Composition for ameliorating side effects of steroid drugs

Abstract

The present invention provides a composition containing, as an active ingredient, a ginseng extract selected from the group consisting of ginseng extract, red ginseng extract, and black ginseng extract. When the composition according to the present invention is administered in combination with a steroid drug, it has the effect of improving or suppressing side effects caused by the steroid drug, such as weakened immunity and increased risk of infection, steroid-induced diabetes, osteoporosis, increased blood pressure and electrolyte abnormalities, changes in body shape, myopathy, osteonecrosis, cataracts, skin changes, and behavioral disorders.

Description

Technology Field

[0001] The present invention relates to a composition for improving the side effects of steroid drugs, and more specifically, to a composition for improving the side effects of steroid drugs using ginseng, red ginseng, and black ginseng extracts as active ingredients. Background Technology

[0003] Steroid preparations are widely prescribed due to their excellent efficacy in treating difficult-to-treat inflammatory diseases. However, steroids are one of the drugs that raise concerns regarding serious side effects caused by the development of resistance, and these side effects are as follows.

[0005] Weakened immunity and increased risk of infection: You may become vulnerable to infections, and the frequency of conditions such as shingles and tuberculosis increases.

[0007] Steroid-induced diabetes: An increase in blood glucose levels can be observed in about 50% of patients receiving steroid treatment, and it can induce diabetes or worsen blood glucose control in patients with diabetes. It is known to raise blood glucose levels through various mechanisms, such as releasing glucose from the liver and inducing gluconeogenesis.

[0009] Osteoporosis: Osteoporosis occurs in 30–50% of patients receiving long-term steroid treatment, increasing the risk of fractures. It can occur in all age groups, is more likely to occur with higher doses and longer treatment durations, and the ribs and vertebrae are the most common sites of fracture. Since bone loss is known to be most severe during the first six months of steroid treatment, it is advisable to perform a bone density test before starting treatment if steroid treatment is required for more than three months.

[0011] Increased blood pressure and electrolyte abnormalities: Since an increase in blood pressure is common, it is advisable to measure blood pressure frequently and limit salt intake, which may be accompanied by a decrease in potassium and an increase in the number of white blood cells in the blood is also commonly observed.

[0013] Changes in body shape: the face becomes round (moon face), the shoulders and lower back of the neck become prominent (buffalo hump), the torso becomes larger (central obesity), and the limbs become thinner.

[0015] Myopathy: This can occur when taking high doses of steroids, and the weakness of the muscles in the arms and legs becomes significant, making it difficult to sit down and stand up or to lift the arms.

[0017] Osteonecrosis: Also known as avascular necrosis or aseptic necrosis, it most commonly occurs in the head of the femur, but can also occur in the head of the humerus or the distal end of the femur. Initial symptoms include joint pain and stiffness. While the frequency increases with long-term use of high-dose steroids, it can also occur with short-term high-dose therapy.

[0019] Cataracts: This is related to the steroid dosage and duration of use, and the risk is higher in children; even if treatment is discontinued, lens opacity does not completely improve and may continue to progress.

[0021] Skin changes: Wounds do not heal well, the skin becomes thin, and bruises or contusions may occur easily.

[0023] Behavioral disorders: One may become irritable, experience depression and sleep disorders, undergo mood swings, and develop psychotic symptoms.

[0025] Representative steroid drugs include dexamethasone, prednisolone, methylprednisolone, triamcinolone, hydrocortisone, desonide, clobetasol, and betamethasone.

[0027] As the risks of steroid side effects become known, concerns are mounting that steroid usage should be reduced; however, the prescription rate of steroids at domestic clinics, hospitals, and tertiary general hospitals is actually on the rise.

[0029] Representative steroid replacement drugs currently in use include non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, meloxicam, nimesulide, etololac, celecoxib (Celebrex), rofecoxib (Vioxx), etoricoxib, and valdecoxib (Bextra). These drugs work by reducing a substance called cyclooxygenase, which synthesizes prostaglandins that cause inflammation, and are widely used in combination with steroid drugs.

