Agent for increasing force of urine flow

Abstract

To provide a pharmaceutical for increasing the force of urine flow.SOLUTION: A herbal medicine mixture A containing Poria sclerotium and Plantago seeds, a herbal medicine mixture B containing Poria sclerotium, cinnamon bark and aconite root, and / or their extracts are suitable as an active ingredient of an agent for increasing the force of urine flow.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to a urinary flow increaser. [Background technology]

[0002] Normal urination consists of a urination cycle of urination (urinating) and storage (storing urine), and when this cycle does not function smoothly, it is called urinary dysfunction. The number of people who suffer from urinary dysfunction increases with age, regardless of gender, and it is said to significantly impair quality of life (QOL).

[0003] Drug therapies for urinary disorders include anticholinergics, which increase bladder capacity, and α- and β-adrenergic receptor stimulants, which tighten the urethra and relax the bladder. However, because these Western drugs have side effects, herbal medicines may be chosen instead. For example, Rokumi-gan (Non-Patent Document 1) is used as a herbal medicine for urinary difficulty and frequent urination. [Prior art documents] [Non-patent literature]

[0004] [Non-Patent Document 1] Kampo preparation Tsumura Rokumi-gan extract granules (medical use) appendix, revised May 2007 Summary of the Invention [Problem to be solved by the invention]

[0005] Chinese herbal medicines that are effective for urinary problems have few side effects and are easy to incorporate into treatment, but the effects are often difficult to feel.

[0006] In addition, even if urinary problems do not develop, the force of urine weakens with age, so if there were a medicine that could increase the force of urine (urinary flow), it would be possible to provide a medicine whose effects are easily noticeable.

[0007] The present disclosure aims to provide a pharmaceutical agent that increases urinary flow. [Means for solving the problem]

[0008] As a result of intensive research, the present inventors have found that a herbal medicine mixture containing a specific combination of herbal medicines or an extract thereof has the effect of increasing urinary flow. The present disclosure has been completed based on this finding and through further research.

[0009] That is, the present disclosure provides the inventions of the following aspects. Item 1. A urinary flow enhancer comprising a herbal mixture A containing Poria Sclerotium and Shazenshi, a herbal mixture B containing Poria Sclerotium, Cinnamon and Bushi, and / or an extract thereof. Item 2. The urinary flow-increasing agent according to Item 1, which is used to increase urinary flow in a subject suffering from nocturia. Item 3. The urinary flow increaser according to Item 1 or 2, wherein the herbal mixture A comprises Lotus Root, Bakumondou, Poria Cocos, Ginseng, Shazenshi, Scutellaria Root, Astragalus Root, Zikoppi, and Licorice. Item 4. The urinary flow increaser according to Item 1 or 2, wherein the herbal mixture B comprises Rehmannia Root, Cornus Cherry, Dioscorea Rhizome, Poria Coccinea, Peony Bark, Cinnamon Bark, and Brussels Root. Item 5. The urinary flow increaser according to Item 1 or 2, wherein the herbal mixture A or B comprises Goshitsu, Shazenshi, Rehmannia Root, Cornus Cherry, Dioscorea Rhizome, Takusha, Poria Coccinea, Peony Bark, Cinnamon Bark, and Bushi. Item 6. The agent for increasing urinary flow according to any one of Items 1 to 5, which is used for increasing urinary flow in a subject without urinary dysfunction. Item 7. A method for increasing urinary flow, comprising administering to a subject in need of increasing urinary flow an effective amount of a herbal mixture A containing Poria Sclerotium and Shazenshi, a herbal mixture B containing Poria Sclerotium, Cinnamon and Bushi, and / or an extract thereof. Item 8. Use of herbal mixture A containing Poria Scutellaria and Shazenshi, herbal mixture B containing Poria Scutellaria, Cinnamon and Bushi, and / or extracts thereof for the manufacture of a composition for increasing urinary flow. Item 9. Herbal mixture A containing Poria Scutellaria and Shazenshi, herbal mixture B containing Poria Scutellaria, Cinnamon and Bushi, and / or extracts thereof, for use in treating diseases associated with weak urinary flow. Effect of the Invention

[0010] According to the present disclosure, a pharmaceutical agent for increasing urinary flow is provided. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The urinary flow increaser of the present disclosure is characterized by containing a herbal mixture A containing Poria Scutellaria and Shazenshi, a herbal mixture B containing Poria Scutellaria, Cinnamon and Bushi, and / or an extract thereof. The urinary flow increaser of the present disclosure will be described in detail below.

