ANALYTICAL REPORT - DOC by jayjkayelle

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									                             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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