Glauconite-based intestinal sorbent and its production method

Abstract

FIELD: intestinal sorbents.SUBSTANCE: invention can be used in the food industry for the manufacture of dietary supplements (DS) and in healthcare to normalize the gastrointestinal tract (GIT) and other body system condition. A glauconite-based intestinal sorbent with ion-exchange properties is a powder of 0.001-0.01 mm fraction of glauconite with a glauconite content of 80-90%, enriched by magnetic separation with the “СМС-20-ПМ1” unit.EFFECT: intestinal sorbent has enhanced sorption and ion exchange properties.1 cl, 3 tbl, 3 ex

Description

[0001] The invention relates to the field of food biotechnology, namely to enterosorbents and the technology for their production, and is intended for use in the food industry for the production of biologically active food supplements (BAA) and in healthcare for the normalization of the gastrointestinal tract (GIT) and other body systems, as well as related sectors of the national economy (veterinary science, chemistry, cosmetology, pharmacy and food industry).

[0002] Enterosorbents are products used to bind metabolites, toxins, and other substances in the digestive tract. They are typically used to optimize human and animal nutrition, reduce the intake of environmentally harmful substances (including radionuclides, pesticides, and heavy metals), and prevent and treat a number of diseases, such as dysentery, viral hepatitis, drug and food allergies, bronchial asthma, diabetes, and lipid metabolism disorders.

[0003] Ion exchangers are used to enrich the body with essential microelements that are not supplied with food or are not available in sufficient quantities.

[0004] Various mineral substances, such as zeolites, bentonites, activated carbon, microcrystalline cellulose, lignins and their derivatives, are currently widely used as enterosorbents.

[0005] The most well-known enterosorbent is activated charcoal (VIDAL Handbook. Medicines in Russia. - M .: OVPEE - Astra Pharm Service, 2000 - S.E-8), widely used in the chemical, food, pharmaceutical industries and in medicine. However, it does not have ion-exchange properties, while it has a relatively low sorption activity with low selectivity of the sorption action to such substances as cholesterol, bilirubin, urea, uric acid, which are usually removed from the body by the excretory organs. With its use, constipation and diarrhea are possible; and with long-term use - hypovitaminosis, impaired absorption of nutrients from the gastrointestinal tract. Activated carbon is contraindicated in ulcerative lesions of the gastrointestinal tract, with gastric bleeding.

[0006] There is a known medicinal product (RU 2124358, 1999) for the treatment of gastrointestinal diseases with aluminum phosphate as an active ingredient, however, it does not have ion-exchange properties and only has an effect on reducing acidity, while it is ineffective in removing toxic substances from the body.

[0007] A drug (BG 61500, 1997) is also known, which uses a mixture of aluminum and magnesium hydroxide in combination with lysozyme as an enterosorbent. It has bactericidal properties due to the presence of lysozyme, but lacks ion-exchange properties and cannot absorb and remove harmful toxic substances from the body, nor normalize gastrointestinal function.

[0008] Glauconite is one of the promising enterosorbents with ion-exchange properties. Glauconite is used in various fields of technology, including the processing of beverages for the purpose of their clarification (RU 94021998, 1996); in foundry molding mixtures to improve the quality of foundry cores and molds (SU 1388184, 1988); to reduce water hardness, fertilize soils, and manufacture paints (SES, Moscow, "Soviet Encyclopedia", 1990, p. 313); in crop production to reduce the content of pesticides in plants, improve seed germination, increase the biological mass of plants, as a complex fertilizer of gradual action for many crops (rice, millet, wheat, potatoes, corn, tomatoes and others), to increase the green mass of annual grasses, to improve the water-physical regime of the soil, etc. (Atlas of non-traditional types of agrochemical mineral raw materials of the USSR / USSR Ministry of Geology; All-Union Scientific Research Institute of Geology and Non-Metallic Minerals; Comp. P.O. Ablamitov, A.I. Burov, I.S. Guziev, et al.: Ed. by U.G. Distanov, A.S. Filko, V.F. Semenov. - M.: Nedra, 1989, 64 p., Srodnykh O.E., Kovalchuk A.I. Experimental research work on the use of opal-cristobolite rocks for growing plants / Report. NPO "Sredneuralskoye" (UralNIISelkhoz) IGG RAS, Ekaterinburg, 1998).

