Stress urinary incontinence improver

Abstract

To provide a Chinese herbal drug that can improve stress urinary incontinence.SOLUTION: Hachimi-jio-gan extract is useful as an active ingredient of a stress urinary incontinence improver.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to an agent for improving stress urinary incontinence. [Background technology]

[0002] Urinary incontinence is defined as the involuntary leakage of urine. Although urinary incontinence is not usually life-threatening, it is a condition that threatens quality of life (QOL), causing mental distress and reducing activities of daily living.

[0003] The National Center for Geriatrics and Gerontology has provided guidelines (Non-Patent Document 1, hereinafter also referred to as "guidelines") that indicate recommended diagnostic and treatment methods for urinary incontinence in the elderly based on scientific evidence.

[0004] Urinary incontinence is classified into urge incontinence, stress incontinence, reflex incontinence, overflow incontinence, and functional incontinence. Of these, urge incontinence is a type of incontinence in which urine leaks out when there is a strong urge to urinate, and is caused by an overactive bladder. Urge incontinence is often accompanied by frequent urination. Stress incontinence is a type of incontinence in which urine leaks out even though the bladder does not contract when abdominal pressure increases due to coughing, sneezing, laughing, exercise, etc., and is caused by pelvic floor relaxation or sphincter dysfunction. According to guidelines, approximately 30% of women with stress urinary incontinence Urge urinary incontinence is also present.

[0005] The guidelines state that, regarding urinary incontinence, "In order to provide appropriate treatment, it is necessary to determine whether the incontinence is urge, stress, reflex, overflow, or functional, or whether multiple factors are involved." As with other types of urinary incontinence, stress urinary incontinence can be treated with behavioral therapy, drug therapy, and surgical therapy, but the guidelines state, "However, in the opinion of specialists, drug therapy is unlikely to be the primary treatment for stress urinary incontinence, and behavioral therapy or surgical therapy should be attempted first. Drug therapy may be used as an adjunctive therapy, but should not be used long-term unless it is effective."

[0006] In recent years, there has been growing interest in self-medication, which is treating poor health on one's own, and opportunities to use herbal medicines as a means of this are increasing. In particular, when it comes to urinary problems, although many people suffer from them, there are many cases where they are unable to deal with them due to shame and endure them, so the use of herbal medicines as a form of self-medication is significant.

[0007] In traditional Chinese medicine, a state in which kidney function is weakened is called "kidney deficiency" (Non-Patent Document 2), and several traditional Chinese medicines for kidney deficiency are known. In recent years, there has also been active research into the mechanisms of action of traditional Chinese medicines from the perspective of Western medicine.

[0008] Specifically, herbal medicines for kidney deficiency include Hachimijiogan (Non-patent Document 3), which improves microcirculation, lowers blood sugar in diabetes, prevents nephropathy, and improves symptoms associated with aging by reducing radicals, Shichimotsukakoto, which is used to treat chronic kidney disease in combination with a therapeutic drug that acts on the renin-angiotensin system, Saireito, which is effective against nephrotic syndrome thought to be related to allergies and IgA nephropathy in children, and Saireito, which is effective against the progression of chronic renal failure (Non-patent Document 4). An example is Unpi-to (Non-Patent Document 5), which has been shown to be effective.

[0009] Furthermore, examples of herbal medicines for urinary problems include Seishinrenshiin (Non-Patent Document 6), which improves frequent urination by suppressing contraction of the bladder smooth muscle. [Prior art documents] [Non-patent literature]

[0010] [Non-Patent Document 1] Guidelines for Urinary Incontinence in the Elderly, FY2000 Ministry of Health, Labour and Welfare Research Grant (Comprehensive Research Project on Longevity Science), National Center for Geriatrics and Gerontology [Non-patent document 2] Japanese Journal of Oriental Medicine 47:532-538, 1997 [Non-patent document 3] The potential of Kampo medicine for frailty as revealed through pharmacological action phi Kampo No. 63 [Non-patent document 4] Japanese Journal of Oriental Medicine 64(1), 10-15, 2013 [Non-Patent Document 5] Journal of the Japanese Society of Nephrology 41(8): 769-777, 1999 [Non-patent document 6] Abstracts of the 31st Annual Meeting of the Japanese Society of Traditional Chinese Medicine, p.90, 2014 Summary of the Invention [Problem to be solved by the invention]

[0011] As mentioned above, stress urinary incontinence is rarely treated with medication, and has therefore been considered unsuitable for self-medication. In addition, it is not easy to engage in behavioral therapy on one's own, and of course surgical treatment is not possible on one's own.

[0012] Herbal medicines such as Hachimijiogan, Shichimotsukakkoto, Saireito, and Onpito can be said to treat kidney deficiency by improving kidney function. Therefore, in view of their mechanism of action, these herbal medicines are unlikely to be used for stress urinary incontinence caused by pelvic floor relaxation or sphincter dysfunction.

[0013] On the other hand, considering the mechanism of action of Seishinrenshiin, it is unclear whether it is related to pelvic floor relaxation or sphincter function, which are involved in stress urinary incontinence, but it may be effective for urinary incontinence accompanied by frequent urination. In any case, considering that caution is needed regarding the side effects of Seishinrenshiin, which contains licorice, new herbal medicines effective for stress urinary incontinence are desired.

