -40 ^o C. And finally, the frozen creamy mass of placental material is subjected to freeze drying, which initially causes the release of dimethyl sulfoskide vapor from the mass, and then draws water from it with its channels to form a solid porous structure. After drying, the time of which depends on the dryer used, the resulting porous mass is crushed to a powder from particles with a porous structure, for example, milled in a mill and 150 g of powder with a particle porosity of up to 60% are obtained.

 The manufacturing method of this base allows you to make a creamy mass of placental material, impregnate it with dimethyl sulfoxide, freeze and freeze-dry, and then obtain a powder with porous particles, which in principle changes the properties of the base from the placental material, but retains its native structure.

 The present drug base contains placental material in the form of solid particles, each of which has a porous structure. As a result, each particle has a well-developed surface, which allows it to contact a large area with the environment.

 In addition, the pores create conditions for the placental material to exhibit the properties of a natural ion exchanger, which in a known basis cannot be obtained from the placenta.

 The presence of such a structure for each particle of the proposed base reduces the possibility of caking, and also eliminates clumping.

 Thus, the present base is made of placental material with solid particles in the form of a powder. This powder has particles with a color from light brown to dark brown (a reddish tint is possible) with porosity from 30% to 60% by volume.

This design allows you to:
- increase the intensity of sorption-resorption processes;
- impregnate the base with other medicinal components, enhancing their effectiveness;
- have a prolonging effect;
- conduct gradual absorption of biologically active substances.

A biochemical analysis showed:
Protein content - 250 - 300 mg / g of powder
The content of total lipids and phospholipids:
Total lipids - 95.1 mg / g of the drug
Phospholipids - 41.2 mg / g
The content of individual phospholipids.%:
1. Phosphatidylcholine - 25.8
2. Lysophosphatidylcholine - 3.5
5. Sphingomyelin - 5.5
4. Phosphatidylethanolamine - 17.4
5. Phosphatidylserine - 22.6
6. Phosphatidylinositol - 14.3
7. Phosphatidic acid - 13.2
These data allow us to draw the following conclusions.

 The presence of a large number of phospholipids, which are the main elements in the structure of the cell membrane, makes it possible to regulate its permeability and beneficially affect ion exchange and internal respiration, biological oxidation, fixation of respiratory enzymes in mitochondria, and oxidative phosphorylation in energy metabolism of cells. A lack of phospholipids, for example, in some liver diseases leads to a violation of the functions of the cell membrane and a violation of fat metabolism, which leads to fatty degeneration of the liver. In addition, the presence of a developed pore structure in this basis enhances an additionally powerful detoxification effect.

All of the above allows you to use the specified basis as an effective tool for the treatment of:
fatty degeneration of the liver, acute and chronic hepatitis and other liver functions;
radiation syndrome;
poisoning;
psoriasis;
diseases of the gastrointestinal tract.

 Compared with known medicines of similar use, the proposed base is at their level, and in some cases they are superior, for example, in terms of biological value, balance of biologically active substances, selectivity of sorption-resorption processes, etc.

 The present drug base can be used, for example, in admixture with the well-known Almagel preparation, to produce a drug effective in the treatment of gastritis.

 To do this, take the proposed basis, in particular, in the amount of one gram and mix with 200 ml of Almagel drug and get a drug that has a higher therapeutic effect compared to the traditional one, in particular due to the developed pore structure, the presence of a balanced amount of biologically active substances.

 In addition, the real basis of the drug itself can serve as an independent drug, for example, for the treatment of certain metabolic disorders, diseases of the gastrointestinal tract, liver and musculoskeletal system.

 To do this, the proposed base is placed in capsules, tableted, or used in powder form.

 The proposed first drug is prepared as follows.

 The obtained base according to the technology considered earlier, in the form of a liquid-like mass of placental material and in a creamy state, for example, is mixed with the target additive, which can be formed in advance or formed during mixing with the base of the following components: vegetable oil, for example, castor oil, olive and ethanol. These components are taken as much as required to give the base emulsion properties.

 The ratio of the components of the target additive, their amount is determined by the purpose of the drug, the mass of the liquid phase in the base, as well as the type and type of vegetable oil.

 It is applied externally in the form of applications.