[0009] Currently, in medicine and veterinary science, glauconite is used mainly as a component of various complex preparations used in veterinary science and medicine, as well as as a feed additive.

[0010] For example, a composite sorbent for radionuclide sorption is known, which contains a mixture of glauconite and polymethylsiloxane polyhydrate in a weight ratio of 5:95 to 95:5 (patent RU 2570877). Also known is a dry form of a therapeutic and prophylactic probiotic preparation, consisting of a dose of Bacillus spore biomass and a sorbent made of natural zeolite. The zeolite can be glauconite, a mineral obtained from the Kari deposit in the Chelyabinsk region by grinding it to a fraction of 0.01-0.1 mm (RU 43767).Patent RU 2706549 (2018) discloses an enterosorbent for animals and a method for producing it, which is characterized in that glauconite concentrate with a rock content of 40-95% is treated with a 0.1 M NaOH solution in a glauconite / solution weight ratio of 1:20 for 20 minutes, washed from alkali with distilled water and treated with a 0.1 M HCl solution for 20 minutes, followed by washing from acid, then glauconite is converted to the Na form in a 3.0 M NaCl solution for 1 hour, followed by washing from chlorine ions, the prepared glauconite is mixed with grain flour in the form of a 10% aqueous solution and sugar in the form of a 50% aqueous solution in a ratio of parts of 75:1:24, heated until the ingredients are completely dissolved, from the resulting homogeneous The masses form boluses with a glauconite concentrate content of 75% and are dried at ambient temperature until excess moisture evaporates.In addition, an enterosorbent is known, which is an aqueous solution of agar containing 1.8-2.2 g of glauconite of fraction 0.01-0.1 mm (RU 2188652, 2002).

[0011] However, known products have a number of drawbacks, including the use of glauconite rocks only from certain deposits (Kariyskoye deposit, Bondarskoye deposit), poor sorption and ion-exchange properties, and the use of complex technologies in the production of complex preparations, which reduces the quality of the resulting products. Other disadvantages include the difficulty of suspending them in pure form, the instability of the resulting suspension due to its high density, and, consequently, a decrease in the effectiveness of such products.

[0012] As an analogue, we can use patent RU 2545711 (2013), which discloses an enterosorbent based on glauconite, which is a 40-80% suspension in water of a fraction of 1.0-10 μm of glauconite. To obtain the specified suspension, glauconite is ground in a ball mill; selected to a size of 1-10 μm, using magnetic separation on magnetic drum separators of the SMBM type manufactured by NPO Erga with adjustable induction from 200 to 250 mT and a field gradient of 50 to 70 mT / cm, a rock containing from 20 to 95% of glauconite is selected; a 40-80% suspension of glauconite in water is prepared; and then the resulting mixture is treated with ultrasound at a frequency of 15-25 kHz for 2-5 minutes.

[0013] The enterosorbent obtained in the form of a suspension by the specified method has a number of disadvantages, among which are the instability of the resulting suspension due to its high density, as well as the insufficient effectiveness of the resulting drug due to a decrease in sorption and ion-exchange properties during suspension and ultrasonic treatment.

[0014] It should also be noted that glauconite is a mineral of variable (inconstant) composition, and composition variations are associated with isomorphic substitutions. The content of the main components is usually within the range, %: Si2- 47-50.5; Al2O3- 5-10; Fe2O3- 15-22; FeO - 2-4; MgO - 3-4; CaO - 0-0.8; Na2O - 0-0.5; K2O - 6-8; H2O - 7-9. Also, the composition may include copper, silver, nickel, cobalt, manganese, zinc, molybdenum, arsenic, chromium, tin, beryllium, cadmium and other trace elements.Moreover, despite the fact that the analogue for obtaining a suspension uses an intermediate product obtained by grinding, selection to a size of 1-10 μm, with subsequent magnetic separation to select a rock containing from 20 to 95% glauconite content, it was revealed that the said intermediate product has a number of disadvantages, which, as a result of the technology used, include obtaining a product with a depleted (not complete) qualitative and quantitative composition, with a low specific surface area and with increased dusting properties, which, among other things, leads to obtaining a suspension with low stability and low sorption and ion-exchange properties.