[0012] Active ingredients The urinary flow increaser of the present disclosure contains, as active ingredients, herbal mixture A containing Poria Sclerotium and Shazenshi, herbal mixture B containing Poria Sclerotium, Cinnamon and Bushi, and / or extracts thereof.

[0013] The herbal mixture A is not particularly limited as long as it contains Poria Columbine and Shazenshi, and may contain any other herbal medicines, but from the viewpoint of enhancing the effect of increasing urinary flow, preferred examples include herbal mixture a consisting of Lotus Root, Bakumondou, Poria Columbine, Ginseng, Shazenshi, Scutellaria Root, Astragalus Root, Zikoppi, and Licorice, and herbal mixture ab consisting of Goshitsu, Shazenshi, Rehmannia Root, Cornus Cherry, Dioscorea Rhizome, Takusha, Poria Columbine, Peony Pea, Cinnamon Bark, and Bushi.

[0014] The herbal mixture B is not particularly limited as long as it contains Poria Columbine, Cinnamon Bark, and Atractylodes Mucor, and may contain any other herbal medicines; however, from the viewpoint of enhancing the effect of increasing urinary flow, preferred examples include herbal mixture b consisting of Rehmannia Root, Cornus Cherry, Dioscorea Rhizome, Alpinia Root, Poria Columbine, Peony Bark, Cinnamon Bark, and Atractylodes Mucor, and herbal mixture ab consisting of Goshitsu, Shazenshi, Rehmannia Root, Cornus Cherry, Dioscorea Rhizome, Alpinia Root, Poria Columbine, Peony Bark, Cinnamon Bark, and Atractylodes Mucor.

[0015] The mixing ratio of the herbs that make up the herb mixture a is not particularly limited, and examples include 2 to 5 parts by weight, preferably 3 to 4 parts by weight, of Lotus Saxifraga; 1.5 to 4 parts by weight, preferably 2 to 3 parts by weight, of Poria Cocos Root; 2 to 4 parts by weight, preferably 2.5 to 3.5 parts by weight, of Ginseng; 1.5 to 3 parts by weight, preferably 2 to 4 parts by weight, of Shazenshi Fruit; 1.5 to 3 parts by weight, preferably 2 to 2.5 parts by weight, of Scutellaria Root; 1 to 4 parts by weight, preferably 2 to 3 parts by weight, of Astragalus Root; 1 to 3 parts by weight, preferably 2 to 2.5 parts by weight, of Zygophyll A.

[0016] The mixing ratio of the herbs constituting the herb mixture b is not particularly limited, and examples thereof include 2.5 to 8 parts by weight, preferably 6 to 8 parts by weight, of Rehmannia Root; 1.5 to 4 parts by weight, preferably 3 to 4 parts by weight, of Cornus Cherry; 1.5 to 4 parts by weight, preferably 3 to 4 parts by weight, of Dioscorea Rhizome; 1.5 to 3 parts by weight, preferably 2 to 3 parts by weight, of Poria Scutellaria; 1.5 to 3 parts by weight, preferably 2 to 3 parts by weight, of Poria Coix Seed; 1.5 to 3 parts by weight, preferably 2 to 4 parts by weight, of Peony Root; 0.5 to 1 part by weight, preferably 0.8 to 1 part by weight, of Cinnamon Bark; and 0.25 to 1 part by weight, preferably 0.5 to 1 part by weight, of Bushi (processed Bushi).

