Pharmaceutical composition for preventing or treating lower urinary tract symptoms, comprising salvia miltiorrhiza extract as active ingredient

Abstract

The present invention relates to a pharmaceutical composition for preventing or treating lower urinary tract symptoms, comprising a Salvia miltiorrhiza extract as an active ingredient. Specifically, one or more symptoms selected from the group consisting of incomplete emptying, intermittency, frequency, urgency, and nocturia are alleviated, and thus the quality of life of patients with lower urinary tract symptoms can be improved.

Description

Pharmaceutical composition for the prevention or treatment of lower urinary tract symptoms containing Salvia miltiorrhiza extract as an active ingredient

[0001] The present invention relates to a pharmaceutical composition for the prevention or treatment of lower urinary tract symptoms comprising Salvia miltiorrhiza extract as an active ingredient.

[0002] The prevalence of urological diseases increases with age, and the most common problem is lower urinary tract symptoms (LUTS). Lower urinary tract symptoms refer collectively to symptoms occurring in the biological structures and organs below the bladder through which urine passes, including the bladder, urethra, and urethral sphincter. These include various symptoms related to the storage and elimination of urine, such as difficulty initiating urination, residual urine, frequent urination, weak stream, straining during urination, nocturia, urgency, and intermittent urination.

[0003] When lower urinary tract symptoms become severe, activity becomes restricted, and the patient is constantly in a state of anxiety and tension, causing significant mental stress. In particular, frequent trips to the bathroom during sleep, coupled with resulting sleep deprivation and increased physical fatigue, lead to various physical problems and cause psychological withdrawal, significantly lowering the quality of life.

[0004] The major diseases causing lower urinary tract symptoms are outlet obstruction due to benign prostatic hyperplasia in men, and stress incontinence and overactive bladder in women. In addition, symptoms may also be caused by detrusor hypoactivity, detrusor instability, and sensory urgency. In particular, with the increase in the elderly population, the number of female patients with voiding disorders is increasing, and about one-quarter of women with lower urinary tract symptoms complain of voiding disorders.

[0005] Meanwhile, phytotherapy, which uses plant-derived drugs for the prevention and treatment of diseases, has fewer side effects and can provide a broader approach to disease treatment. Accordingly, various herbal extracts are being investigated to determine whether they can treat or improve lower urinary tract symptoms.

[0006] Salvia miltiorrhiza (SM), commonly known as red sage, is a medicinal herb that has been widely used in traditional Korean medicine since ancient times. It is a perennial plant belonging to the order Lamiales and the family Lamiaceae, and its origin is China. Cryptotanshinone, tanshinone I, tanshinone IIA, tanshinone IIB, dihydrotanshinone, salvianolic acid B, methyl tanshinonate, methylene tanshinquinone, beta-sitosterol, hydroxytanshinone, neotanshinone, salviol, isocryptotanshinone, miltirone, tanshinol I, tanshinol II, and vitamin E have been reported as components contained in the roots of Salvia miltirone. Furthermore, Salvia miltiorrhiza has been reported to possess various efficacies, including protection against ischemic injury, coronary artery relaxation, inhibition of atherosclerosis, antihypertensive, antihyperlipidemic, antidiabetic, antibacterial, antioxidant, anticancer, antimutagenic, and antithrombotic effects. In vitro experiments have revealed that this extract can inhibit the proliferation of prostate cancer cell lines and reduce prostate size and improve other indicators of prostate health in a rat BPH model. While research is ongoing regarding the diverse applications of Salvia miltiorrhiza extract, there are currently no studies specifically addressing its direct improvement of lower urinary tract symptoms.

[0007] The objective of the present invention is to provide a pharmaceutical composition for the prevention or treatment of lower urinary tract symptoms comprising Salvia miltiorrhiza extract as an active ingredient.

[0008] The present invention provides a pharmaceutical composition for the prevention or treatment of lower urinary tract symptoms (LUTS), characterized by comprising a Salvia miltiorrhiza extract containing Salvia miltiorrhiza extract as an active ingredient.

