KR101455163B1 - Extract of herbal medicine mixture and pharmaceutical composition or health food containing the same - Google Patents

Abstract

The present invention provides a mixed extract of herbal medicines and a pharmaceutical composition or health functional food containing the same as an active ingredient. The herbal composition-mixed extract has an effect of reducing the number of urine in patients with irritable bladder.

Description

[0001] The present invention relates to a herbal medicine mixed extract and a pharmaceutical composition or health functional food containing the same,

The present invention relates to a herbal composition-mixed extract and a pharmaceutical composition or health functional food containing the same.

Overactive bladder (OAB) is increasingly clinically important due to functional impairment associated with the tense life of modern people. In 2001, the Standardization Subcommittee of the International Incontinence Society (IHS) established a new term to refer to cases of urinary tract infections and urinary incontinence, with or without urge incontinence, bladder syndrome, urge syndrome, and frequency-urgency syndrome. Typical symptoms include increased frequency of urination (frequency, frequency) more than 8 times a day, strong and sudden urge (urgency), urge incontinence.

Based on the symptoms of the irritable bladder, it seems to be perceived as categories of urinal incontinence (urinary frequency), incontinence (urination incontinence) and urine (urine urine).

Studies of the prevalence of irritable bladder indicate that the prevalence increases with age and is common among the elderly, especially women. According to the study, the prevalence of this disease varies between 3 and 43%, as there was a difference in the definition of overactive bladder among the researchers.

In a Korean study, 2,005 adults over 40 years of age were enrolled in a telephone survey. The prevalence of strict definition was 7.1% and the broader definition was 30.5%.

The development of irritable bladder is characterized by the disappearance of the central or peripheral inhibitory mechanism, the increase of the afferent stimulus from the lower urinary tract, the appearance of the bladder reflex pathway resistant to the inhibitory mechanism of the central nervous system, and the excitatory stimulation Can be divided into cases. However, many studies on the development of overactive bladder have been under way, but the precise mechanisms have not yet been elucidated.

Treatment of irritable bladder include behavioral therapy, medication, neuromodulation, hydrostatic expansion of the bladder, and enlargement of the bladder. Among them, drug therapy is the first choice for rapid treatment. However, frequent side effects such as constipation and constipation are being questioned.

In the meantime, until now, there have been few studies on the study of oriental medicine and clinical studies on irritable bladder.

Thus, overactive bladder is a disease that has not been studied in oriental medicine yet, but its prevalence is high and modern medical treatment effect is still insufficient. Therefore, it is considered to be an active disease of oriental medicine.

The present inventors repeatedly studied on herbal treatment of irritable bladder, and the 2009 paper (Clinical Results Analysis of Irritable Bladder: A Retrospective Study, Journal of Oriental Obstetrics and Gynecology, Vol. 3: 169-184 (2009)), suggesting the possibility of treatment of irritable bladder by oriental medicine.

Clinical outcome of overactive bladder: A retrospective study (Korean Journal of Oriental Obstetrics & Gynecology, Vol.22 No.3: 169-184 (2009))

It is an object of the present invention to provide a herbal medicine mixed extract having an effect on an overactive bladder, a pharmaceutical composition using the same, or a health functional food.

The present invention provides a mixed extract of medicinal herbs.

The herbal medicines contained in the mixed extract may include anchovy, licorice, Angelica gigas, rich, peony, and hanagi.

The medicinal herb comprises 10 to 80 parts by weight of licorice, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of peach, 10 to 80 parts by weight of peanuts and 50 to 200 parts by weight of sulfur Do.

The medicinal herb may further include sewage, and in this case, it is preferable that the medicinal herb is contained in the medicinal herb in an amount of 10 to 80 parts by weight based on 100 parts by weight of the interstice.

The mixed extract of the present invention may be extracted with an extraction solvent selected from water, C1-C4 alcohol, or a mixture thereof, more preferably a hydrothermal extract.

The present invention also provides a pharmaceutical composition for the treatment or prevention of an overactive bladder containing a mixed extract of the medicinal herb as an active ingredient.

Furthermore, the present invention provides a health functional food for the amelioration of an overactive bladder containing a mixed extract of the medicinal herb as an active ingredient. The health functional food is preferably a health functional beverage.

The herbal mixed extract of the present invention exhibits an action effect of reducing the number of urine in an overactive bladder patient and eliminating or alleviating symptoms of overactive bladder.

Hereinafter, the present invention will be described in detail.

Herbal medicine mixed extract

The present invention provides a mixed extract of medicinal herbs.

The medicinal herbs of the present invention may include ginseng, licorice, giganti, suzuki, peony, and hwanggi. In addition, the herbal medicine may further include Sucrose.

The characteristics of the medicinal herbs used in the present invention are as follows:

(1)

Guijie refers to the young branches of the broiler ( Cinnamomum cassia Presl ) or other related plants belonging to the Camphor family (Lauraceae). The staple may be purchased commercially or directly grown.

