KR102015858B1 - Pharmaceutical composition for immunity enhancement containing detoxicated arsenic trioxide - Google Patents

Abstract

The present invention provides a pharmaceutical composition containing a regulated emergency for increasing immune function of cancer patients as well as chronic cold and chronic fatigue syndrome with reduced immunity, and furthermore, the prescribed emergency is purified water, propolis solution, fermented propolis. Pharmaceutical, for enhancing immunity prepared by dissolving in any one or more selected from the group consisting of liquid, ginseng extract, fermented ginseng extract, goat ginseng extract, goat goat ginseng extract, fermented goat ginseng extract, fermented goat ginseng extract, hydrogen water and alkali reduced water To a composition. The pharmaceutical composition according to the present invention has an excellent effect as an adjuvant for anticancer treatment, and also shows an excellent effect as a high efficiency immunoadjuvant with stable stability even in a relatively low immunity such as chronic cold patients.

Description

Pharmaceutical composition for immunity enhancement containing detoxicated arsenic trioxide}

The present invention relates to a pharmaceutical composition for enhancing immunity, and more particularly, a pharmaceutical composition containing a regulated emergency for increasing immune function of cancer patients as well as chronic cold and chronic fatigue syndrome with reduced immunity. Immunity prepared by dissolving the legislation in purified water, propolis solution, fermented propolis solution, ginseng extract, fermented ginseng extract, goat ginseng extract, goat ginseng extract, fermented goat ginseng extract, fermented goat ginseng extract, hydrogen water and alkaline reduced water It relates to a pharmaceutical composition for augmentation.

Tumors are the product of abnormal, uncontrolled and disordered cell proliferation resulting from abnormal cell excess, and are classified as malignant tumors when these tumors have disruptive proliferative, invasive and metastatic properties.

In particular, from a molecular biology point of view, it can be said to be a genetic disease caused by mutation of a gene. To date, there are three methods of treating cancer in modern medicine, namely, surgical treatment, radiation therapy, and anticancer drug therapy, and one or a combination thereof is used to treat cancer.

The most preferred chemotherapy is a treatment that selectively kills cancer cells and does not damage normal cells as much as possible. However, neither chemotherapy or radiation therapy can avoid some damage to normal tissues. Immunotherapeutic therapy is to treat cancer cells by killing or inhibiting their growth by minimizing these side effects and increasing self-healing ability by restoring or enhancing immune function, which is one of the body's defense systems against diseases.

In general, anticancer agents are both anticancer agents and carcinogens that cause new cancers. On the other hand, immunotherapy suppresses cancer growth and removes cancer like anticancer drugs, but has no side effects or toxicity. In addition, it can be said that it is an ideal cancer treatment that helps the human body overcome the cancer fundamentally by normalizing the function of our body that is ravaged by cancer and strengthening immunity.

Currently, immunostimulants have been developed such as hematopoietic growth factors such as interferon, interleukin and erythropoietin, tumor necrosis factor and monoclonal antibodies, tumor vaccines, gene therapy, and nonspecific immune substances.

In modern medicine, cytokines are proteins with a variety of functions produced by leukocytes and many related cells, and they play a role in regulation of the immune system as well as hematopoietic activity. Major cytokines include interferon, IFN and interleukin. Interferon, IFN, is the first cytokine found to be a glycoprotein with immunomodulatory activity and cell proliferation inhibition. An important mechanism of tumor treatment with interferon is stimulation of cytotoxic T-lymphocytes and activation of major histocompatibility complex antigens. In addition, it has an immune enhancing effect of stimulating natural killer cells and macrophages, and is known to have a direct proliferation inhibitory effect on cancer cells.

Interleukin is an immunomodulatory substance secreted from macrophages or lymphocytes that acts at various stages of the immune response and plays a crucial role in the defense of the body by regulating the immune response.

In oriental medicine, a variety of prescriptions are used for the purpose of strengthening immunity. Of these, some herbal medicines have recently been found to have a component that enhances the immune function of the human body experimentally. The representative of these herbs is fermented ginseng. Fermenting ginseng revealed that ginseng saponin, a representative active ingredient of ginseng, is metabolized by the strain to produce an immune enhancing compound called compound K.

Such information can be confirmed by Korean Patent Application Publication No. 10-2013-0010987, and also by Korean Patent Registration No. 10-0673566 for another immune enhancer.