[0031] However, it is not as potent as steroid drugs, and long-term use can lead to other side effects such as gastric ulcers, worsening of asthma symptoms, and kidney problems. Prior art literature

[0033] 1. Republic of Korea Registered Patent No. 10-14774802, Republic of Korea Published Patent No. 10-2020-0070778 The problem to be solved

[0034] Therefore, the problem that the present invention aims to solve is to provide a composition that can reduce the side effects of a steroid drug while maintaining its effects. means of solving the problem

[0036] To achieve the above objective, the present invention provides a composition for improving the side effects of a steroid drug containing, as an active ingredient, a ginseng extract selected from the group consisting of ginseng extract, red ginseng extract, and black ginseng extract.

[0038] In the composition according to the present invention as described above, the ginseng extract may be extracted using water or ethanol as an extraction solvent.

[0040] In the composition according to the present invention as described above, the steroid drug may be one or more selected from the group consisting of dexamethasone, prednisolone, methylprednisolone, triamcinolone, hydrocortisone, desonide, clobetasol, and betamethasone, and the side effects improved may be one or more selected from the group consisting of weakened immunity and increased risk of infection, steroid-induced diabetes, osteoporosis, increased blood pressure and electrolyte abnormalities, changes in body shape, myopathy, osteonecrosis, cataracts, skin changes, and behavioral disorders. Effects of the invention

[0042] The composition according to the present invention has the effect of improving or suppressing side effects caused by steroid drugs when administered in combination with steroid drugs, such as weakened immunity and increased risk of infection, steroid-induced diabetes, osteoporosis, increased blood pressure and electrolyte abnormalities, changes in body shape, myopathy, bone necrosis, cataracts, skin changes, and behavioral disorders. Brief explanation of the drawing

[0044] Figure 1 is a diagram of a black ginseng injection. Figure 2 is a diagram of the test results for the spleen. Figure 3 is a diagram of the test results for the lymph nodes. Specific details for implementing the invention

[0045] Hereinafter, specific details for implementing the present invention will be described in detail.

[0047] The present invention relates to a composition for improving the side effects of steroid drugs, wherein the active ingredients of the present invention are a ginseng extract selected from the group consisting of ginseng extract, red ginseng extract, and black ginseng extract, an enzyme-treated product of such ginseng extract, and a fermented product of the ginseng extract.

[0049] The active ingredient of the present invention, as described above, allows for the safe use of steroid drugs by maintaining the effects of the steroid drugs when used in combination with them, while improving side effects such as weakened immunity and increased risk of infection, steroid-induced diabetes, osteoporosis, increased blood pressure and electrolyte imbalances, changes in body shape, myopathy, osteonecrosis, cataracts, skin changes, and behavioral disorders.

[0051] In the present invention as described above, the steroid drug refers collectively to fat-soluble compounds having a stereonucleus such as sterols, bile acids, and sex hormones. It is a lipid and organic compound that does not contain fatty acids and has a common basic structure consisting of three rings of six carbon atoms and one ring of five carbon atoms, i.e., four rings combined. It is not subject to any particular limitation as long as it is widely known in the technical field to which the present invention belongs, but examples thereof may be any one selected from the group consisting of dexamethasone, prednisolone, methylprednisolone, triamcinolone, hydrocortisone, desonide, clobetasol, and betamethasone.

[0053] The ginseng extracts used in the present invention collectively refer to ginseng extracts (including dried ginseng to fresh ginseng extracts), red ginseng extracts, and black ginseng extracts. The methods for manufacturing red ginseng and black ginseng may be used without special limitations as long as they are widely known in the technical field to which the present invention belongs; that is, they may be used without special limitations regarding commonly used and distributed ginseng, red ginseng, and black ginseng.

[0055] In addition, the extraction method of the invention may be used without special limitations as long as it is widely known in the technical field to which the invention belongs, and examples include selecting and using methods such as heat extraction, cold maceration extraction, reflux cooling extraction, steam distillation, ultrasonic extraction, elution, and pressing. Furthermore, depending on the purpose, the extract may undergo a conventional fractionation process and may be purified according to a conventional purification method.