(2) licorice (licorice)

Liquorice is licorice licorice belonging to Leguminosae / Fabaceae, root of Manchuria licorice or other oriental plants, and dried liquorice (licorice with peel) Peeled licorice). In the present invention, it can be used regardless of the origin or the shell, and it can be purchased commercially or directly grown.

(3)

Angelica gigas Nakai is the roots of Angelica gigas Nakai belonging to Apiaceae / Umbelliferae. The Angelica gigas can be purchased commercially or directly grown.

(4) The rich (附子)

Buzha refers to a rich, rich, and prosperous person who is made by processing the root of an Aconitum carmichaeli Debuax belonging to the Ranunculaceae family. It is most preferred to use an aspirator without double toxicity. The rich can be purchased commercially or directly grown.

(5) Peony (渔药)

Peony (藥药) is a perennial herbaceous peony ( Paeonia lactiflora Pallas) belonging to Ranunculaceae (Ranunculaceae) or other root relative to the root of relative plants. The peony can be purchased commercially or directly grown.

(6) Emperor

Hwanggi (黄耆) is a perennial plant belonging to leguminosae (Leguminosae / Fabaceae) and is the root of the root of the plant is related to Danragon ( Astragalus mongholicus Bunge). The hwanggi can be purchased commercially or directly grown.

(7) sewage

Hashuo is the root of Polygonum multiflorum Thunb., A perennial chronic herb that belongs to the Polygonaceae family (Polygonaceae). In the sewage, there is an enemy sewage and a back sewer, and it can be used without discrimination in the present invention. The sewage sludge may be purchased commercially or directly grown.

The medicinal herb composition of the present invention comprises 10 to 300 parts by weight of licorice, 10 to 300 parts by weight of Angelica keiskei, 10 to 300 parts by weight of peach, 10 to 300 parts by weight of peony root and 10 to 500 parts by weight of sulfur . More preferably, the medicinal herb mixture comprises 10 to 80 parts by weight of licorice, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of peach, 10 to 80 parts by weight of peony root and 10 to 80 parts by weight of sulfur can do. Outside of this range, no significant effect on the bladder can be seen.

In addition, when the medicinal herb mixture further comprises sewage, the sewage sludge may further comprise 10 to 300 parts by weight, and preferably 10 to 80 parts by weight.

The herbal mixed extract of the present invention may be extracted with an extraction solvent selected from water, C1-C4 alcohols or a mixture thereof, and is preferably a hydrothermal extract.

Preparation method of herbal extracts

The herbal mixed extract of the present invention is preferably, but not limited to, prepared by a manufacturing method comprising the following steps:

(1) removing foreign matter mixed in the herbal medicines and washing them;

(2) extracting the extract by adding an extraction solvent to the mixture of the herbal medicines;

(3) concentrating the extract under reduced pressure;

(4) filtering the concentrate; And

(5) drying the filtered extract.

The washing of step (1) is preferably repeated one to five times.

The extraction of the step (2) can be performed by shaking extraction, Soxhlet extraction, or a reflux extraction method, but is not limited thereto.

As the extraction solvent, water, a C1 to C4 alcohol or a mixture thereof may be used, and it is most preferable to perform hydrothermal extraction. The extraction solvent is preferably extracted by adding an extraction solvent of 3 to 10 times the total weight of the herbal medicine preparation.

The hydrothermal pressure extraction is preferably performed at a pressure of 1.1 to 2 atm, more preferably at a pressure of 1.2 to 1.5 atm.

In addition, the temperature during hydrothermal extraction is preferably 60 to 100 ° C, more preferably 80 to 100 ° C. The extraction time is preferably 2 to 24 hours, and the extraction time is preferably 1 to 5 times.

It is preferable to use a vacuum decompression concentrator or a vacuum rotary evaporator for the decompression concentration in the step (3). In step (3), the extract is preferably concentrated to a solid content of 40% or more.

The drying in step (5) may be performed by vacuum drying, vacuum drying, boiling drying, spray drying or freeze drying, but is not limited thereto.

Pharmaceutical composition for the treatment or prevention of irritable bladder

The present invention provides a pharmaceutical composition for the treatment or prevention of an overactive bladder containing the herbal composition-mixed extract as an active ingredient.

The pharmaceutical composition for the treatment or prevention of the overactive bladder can treat or prevent the overactive bladder symptom by decreasing the number of urine.

The herbal mixture-containing extract is preferably contained in an amount of 0.1 to 50% by weight based on the total weight of the pharmaceutical composition of the present invention, but is not limited thereto.

The pharmaceutical composition of the present invention can be administered in various formulations, oral and parenteral, at the time of actual clinical administration. In the case of formulation, it may be prepared using diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrating agents and surfactants which are usually used.

Solid formulations for oral administration include tablets, pills, powders, granules, capsules, and the like, and such solid preparations can be prepared by incorporating into the pharmaceutical composition of the present invention at least one or more excipients such as starch, calcium carbonate, sucrose, lactose And gelatin. In addition to simple excipients, lubricants such as magnesium, stearide, and talc may also be used.