Functional water such as hydrogen water and alkaline reduced water removes free radicals in the body and simultaneously exerts immune enhancing effects. Free radicals are the main culprit of oxidation, attacking normal tissues and immune bodies. Attack genes to promote aging, alter the shape of genes in the body, or damage cells to expose them to diseases. In particular, when the concentration of free radicals in the body is deeply reduced immunity.

Cancer is a disease that results from a compromised immune system and reduced immunity. Immune therapy that helps immune cells and strengthens immunity is very important. Immunity is controlled by lymphocytes in white blood cells. The percentage of macrophages, granulocytes, and lymphocytes in leukocytes is 5%, 54-65%, and 35-41%, respectively.

People with lymphocytes of 20-30% of leukocytes are prone to goblet disease, those with 10-20% are susceptible to major illness, and those within 10% may die within 1-2 months. When the number of lymphocytes is less than 5%, they die soon. This level of immunity is deeply related to human life.

1. Republic of Korea Patent Publication No. 10-2004-0087407 2. Republic of Korea Patent Publication No. 10-2013-0010987

The present invention is in the group consisting of statutory emergency and purified water, propolis solution, fermented propolis solution, ginseng extract, fermented ginseng extract, goat ginseng extract, goat ginseng extract, fermented goat ginseng extract, fermented goat ginseng extract, hydrogen water and alkaline reduced water Immunity enhancement therapy for administering a solution in which at least one selected is added by dissolving the above-mentioned emergency is completed by confirming the immune promotion of a normal person and a cancer patient, and therefore, the problem to be solved by the present invention is that both a normal person and a cancer patient To provide a pharmaceutical composition that can enhance the immunity in.

In order to achieve the above technical problem, the present invention provides a pharmaceutical composition capable of enhancing immunity in both normal and cancer patients, characterized in that it comprises a legal emergency as an active ingredient.

In the pharmaceutical composition according to the present invention as described above, the legal emergency

(a) decoction of emergency and megakary jujube in water, squeeze out any dregs, put the emergency back in the water and heat until water dries;

(b) adding the jujube prepared in step (a) into the jujube water and repeating the decoction three times;

(c) inserting the emergency obtained in step (b) into the juice of ginger and repeating the decoction nine times; And

(d) The emergency obtained in step (c) may be a powder prepared by drying a filtrate in which caustic soda is dissolved, heated to 80-100 ° C., melted and cooled to room temperature to remove undissolved impurities. .

 The pharmaceutical composition according to the present invention as described above is purified water, propolis solution, fermented propolis solution, ginseng extract, fermented ginseng extract, goat's ginseng extract, goat's ginseng extract, fermented goat's ginseng extract, fermented goat's ginseng extract, hydrogenated water and alkali It further comprises any one or more selected from the group consisting of reduced water, purified water, propolis liquid, fermented propolis liquid, ginseng extract, fermented ginseng extract, goat's ginseng extract, goat's wild ginseng extract, fermented goat's ginseng It is preferably prepared by dissolving in any one or more selected from the group consisting of an extract, fermented wild ginseng extract, hydrogen water and alkali reduced water.

In the pharmaceutical composition according to the present invention as described above, the fermentation propolis solution is filtered by removing the wax contained in the natural propolis, and then fermented by adding an edible strain to the purified propolis solution to propolis human body It is preferable that the gastrointestinal tract is manufactured so that digestion and absorption are good.

In the pharmaceutical composition according to the present invention as described above, it is preferable that the emulsified emergency is dissolved at a concentration of 1.0-20 mg / 10 ml.

The pharmaceutical composition according to the present invention has an excellent effect as an adjuvant during chemotherapy, and also shows an excellent effect as a high-efficiency immunopotentiator with stability even to a relatively low immunity such as chronic cold patients.

Hereinafter, specific contents for carrying out the present invention will be described.

The present invention provides a pharmaceutical composition capable of enhancing immunity in both normal and cancer patients, characterized in that it comprises a legal emergency as an active ingredient.