[0009] The above Salvia miltiorrhiza extract may be a distilled water or ethanol extract, and other solvents may also be used. Depending on the type of extraction solvent, the extraction temperature, extraction time, amount of solvent, and method of treating residual components may be designed differently. Various solvents may also be used for extraction, and extractable solvents include water, ethanol, methanol, fatty oil, glycerin, horse oil, ethyl acetate, acetone, butanol, isopropanol, methylene chloride, and supercritical carbon dioxide.

[0010] The above Salvia miltiorrhiza extract may be an extract obtained particularly with an alcohol having 1 to 6 carbon atoms or a mixed solvent thereof. The alcohol may be ethanol, and may be 40 to 99% ethanol. Preferably, the Salvia miltiorrhiza extract of the present invention is an aqueous alcohol extract.

[0011] The above Salvia miltiorrhiza extract can be concentrated. Additionally, moisture can be removed by heating the extract at 40 to 80°C using a microwave drying method. Alternatively, the extract can be concentrated and dried using a low-temperature vacuum drying method. Low-temperature vacuum drying is a drying method in which the pressure inside the dryer is maintained at a vacuum and the temperature is controlled to approximately 5 to 15°C, which prevents denaturation of the extract components and ensures that the taste and aroma are not lost. Depending on the design conditions, methods such as spray drying, cold air drying, hot air drying, freeze drying, far-infrared drying, shade drying, and vacuum drying may also be used.

[0012] The above Salvia miltiorrhza concentrate can be dried to produce various formulations. The extract can be concentrated and dried using a spray drying method and then prepared into various formulations. For example, it can be prepared as a powder. Low-temperature vacuum drying is a drying method in which the pressure inside the dryer is maintained at a vacuum and the temperature is controlled to approximately 5 to 15°C; this method prevents denaturation of the extract components and ensures that the taste and aroma are not lost. Depending on the design conditions, methods such as cold air drying, hot air drying, freeze-drying, far-infrared drying, shade drying, and reduced-pressure drying may also be used. Preferably, Salvia miltiorrhza can be eluted with 50 L of ethanol for 24 hours and then concentrated under reduced pressure. To this, 1500 mL of water is added, and equal amounts of n-hexane, dichloromethane (CH2Cl2), and ethyl acetate (EtOAc) are added in sequence and extracted twice to produce a red extract in a gel state.

[0013] The above pharmaceutical composition may include a carrier or an excipient, and each of the above may be added in an amount preferably from 0.001% to 90% by weight, more preferably from 0.001% to 50% by weight, and most preferably from 0.001% to 30% by weight based on the total weight of the pharmaceutical composition.

[0014] The appropriate dosage of the above pharmaceutical composition can be prescribed in various ways depending on factors such as the formulation method, mode of administration, patient's age, body weight, sex, pathological condition, food, time of administration, route of administration, excretion rate, and response sensitivity. The pharmaceutical composition of the present invention contains the above tanshinone derivatives as active ingredients. The above pharmaceutical composition can be administered orally or parenterally during clinical administration and can be used in the form of a general pharmaceutical formulation. That is, the composition of the present invention can be administered in various oral and parenteral formulations during actual clinical administration; when formulated, it is prepared using diluents or excipients such as commonly used fillers, volume expanders, binders, humectants, disintegrants, and surfactants. Solid formulations for oral administration include tablets, pills, powders, granules, and capsules, and these solid formulations are prepared by mixing at least one or more excipients, such as starch, calcium carbonate, sucrose, lactose, and gelatin, with the tanshinone derivatives. In addition to simple excipients, lubricants such as magnesium styrate and talc are also used. Liquid formulations for oral administration include suspensions, oral liquids, emulsions, and syrups; in addition to commonly used simple diluents such as water and liquid paraffin, various excipients, such as humectants, sweeteners, flavorings, and preservatives, may be included. Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations, and suppositories. Propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate may be used as non-aqueous solvents and suspension solvents. Witepsol, macrogol, Tween 61, cocoa paste, laurin paste, glycerol, and gelatin may be used as bases for suppositories.