Another drug on one of the proposed foundations, for example, to regulate metabolic processes in tissues, is obtained in the following way. From healthy women in labor, plantar material is taken in the native state, it is checked for the absence of infection (AIDS, hepatitis, syphilis). This is the semi-finished product discussed earlier. If the result is positive, it is ground in a homogenizer to a creamy mass and treated with dimethyl sulfoxide. This is the foundation that was described earlier. Then mix thoroughly with a new portion of dimethyl sulfoxide and packaged in dark glass vials. The components are taken in the ratio, wt.%:
Placental material - 10 - 90
Dimethyl Sulfoxide - Else
The finished product, including these two components in a certain ratio, exhibits a synergistic effect, i.e. has a higher result than each individual component, for example, shorter periods of manifestation of a therapeutic effect, a more powerful analgesic effect.

 Example 1

 Patient S., 61 years old. Diagnosis: injected fracture of the neck of the right thigh. Injury 02/01/93, was hospitalized in the hospital, where gypsum was applied, conventional therapy was used. After 10 days, she was discharged for outpatient treatment.

 A month after the injury, 03/02/93, complained of pain in the area of injury in the right leg. Radiographs were taken that showed a lack of fracture healing. On examination, pronounced muscle atrophy was established. Gypsum is great.

 The patient was prescribed the application of the agent containing, wt.%: Placental material - 38, dimethyl sulfoxide - 62. Through a hole made in gypsum, a thin layer of the agent was applied with a spatula to the skin in the fracture area, kept for 30 minutes, then the rest of the agent was removed with a tampon. Applications were performed once a day daily for 30 days. The pain stopped after the second application. A gradual increase in muscle tissue was noted. Gypsum became cramped. 04/03/93, the plaster was removed. No bedsores. The tissue turgor is normal. Radiographs showed the presence of bone marrow. Pain does not bother.

 From 05.04.93, the patient began to walk on crutches, 05/03/93, walking with a cane, 05/29/93 was discharged to work. Repeated radiographs showed complete healing of the fracture.

 Traditionally, the treatment period for a femoral neck fracture is 4-6 months, and at the age of over 60, the prognosis of cure is often unfavorable.

 Thus, in the course of treatment with the claimed agent, a positive effect on metabolic processes in the bone and muscle tissues was noted, which allowed a sharp reduction in the duration of treatment, no side effects were detected.

 Example 2

 Patient M., 24 years old. Diagnosis: rheumatoid polyarthritis. Sick since 12 years. Traditional therapy (ortofen tablets, voltaren injections, Viprosal ointment, etc.) did not produce significant results. Appealed during an exacerbation of the disease. Complaints of joint pain, calming with movement. Notes morning stiffness. Almost all joints are affected, their swelling and deformation are noted. The patient hardly moves, especially when lowering the stairs. Radiographs showed the presence of osteoporosis and narrowing of the joint space.

In June 1992, a course of treatment was started. The patient was prescribed the application of the drug containing, wt.%:
Placental material - 55
Dimethyl sulfoxide - 54
Applications were carried out once a day, daily (with short breaks on weekends). The agent was applied with a spatula to the affected areas, kept for 20-30 minutes before drying, then its residues were removed with a tampon. A total of 45 applications were performed over 2.5 months.

 The pain decreased after two sessions. After 5 sessions, joint mobility began to increase, morning stiffness decreased, it became easier to move. The swelling in the joints began to decrease after 10 applications. After 45 sessions, the condition is satisfactory. Pain practically does not bother. Movement in the joints is almost free.

 A satisfactory condition is maintained 10 months after discontinuation of treatment; normal seasonal exacerbations were not observed. Repeated radiographs showed an increase in the joint space, a decrease in the manifestation of osteoporosis.

 Usually rheumatoid arthritis is difficult to treat, the remissions achieved during treatment are often short-lived, the treatment time is long - from several months to several years.

 Thus, in the course of treatment with the claimed agent, a positive effect on metabolic processes in bone and cartilage tissues was noted, which allowed to shorten the duration of treatment and increase the duration of remission. Side effects were not identified.

 Example 3

Patient O., 37 years old. Diagnosis: thermal burn of the II degree of the hand and forearm of the right hand. He turned the day after the burn. Complaints of pain in the hand. On examination, it was found: hyperemia of the hand and forearm of the right hand, the presence of large, filled with a transparent liquid, merging bubbles on the forearm of the hand and between the fingers. The patient was prescribed the application of the drug containing, wt.%:
Placental material - 64
Dimethyl sulfoxide - 36
Applications were carried out once a day daily for 8 days. The agent was applied with a spatula with a thin layer on the affected areas, kept for 20-30 minutes until drying.