The legislative emergency

(a) decoction of emergency and megakary jujube in water, squeeze out any dregs, put the emergency back in the water and heat until water dries;

(b) adding the jujube prepared in step (a) into the jujube water and repeating the decoction three times;

(c) inserting the emergency obtained in step (b) into the juice of ginger and repeating the decoction nine times; And

(d) The emergency obtained in step (c) may be a powder prepared by drying a filtrate in which caustic soda is dissolved, heated to 80-100 ° C., melted and cooled to room temperature to remove undissolved impurities. .

This will be described in detail as follows.

First, put 1 root (600 grams) of emergency and 5 roots (3000 grams) of megakary date jug in a pot with about 1 horse of water (18 liters) and hang for a long time. Emergency and jujube Boiled water should be squeezed and discarded, and 1 g (600 grams) of emergency water is added to the water.

Long months, the water dries out, leaving only the emergency. Repeat this emergency again with the jujube in the water of the moon and repeat three times.

Next, take 5 geun of ginger juice, and put it in the juice three times in jujube boiled water so far and repeat it nine times.

Put a certain amount of emergency (arsenic trioxide) as described above into a container, and a sheep lye heated at 150-250 ° C. in advance to the container (adding a certain amount of water to caustic soda at about 60-80 ° C.) to a solution of 50-80% by weight.) In this case, the weight ratio of arsenic (arsenic trioxide) and lye is preferably about 0.8: 1 or 1: 2.

The contents of this vessel are heated to about 80-100 ° C., then cooled to room temperature and filtered through a filter paper or filtration device. After dissolving with water and filtering, the filtrate is removed and transferred separately. The insoluble material on the filter paper or the filter is repeated 10 times or more, and the filtrate is collected and cooled to room temperature. Finally, the filtrate is evaporated to dryness.

The emergency prepared by the above-mentioned preparation method is once again purified to make a water-soluble powder. The purified water soluble powder is chemically the sodium salt of metaarsenite.

Subsequently, the present invention provides the above-mentioned stabilization of purified water, propolis solution, fermented propolis solution, ginseng extract, fermented ginseng extract, goat ginseng extract, goat ginseng extract, fermented goat ginseng extract, fermented goat ginseng extract, hydrogenated water and alkali The pharmaceutical composition prepared by dissolving in any one or more selected from the group consisting of reduced water may be provided as an immunopotentiator, and the concentration may vary, but the final concentration was effectively 1.0 to 20mg / 10ml. The most preferred concentration was 2.5 mg / 10 ml.

In addition, the pharmaceutical composition prepared at the final concentration showed a sufficient effect once a day administration.

The purified water, propolis solution, fermented propolis solution, ginseng extract, fermented ginseng extract, goat ginseng extract, goat goat ginseng extract, fermented goat ginseng extract, fermented goat ginseng extract, hydrogen water and alkaline reduced water are widely known to enhance immunity, What is produced according to the conventional manufacturing method well known in the art to which this invention belongs is used.

Particularly, fermented propolis solution is highly effective because the wax contained in natural propolis is removed by filtration and edible strain is added to the purified propolis solution for a certain period of time so that the propolis can be digested and absorbed well in the human gastrointestinal tract. It is because you use what you have made possible.

The edible strain generally means a strain used for the production of fermented foods, such as lactic acid bacteria, kimchi lactic acid bacteria, acetic acid fermentation strain, yeast, if the strain is widely known in the field to which the present invention belongs can be used without particular limitation.

The solution which melt | dissolved the emergency prescribed | regulated in this fermentation propolis liquid was called the complementary life solution (immune active liquid) for this inventor.

Hereinafter, the present invention will be described in detail with reference to the following examples.

How to measure lymphocyte levels in the blood in cancer patients and normal people

Lymphocytes in white blood cells were collected using a lymphocyte counting device (AUTOMATIC BLOOD CELL COUNTER) by collecting 13 microliters of total blood from cancer patients and normal subjects before and after administering the composition according to the present invention. The percentage (%) was measured. Dosing of the composition according to the present invention, the water-soluble powder formulated in purified water (Examples 1 and 2), propolis solution (Examples 3 and 4), fermented propolis solution (Examples 5 and 6, supplementary life solution), ginseng Dissolved in extracts (Examples 7, 8), fermented ginseng extracts (Examples 9 and 10), goat's ginseng extracts (Examples 11 and 12) and goat's wild ginseng extracts (Examples 13 and 14) at a concentration of 2.5 mg / 10 ml. Oral administration was given once every 2 to 7 days, and once to cancer patients daily, depending on the condition.

