ANALYTICAL REPORT on medical-ecological examination of BIOFILAM preparation, submitted by Pacific Bio Technologies Co. Ltd BIOFILAM preparation, produced by Pacific Bio Technologies Co. Ltd, has been submitted for the medical-ecological examination. The examination has been conducted in accordance with “Regulations for medical-ecological examinations of preventive substances, intended for use in ecologically adverse territories” (approved by the Chairman of the Inter Departmental Scientific Council No. 50 at the Russian Academy of Medical Sciences and the Ministry of Health of the Russian Federation) by the medical- ecological research laboratory at the General Research Centre of the preventive medicine, Ministry of Health of the Russian Federation (Professor Y. I. Prokopenko – Director, I. N. Ilchenko – chief executive, V. P. Iliin – executive officer, A. L. Aleksandri – executive officer). The goal of medical-ecological examination of BIOFILAM preparation is to determine its potential antitoxic properties and give recommendations on its use in relation to the level of environmental pollution and the state of health. The following List of documents has been submitted for the medical-ecological examination: Application for conducting the medical-ecological examination Hygienic Certificate Raw material information, technology of production Qualitative and quantitative structure of the preparation Clinical and public tests data; experimental research data Studies of the general toxic properties data The above List of submitted documents meets the requirements of “Regulations for medical-ecological examinations of preventive substances, intended for use in ecologically adverse territories”. Definition of the preparation. BIOFILAM (capsules, powders) is a natural vegetative product, made of brown seaweeds related to the genera of Alaria, Laminaria, Sargassum, Artrotamnus, Costaria and grown in the coastal seas of Sakhalin, Kuril Islands and Japan. Capsules and powders of BIOFILAM are a balanced complex of bioactive components of the seaweeds. The main active component is the polysaccharides that are found in the preparation in significant quantities, namely, sodium alginates, fucoidan, seaweed fiber, soluble polysaccharides (bound forms of fucose, mannose, glucose, galactose, mannit). Mineral substances are found in the preparation in the bound form of inorganic salts. The most important among them are iodine, sodium, potassium, calcium, magnesium, ferrous and a range of microelements. Vitamin content in the preparation is not significant. Vitamins are represented by Vitamins A, B, C. There are some other bioactive substances in the preparation, such as: proteins, neutral sugars, insignificant content of lipids. Technology of producing BIOFILAM is original (patented). It allows preserving high biological activity of the separate components. As for the alginic acid – it suggests enrichment of the final product. Quantitative estimation of ingredients found in the preparation. Quantitative estimation of ingredients found in the preparation was conducted in accordance with the rate of daily requirement of the main active components for the ecologically normal areas and ecologically stressed. Estimation has been made at a rate of the recommended daily dosage 5g/ day for the adults and 1.25g/ day for children. Amount of substance in a daily dosage g/ mg BIOFILAM ingredients (% - compensation of a daily requirement) __________________________________ Adults Children Polysaccharides, g (%) Alginic acid 0,68 (11,3 – 17,0) 2,7 (45,0) Fucoidan 0,05 ( - ) ( - ) Seaweed fiber 0,42 ( - ) ( - ) TOTAL: 1,15 (6,7 – 9,5) 4,57 (19,9) Vitamins, mg (%) A 0,01 (1,4) 0,05 (10,0) B1 0,002 (0) 0,009 (0,6) B2 0,005 (0,5) 0,02 (1,2) C 0,16 (0) 0,64 (1,1) Minerals, mg (%) Na 32,3 ( - ) 129,0 ( - ) K 55,0 ( - ) 220,0 (3,8) Ca 30,1 (3,4) 120,2 (10,0) Mg 20,7 (17,3) 82,6 (23,6) Fe 0,77 (7,7) 3,1 (31,0) J 0,31 (200-300) 1,23 (600) Zn 0,09 (0,9) 0,35 (2,3) Mn 0,03 (2,0) 0,11 (5,5) Cu 0,01 (1,0) 0,05 (3,3) The above analysis showed, that containing in BIOFILAM active ingredients, represented by the polysaccharides and comprising 91% of the dry weight, cover the daily requirement in the food fibers up to 5,7 – 9,5% for children and up to 19,9% for adults. Taken, that alginic acid by its chemical structure and main biological