[0015] The technical objective of the proposed invention is to create a new enterosorbent based on glauconite, which has increased sorption capacity and high ion-exchange capacity with a complete qualitative and quantitative composition, in the form of a powder with a low dusting level and does not require special storage conditions (including freezing and thawing).

[0016] According to the present invention, a glauconite-based enterosorbent is an 80-90% glauconite powder of 0.001-0.01 mm fraction, enriched by magnetic separation. To obtain the glauconite-based enterosorbent, glauconite is ground and its fraction is collected. After grinding the glauconite with a rock content of 80 to 95%, the 0.001-0.01 mm fraction is collected, followed by enrichment using magnetic separation.

[0017] It should be noted that glauconite activation following enrichment occurs through magnetic separation of 80-90% of the 0.001-0.01 mm glauconite powder. Separation is performed using the SMS-20-PM1 separator, but other similar separators can also be used. Glauconite rock can be obtained from any deposit, ensuring the versatility of the proposed enterosorbent, which contains the maximum amount of microelements in chelated form.

[0018] As a result, due to the technology of obtaining activated 80-90% powder of 0.001-0.01 mm fraction of glauconite, the resulting stable product (the declared enterosorbent) with an increased specific surface area of ​​glauconite and a complete qualitative and quantitative composition is characterized by high sorption and ion-exchange properties, ease and effectiveness of use in the form of powder with a low dusting level and the possibility of storage in a wide range of temperatures from minus 30 to plus 50 ° C.

[0019] Please note that this enterosorbent can be used either in pure powder form or in a stable suspended form. Stability is achieved due to the properties of the enterosorbent powder obtained by the stated method. It binds and removes pathogenic bacteria and bacterial toxins, medications, poisons, heavy metal salts, alcohol, allergens, as well as excess metabolic products, including bilirubin, cholesterol, urea, and metabolites responsible for the development of endogenous toxicosis. Unlike antibacterial agents, it does not lead to the development of dysbiosis, but rather ensures the normalization of intestinal microflora. It is non-toxic and is completely eliminated from the intestines within 24 hours.

[0020] Example 1. Sorption activity.

[0021] The adsorption activity was determined in relation to the dye methylene blue (a marker of low-molecular toxins), the dye Congo red, and serum albumin.

[0022] Table 1. Adsorption activity of enterosorbent (glauconite: water ratio 50:50)

[0023] Product Adsorption activity, mg / g Serum albumin (HSA 0.5% aqueous solution) at an initial protein solution concentration of 1000 mg / l methylene blue Congo red Enterosorbent 601±12,0 47,2±0,4 87±3,5 Enterosorbent analogue (RU 2545711) 550±19,0 6,2±0,3 62±9,5 Enterosgel 18,2±1,0 17,4±0,7 12±1,5 Noolite 37,1±0,5 3,8±0,5 65,3±9,4 Zeolite 510±15,0 4,8±0,5 72±8,5 Smectite 577±11,0 45,5±0,2 85,5±6,1 Activated carbon 200,2±9,8 1,1±0,1 61,6±9,7 Polyphepan 48,9±9,9 2,5±0,4 84,6±6,5 Polysorb 41,7±5,0 1,5±0,3 372,5±7,3

[0024] Based on the results of the experiments, it follows that the declared enterosorbent significantly exceeds the sorption activity of its analogues in terms of adsorption activity.

[0025] Example 2. Comparative analysis of the clinical effectiveness of enterosorbents in the treatment of iron deficiency anemia.

[0026] 211 patients diagnosed with iron deficiency anemia (hereinafter referred to as IDA) were observed.

[0027] Research conditions:

[0028] - the average age of patients is 45.3 ± 12.7 years,

[0029] - body mass index (BMI) - 30.7 ± 7.3 kg / m2,

[0030] - experimental group - included 55 patients (23 women, 32 men) receiving the claimed enterosorbent based on glauconite (hereinafter referred to as Glauconite) at 5 g / day for 60 days,

[0031] - control group 1 - included 56 patients (32 women, 24 men) receiving Sorbifer Durules (iron sulfate + ascorbic acid) at the manufacturer's dosage,

[0032] - control group 2 - included 46 patients (21 women, 25 men) receiving the dietary supplement "Feroglobin B12" (ferrous iron, copper, zinc, iodine, vitamins B1, B6, B12 and folic acid) at the manufacturer's dosage,

[0033] - control group 3 - included 54 patients (23 women, 31 men) receiving a suspension similar to (patent RU 2545711) at 100 ml (5 g glauconite) per day for 60 days.