[0057] In the present invention, it is preferable to use an extract obtained by a conventional extraction method using water or ethanol as an extraction solvent, or a mixture thereof, as a ginseng extract.

[0059] In addition, the extracted primary extract can be powdered through additional processes such as vacuum distillation, freeze-drying, or spray drying, and purified fractions can be obtained through various chromatographs such as silica gel column chromatography, high performance liquid chromatography, and thin layer chromatography.

[0061] Therefore, in the present invention, the term "extract" can be understood as a concept that includes all extracts, separated compounds, fractions, and purified products obtained at each stage of extraction, fractionation, or purification, as well as their dilutions, concentrations, and dried products.

[0063] In addition, in the present invention, ginseng extracts can be used after being treated with enzymes or fermented, and can be used after being treated with enzymes and then fermented.

[0065] The enzyme used in the present invention is preferably one or more selected from the group consisting of beta-galactosidase, beta-glucosidase, beta-glucanase, alpha-amylase, and cellulase.

[0067] The strain used for fermentation in the present invention may be any strain known to ferment ginseng extracts, and preferably may be other bacterial, yeast, or fungal strains suitable for food or pharmaceutical production, examples thereof may be one or more selected from the group consisting of Lactiplantibacillus plantarum, Lactobacillus brevis, Leuconostoc mesenteroides, Lactococcus lactis, Bifidobacterium longum, Bifidobacterium breve, Saccharomyces cerevisiae, Aspergillus oryzae, and Aspergillus niger.

[0069] Specifically, the preparation of the ginseng extract used in the present invention is

[0070] An extraction step of extracting one or more types of ginseng selected from the group consisting of ginseng (dried or fresh ginseng), red ginseng, and black ginseng with hot water at 70 to 100°C, or an extraction step of extracting the ginseng using 70% by weight ethanol;

[0071] An enzyme treatment step in which an enzyme is added to the extract of the above extraction step and the extract is treated with the enzyme at 25 to 65°C for 2 to 7 hours; and

[0072] To the extract after the enzyme treatment above, lactic acid bacteria or yeast, preferably Saccharomyces crevicia (Saccharomyces cerevisiae It can be carried out through a fermentation step in which ) is added and fermented at 20 to 40°C for 10 to 48 hours.

[0074] There are no specific restrictions on the amount of ginseng extract used as described above, but preferably, it is 2 to 5 g per day based on solid content per 60 kg of the subject to administration.

[0076] The composition of the present invention as described above is used without special restrictions on the use of additives, excipients, other antiviral agents, etc., used to prepare the composition, in ordinary procedures, and the formulation of the composition is also not subject to special restrictions.

[0078] The present invention will be described in more detail below through examples and test examples. These examples are intended solely to explain the present invention more specifically, and it will be obvious to those skilled in the art that the scope of the present invention is not limited by these examples according to the gist of the invention.

[0080] Example 1. Improvement of weakened immunity

[0081] 1.1 Purpose of the test

[0082] Glucocorticoids are drugs that exhibit potent anti-inflammatory and immunosuppressive effects and are used to treat various inflammatory diseases. However, repeated or high-dose administration of glucocorticoids can cause various side effects, such as metabolic abnormalities and weakened immunity.

[0083] Dexamethasone (DEX) is a synthetic glucocorticoid known to cause atrophy and morphological changes in immune organs through repeated administration.

[0085] Therefore, in this study, a steroid-induced adverse effect model was established by repeatedly administering DEX at doses of 1, 3, and 10 mg / kg / day for 4 weeks, and changes in the morphology and weight of the administered immune organs were evaluated. In addition, the potential for alleviating changes induced by DEX was evaluated by co-administering black ginseng at 300 mg / kg / day under the same conditions.

[0087] 1.2. Test Substance Information

[0088] 1.2.1. Dexamethasone (DEX)

[0089] Physical appearance: Solid (White to off-white powder)

[0090] FW : 392.47 Da

[0091] Molecular formula: C₂₂H₂?FO?