properties is close to those of pectins, the conducted analysis determined the ratio of daily pectin requirement: 11% – 17% for children and 45% for adults. Vitamin content in BIOFILAM is insignificant, except for Vitamin A for adults (compensates up to 10% of the daily requirement). As far as minerals go, BIOFILAM is rich in organic iodine, which exceeds the daily preventive dose for children 2-3 times and 6 times for adults. Despite the fact, scientific reports prove, that organic iodine even in higher rates does not result in the oversaturation of the body. BIOFILAM shows quite a big quantity of magnesium and iron, to the less extent of calcium. Mechanism of antitoxic activity of the main components of BIOFILAM. The key mechanism of antitoxic activity of BIOFILAM is its adsorbent property, which puts BIOFILAM in the class of adsorbents according to the Classification of antitoxic materials. Pectin containing elements, which the alginic acid is tightly related with, show high antidotal activity towards radiochemicals (Strontium, Cesium, Iodine) as well as towards the salts of heavy metals, such as: Mercury, Plumbum, Cadmium, Copper. It’s important to note, that due to the original technology of producing BIOFILAM, the content of alginates in the final product is very high, between 30-60%, as compared to similar products made by traditional technologies, between 18-40% (LAMIN, MARINID, MODIFILAN). The principal activity of alginates is to bond the toxic elements that may come along with food in the GI tract and then remove them through the tract. The seaweed fibers, that are found in BIOFILAM in good quantities, stimulates GI motility, increases value of many foodstuffs, improves metabolism, relieves body of the excessive cholesterol and products of its dissolution, thus providing a normalization of the lipid exchange. As a whole, significant amount of the polysaccharides in the final product (54% - 96%) provides protective and stimulant effect on the immune system. The intracellular and somatic polysaccharides are the energy and structural materials of a cell. This implies the use of BIOFILAM as a fighting agent against the immunosuppressants. Besides, there’s quite a significant content of the organic Iodine in the preparation. The Iodine is known to prevent diseases of the thyroid glands in endemic areas as well as in cases of radioactive Iodine pollution. BIOFILAM lowers absorption of the radioactive Iodine by the thyroid glands by blocking hormonogenesis of the gland, restricting accumulation of the radioactive Iodine. Apart from that, Iodine blocks atherogenic process. Organic Magnesium and Iron are also well represented in the preparation (compensates up to 10-30% of the daily requirement). A great many man-made pollutants and radiochemicals have a negative effect on the synthesis of heme, depress the synthesis of cytochrome oxidase. The significance of biologically digestible forms of iron increases a lot in such conditions. Biologically active Magnesium takes part in the synthesis of phosphoproteins that build quite a large part of the central nervous system. In cases of neurotropic impact of the ecotoxins on the body by the salt of heavy metals, BIOFILAM may prove an efficient remedy on account of its adsorbent properties and Magnesium content. Clinical and public tests. Clinical test were conducted in the areas with increased level of radioactive pollution (town of Novozybkov: Cs137 – 18.1 Ci/ m2). Research work was performed by the Institute of Immunology officers. A positive effect was registered when the preparation was taken at 3.0 g/ day in the course of a month. Public tests were conducted by the officers of the General Research Center of the Preventive Medicine, Ministry of Health, Russian Federation in the town of Klintsy with the average registered radioactive pollution level of Cs137 – 5-10 Ci/ m2 among children aged 3 – 7. Consumed as prescribed during 4 months, the preparation showed improvement in the unspecific resistance of the children’s bodies: reduction in number of acute respiratory diseases, improvement in the state of pharyngonasal cavity and the lymph nodes. Besides, a positive dynamics in the current condition of the skin, nails, hair, mucous coat, gums was reported. Clinical tests of BIOFILAM were also conducted on a group of cardiac patients (ischemic