 The pain disappeared after the first session. On the 5th day - the beginning of epithelization. There is no suppuration. On the 10th day - a complete restoration of the skin without scarring. With conventional therapy, the healing period of a II degree burn is at least 3 weeks. At the same time, suppuration and scarring are frequent.

 Thus, when using the claimed funds for the treatment of burns, a positive effect on metabolic processes in the tissues of the skin was noted, which allowed to shorten the duration of treatment and avoid suppuration and scarring. No side effects have been identified.

 Example 4

Patient V., 31 years old. Diagnosis: psoriasis. Sick for 12 months. Treatment with known agents has not yielded significant results. Asked for help during an exacerbation of the disease. Complaints of itching at the locations of psoriatic sores. On examination, the presence of thickened psoriatic plaques on the chest in the sternum and on the elbows was established. In September 1991, the patient was prescribed a course of 10 applications of a drug containing, wt.%:
Placental material - 57
Dimethyl sulfoxide - 43
Applications were carried out once a day, daily.

 The agent was applied to the affected area with a spatula in a thin layer, kept for 20-30 minutes to dry, then the residues were removed with a swab. 15 sessions were conducted over 20 days (with short breaks on weekends). After the 2nd session, the itching decreased and stopped by the 5th session.

 The detachment of the scales occurred painlessly, they were removed with a swab along with the remnants of the product after the session.

 After the course of treatment, a complete disappearance of psoriatic plaques was observed.

 Thus, when using the inventive agent for the treatment of psoriasis, a positive effect on metabolic processes in the tissues of the skin was noted, which led to a reduction in the duration of treatment.

 No side effects have been identified.

 The above examples prove that the use of the claimed drug in the treatment of metabolic disorders in tissues that occur during inflammation of various origins, injuries, burns, skin diseases, etc., can reduce treatment time, as well as expand the arsenal of agents that affect tissue metabolism and applied externally.

Another drug on the proposed basis, for example, to regulate tissue metabolism, is obtained in the following way. From healthy women in labor, placental material is taken in their native state and checked for the absence of infections (AIDS, hepatitis, syphilis). This is a semi-finished product. Then it is crushed in a homogenizer to a creamy mass while maintaining the native state of its material. This is the basis. A water-oil-alcohol emulsion is added, mixed thoroughly and packaged in dark glass vials. The components are taken in the ratio, wt.%:
Placental material - 30-70
Water-oil-alcohol emulsion - Other
A water-oil-alcohol emulsion is prepared separately by mixing the components, which are taken in a ratio of 1: 1: 1, with ethanol being used as the alcohol, and vegetable oil, for example, castor oil, as the oil fraction.

 Example 1

Patient O., 48 years old. Diagnosis: osteochondrosis of the thoracic spine. Sick for 4 years. Appealed during an exacerbation of the disease. Complaints of pain in the thoracic spine, aggravated by tilting and turning the body, lifting weights. Pain on palpation, muscle tension in the interscapular region, crunching during movement are noted. The patient was prescribed the application of the drug, containing, wt.%:
Placental material - 43
Water-oil-alcohol emulsion - 57
Applications were performed 1 time per day daily. A total of 25 sessions. After the 3rd session, an improvement in general condition and pain relief were noted. After the 7th - a significant reduction in pain and improved sleep. After the 11th session - an increase in mobility in the thoracic spine, pain only in the evenings. After the 20th session, the pain is practically not disturbed, the movement in the spine is free, the crunch has disappeared.

 Usually, osteochondrosis is difficult to treat, under favorable conditions, the period for the appearance of signs of improvement is more than 2 months. Thus, in the treatment process by the claimed means, a positive effect on metabolic processes in the bone and cartilage tissues was noted, which allowed to shorten the treatment period, no side effect was detected.