[0015] The dosing unit may contain, for example, 1, 2, 3, or 4 times the individual dose, or 1 / 2, 1 / 3, or 1 / 4 times. The individual dose preferably contains an amount of the active drug administered in a single dose, which corresponds to the entire, 1 / 2, 1 / 3, or 1 / 4 of the daily dose. The effective dose of tanshinone derivatives is concentration-dependent but preferably 0.1 mg to 1,000 mg / kg, more preferably 0.4 to 500 mg / kg, and may be administered 1 to 6 times a day. Thus, it may be administered in the range of 0.1 to 6,000 mg / day per kg of adult body weight.

[0016] The above pharmaceutical composition may be administered to mammals, such as rats, livestock, and humans, via various routes. Any mode of administration is expected, for example, by oral, rectal or intravenous, intramuscular, subcutaneous, intrauterine dura mater, or intracerebrovascular injection.

[0017] In the present invention, the lower urinary tract symptoms are one or more selected from the group consisting of incomplete emptying, intermittent urination, frequency, urgency, and nocturia.

[0018] In this invention, incomplete emptying refers to a symptom in which one feels that urine remains in the bladder even immediately after urination. Frequency refers to the symptom of urinating too often, and intermittency refers to cases where there is a problem in initiating or maintaining the flow of urine, particularly when the flow is not continuous. Urgency refers to a sudden urge to urinate that is uncontrollable, and in severe cases, urine may leak out before reaching the toilet. Weak stream refers to a symptom in which the stream of urine is weak and drips, and straining refers to cases where one must exert force to initiate urination. Additionally, nocturia refers to the phenomenon of waking up at night due to the urge to urinate. In this invention, the evaluation of quality of life assesses the degree of discomfort experienced when maintaining the urination lifestyle at the time of the survey.

[0019] The above composition of the present invention can improve the storage phase or voiding phase of urine using a Salvia miltiorrhiza extract. In the present invention, the storage phase of urine refers to the phase in which urine slowly fills the bladder, and the voiding phase refers to the phase in which a contracted bladder opens the external sphincter to discharge urine through the urethra. By improving the storage phase and / or voiding phase of urine, the above composition of the present invention can improve lower urinary tract symptoms and improve the quality of life of patients with lower urinary tract symptoms.

[0020] The present invention provides a health functional food for preventing or improving lower urinary tract symptoms (LUTS), characterized by containing a Salvia miltiorrhiza extract as an active ingredient. The Salvia miltiorrhiza extract may be an extract obtained by extracting Salvia miltiorrhiza (Salvia miltiorrhiza Bunge) with water, an alcohol having 1 to 6 carbon atoms, or a mixed solvent thereof.

[0021] The Salvia miltiorrhiza extract of the present invention may be added in an amount of preferably 0.001% to 100% by weight, more preferably 0.001% to 70% by weight, and most preferably 0.001% to 50% by weight, based on the total weight of the health functional food.

[0022] The above-mentioned health functional foods include forms such as tablets, capsules, pills, granules, oral films, or liquids, and foods to which the extract of the present invention may be added include, for example, meat, sausages, bread, chocolate, candies, snacks, confectionery, pizza, ramen, other noodles, chewing gum, powdered milk, health food, raw food, fermented milk, dairy products including ice cream, various soups, beverages, tea, drinks, alcoholic beverages, and vitamin complexes. Specifically, health foods containing Salvia miltiorrhiza extract may include health foods and confectionery such as juices, teas, jellies, and juices made with Salvia miltiorrhiza extract as the main ingredient, as well as folk remedies intended for edema, nephritis, urethritis, etc.

[0023] The present invention provides a method for preventing or treating lower urinary tract symptoms (LUTS) in a subject requiring treatment, wherein the method comprises administering a therapeutically effective amount of Salvia miltiorrhiza (Dansam) extract to the subject.

[0024] The above method is characterized in that the Salvia miltiorrhiza extract is obtained by extracting Salvia miltiorrhiza Bunge with water, an alcohol having 1 to 6 carbon atoms, or a mixed solvent thereof.