[0092] CAS RN : 50-02-2

[0093] Purity : >99.0% (HPLC)

[0094] Chemical class: Synthetic glucocorticoid

[0095] Product No. : D1961

[0096] Company name: Tokyo Chemical Industry Co., Ltd. (TCI)

[0097] Physical state (20℃): Solid

[0098] Research use: Research Use Only (RUO)

[0099] Dose: 1, 3, 10 mg / kg / day

[0100] route: intraperitoneal administration

[0102] 1.2.2. Black Ginseng

[0103] A black heart injection as shown in Fig. 1 was used.

[0104] Dose: 300 mg / kg / day

[0105] route: intraperitoneal administration

[0107] 1.3. Test Method

[0108] 1.3.1. Setting DEX Dosage

[0109] To evaluate dose-dependent changes following DEX administration, 1, 3, and 10 mg / kg / day were set as test doses. Each dose was set to evaluate systemic physiological changes and histological and morphological changes resulting from repeated glucocorticoid exposure.

[0111] 1.3.2. Test Procedure

[0112] Changes resulting from repeated glucocorticoid exposure were induced by administering DEX intraperitoneally (ip) to mice once daily for 4 weeks. In the black ginseng co-administration group, 300 mg / kg / day of black ginseng was administered every morning, followed by the administration of DEX at an interval of at least 4 to 5 hours.

[0114] After the experiment was completed, the animals were sacrificed to collect immune organs, and the macroscopic morphology and weight of the organs were evaluated.

[0116] 1,3.3. Exam End Time

[0117] The end point of the study was set based on the change in body weight confirmed during the study period. In the DEX administration group, continuous weight loss was observed compared to the control group, while in the black ginseng co-administration group, some signs of recovery were observed. Accordingly, the study was terminated after repeated administration for 4 weeks, and the animals were sacrificed to collect samples.

[0119] 1.4. Test Results

[0120] 1.4.1 Spleen

[0121] The test results are shown in Figure 2. As shown in Figure 2, the macroscopic shape and organ weight of the spleen were evaluated, and a tendency for the size and weight of the spleen to decrease was observed in the DEX administration group compared to the control group. Additionally, a tendency for the size and weight of the spleen to decrease was observed as the DEX administration dose increased.

[0123] In the group administered with black ginseng according to the present invention, a tendency for the size and weight of the spleen to increase was observed compared to the group administered with DEX alone.

[0125] Therefore, it was found that the decrease in spleen size and weight caused by DEX administration was restored by the combined administration of black ginseng under the test conditions.

[0127] 1.4.2 Lymph node

[0128] The test results are shown in Figure 3. As shown in Figure 3, the macroscopic morphology and organ weight of the lymph nodes were evaluated, and a tendency for the size and weight of the lymph nodes to decrease was observed in the DEX administration group compared to the control group. Additionally, a tendency for the size and weight of the lymph nodes to decrease was observed with increasing DEX dosage.

[0130] In the group administered with black ginseng, a tendency for lymph node size and weight to increase was observed compared to the group administered with DEX alone.

[0132] Therefore, under the test conditions, it was found that the reduction in lymph node size and weight caused by DEX administration was restored by the combined administration of black ginseng.

[0134] 1.5 Conclusion

[0135] In this study, a steroid-induced adverse effect model was established by repeatedly administering DEX at doses of 1, 3, and 10 mg / kg / day for 4 weeks, and the alleviation of changes by co-administration of black ginseng 300 mg / kg / day was evaluated.

[0137] In the DEX administration group, a decrease in organ size and weight was observed in the spleen and lymph nodes compared to the control group, and a decreasing trend was confirmed with increasing DEX dosage.

[0139] In the group administered with black ginseng according to the present invention, a tendency for the size and weight of the spleen and lymph nodes to increase was observed compared to the group administered with DEX alone, confirming the effect of ginseng extracts on protecting immune organs and preventing weakening of immunity against changes in immune organs caused by steroid drugs.