 Example 2

Patient L., 52 years old. Diagnosis: chronic dermatitis of unknown etiology in the palms of both hands. Sick for several years. Treatment with corticosteroid ointments (flucinar, prednisone) did not give significant results. On examination, congestive hyperemia, numerous vesicles, erosion, crusts, scales and cracks were noted. The patient was prescribed the application of the drug, containing, wt.%:
Placental material - 51
Water-oil-alcohol emulsion - 49
Applications were carried out once a day daily. The agent was applied with a spatula to the affected areas, kept for 20-30 minutes until drying. Conducted a total of 6 applications. After the 2nd session, an improvement in the general condition, a gradual decrease in hyperemia, a decrease in the number of vesicles, exfoliation of crusts and scales, and healing of cracks were noted. Complete epithelization occurred after 5 sessions. 3 months after the end of treatment, no new skin lesions were observed. Thus, in the course of treatment with the claimed agent, a positive effect on tissue metabolism in the skin was noted, which allowed to shorten the duration of treatment and increase the duration of remission. No side effects have been identified.

 Example 3

 Patient V., 55 years old. Diagnosis: post-injection soft tissue abscess of the left thigh. Complaints of pain in the left thigh. On examination, swelling, hyperemia, soreness, swelling in the center of a dense infiltrated zone, the size of which was 10 cm in diameter, were noted.

The patient was prescribed a course of applications of a drug containing, wt.%:
Placental material - 62
Water-oil-alcohol emulsion - 38
Applications were carried out once a day daily, in total 7 sessions were conducted. After the 1st procedure, the pain stopped, after the 2nd session - the abscess opened on its own with the release of pus. After 7 days of treatment, the discharge of pus stopped, the wound healed. Usually, abscesses are opened surgically, the wound is cleaned, Vishnevsky ointment is applied. The healing period is about a month. Thus, when using the claimed means for the treatment of abscess, a positive effect on metabolic processes in the tissues of the skin was noted, which allowed to shorten the duration of treatment. No side effects have been identified. In all the examples cited, a water-oil-alcohol emulsion of the following composition was used: distilled water, castor oil and ethanol in a ratio of 1: 1: 1. Thus, the use of the claimed funds in the treatment of tissue metabolism disorders arising from inflammations of various origins, injuries, burns, skin diseases, etc., can reduce the treatment time, as well as expand the arsenal of drugs that affect tissue metabolism and are applied externally.

 Another proposed drug is prepared as follows.

 From healthy women in labor, placental material is taken in their native state, checked for absence of infection (AIDS, hepatitis, syphilis). This is a semi-finished product that has been proposed and reviewed previously. Then it is crushed in a homogenizer to a creamy mass, which has a homogeneous structure, and the material is a native state, treated with 6-10% acetic acid in an amount of up to 10% of the total mass. This is the basis of the drug, one of the previously considered. To obtain the drug, it is mixed with the target additive, in which 6-10% acetic acid is used in an amount equal to or greater than the amount of the base material. The rate of grinding, homogenization and mixing is chosen from the conditions of preservation of the placental material of the native state.

 The amount of 6-10% acetic acid is selected depending on the purpose of the drug, the mass of the liquid phase in the base. It is applied externally and internally.

 Example.

 Patient M., 49 years old. Diagnosis: gastroduodenitis. One teaspoon was given in 0.5 cups of water 30 minutes before meals, once a day. After the first application - the disappearance of belching and pain in the epigastrium. After a week of treatment, the load of alcohol did not give the expected sensations.

 Another proposed drug is prepared as follows.

 From healthy women in labor, placental material is taken in their native state, checked for the absence of infection (AIDS, hepatitis, syphilis). This is a semi-finished product that has been proposed and reviewed previously. Then it is ground in a homogenizer to a liquid-like mass, treated with dimethyl sulfoxide in an amount of up to 10% of the total mass. The material is in its native state, and the mass has a homogeneous structure. This is one of the proposed and reviewed basics of the drug.

 To obtain a medicinal product, it is mixed with the target additive, which is used stearic acid or soap in the amount and proportions forming a foamed mass. To close its structure, it is advisable to add glycerin.

 Example.

 Patient M., 57 years old. I rubbed my right shin. Abrasion turned into inflammation. By applying the drug (placental material in the native state + soap), pain in the affected area was removed during the day.

 Another proposed drug is prepared as follows.

 From healthy women in labor, placental material is taken in their native state, checked for absence of infection (AIDS, hepatitis, syphilis). If the result is positive, it is a semi-finished product, considered earlier. Then, the amniotic membrane is separated from the placental material, it is treated with a 0.5 molar solution of sodium chloride. This is the basis of the drug, proposed and considered earlier. Typically, such a base is still processed with glycerol and is in a frozen state.