Example 1 Changes in Lymphocyte Number in Blood Before and After Administration of Purified Water to Normal Subjects

The change in lymphocytes (unit:%) in blood before and after dosing purified water in which a soluble powder prepared in a normal person was dissolved was shown in Table 1 below. Table 1 shows that '3', a weak immunity, is in the normal range due to an increase in the percentage of lymphocytes in leukocytes (%) after 8 weeks of administration, whereas '1' and '2' in normal states are lymphocytes in leukocytes after 8 weeks of administration (%) Was slightly below the normal range, but it was confirmed that the increase was higher than before.

patient Before dosing After 4 weeks of administration After 8 weeks of administration Normal range One 28 28 32 35 to 41% 2 24 28 30 3 30 35 38

Example 2 Changes in Lymphocyte Counts in Blood Before and After Administration of Purified Water in Cancer Patients

The change in lymphocytes (unit:%) in the blood before and after the administration of purified water in which the water-soluble powder prepared in cancer patients was administered is shown in Table 2 below. In Table 2, cancer patients '2' with weak immunity were found to have a normalized lymphocyte ratio (%) among leukocytes after 8 weeks of administration, whereas cancer patients '1' and '3' showed leukocytes after 8 weeks of administration. Lymphocyte percentage (%) slightly exceeded the normal range.

patient Before dosing After 4 weeks of administration After 8 weeks of administration Normal range One 55 47 42 35 to 41% 2 46 44 40 3 47 42 43

Example 3 Changes in Lymphocyte Number in Blood Before and After Administration of Propolis Solution to Normal Subjects

The change in lymphocytes in blood (unit:%) before and after the administration of propolis solution in which the soluble powder prepared in the normal solution was administered is shown in Table 3 below. In Table 3, it was confirmed that the proportion of leukocyte lymphocytes (%) increased in the normal range of '3' which is a weak immunity. However, in the case of normal '1' and '2', the percentage of lymphocytes in leukocytes (%) was slightly below the normal range after 8 weeks, but it was higher than before administration.

patient Before dosing After 4 weeks of administration After 8 weeks of administration Normal range One 30 31 34 35 to 41% 2 28 29 30 3 31 32 36

Example 4 Changes in Lymphocyte Number in Blood Before and After Administration of Propolis Solution to Cancer Patients

The change in lymphocytes in blood (unit:%) before and after the administration of propolis solution in which the aqueous solution of the powder dissolved in cancer patients was administered is shown in Table 4 below. In Table 4, it was confirmed that the lymphocyte ratio (%) of the white blood cells of cancer patients '2' with weak immunity was normal. After 8 weeks of cancer patients' 1 ', the percentage of lymphocytes in leukocytes was slightly below the normal range but increased more than before.In the case of cancer patients 3', lymphocytes in leukocytes after 8 weeks (%) Slightly exceeded the normal range.

patient Before dosing After 4 weeks of administration After 8 weeks of administration Normal range One 29 34 34 35 to 41% 2 47 43 40 3 45 46 42

Example 5 Changes in Lymphocyte Counts in Blood Before and After Administration

The change in lymphocytes in blood (unit:%) before and after administration of the supplemental bowel solution prepared using the fermented propolis solution fermented with Lactobacillus subtilis to the normal person was shown in Table 5 below. Looking at Table 5, it was confirmed that the lymphocyte ratio (%) of leukocytes increased to normal after 8 weeks in all normal subjects with weak immunity.

patient Before dosing After 4 weeks of administration After 8 weeks of administration Normal range One 30 31 36 35-41% 2 25 32 38 3 27 31 37

Example 6 Changes in Lymphocyte Counts in Blood before and After Administration of Complementary Clear Solution to Cancer Patients

The change in lymphocytes in blood (unit:%) before and after administration of the supplemental bowel solution prepared using the fermented propolis solution fermented with Lactobacillus subtilis to cancer patients is shown in Table 6 below. In Table 6, it was confirmed that the lymphocyte ratio (%) of leukocytes after 8 weeks of all cancer patients with weak immunity became normal.

patient Before dosing After 4 weeks of administration After 8 weeks of administration Normal range One 56 47 40 35 to 41% 2 48 43 38 3 25 30 35