[0025] The above lower urinary tract symptoms are one or more selected from the group consisting of incomplete emptying, intermittent urination, frequency, urgency, and nocturia.

[0026] The present invention relates to a pharmaceutical composition for the prevention or treatment of lower urinary tract symptoms comprising a Salvia miltiorrhiza extract as an active ingredient, and specifically, can improve the quality of life of patients with lower urinary tract symptoms by improving one or more symptoms selected from the group consisting of incomplete emptying, intermittency, frequency, urgency, and nocturia.

[0027] Figure 1 is a diagram of the Consolidated Standards of Reporting Trials (CONSORT) for patients who participated in this clinical trial.

[0028] Figure 2 is a graph showing the changes in the LUTS voiding subscore (sum of subscores for residual urine, intermittent urination, weak urination, and urinary strain) (A) and the LUTS storage subscore (sum of subscores for frequent urination, urgency, and nocturia) (B) of the clinical trial.

[0029] Preferred embodiments of the present invention are described in detail below. However, the present invention is not limited to the embodiments described herein and may be embodied in other forms, and the contents introduced herein are provided to sufficiently convey the concept of the present invention.

[0030] <Example 1. Preparation of Salvia miltiorrhiza extract (SAGX)>

[0031] After crushing the roots of *Salvia miltiorrhiza*, they were extracted with a 40–99% ethanol aqueous solution at 30–80°C. The process of extracting in the ethanol aqueous solution for 2 to 24 hours and, if necessary, extracting again in fresh ethanol for 2 to 12 hours was repeated 2 to 5 times to collect the extracts, which were then centrifuged to obtain the supernatant. Subsequently, the obtained supernatant was collected, evaporated and dried at 45–75°C, ground, and filtered through a mesh of 80 or larger to prepare the *Salvia miltiorrhiza* extract (SAGX).

[0032]

[0033] <Example 2. Clinical Trial on Improvement of Lower Urinary Tract Symptoms with Salvia miltiorrhiza Extract>

[0034] The clinical trial participants were adults aged 40 to 80 diagnosed with lower urinary tract symptoms.

[0035] The intake of Salvia miltiorrhiza extract was determined to be approximately 400 mg / 60 kg (S-400) and 800 mg / 60 kg (S-800) by applying the human equivalent dose (HED) calculated for a body weight of 60 kg based on the results of previous animal studies, and in human clinical trials, the daily intake of Salvia miltiorrhiza extract was ultimately set to 400 mg / day and 800 mg / day.

[0036] Figure 1 shows the Consolidated Standards of Reporting Trials (CONSORT) diagram of the patients who participated in this clinical trial.

[0037] The clinical trial aimed to evaluate the efficacy and safety of S-400 and S-800 compared to a placebo in improving lower urinary tract symptoms (LUTS), and a total of 110 participants, including 39 in the S-400 group, 36 in the S-800 group, and 35 in the placebo group, completed a 12-week study.

[0038] Lower urinary tract symptoms were evaluated equally for men and women based on incomplete emptying, frequency, intermittent urination, urgency, weak stream, straining, nocturia, and quality of life.

[0039] An example of a survey on evaluation items is shown in Table 1 below.