[0014] The present invention aims to provide a herbal medicine that can improve stress urinary incontinence. [Means for solving the problem]

[0015] As a result of extensive research, the present inventors have unexpectedly found that Hachimijiogan extract, which would not be expected to be applied to stress urinary incontinence based on its known mechanism of action, has the effect of improving stress urinary incontinence. Based on this finding, the present invention was completed through further research.

[0016] That is, the present invention provides the following aspects. Item 1. A drug for improving stress urinary incontinence containing Hachimijiogan and / or its extract. Item 2. The agent for improving stress urinary incontinence according to Item 1, which is used for treating urinary leakage that occurs after sneezing and / or coughing. Item 3. The stress urinary incontinence improving agent according to Item 1 or 2, which is used for subjects in their 30s to 50s. Item 4. The stress urinary incontinence improving agent according to any one of Items 1 to 3, which is used for treating urinary incontinence not accompanied by overactive bladder. [Effects of the Invention]

[0017] According to the present invention, a Chinese herbal medicine capable of improving stress urinary incontinence is provided. DETAILED DESCRIPTION OF THE INVENTION

[0018] The agent for improving stress urinary incontinence of the present invention is characterized by containing Hachimijiogan and / or an extract thereof. The agent for improving stress urinary incontinence of the present invention will be described in detail below.

[0019] Active ingredient The agent for improving stress urinary incontinence of the present invention contains Hachimijiogan and / or its extract as an active ingredient. Hachimijiogan is a mixed herbal medicine based on the prescription composition described in "Jingui Yaolue" and consisting of Rehmannia Root, Cornus Cherry, Dioscorea Root, Atractylodes Rhizome, Poria Root, Peony Bark, Cinnamon Bark, and Bush Tree (Bushimatsu).

[0020] In the present invention, the mixing ratio of the herbal medicines that make up Hachimijiogan is not particularly limited, but typically includes 2.5 to 8 parts by weight of Rehmannia Root, 1.5 to 4 parts by weight of Cornus Cherry, 1.5 to 4 parts by weight of Dioscorea Rhizome, 1.5 to 3 parts by weight of Aleurites Root, 1.5 to 3 parts by weight of Poria Root, 1.5 to 3 parts by weight of Peony Root, 1.5 to 3 parts by weight of Cinnamon Bark (Cinnamon Bark), and 0.25 to 1 part by weight of Bush Tree (Bushimatsu).

[0021] A suitable example of a herbal medicine preparation to be used in the preparation of Hachimijiogan used in the present invention is a mixture of 2.5 parts by weight of Rehmannia Root, 1.5 parts by weight of Cornus Cherry, 1.5 parts by weight of Dioscorea Rhizome, 1.5 parts by weight of Aleurites Rhizome, 1.5 parts by weight of Poria Root, 1.5 parts by weight of Peony Fruit, 0.5 parts by weight of Cinnamon Bark, and 0.5 parts by weight of Bushi (Bushimatsu).

[0022] In the agent for improving stress urinary incontinence of the present invention, the active ingredient is preferably hachimijiogan extract, from the viewpoint of further enhancing the improving effect on stress urinary incontinence.

[0023] The extract of Hachimijiogan may be in the form of a liquid extract such as a fluid extract or a soft extract, or a solid dry extract powder.

[0024] A liquid extract of Hachimijiogan can be obtained by extracting a mixture of herbal medicines according to Hachimijiogan and concentrating the resulting extract as necessary. The extraction solvent used for the extraction is not particularly limited, and examples thereof include water or aqueous ethanol, preferably water. Furthermore, a dried extract powder of Hachimijiogan can be obtained by drying the liquid extract. The drying method is not particularly limited, and examples include spray drying, and a method in which a suitable adsorbent (e.g., silicic anhydride, starch, etc.) is added to a soft extract with a high extract concentration to obtain an adsorbed powder.

[0025] In the present invention, the Hachimijiogan extract may be an extract prepared by the method described above, or a commercially available product. For example, commercially available products include Hachimijiogan Extract (22D·Q) (manufactured by Nippon Funa Yakuhin Co., Ltd.) and Hachimijiogan Dried Extract-F (manufactured by Alps Yakuhin Co., Ltd.).

[0026] In the stress urinary incontinence improving agent of the present invention, the content of Hachimijiogan and its extract is not particularly limited as long as the effects of the present invention are exhibited, and can be determined appropriately depending on the formulation, etc.

[0027] Other ingredients The agent for improving stress urinary incontinence of the present invention may consist solely of the active ingredient, or may contain additives or bases appropriate for the formulation. Such additives and bases are not particularly limited as long as they are pharmaceutically 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, corrigents, fragrances, powders, thickeners, pigments, and chelating agents. These additives may be used alone or in combination of two or more. The content of these additives and bases is appropriately determined depending on the type of additives and bases used, the formulation of the agent for improving stress urinary incontinence, and other factors.