Example 7 Changes in Lymphocyte Count in Blood Before and After Administration of Ginseng Extracts to Normal Subjects

Changes in lymphocytes (unit:%) in blood before and after dosing ginseng extract dissolved in a legally soluble powder were shown in Table 7 below. Table 7 shows that the lymphocyte ratio (%) of leukocytes increased after 8 weeks in normal '1' and '2' with weak immunity. %) Was slightly below the normal range, but increased more than before administration.

patient Before dosing After 4 weeks of administration After 8 weeks of administration Normal range One 30 33 35 35 to 41% 2 25 27 36 3 28 31 34

Example 8 Changes in Lymphocyte Counts in Blood before and After Administration of Ginseng Extract in Cancer Patients

The change in lymphocytes in blood (unit:%) before and after dosing ginseng extract dissolved in a water-soluble powder formulated in cancer patients is shown in Table 8 below. In Table 8, it was confirmed that the lymphocyte ratio (%) of leukocytes became normal after 8 weeks of '1' and '3' cancer patients with weak immunity. However, after 8 weeks of cancer patients '2', the percentage of lymphocytes in leukocytes (%) slightly exceeded the normal range.

patient Before dosing After 4 weeks of administration After 8 weeks of administration Normal range One 46 47 40 35 to 41% 2 45 44 42 3 34 38 35

Example 9 Changes in Lymphocyte Counts in Blood Before and After Fermented Ginseng Extracts in Normal Subjects

Lymphocyte changes in blood (unit:%) before and after dosing the fermented ginseng extract fermented with strains such as Lactobacillus subtilis, which dissolved the water-soluble powder prepared in normal subjects, were measured and shown in Table 9 below. In Table 9, it was confirmed that the lymphocyte ratio (%) of leukocytes increased after 8 weeks in normal '1' and '3' with weak immunity, but it was within the normal range. The percentage of lymphocytes was slightly below the normal range, but increased more than before administration.

patient Before dosing After 4 weeks of administration After 8 weeks of administration Normal range One 33 36 38 35 to 41% 2 29 29 34 3 30 34 37

Example 10 Changes in Lymphocyte Number in Blood Before and After Fermented Ginseng Extract in Cancer Patients

The change in lymphocytes in blood (unit:%) before and after administration of fermented ginseng extract fermented with strains such as Lactobacillus subtilis, which dissolved the water-soluble powder prepared in cancer patients, was shown in Table 10 below. In Table 10 below, it was confirmed that the lymphocyte ratio (%) of leukocytes after 8 weeks of cancer patients '1' and '2' with weak immunity was normal, but the cancer patients '3' after 8 weeks of administration Lymphocyte percentage (%) was slightly below the normal range, but slightly increased than before administration.

patient Before dosing After 4 weeks of administration After 8 weeks of administration Normal range One 26 28 35 35 to 41% 2 46 44 41 3 32 34 34

Example  11. To normal people Goat's ginseng  Changes in the number of lymphocytes in the blood before and after dosing the extract

Changes in lymphocytes (unit:%) in blood before and after dosing goat ginseng extract dissolved in a legally soluble powder were shown in Table 11 below. In Table 11, it was confirmed that the percentage of lymphocytes in the white blood cells (%) increased after 8 weeks in normal '1' and '2' with weak immunity. %) Was slightly below the normal range, but increased more than before administration.

patient Before dosing After 4 weeks of administration After 8 weeks of administration Normal range One 24 33 35 35 to 41% 2 26 27 36 3 28 31 34

Example  12. To cancer patients Goat's ginseng  Changes in the number of lymphocytes in the blood before and after dosing the extract

The change in lymphocytes in blood (unit:%) before and after dosing goat ginseng extract dissolved in a water-soluble powder formulated in cancer patients is shown in Table 12 below. In Table 12, it was confirmed that the lymphocyte ratio (%) of leukocytes was normal after 8 weeks of '1' and '3' cancer patients with weak immunity. However, after 8 weeks of cancer patients '2', the percentage of lymphocytes in leukocytes (%) slightly exceeded the normal range.

patient Before dosing After 4 weeks of administration After 8 weeks of administration Normal range One 46 47 40 35 to 41% 2 45 44 42 3 34 38 35

Example 13 Changes in Lymphocyte Counts in Blood Before and After Dosing Sanyang Ginseng Extracts to Normal Subjects