[0040] No. Questionnaire Item 1 (Incomplete emptying) How often in the past month did you feel that your bladder did not completely empty after urinating? ○ Never (0 points) ○ 1 in 5 times (1 point) ○ 1-2 times in 5 times (2 points) ○ 2-3 times in 5 times (3 points) ○ 3-4 times in 5 times (4 points) ○ Almost always (5 points) 2 (Frequency) How often in the past month did you need to urinate again within 2 hours of urinating? ○ Never (0 points) ○ 1 in 5 times (1 point) ○ 1-2 times in 5 times (2 points) ○ 2-3 times in 5 times (3 points) ○ 3-4 times in 5 times (4 points) ○ Almost always (5 points) 3 (Intermittency) How often in the past month did you stop and start urinating multiple times? ○ Never (0 points) ○ 1 out of 5 times (1 point) ○ 1-2 out of 5 times (2 points) ○ 2-3 out of 5 times (3 points) ○ 3-4 out of 5 times (4 points) ○ Almost always (5 points) 4 (Urgency) How often have you had difficulty holding your urine in the past month? ○ Never (0 points) ○ 1 out of 5 times (1 point) ○ 1-2 out of 5 times (2 points) ○ 2-3 out of 5 times (3 points) ○ 3-4 out of 5 times (4 points) ○ Almost always (5 points) 5 (Weak stream) How often have you experienced symptoms of a weak urine stream in the past month? ○ Never (0 points) ○ 1 out of 5 times (1 point) ○ 1-2 out of 5 times (2 points) ○ 2-3 out of 5 times (3 points) ○ 3-4 out of 5 times (4 points) ○ Almost always (5 points) 6 (Straining) Last During the past month, how often did you strain or have to strain to urinate? ○ Never (0 points) ○ 1 in 5 times (1 point) ○ 1-2 times in 5 times (2 points) ○ 2-3 times in 5 times (3 points) ○ 3-4 times in 5 times (4 points) ○ Almost always (5 points) 7 (Nocturia) During the past month,From the time you went to bed at night until you woke up in the morning, how many times did you most frequently get up to urinate? ○ Never (0 points) ○ 1 out of 5 times (1 point) ○ 1-2 out of 5 times (2 points) ○ 2-3 out of 5 times (3 points) ○ 3-4 out of 5 times (4 points) ○ Almost always (5 points) 8 (Quality of life) How would you feel if you were to live your entire life with your current urinating condition? ○ No problem (0 points) ○ Okay (1 point) ○ Mostly satisfied (2 points) ○ Half satisfied / 50 dissatisfied (3 points) ○ Mostly dissatisfied (4 points) ○ Distressed (5 points) Consider your usual urination habits (over the past month) and rate how many times the following uncomfortable symptoms appear if you urinate approximately 5 times.

[0041] The survey in Table 1 above was administered on the start date of the clinical trial, at week 6, and at week 12, and the difference between the survey scores administered on the start date of the clinical trial and at week 6 or week 12 was calculated and shown in Table 2.

[0042] S-400(N=39)S-800(N=36)Placebo (P)(N=35)p-value*S-400 vs P W S-800 vs P W Incomplete emptying B 1.93±1.052.38±1.292.12±1.170.4184Δ6wk-0.70±0.94-0.95±1.10-0.15±1.0 20.0010.0017Δ12wk-0.70±1.16-1.13±1.42-0.12±1.150.00260.001Frequency B 1.68±1.021.51±1.251.56±1.280.6697Δ6wk-0.38±0.90-0.59±1.02-0.35±0.770. 90330.1302Δ12wk-0.68±0.97-0.72±1.21-0.24±0.960.04730.0135Intermittency B2.05±1.132.41±1.412.15±1.420.5514Δ6wk-0.73±0.82-0.82±1.32-0.24±1.0 70.00660.0514Δ12wk-0.75±1.17-1.00±1.30-0.18±1.060.00170.0017Urgency B 0.85±0.801.28±1.230.91±1.160.2396Δ6wk-0.08±0.69-0.46±0.820.06±0. 850.38780.0263Δ12wk-0.20±0.76-0.38±1.180.03±0.940.16190.2917Weak stream B 2.63±1.192.56±1.102.79±1.200.4045Δ6wk-0.68±1.07-0.41±0.97-0.18±1.4 20.03050.1481Δ12wk-0.65±1.10-0.44±1.100.00±1.350.0010.006Straining B 1.30±1.111.33±0.981.29±1.120.9394Δ6wk-0.30±0.97-0.54±0.82-0.47±1.16 0.38180.8045Δ12wk-0.63±0.90-0.64±0.90-0.32±0.810.07110.0866Nocturia B 2.00±1.131.92±0.932.12±0.880.5925Δ6wk-0.85±0.86-0.64±0.87-0.32±0.9 10.00210.0146Δ12wk-0.80±0.85-0.72±0.86-0.24±0.700.00020.001Quality of life B 3.70±0.69 3.59±0.99 3.79±0.54 0.9149Δ6wk-0.75±0.90-0.56±1.05-0.38±0.95 0.037 0.0962Δ12wk-1.10±0.87-0.79±1.00-0.32±0.84<.0001 0.0026Δ: Change in score from baseline, B: Baseline, *: Comparison between groups (Kruskal-Wallis test or ANOVA), W: Comparison between two groups (Wilcoxon rank sum test, GLM adjusted baseline), Data are expressed as mean ± standard deviation