heart disease, diabetes, hyper high blood pressure) at the Regional Hospital of Yuzhno-Sakhalinsk. Efficiency of BIOFILAM was reported in relation to lipid exchange normalization (general Cholesterol level) with the patients who suffered average hyper cholesterol (daily dose – 10g in the duration of 2 months). The Institute of Biophysics conducted research studies of the efficiency of BIOFILAM in blocking and reducing of suction of radioactive Strontium, Cesium, Iodine in the GI tract. It was proved, with single and multiple injections of the radionuclides to the white rats, that the use of BIOFILAM reduced the dosage load of Sr90 on a bone tissue to 30%, dosage load of J131 on a thyroid gland to 72%. The most effective in adsorption of radioactive Sr and J proved to be Laminaria sample. Another research study, conducted by the Vladivostok Medical Institute on the white rats in the process of a subacute experiment (results observed in 1-3 months), showed a positive effect of BIOFILAM on the lipid exchange, glycolysis, natural immunity, muscle performance. Besides, the allergenic properties of BIOFILAM were studied by conducting a reaction of indirect degranulation of the rats’ fat cells. The results proved, that BIOFILAM had no allergenic activity. Toxicity of BIOFILAM. Techno-Medical Center in Vladivostok assessed a general toxic activity of BIOFILAM in the process of a subacute experiment. The studies showed no toxic effect in consuming BIOFILAM by the rats in the course of 3 months. It was proved, that the use of BIOFILAM was safe in relation to the immunization. Conclusion. The detailed analysis of all materials, presented for the medical-ecological examination, makes it possible to conclude, that BIOFILAM is a high efficiency preparation for use by the population living in the man-made and radiation polluted territories. Judging by the mechanisms of work of the main active components, the powders and capsules of BIOFILAM are classified as “Adsorbents” according to the Classification of antitoxic materials. The preparation has distinct adsorption properties, lipotropic and immunogenic effects. Altogether, mechanisms of work of the main active components of BIOFILAM, clinical, public and experimental research data, show that the preparation appears to be a primary choice for the population on the following conditions: 1. Living in the territories polluted by radiation. Most effective in removing radioactive Iodine and Strontium. Recommended for use by all population, by the risk groups subjected to cancerous formations of the thyroid glands and other cancerous diseases. 2. Living in the territories polluted by the salts of heavy metals. Recommended for use by all population and by the high risk groups. Preferred way is to consume with the vitamin-mineral complexes, rich in Iron, Calcium, Copper and Zinc. 3. Affected by the ecological toxins with immunosuppressant properties (inorganic, non-metal, organic compounds and other). 4. Affected by the unfavorable ecological factors and chronic latent diseases, first of all by cardiovascular diseases. In order to get an antitoxic effect, BIOFILAM is recommended for use in the following dosages: 1,25 g/ day for children, 5 g/ day for adults in a duration of time (minimal course is 2 months). The report was made by: PhD. I. N. Ilchenko REFERENCE LITERATURE 1. Program of measures to maintain medical-preventive nutrition of children, living in the radiation polluted areas of the Tulskiy Territory. M. 1994 2. Martindale “The Extra Pharmacopea”, 29th edition, Clinical Trial Data. 3. Goodman, Gilmen “The Pharmacological Basis of Therapeutics”, ed. 8th, v. 2. 4. Prokopenko Y. I. Specific and general means of health correction under influence of the polluted environment. Regional and local issues of the chemical pollution of the environment and the public health. M. 1995. p. 191-196. 5. Air Quality Guidelines for Europe. – WHO Regional Publication. Series No. 23, 1987. 6. Occupational Medicine. – Joseph Ladau. USA, 1990. 7. Harmful chemical substances. Inorganic compounds of the elements. – L. 1988. 8. Chemistry of the biologically active natural compounds. M. 1976. 9. Lead exposure and child development. Rd. M. A. Smith, L. D. Grant, A. I. Sors, USA, 1989 10. Kovaleva N. G. Healing with herbs. M. 1972.
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