[0141] Example 2: Improvement of Weakened Immunity

[0142] 2.1. Rearing and Management of Experimental Animals

[0143] 7-week-old ICR rats (Young Bio, Seongnam, Gyeonggi-do, Korea) were reared in an animal room with a regular light source with a 12-hour light / dark cycle, a temperature of 22-24℃, and a humidity of 55-60%.

[0145] 2.2. Preparation of Ginseng Extracts

[0146] Ginseng, red ginseng, and black ginseng were each sliced ​​and prepared at a concentration of 100 g / L, and then hot water extracted for 2 hours. Afterward, the hot water extract was filtered using 3M filter paper, freeze-dried for more than 24 hours, and then powdered.

[0148] Next, the powder was dissolved in purified water to prepare a concentration of 500 mg / kg and administered orally to test animals.

[0150] 2.3. Preparation of an animal model of immunodeficiency induced by steroid administration

[0151] A steroid-induced muscle atrophy animal model was prepared by administering dexamethasone (600 µg / kg) intraperitoneally for 5 consecutive days to rats (SD; 10-11 weeks of age).

[0153] Ginseng extract was dissolved in water at a concentration of 500 mg / kg and administered orally at the same time every day for 5 days.

[0155] The test group is as follows:

[0156] normal group treated with vehicles

[0157] Dexamethasone-treated DEX group

[0158] DEX+ginseng treatment group treated with dexamethasone and ginseng extracts

[0160] 2.4. Effects on the measurement of interferon gamma (IFN-γ) secretion

[0161] To confirm the prevention of ginseng extracts against immunosuppression induced by steroid drugs, blood was collected from rats in each test group on the 5th day and the interferon gamma (IFN-γ) secretion amount was measured, and the results are shown in Table 1. The measurement of interferon gamma (IFN-γ) secretion amount was performed using a commercially available kit according to the provided test method.

[0164] Interferon gamma secretion amount (pg / ml) Normal group 35.12±2.5 DEX treatment group 11.78±1.8 DEX+Ginseng Treatment Group 34.26±2.5 DEX+ Red Ginseng Treatment Group 34.87±2.5 DEX+Black Ginseng Treatment Group 35.08±2.5

[0166] As shown in Table 1, the secretion of interferon gamma (IFN-γ) was significantly restored, confirming an improvement in weakened immunity.

[0168] Example 3. Improvement of osteoporosis

[0169] 3.1. Rearing and Management of Experimental Animals

[0170] Rats (SD; 10-11 weeks old) were reared in an animal room with a regular light source with a 12-hour light / dark cycle, a temperature of 22-24°C, and a humidity of 55-60%.

[0172] 3.2. Preparation of Ginseng Extracts

[0173] Ginseng, red ginseng, and black ginseng were each sliced ​​and prepared at a concentration of 100 g / L, and then hot water extracted for 2 hours. Afterward, the hot water extract was filtered using 3M filter paper, freeze-dried for more than 24 hours, and then powdered.

[0175] Next, the powder was dissolved in purified water to prepare a concentration of 500 mg / kg and administered orally to test animals.

[0177] 3.3. Preparation of an animal model of osteoporosis induced by long-term steroid administration

[0178] To construct an animal model of osteoporosis induced by steroid drugs, an animal model with induced osteoporosis was created by administering steroids for a long period to an animal model with induced atopic dermatitis.

[0180] Briefly, rats underwent a 4-day incubation period following primary atopic sensitization with 1% DNCB (2,4-Dinitrochlorobenzene) for 3 days. Subsequently, sensitization was performed with 0.5% DNCB three times a week for 8 weeks.

[0182] Dexamethasone, a steroid drug, was dissolved in a 9:1 mixture of olive oil and PBS at a concentration of 2 mg / kg and applied to the skin three times a week for 8 weeks on the day after sensitization to DNCB.

[0184] Ginseng extract was dissolved in water at a concentration of 500 mg / kg and administered orally 6 times a week at the same time every day for 8 weeks.