[0043]

[0044] As shown in Table 2 above, regarding incomplete emptying, both the S-400 and S-800 intake groups recorded significantly lower scores than the placebo group (P<0.005), and showed a tendency to be dependent on SAGX concentration and duration of intake.

[0045] Intermittency also recorded significantly lower scores in both the S-400 and S-800 intake groups compared to the placebo group (P<0.005), and showed a tendency to be dependent on SAGX concentration and duration of intake.

[0046] In the case of frequency, there was no significant difference between the S-400 and S-800 intake groups after 6 weeks of intake, but after 12 weeks, both the S-400 and S-800 intake groups recorded significantly lower scores (P<0.05), confirming that the S-800 intake group showed greater improvement than the S-400 group.

[0047] In the case of urgency, it was confirmed that there was a significant improvement after consuming S-800 for 6 weeks, and weak stream was confirmed to have significantly improved after 12 weeks in both the S-400 and S-800 consumption groups (P<0.005).

[0048] In the case of urinary straining, no significant improvement was observed with the intake of Salvia miltiorrhiza extract (SAGX), but after 12 weeks, both the S-400 and S-800 intake groups showed a tendency to improve compared to the placebo group.

[0049] In particular, Salvia miltiorrhiza extract significantly improved nocturia in both the S-400 and S-800 intake groups after 6 and 12 weeks (P<0.005).

[0050] Overall, participants in this clinical trial confirmed that the Salvia miltiorrhiza extract of the present invention improved the quality of life, and after 12 weeks, both the S-400 and S-800 intake groups confirmed that the quality of life was significantly improved.

[0051] <Example 3. Clinical Trial on Improvement of Lower Urinary Tract Symptoms with Salvia miltiorrhiza Extract>

[0052] Normal urination consists of two phases: the storage phase and the voiding phase. The storage phase involves the passive filling of the bladder, whereas the voiding phase requires precise coordination between bladder contraction and the relaxation of the external and internal sphincters. The central nervous system controls this complex urination process, regulating normal urinary retention and voiding by coordinating the activities of the autonomic and somatic nervous systems. The ratio of voiding to storage subscores in the LUTS score is associated with lower urinary tract dysfunction.

[0053] Figure 2 shows the changes in the LUTS voiding subscore (sum of residual urine sensation, intermittent urination, weak urination, and urinary strain subscores) and the LUTS storage subscore (sum of frequent urination, urgency, and nocturia subscores) among the LUTS scores obtained above.

[0054] As shown in Figure 2, the Salvia miltiorrhiza extract of the present invention was shown to improve lower urinary tract dysfunction during the storage phase and voiding phase in both the 400 mg / day (S-400) and 800 mg / day (S-800) treatment groups.

[0055]

[0056] Based on the above results, it was confirmed that the Salvia miltiorrhiza extract of the present invention significantly improves lower urinary tract symptoms (LUTS) and improves the quality of life of patients with lower urinary tract symptoms.

[0057]

[0058] <Formulation Example 1. Pharmaceutical Formulation>

[0059] Formulation Example 1-1. Preparation of Tablets

[0060] 400 mg of the Salvia miltiorrhiza extract of the present invention was mixed with 175.9 g of lactose, 180 g of potato starch, and 32 g of colloidal silica. A 10% gelatin solution was added to this mixture, and the mixture was ground and passed through a 14-mesh sieve. This was dried, and the mixture obtained by adding 160 g of potato starch, 50 g of active ingredient, and 5 g of magnesium stearate was made into tablets.