[0017] The mixing ratio of the herbs constituting the herb mixture ab is not particularly limited, and examples thereof include 1 to 3 parts by weight, preferably 1.5 to 3 parts by weight, of Goshitsu Fruit; 1 to 3 parts by weight, preferably 1.5 to 3 parts by weight, of Shazenshi Fruit; 2 to 8 parts by weight, preferably 2 to 3 parts by weight, of Rehmannia Root; 1 to 4 parts by weight, preferably 2 to 4 parts by weight, of Cornus Cherry; 1 to 4 parts by weight, preferably 1.5 to 4 parts by weight, of Dioscorea Rhizome; 1 to 3 parts by weight, preferably 1.5 to 3 parts by weight, of Poria Scutellaria; 1 to 4 parts by weight, preferably 1.5 to 4 parts by weight, of Peony Root; 0.25 to 2 parts by weight, preferably 0.5 to 2 parts by weight, of Cinnamon Bark; and 0.25 to 1 part by weight, preferably 0.5 to 1 part by weight, of Bushi (processed Bushi).

[0018] In the urine flow-increasing agent of the present disclosure, the active ingredient is preferably an extract of the above-mentioned herbal mixture from the viewpoint of enhancing the urine flow-increasing effect. Also, in the urine flow-increasing agent of the present disclosure, the active ingredient is preferably herbal mixture a, herbal mixture b, or an extract thereof, more preferably an extract of herbal mixture a or an extract of herbal mixture b, and even more preferably an extract of herbal mixture a.

[0019] The form of the extract of the mixture of herbs may be any of a liquid extract such as a liquid extract or a soft extract, and a solid dry extract powder.

[0020] The liquid extract of the herbal mixture can be obtained by subjecting the herbal mixture to an extraction process and concentrating the resulting extract as necessary. The extraction solvent used in the extraction process is not particularly limited, and may be water or aqueous ethanol, preferably water. The dried extract powder of the herbal mixture can be obtained by drying the liquid extract. The drying method is not particularly limited, and may be, for example, a spray drying method, or a method in which a suitable adsorbent (e.g., silicic anhydride, starch, etc.) is added to a soft extract with an increased extract concentration to obtain an adsorbed powder.

[0021] In the urine flow increaser of the present disclosure, the content of the active ingredient is not particularly limited as long as the effect of the present disclosure is exhibited, and is usually 5 to 100% by weight, preferably 10 to 90% by weight, more preferably 20 to 80% by weight, and even more preferably 30 to 60% by weight. When an extract is used as the active ingredient, the content is calculated based on the amount of dried extract powder, which means the amount of the dried extract powder itself when a dried extract powder is used, the amount converted to the amount remaining after removing the solvent when a liquid extract is used, and when the dried extract powder contains additives such as adsorbents added during production, the amount excluding the additives.

[0022] Other Ingredients The urinary flow increasing agent of the present disclosure may be composed of the above-mentioned active ingredient alone, or may contain additives and / or bases according to the formulation. The additives and bases that may or may not be contained in the urinary flow increasing agent of the present disclosure are not particularly limited as long as they are pharmacologic acceptable, and examples thereof include excipients, binders, disintegrants, lubricants, isotonicity agents, plasticizers, dispersants, emulsifiers, solubilizers, wetting agents, stabilizers, suspending agents, adhesives, coating agents, glossing agents, water, oils and fats, waxes, hydrocarbons, fatty acids, higher alcohols, esters, water-soluble polymers, surfactants, metal soaps, lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, UV protection agents, preservatives, flavorings, fragrances, powders, thickeners, dyes, chelating agents, etc. These bases and additives may be used alone or in combination of two or more. The content of these additives and base is appropriately determined depending on the type of additive and base used and / or the formulation form of the urinary flow enhancer.

[0023] In addition, the urinary flow agent of the present disclosure may or may not contain other nutritional components and / or pharmacological components, as necessary, in addition to the above-mentioned active ingredients. The nutritional components and pharmacological components that may or may not be contained in the urinary flow agent of the present disclosure are not particularly limited as long as they are pharmacologic acceptable, and examples thereof include antacids, stomachic agents, digestive agents, intestinal regulators, antispasmodics, mucosal repair agents, anti-inflammatory agents, astringents, antiemetics, antitussives, expectorants, anti-inflammatory enzymes, sedatives, hypnotics, antihistamines, caffeine, cardiac diuretics, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, herbal extracts, vitamins, menthols, etc. These nutritional components and pharmacological components may be used alone or in combination of two or more. The content of these components is appropriately set according to the type of components used, etc.