[0034] Table 2 clearly presents the positive results of patients taking Glauconite, i.e. the claimed enterosorbent based on glauconite.

[0035] Table 2. Efficiency of enterosorbents in the treatment of iron deficiency anemia

[0036] Group Hemoglobin level, g / l Serum iron level, μmol / L Original In 30 days In 60 days Original In 30 days In 60 days Experimental 88,2±5,4 114,0±6,6 141,3±4,6 6,1±1,7 12,2±2,9 25,2±4,5 Test 1 89,7±6,1 102,0±7,1 127,3±5,2 6,4±0,7 8,3±0,9 14,2±4,0 Test 2 90,2±4,3 109,0±5,6 128,3±3,8 6,3±1,1 9,2±1,0 18,7±3,8 Test 3 89,2±4,3 108,0±2,6 123,1±3,2 6,0±1,2 8,2±0,6 12,8±2,3

[0037] It should be noted that in terms of its therapeutic properties - the ability to increase hemoglobin and iron levels, the proposed enterosorbent is superior to known drugs for the treatment of IDA, which is due to its high ion-exchange properties.

[0038] Example 3. Comparative analysis of the clinical effectiveness of enterosorbents in the treatment of dysbiotic intestinal disorders.

[0039] A total of 52 patients with intestinal dysbiotic disorders were observed. The experimental group included 18 patients receiving the claimed Glauconite at 5 g / day for 60 days, control group 1 included 16 patients receiving the drug Polysorb at the manufacturer's dosage, and control group 2 included 18 patients receiving a suspension according to the analogue (patent RU 2545711) at 100 ml (5 g of glauconite) per day for 60 days. All patients had the following symptoms: periodic complaints of bloating and / or abdominal pain, stool disorders (diarrhea, constipation), poor appetite, low bifidobacteria content in feces (no more than 10 2 / G).

[0040] Table 3 clearly presents the positive results of patients taking the claimed Glauconite.

[0041] Table 3. Clinical efficacy of enterosorbents in the treatment of dysbiotic intestinal disorders

[0042] Group Bloating / Abdominal pain Stool disorder The number of bifidobacteria in feces Original In 15 days In 60 days Original In 15 days In 60 days Original In 15 days In 60 days Experimental + - - + - - not higher than 102 / g 102 / g - 104 / g - 105 / g - 106 / g - Test 1 + - + + - / + + not higher than 102 / g 102 / g - 103 / g - 102 / g - 103 / g - Test 2 + - / + - / + + + - / + not higher than 102 / g 102 / g - 103 / g - 102 / g - 104 / g -

[0043] According to the results of the conducted studies, a more effective and rapid restoration of normal intestinal microflora was observed in patients who received the stated enterosorbent Glauconite, which was reflected in a noticeable improvement in well-being, improved appetite, complete disappearance of bloating and abdominal pain, normalization of stool and a significant increase in bifidobacteria in the stool mass.

[0044] Thus, the proposed glauconite-based enterosorbent, obtained in accordance with the claimed method, provides high sorption and ion-exchange properties, which makes it possible to increase the efficiency of using the claimed glauconite powder as an enterosorbent.

Claims

1. Enterosorbent based on glauconite with ion-exchange properties, which is 80-90% powder of 0.001-0.01 mm fraction of glauconite, enriched by magnetic separation.

2. Enterosbent according to paragraph 1, characterized in that glauconite is activated using magnetic separation.

3. Enterosbent according to paragraph 1, characterized in that it contains the maximum amount of microelements in chelated form.

4. A method for producing an enterosorbent based on glauconite, which includes grinding glauconite, selecting its fraction, and after grinding glauconite with a rock content of 80 to 95%, a fraction of 0.001-0.01 mm is selected, followed by enrichment using magnetic separation.