 For the preparation of a medicinal product, the aforementioned base is taken from the amniotic membrane of the placental material and the target additive, for example 10% dimethyl sulfoxide. In this case, the drug is stored for a long time without losing its healing properties. It is recommended to store, as well as all the means described in this application, in a jar in a cool dark place. It is used without preliminary preparation and without special treatment of the skin by applying it to a sore spot and gluing or dressing is fixed on it.

 Such a drug works as a semipermeable membrane, creating normal conditions for tissue respiration, which is due to the stimulation of skin regeneration by the collagen base of the membrane and its native structure.

 And the last of the proposed drugs are prepared as follows.

 From healthy women in labor, placental material in their native state is taken. Check for the absence of infection (AIDS, hepatitis, syphilis). If the result is positive, it is a semi-finished product, considered earlier. Then the material is ground and treated with dimethyl sulfoxide and get, for example, a creamy mass. This is the foundation discussed earlier.

To obtain a medicinal product, such a base is mixed with the target additive - dimethyl sulfoxide in an amount of more than 10% of the total mass, kept at room temperature for 7-10 days. Then the liquid phase is isolated and it is frozen, for example, at -10 ^° C, and then thawed and the temperature of the thawed liquid is maintained. This is a finished medicine.

 Such a medicine can be used to treat the following diseases: arthritis, arthrosis, the consequences of fractures and injuries and some other diseases of the musculoskeletal system, metabolic disorders, psoriasis, and can also be used for medical and cosmetic purposes, etc.

 This is due to the fact that biologically active substances are in the most favorable natural state for them in melt liquid from placental material, when the processes of absorption of biologically active substances, regenerative processes in the body are sharply accelerated, and inflammatory phenomena of various nature are removed; the adaptive abilities of both individual tissues and the body as a whole increase; the body’s ability to self-regulate improves, the effect of biological feedback arises. All of the above leads the body, ultimately, to a harmonious balance of all physiological and biochemical functions.

 In addition, it is possible to use the proposed drug in frozen form for biologically active cryomassage, inhalation and externally in some cases.

 It is advantageous to use this drug as a prophylactic after dental procedures, and in the treatment of periodontal disease by irrigation of the oral cavity or by applying a swab moistened with this liquid.

The proposed semi-finished product for obtaining the base of the medicinal product, the base of the medicinal product from this semi-finished product, the medicinal product on this basis are close to "ideal" to achieve the final result: they are applied externally and penetrate freely through the skin; the effect of self-dosing, i.e. the body itself doses the amount of biologically active substances it needs (there is no likelihood of an overdose); do not require special instrumentation, difficult conditions and restrictions on movements for the patient. With the external use of the proposed medicines, the basics are observed:
slight hyperemia resulting from a mild vasodilating effect;
analgesic effect (analgesia) due to biologically active substances (BAS) of natural origin;
strengthening of regenerative and regenerative processes in various tissues, regeneration and restoration of sensitivity of nerve endings, cartilage tissue regeneration, etc .;
reduction of puffiness and complete removal of edema of various origins;
anti-inflammatory effect;
restoration of joint mobility, elasticity of muscles and ligaments;
improvement and normalization of trophic functions of the skin and tissues.

 The present invention does not cause unwanted side effects.

 Thus, the proposed inventions are united by a single inventive concept and constitute a comprehensive solution that encompasses the technological chain of transformation of the source material to obtain medicines based on it, which, like their constituent components, have industrial applications in medicine, veterinary medicine, and cosmetology.