[0185] The test group is as follows:

[0186] Normal group treated with PBS and vehicle applied

[0187] DNCB sensitization and dexamethasone-coated DEX treatment group

[0188] DEX+ginseng treatment group sensitized to DNCB, topical dexamethasone, and orally administered ginseng extract

[0190] 3.4. Effects on Bone Density and Microstructure of the Femur

[0191] To confirm the preventive effect of ginseng extracts on osteoporosis induced by steroid drugs, femurs were isolated from rats in each test group and analyzed for bone density and microstructure, and the results are shown in Table 2.

[0193] Bone density (g / cm²) 2 ) Width between bone marrow (mm) Normal group 0.18±0.2 0.30±0.1 DEX treatment group 0.08±0.1 0.60±0.3 DEX+Ginseng Treatment Group 0.17±0.2 0.33±0.2 DEX+ Red Ginseng Treatment Group 0.17±0.2 0.32±0.2 DEX+Black Ginseng Treatment Group 0.18±0.2 0.31±0.2

[0195] As shown in Table 2, regarding bone mineral density, the DEX treatment group, which was administered dexamethasone for a long period, showed a decrease of about 50% compared to the normal group (Nor group), while the DEX+ginseng treatment group, which was treated with dexamethasone and ginseng, showed an increase in bone mineral density that was close to that of the normal group. Regarding trabecular separation, the DEX treatment group widened to about 0.60 mm compared to the normal group (about 0.30 mm), whereas the DEX+ginseng treatment group became dense enough to be close to that of the normal group.

[0197] Therefore, it was confirmed that ginseng extracts are effective in preventing osteoporosis induced by steroid drugs, as they exhibited femoral bone density and microstructure similar to that of the normal group not treated with dexamethasone when treated with steroid drugs.

[0199] Example 4: Effect of preventing muscle atrophy

[0200] 4.1. Rearing and Management of Experimental Animals

[0201] 7-week-old ICR rats (Young Bio, Seongnam, Gyeonggi-do, Korea) were reared in an animal room with a regular light source with a 12-hour light / dark cycle, a temperature of 22-24℃, and a humidity of 55-60%.

[0203] 4.2. Preparation of Ginseng Extracts

[0204] Ginseng, red ginseng, and black ginseng were each sliced ​​and prepared at a concentration of 100 g / L, and then hot water extracted for 2 hours. Afterward, the hot water extract was filtered using 3M filter paper, freeze-dried for more than 24 hours, and then powdered.

[0206] Next, the powder was dissolved in purified water to prepare a concentration of 500 mg / kg and administered orally to test animals.

[0208] 4.3. Preparation of an animal model of steroid-induced muscle atrophy

[0209] A steroid-induced muscle atrophy animal model was prepared by administering dexamethasone (600 µg / kg) intraperitoneally for 5 consecutive days to rats (SD; 10-11 weeks of age).

[0211] Ginseng extract was dissolved in water at a concentration of 500 mg / kg and administered orally at the same time every day for 5 days.

[0213] The test group is as follows:

[0214] normal group treated with vehicles

[0215] Dexamethasone-treated DEX group

[0216] DEX+ginseng treatment group treated with dexamethasone and ginseng extracts

[0218] 4.4. Effects on Muscle Weight and Strength Function Assessment

[0219] To confirm the preventive effect of ginseng extracts on muscle atrophy induced by steroid drugs, rats in each test group were necropsied on the 5th day, and muscle strength function was evaluated using a muscle weight and grip strength measuring device, and the results are shown in Table 3.

[0221] Weight of soleus muscle (g) Gastrocnemius weight (g) Grip strength (kg) Normal group 0.21±0.1 2.61±0.7 1.24±0.4 DEX treatment group 0.14±0.1 2.28±0.6 0.97±0.2 DEX+Ginseng Treatment Group 0.19±0.1 2.57±0.7 1.23±0.4 DEX+ Red Ginseng Treatment Group 0.20±0.1 2.57±0.7 1.24±0.4 DEX+Black Ginseng Treatment Group 0.21±0.1 2.58±0.7 1.25±0.4

[0223] As shown in Table 3, the decrease in muscle weight was suppressed, and grip strength was significantly recovered, confirming the improvement in muscle function.