Changes in lymphocytes (unit:%) in blood before and after dosing the goats ginseng extract prepared by dissolving the legally soluble powder were shown in Table 13 below. In Table 13, it was confirmed that the lymphocyte ratio (%) of leukocytes increased after 8 weeks in normal '1' and '3' with weak immunity, but it was within the normal range. The percentage of lymphocytes was slightly below the normal range, but increased more than before administration.

patient Before dosing After 4 weeks of administration After 8 weeks of administration Normal range One 33 36 38 35 to 41% 2 29 29 34 3 30 34 37

Example  14. To cancer patients Sanyang Sansam  Changes in the number of lymphocytes in the blood before and after dosing the extract

The change in lymphocytes in blood (unit:%) before and after the administration of the yangsan ginseng extract in which the water-soluble powder prepared in the cancer patients was administered is shown in Table 14 below. In Table 14 below, it was confirmed that the lymphocyte ratio (%) of leukocytes was normal after 8 weeks of cancer patients '1' and '2' with weak immunity. Lymphocyte percentage (%) was slightly below the normal range, but slightly increased than before administration.

patient Before dosing After 4 weeks of administration After 8 weeks of administration Normal range One 26 28 35 35 to 41% 2 46 44 41 3 32 34 34

As described above, as a result of administering the pharmaceutical compositions according to the present invention, it was confirmed that the immunity of the normal or cancer patients suffering from chronic cold or chronic fatigue syndrome is increased. In particular, in Examples 5 and 6 administered supplementary solution showed excellent immunostimulating effect.

Unlike the conventional emergency used in dilution with an organic solvent, the legal emergency used in the present invention is expected to have a great effect even at the same concentration because it is water-soluble. Therefore, the potential as an immunotherapeutic agent is presented and demonstrated through the present invention.

In addition, when the composition according to the present invention is administered in combination with an existing anticancer agent, by overcoming the immune avoidance mechanism of the tumor, by enhancing the immune function of the cancer patient, it is possible to maximize the cancer treatment effect. This is because the use of a low level of legislation as in the present invention increases the number of lymphocytes in the blood. The route of coadministration of the composition according to the invention is based on oral administration.

The above embodiments are merely illustrative of the present invention, and the content of the present invention is not limited to the embodiments, and various modifications that may be made by those skilled in the art within the technical idea of the present invention. It is obvious that it includes everything.

Claims (5)

(a) decoction of emergency and megakary jujube in water, squeeze out any dregs, put the emergency back in the water and heat until water dries;
(b) repeating the emergency obtained in step (a) into the jujube decoction water three times to decoction until the water dries;
(c) inserting the emergency obtained in step (b) into the juice of ginger and repeating the decoction nine times; And
(d) The emergency obtained in step (c) was put into water containing dissolved caustic soda, heated to 80-100 ° C. to dissolve, and cooled to room temperature to remove undissolved impurities. A pharmaceutical composition capable of enhancing immunity in both normal and cancer patients, comprising emergency as an active ingredient. The method of claim 1,
The composition is any one selected from the group consisting of purified water, propolis solution, fermented propolis solution, ginseng extract, fermented ginseng extract, goat ginseng extract, goat ginseng extract, fermented goat ginseng extract, fermented goat ginseng extract, hydrogen water and alkaline reduced water It further includes the above, further includes the statutory emergency, purified water, propolis solution, fermented propolis solution, ginseng extract, fermented ginseng extract, goat ginseng extract, goat goat ginseng extract, fermented goat ginseng extract, fermented goat ginseng extract, hydrogen water And alkali-reduced water, which is prepared by dissolving in any one or more selected from the group consisting of pharmaceutical compositions capable of enhancing immunity in both normal and cancer patients. The method of claim 2, wherein the fermented propolis solution is filtered by removing the wax contained in the natural propolis and then fermented by adding an edible strain to the purified propolis solution can be digested and absorbed well in the human gastrointestinal tract. A pharmaceutical composition capable of enhancing immunity in both normal and cancer patients, characterized in that it is prepared to. The pharmaceutical composition capable of enhancing immunity in both normal and cancer patients according to claim 2, wherein the statutory emergency is dissolved at a concentration of 1.0 to 20 mg / 10 ml. delete