Claims (18)

 1. Prefabricated to obtain the basis of the medicinal product containing placental material, characterized in that the placental material is in a native state.  2. The semi-finished product for obtaining the drug base according to claim 1, characterized in that the placental material is mixed with a cryoprotectant preserving its native state, for example with glycerin, and frozen, the amount of glycerol being up to 3% by weight of the said material.  3. A semi-finished product for the preparation of a drug base according to claims 1 and 2, characterized in that the placental material is treated with a preservative in an amount of up to 10% of the total mass, with dimethyl sulfoxide or 6-10% acetic acid being used as a preservative.  4. The semi-finished product for producing a medicine according to claim 2, characterized in that a part separated from its amniotic membrane is used as the placental material.  5. The basis of the medicinal product containing a semi-finished product from placental material, characterized in that the semi-finished product from placental material used amniotic membrane isolated from the said material in its native state, and treated with a 0.5 molar solution of sodium chloride, as well as impregnated with glycerin and frozen.  6. The basis of the medicinal product containing crushed semi-finished product from placental material, characterized in that the crushed material of the semi-finished product is in the native state.  7. The drug base according to claim 6, characterized in that the crushed material of the semi-finished product, which is in its native state, is impregnated with glycerin and frozen.  8. The drug base according to claim 6, characterized in that the crushed semi-finished product has placental material mixed with dimethyl sulfoxide in the amount and proportions forming a liquid-like mass with a homogeneous structure and being in a native state.  9. The basis of the drug according to claim 8, characterized in that the liquid-like mass is in a creamy and / or jelly-like state.  10. The basis of the drug according to claim 9, characterized in that the liquid mass is impregnated with glycerol and frozen.  11. The basis of the medicinal product containing solid particles of crushed semi-finished product from placental material, characterized in that each solid particle of crushed semi-finished product has at least pores on its surface formed by the liquid phase of the material mixed with dimethyl sulfoxide and a native structure.  12. A medicine containing a base of crushed placental material and a target additive mixed with it, characterized in that the liquid-like mass of the placental material is used as the base, which has a homogeneous structure and is in a creamy state, and its placental material is in the native state, impregnated with glycerol and treated with dimethyl sulfoxide in an amount up to 10% of the total mass, while the target additive is formed from vegetable oil and ethanol in an amount and proportions giving ove type emulsion and ensure the safety of the material in its native state. 13. A medicine containing a base of crushed placental material and a target additive mixed with it, characterized in that the liquid mass of the placental material is used as the base, which has a homogeneous structure, and its material is impregnated with glycerin and is in its native state, as well as processed dimethyl sulfoxide in an amount up to 10% of the total mass, while dimethyl sulfoxide was used as the target additive in the following ratio of components, wt.%:
Base - 10 - 90
Target Supplement - Else
14. A medicinal product containing a base of ground placental material and a target additive mixed with it, characterized in that the liquid mass of the placental material is used as the base, which has a homogeneous structure, and its material is in its native state and treated with dimethyl sulfoxide in an amount of up to 10 % of the total mass, while a water-oil-alcohol emulsion was used as the target additive in the following component ratios, wt.%:
Base - 30 - 70
Target Supplement - Else
15. The drug according to 14, characterized in that in the water-oil-alcohol emulsion, vegetable oil, castor oil are used as the oil fraction, and ethanol is used as the alcohol fraction in the ratio of the components of the emulsion 1: 1: 1.  16. A medicine containing a base of crushed placental material and a target additive mixed with it, characterized in that a liquid-like mass of placental material is used as a base, which has a homogeneous structure and is in a creamy state, and its material is in its native state and processed 6 - 10% acetic acid in an amount up to 10% of the total mass, while 6 - 10% acetic acid in an amount equal to or greater than the amount of the base material was used as the target additive.  17. A medicine containing a base of crushed placental material and a target additive mixed with it, characterized in that the base with a target additive mixed with it is in a foamed mass, in which a liquid-like mass of placental material having a homogeneous structure is used, and its material treated with dimethyl sulfoxide in an amount of up to 10% of the total mass is the native state, while stearic acid or soap in the amount and proportions, arr. foam-forming mass.  18. A medicinal product containing a placental base material and a target additive, characterized in that an amniotic membrane is used as the base, separated from the placental material in the native state, and dimethyl sulfoxide and / or antibiotic are used as the target additive in the amount and proportions synergistically enhancing the therapeutic effect of the base material, while the amniotic membrane is treated with a 0.5 molar solution of sodium chloride and has a native structure.  19. The drug according to p. 18, characterized in that the amniotic membrane is impregnated with glycerol and frozen.  20. A medicine containing a base of crushed placental material and a target additive mixed with it, characterized in that the base with a target additive mixed with it is in a liquid state with a melt liquid structure isolated from a liquid-like placental material treated with the target additive as which is used dimethyl sulfoxide, taken in an amount of more than 10% by weight of the mentioned material.

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