[0225] Therefore, it was confirmed that ginseng extracts are effective in preventing muscle atrophy induced by steroid drugs, as they exhibited muscle weight and grip strength similar to those of the normal group not treated with dexamethasone when treated with steroid drugs.

[0227] Example 5: Diabetes prevention effect

[0228] In Example 3, blood glucose and plasma insulin levels were measured during the autopsy, and the results are shown in Table 4.

[0230] Blood sugar level (mg / dL) Plasma insulin levels (ng / ml) Normal group 149±4.5 1.2±0.4 DEX treatment group 217±7.5 5.3±1.1 DEX+Ginseng Treatment Group 151±4.5 1.3±0.4 DEX+ Red Ginseng Treatment Group 150±4.5 1.3±0.4 DEX+Black Ginseng Treatment Group 150±4.5 1.2±0.4

[0232] As shown in Table 4, both blood glucose and insulin levels increased with the administration of dexamethasone, but when ginseng extract was treated together with steroid drugs, the levels were corrected to a level similar to that of the normal group, confirming that it has a preventive effect against diabetes.

[0234] As described above, it can be seen that when the composition according to the present invention is administered in combination with a steroid drug, it has the effect of improving or suppressing side effects caused by the steroid drug, such as weakened immunity and increased risk of infection, steroid-induced diabetes, osteoporosis, increased blood pressure and electrolyte abnormalities, changes in body shape, myopathy, osteonecrosis, cataracts, skin changes, and behavioral disorders.

Claims

Claim 1 A composition for improving the side effects of a steroid drug containing, as an active ingredient, a ginseng extract selected from the group consisting of ginseng extract, red ginseng extract, and black ginseng extract. Claim 2 A composition for improving the side effects of a steroid drug, characterized in that, in claim 1, the ginseng extract is extracted using water or ethanol as an extraction solvent. Claim 3 A composition for improving the side effects of a steroid drug, characterized in that, in claim 1 or 2, the ginseng extract is treated with one or more enzymes selected from the group consisting of β-galactosidase, β-glucosidase, β-glucanase, α-amylase, and cellulase after extraction. Claim 4 A composition for improving the side effects of a steroid drug according to claim 1 or 2, characterized in that the ginseng extract is fermented with lactic acid bacteria or yeast after extraction, preferably with one or more selected from the group consisting of Lactiplantibacillus plantarum, Lactobacillus brevis, Leuconostoc mesenteroides, Lactococcus lactis, Bifidobacterium longum, Bifidobacterium breve, Saccharomyces cerevisiae, Aspergillus oryzae, and Aspergillus niger. Claim 5 A composition for improving the side effects of a steroid drug according to claim 3, characterized in that the ginseng extract is treated with one or more enzymes selected from the group consisting of β-galactosidase, β-glucosidase, β-glucanase, α-amylase, and cellulase, and then fermented with one or more lactic acid bacteria or yeasts, preferably selected from the group consisting of Lactiplantibacillus plantarum, Lactobacillus brevis, Leuconostoc mesenteroides, Lactococcus lactis, Bifidobacterium longum, Bifidobacterium breve, Saccharomyces cerevisiae, Aspergillus oryzae, and Aspergillus niger. Claim 6 A composition for improving the side effects of a steroid drug according to claim 1, characterized in that the steroid drug is one or more selected from the group consisting of dexamethasone, prednisolone, methylprednisolone, triamcinolone, hydrocortisone, desonide, clobetasol, and betamethasone. Claim 7 A composition for improving the side effects of a steroid drug according to claim 1 or 6, characterized in that the side effects of the steroid drug are one or more selected from the group consisting of weakened immunity and increased risk of infection, steroid-induced diabetes, osteoporosis, increased blood pressure and electrolyte abnormalities, changes in body shape, myopathy, osteonecrosis, cataracts, changes in skin, and behavioral disorders.

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