[0024] Formulation The formulation form of the urinary flow increasing agent of the present disclosure is not particularly limited, as long as it can be administered orally. Examples of the formulation include solid formulations such as powders, fine granules, granules, tablets, troches, chewable tablets, capsules (soft capsules, hard capsules), and pills; semi-solid preparations such as jellies; and liquid preparations such as solutions, suspensions, and syrups, and preferably include pills, granules, or tablets.

[0025] Manufacturing method The method for producing the urinary flow increasing agent of the present disclosure may involve formulating the above-mentioned herbal ingredients in accordance with a conventional formulation method employed in the medical field.

[0026] Purpose The urinary flow-increasing agent of the present disclosure is used for the purpose of increasing the flow of urine during urination. The target increase in urinary flow is 1.5 times or more, preferably 2 times or more, more preferably 2.4 times or more of the urinary flow (mL / sec, daily average) before taking the urinary flow-increasing agent of the present disclosure.

[0027] The urinary flow-increasing agent of the present disclosure has a high effect of increasing urinary flow, particularly in subjects with nocturia (a symptom of having to urinate once or more, preferably twice or more, after going to bed.) Therefore, preferred subjects for which the urinary flow-increasing agent of the present disclosure is used include subjects with nocturia.

[0028] The urinary flow-increasing agent of the present disclosure can effectively increase urinary flow even in people who do not have urinary disorders, specifically, in subjects who do not have bladder contraction disorders. Therefore, preferred subjects for which the urinary flow-increasing agent of the present disclosure is used include subjects who do not have urinary disorders.

[0029] The gender of the target of the urinary flow-increasing agent of the present disclosure is not limited to males or females. The age of the target of the urinary flow-increasing agent of the present disclosure is not particularly limited to, but may be, for example, 40 years old or older, preferably 50 years old or older, or 60 years old or older, and the upper limit of the age may be, for example, 80 years old or younger, preferably 70 years old or younger.

[0030] Dosage / Usage The urine flow increaser of the present disclosure is used by oral administration. The dosage of the urine flow increaser of the present disclosure is appropriately set according to the age, constitution, severity of symptoms, etc. of the person to be administered, but for example, in the case of herbal mixture A, the total amount of Poria columbine and Shazenshi Rhizome in terms of the raw herbal drug equivalent is, for example, 2.4 to 7 g, preferably 2.9 to 5 g, per day for humans, and in the case of herbal mixture B, the total amount of Poria columbine, Cinnamon Bark, and Brussels sieboldii in terms of the raw herbal drug equivalent is, for example, 2 to 7 g, preferably 2.4 to 5 g.

[0031] The daily dose of the urinary flow enhancer of the present disclosure for humans is, in the case of herbal mixture a, for example, 12 to 35 g, preferably 20 to 25 g, in terms of the total amount of the raw herbal medicines of the herbal mixture a, and in the case of the extract of herbal mixture a, for example, 1.5 to 3 g, preferably 2 to 2.5 g, in terms of the dried extract powder; in the case of herbal mixture b, for example, 8 to 22 g, preferably 10 to 14 g, in terms of the total amount of the raw herbal medicines of the herbal mixture b, and in the case of the extract of herbal mixture b, for example, 1 to 4 g, preferably 1.5 to 2.5 g, in terms of the dried extract powder; in the case of herbal mixture ab, for example, 10 to 35 g, preferably 12 to 20 g, in terms of the total amount of the raw herbal medicines of the herbal mixture ab, and in the case of the extract of herbal mixture ab, for example, 2 to 5 g, preferably 2 to 3 g, in terms of the dried extract powder.

[0032] The frequency of administration of the urinary flow increasing agent of the present disclosure is 1 to 3 times a day, preferably 2 times a day. The timing of administration is not particularly limited and may be before, after, or between meals, but is preferably before (30 minutes before a meal) or between meals (2 hours after a meal).