[0061] Formulation Example 1-2. Preparation of Injectable Solution

[0062] 100 mg of the Salvia miltiorrhiza extract of the present invention, 0.6 g of sodium chloride, and 0.1 g of ascorbic acid were dissolved in distilled water to make 100 ml. This solution was placed in a bottle and sterilized by heating at 20°C for 30 minutes.

[0063] <Preparation Example 2. Preparation of a Health Functional Food>

[0064] Preparation Example 2-1. Preparation of a health functional food

[0065] The present invention was prepared by mixing 400 mg of Salvia miltiorrhiza extract, an appropriate amount of a vitamin mixture, 70 μg of vitamin A acetate, 1.0 mg of vitamin E, 0.13 mg of vitamin B1, 0.15 mg of vitamin B2, 0.5 mg of vitamin B6, 0.2 μg of vitamin B12, 10 mg of vitamin C, 10 μg of biotin, 1.7 mg of nicotinamide, 50 μg of folic acid, 0.5 mg of calcium pantothenate, an appropriate amount of a mineral mixture, 1.75 mg of ferrous sulfate, 0.82 mg of zinc oxide, 25.3 mg of magnesium carbonate, 15 mg of monopotassium phosphate, 55 mg of disodium phosphate, 90 mg of potassium citrate, 100 mg of calcium carbonate, and 24.8 mg of magnesium chloride to form granules, but it can be prepared by modifying it into various formulations depending on the use. In addition, the composition ratio of the above vitamin and mineral mixture may be arbitrarily modified, and the above ingredients may be mixed and manufactured according to a conventional method for manufacturing health functional foods.

[0066] Preparation Example 2-2. Preparation of a health functional beverage

[0067] 400 mg of the Salvia miltiorrhiza extract of the present invention, 0.1 g of citric acid, 100 g of fructooligosaccharide, and 900 g of purified water were mixed and a beverage was prepared by stirring, heating, filtering, sterilizing, and refrigerating according to a conventional beverage preparation method.

Claims

1. A pharmaceutical composition for the prevention or treatment of lower urinary tract symptoms (LUTS), characterized by containing Salvia miltiorrhiza extract as an active ingredient.

2. In Paragraph 1, A pharmaceutical composition for the prevention or treatment of lower urinary tract symptoms (LUTS), characterized in that the above-mentioned Salvia miltiorrhiza extract comprises an extract of Salvia miltiorrhiza Bunge obtained with water, an alcohol having 1 to 6 carbon atoms, or a mixed solvent thereof.

3. In Paragraph 1, A pharmaceutical composition for the prevention or treatment of lower urinary tract symptoms (LUTS), characterized in that the above lower urinary tract symptoms are one or more selected from the group consisting of incomplete emptying, intermittent urination, frequency, urgency, and nocturia.

4. In Paragraph 1, The above composition is a pharmaceutical composition for the prevention or treatment of Lower Urinary Tract Symptoms (LUTS), characterized by a Salvia miltiorrhiza extract that improves the storage phase or voiding phase of urine.

5. A health functional food for preventing or improving lower urinary tract symptoms (LUTS), characterized by containing Salvia miltiorrhiza extract as an active ingredient.

6. In Paragraph 5, A health functional food for preventing or improving lower urinary tract symptoms (LUTS), characterized in that the above-mentioned Salvia miltiorrhiza extract comprises an extract of Salvia miltiorrhiza Bunge obtained with water, an alcohol having 1 to 6 carbon atoms, or a mixed solvent thereof.

7. As a method for preventing or treating Lower Urinary Tract Symptoms (LUTS) in patients requiring treatment, The above method is characterized by including administering a therapeutically effective amount of Salvia miltiorrhiza (Dansam) extract to a subject.

8. In Paragraph 7, A method characterized by obtaining the above-mentioned Salvia miltiorrhiza extract by extracting Salvia miltiorrhiza Bunge with water, an alcohol having 1 to 6 carbon atoms, or a mixed solvent thereof.

9. In Paragraph 7, A method characterized in that the above lower urinary tract symptoms include one or more selected from the group consisting of incomplete emptying, intermittency, frequency, urgency, and nocturia.

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