[0028] In addition, the stress urinary incontinence improving agent of the present invention may contain, as necessary, other nutritional components or pharmacological components in addition to the above-mentioned active ingredients. Such nutritional components and pharmacological components are not particularly limited as long as they are pharmaceutically acceptable, and examples thereof include antacids, stomachic agents, digestive aids, 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, and menthols. These nutritional components and pharmacological components may be used alone or in combination of two or more. The content of these components is appropriately determined depending on the type of components used.

[0029] Formulation The formulation form of the stress urinary incontinence improving agent of the present invention is not particularly limited, as long as it can be administered orally. Examples include solid formulations such as powders, fine granules, granules, tablets, troches, chewable tablets, capsules (soft capsules, hard capsules), and pills; semi-solid formulations such as jellies; and liquid formulations such as solutions, suspensions, and syrups, with pills, granules, or tablets being preferred.

[0030] Manufacturing method The method for producing the agent for improving stress urinary incontinence of the present invention may be to prepare a formulation using the above-mentioned herbal ingredients according to a conventional formulation method used in the medical field.

[0031] Purpose The agent for improving stress urinary incontinence of the present invention is used for the purpose of improving stress urinary incontinence. Stress urinary incontinence is a symptom in which urine leaks despite the lack of bladder contraction when abdominal pressure increases due to coughing, sneezing, laughing, exercise, etc. Preferably, the agent for improving stress urinary incontinence of the present invention is applied to urinary leakage that occurs after sneezing and / or coughing.

[0032] The stress urinary incontinence to which the stress urinary incontinence improving agent of the present invention is applied may be accompanied by urge urinary incontinence caused by overactive bladder, but preferably, the stress urinary incontinence improving agent of the present invention is applied to urinary incontinence not accompanied by overactive bladder, for example, urinary incontinence not accompanied by polyuria, frequent urination and / or nocturia.

[0033] The stress urinary incontinence improving agent of the present invention can be applied to any age group, but can also be applied to relatively younger age groups, specifically those in their 30s to 50s, or those in their 30s, 40s, 50s, 30s to 40s, or 40s to 50s, and more preferably those in their 40s to 50s.

[0034] The agent for improving stress urinary incontinence of the present invention may be used for both men and women, but is preferably used for women.

[0035] Dosage / Usage The stress urinary incontinence improving agent of the present invention is administered orally. The dosage of the stress urinary incontinence improving agent of the present invention is appropriately determined depending on the age, constitution, severity of symptoms, etc. of the subject. For example, for a human, the total amount of Hachimijiogan (when Hachimijiogan is used as the active ingredient) and the amount of Hachimijiogan extract (when Hachimijiogan extract is used as the active ingredient) per day is, for example, about 5 to 22 g, preferably about 7 to 16 g, more preferably about 9 to 13 g, and is administered 1 to 3 times a day, preferably 3 times a day. The timing of administration is not particularly limited, and may be before meals, after meals, or between meals, but before meals (30 minutes before meals) or between meals (2 hours after meals) is preferred.

[0036] The administration period of the agent for improving stress urinary incontinence of the present invention may be, for example, one week or more, preferably 10 days or more, and more preferably two weeks or more. [Example]

[0037] The present invention will be specifically described below with reference to examples, but the present invention is not limited to these examples.

[0038] (1) Preparation of stress urinary incontinence improving agent The raw herbal ingredients used were 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 Atractylodes Rhizome, 1.5 parts by weight of Poria Root, 1.5 parts by weight of Peony Fruit, 0.5 parts by weight of Cinnamon Bark, and 0.5 parts by weight of Bushi (Bushimatsu). These were chopped and extracted with 10 times the weight of water at approximately 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 Hachimijiogan extract powder. The spray dryer drying was performed by dropping the extract into an atomizer rotating at 10,000 rpm and supplying hot air at 150°C. The extract was then granulated and tableted. Tablets were prepared so that each of the 12 tablets (daily dose) contained 11 g of Hachimijiogan extract obtained from the aforementioned mixed herbal ingredients, calculated as the crude drug equivalent.

[0039] (2) Experimental method The subjects were women in their 30s to 50s (30-59 years old) who suffered from urinary leakage after sneezing or coughing. They took four tablets three times a day for two weeks, either before or between meals. None of the subjects had symptoms of overactive bladder, such as polyuria, frequent urination, or nocturia.

[0040] Before and after taking the medicine, the subjects were asked to rate the severity of urinary leakage after sneezing or coughing on a 5-point scale, with 5 being "suffering" and 1 being "not painful." The results are shown in Table 1.

[0041] [Table 1]

[0042] As shown in Table 1, administration of Hachimijiogan extract was found to be effective in improving urinary leakage after sneezing and coughing. In particular, a tendency for the improvement effect of urinary leakage after sneezing and coughing to be greater was observed in people in their 40s and 50s (40 to 59 years old).

Claims

1. A stress urinary incontinence improving agent containing Hachimijiogan and / or an extract thereof, used to improve urinary incontinence without overactive bladder in subjects in their 30s to 50s.

2. The stress urinary incontinence improving agent according to claim 1, which is applied to urinary leakage that occurs after sneezing and / or coughing.

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