[0033] The duration of administration of the urinary flow-increasing agent of the present disclosure is, for example, 4 days or more, preferably 5 days or more, more preferably 6 days or more, and even more preferably 1 week or more. The upper limit of the administration period is not particularly limited, but since the urinary flow-increasing effect of the urinary flow-increasing agent of the present disclosure appears relatively quickly, the administration period may be, for example, 2 weeks or less, 10 days or less, or 1 week or less. EXAMPLES

[0034] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples.

[0035] (1) Preparation of urinary flow-increasing agent (1-1) Extract of herbal mixture a 3.5 parts by weight of Lotus Root, 2.1 parts by weight of Bakumondou, 2.8 parts by weight of Poria Root, 3.5 parts by weight of Ginseng, 2.1 parts by weight of Shazenshi, 2.1 parts by weight of Scutellaria Root, 2.8 parts by weight of Astragalus Root, 2.1 parts by weight of Zikkōbi, and 0.7 parts by weight of Licorice were used, which were chopped, extracted with 10 times the weight of water at about 100°C for 1 hour, and centrifuged to obtain an extract. The extract was concentrated under reduced pressure and dried using a spray dryer to obtain an extract powder of the herbal mixture a. The drying using the spray dryer was performed by dropping the extract into an atomizer rotating at 10,000 rpm and supplying hot air at 150°C.

[0036] (1-2) Extract of herbal mixture b 2.5 parts by weight of Rehmannia Root, 1.5 parts by weight of Cornus Cherry, 1.5 parts by weight of Dioscorea Radix, 1.5 parts by weight of Thuja Root, 1.5 parts by weight of Poria Coccinea, 1.5 parts by weight of Peony Root, 0.5 parts by weight of Cinnamon Bark, and 0.5 parts by weight of Processed Bhut were used, and after chopping, they were extracted with 10 times the weight of water at about 100°C for 1 hour and centrifuged to obtain an extract. The extract was concentrated under reduced pressure and dried using a spray dryer to obtain an extract powder of herbal mixture b. The drying using the spray dryer was performed by dropping the extract into an atomizer rotating at 10,000 rpm and supplying hot air at 150°C.

[0037] (1-3) Extract of herbal mixture ab 1.5 parts by weight of Goshitsu, 1.5 parts by weight of Shazenshi, 2.5 parts by weight of Rehmannia Root, 1.5 parts by weight of Cornus Cherrier, 1.5 parts by weight of Dioscorea Radix, 1.5 parts by weight of Rhizome, 1.5 parts by weight of Dioscorea Radix, 1.5 parts by weight of Poria Coccinea, 1.5 parts by weight of Peony Root, 0.5 parts by weight of Cinnamon Bark, and 0.5 parts by weight of Processed Bush were used, chopped, and then extracted with 10 times the weight of water at about 100°C for 1 hour and centrifuged to obtain an extract. The extract was concentrated under reduced pressure and dried using a spray dryer to obtain an extract powder of the herbal mixture ab. The drying using the spray dryer was performed by dropping the extract into an atomizer rotating at 10,000 rpm and supplying hot air at 150°C.

[0038] (2) Experimental method Twenty men and women in their 40s to 70s who did not suffer from urinary disorders and who suffered from nocturia (getting up to urinate more than twice after going to bed) were divided into four groups (N=5). Each group was instructed to take tablets of extract of herbal mixture a, tablets of extract of herbal mixture b, tablets of extract of herbal mixture a, and tablets of Rokumi-gan extract twice a day, before breakfast and before dinner, for one week. Twenty men and women in their 40s to 70s who did not suffer from urinary disorders and who suffered from nocturia were divided into four groups (N=5), and each group was instructed to take each tablet under the same conditions as above.

[0039] The dosage for the extract of herbal mixture a is 4.9 g / day in terms of the total amount of the raw herbal medicines of Poria columbine and Shazenshi, 21.7 g / day in terms of the total amount of the raw herbal medicines of herbal mixture a, and 2.2 g / day in terms of the dried extract powder of the extract of herbal mixture a; for the extract of herbal mixture b, 2.5 g / day in terms of the total amount of the raw herbal medicines of Poria columbine, Cinnamon bark, and Bushi, and 2.5 g / day in terms of the total amount of the raw herbal medicines of herbal mixture b. The total amount of raw drug equivalents of Poria Columbine and Shazenshi was 3g / day, the total amount of raw drug equivalents of Poria Columbine, Cinnamon Bark, and Bushi was 2.5g / day, the total amount of raw drug equivalents of raw drug equivalents of raw drug mixture ab was 14g / day, and the total amount of raw drug equivalents of raw drug mixture ab was 2.5g / day. The total amount of raw drug equivalents of Rokumi-gan extract was 20g / day, and the amount of raw drug equivalents was 3.75g / day.

[0040] Before and one week after starting the drug, the subjects were asked to measure the volume and duration of urine in a paper cup each time they urinated, and to record the results in a urination diary. The volume of urine divided by the duration of urination (mL / sec) was used to determine the urinary flow rate. The average daily urinary flow rate for each subject was calculated, and the average daily urinary flow rate was then averaged for each group (average of 5 subjects). The results for the group administered the extract of herbal mixture a are shown in Table 1 (Table 1A shows the results for subjects with nocturia, and Table 1B shows the results for subjects without nocturia), the results for the group administered the extract of herbal mixture b are shown in Table 2 (Table 2A shows the results for subjects with nocturia, and Table 2B shows the results for subjects without nocturia), the results for the group administered the extract of herbal mixture ab are shown in Table 3 (Table 3A shows the results for subjects with nocturia, and Table 3B shows the results for subjects without nocturia), and the results for the group administered the extract of herbal mixture ab are shown in Table 4 (Table 4A shows the results for subjects with nocturia, and Table 4B shows the results for subjects without nocturia).

[0041] [Table 1A]

[0042] [Table 1B]

[0043] [Table 2A]

[0044] [Table 2B]

[0045] [Table 3A]

[0046] [Table 3B]

[0047] [Table 4A]

[0048] [Table 4B]

[0049] As shown by comparing Table 1A, Table 2A, and Table 3A with Table 4A, urine flow was significantly increased (specifically, 1.7 times or more) in Table 1A, Table 2A, and Table 3A. Also, as shown by comparing Table 1A, Table 2A, and Table 3A with Table 1B, Table 2B, and Table 3B, the increase in urine flow was significant in subjects with nocturia. Herbal mixture b (Table 2A) has the same herbal composition as Rokumi-gan (Table 4A) except that it contains cinnamon and tallow tree, but urine flow was significantly increased in Table 2 (group administered extract of herbal mixture b).

[0050] Furthermore, among Tables 1A, 2A and 3A, the increase in urinary force was particularly remarkable in Table 1A (group administered with extract of herbal mixture a) and Table 2A (group administered with extract of herbal mixture b).

Claims

1. A urinary flow increaser comprising a herbal mixture A containing Poria columbine and Shazenshi, a herbal mixture B containing Poria columbine, Cinnamon bark and Bushi, and / or an extract thereof.

2. The urinary flow-increasing agent according to claim 1, which is used to increase urinary flow in a subject suffering from nocturia.

3. 2. The urinary flow increaser according to claim 1, wherein the herbal mixture A comprises Lotus Root, Bacmondsroot, Poria Coccinea, Ginseng, Shazenshi, Scutellaria Root, Astragalus Root, Zikkopi, and Licorice.

4. 2. The urinary flow increaser according to claim 1, wherein the herbal mixture B comprises Rehmannia Root, Cornus Cherry, Dioscorea Rhizome, Poria Coccinea, Peony Bark, Cinnamon Bark, and Brussels Root.

5. 2. The urinary flow increaser according to claim 1, wherein the herbal mixture A or B comprises Goshitsu, Shazenshi, Rehmannia Root, Cornus Cherry, Dioscorea Rhizome, Takusha, Poria Coccinea, Peony Bark, Cinnamon Bark, and Bushi.

6. The urinary flow increasing agent according to claim 1, which is used to increase urinary flow in a subject without urinary dysfunction.

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