Liquid preparations for oral administration include suspensions, solutions, emulsions and syrups. Various excipients such as wetting agents, sweeteners, fragrances and preservatives may be included in addition to water and liquid paraffin, which are commonly used simple diluents. have.

Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations and suppositories. Examples of the non-aqueous solvent and the suspending agent include propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like. Witepsol, macrogol, tween 61, cacao paper, laurin, glycerol, gelatin and the like may be used as a base for suppositories. The pharmaceutical composition of the present invention may be administered via parenteral administration by subcutaneous injection, intravenous injection, or intramuscular injection.

The dosage of the pharmaceutical composition of the present invention varies depending on the condition and body weight of the patient, the degree of disease, the drug form, the administration route and the period, and can be appropriately selected by those skilled in the art. However, for the desired effect, the extract of the present invention is preferably administered at 0.0001 to 100 mg / kg per day. The administration may be carried out once a day or divided into several doses. However, the scope of the present invention is not limited to these dosages.

The pharmaceutical composition of the present invention can be used in combination with other therapeutic methods such as acupuncture treatment or moxibustion treatment for the treatment of overactive bladder.

Health functional food for overactive bladder symptoms

The present invention provides a health functional food for improving the symptoms of an overactive bladder containing the herbal composition-mixed extract as an active ingredient.

The health functional food of the present invention can exhibit an action effect of reducing the number of urine and improving the symptoms of overactive bladder.

The health functional food of the present invention can be used as it is or in combination with other food or food ingredients, and can be suitably used according to conventional methods.

The content of the active ingredient may be suitably determined according to the intended use (prevention, health or therapeutic treatment). In general, the herbal medicinal herbal extract of the present invention may be added in an amount of 0.01 to 15% by weight based on the total weight of the food during the manufacture of food or beverage.

There is no particular limitation on the kind of the health functional food of the present invention. Examples of health functional foods to which the herbal medicine mixed extract of the present invention can be added include beverages, gums, vitamin complexes, and drinks, and include health functional foods in the conventional sense. The health functional food is most preferably a health functional drink which is easy to take.

The health functional beverage of the present invention may contain various flavors or natural carbohydrates as an additional ingredient such as ordinary beverages. Examples of the natural carbohydrate include monosaccharides such as glucose, fructose and the like; Disaccharides such as maltose, sucrose and the like; And polysaccharides, for example, conventional sugars such as dextrin, cyclodextrin and the like, and sugar alcohols such as xylitol, sorbitol and erythritol. Flavoring agents (saccharin, aspartame, etc.) other than those described above may also be used.

The health functional food of the present invention can be used as a nutritional supplement, a vitamin, a mineral (electrolyte), a flavor such as a synthetic flavor and a natural flavor, a colorant and an enhancer (cheese, chocolate etc.), a pectic acid and its salt, , Organic acids, protective colloid thickeners, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonating agents used in carbonated drinks, and the like.

Example

Hereinafter, preferred embodiments of the present invention will be described in order to facilitate understanding of the present invention. However, the following examples are provided only for the purpose of easier understanding of the present invention, and the present invention is not limited by the examples.

≪ Example 1 > Preparation of mixed extract of herbal medicines

The strains were washed with 1,200 g of lichen, 400 g of licorice, 400 g of Angelica gigantei, 400 g of rich ginseng, 800 g of peony root and 1,200 g of ammonia, The mixture was placed in an extraction vessel, and 5 L of water was added and the mixture was extracted at 100 DEG C for 2 hours. The resulting solution was cooled at room temperature and filtered with filter paper.

The extract was concentrated under reduced pressure using a vacuum rotary evaporator and lyophilized to obtain a powdery extract.

≪ Example 2 > Preparation of mixed extract of herbal medicines

500 g of licorice, 400 g of licorice, 400 g of Angelica gigantei, 400 g of rich juice, 800 g of peony root, 1,200 g of pale ginger, 400 g of sucrose, , And the mixture was placed in an extraction vessel and extracted with 5 L of water at 100 ° C for 2 hours. The resulting solution was cooled at room temperature and filtered with filter paper.

The extract was concentrated under reduced pressure using a vacuum rotary evaporator and lyophilized to obtain a powdery extract.

<Example 3> Confirmation of the effect of reducing the number of urination of the herbal mixed extract

1. Outline of experiment

From January 2010 to April 2012, medical records of patients who were diagnosed and treated with OAB in OO clinic were analyzed.

2. Patient setting

Of the patients with urinary disturbance, 16 patients who were excluded from the following criteria among patients diagnosed with irritable bladder with urinary urgency, urgency, urinary frequency, nocturia or urge incontinence , And these experiments were conducted.

(1) patients with uncontrolled severe diabetes

(2) Those with obstructive urinary tract disorders such as urinary stones and urinary tract tumors

(3) Patients with urinary tract infection with positive urine test and urine culture test

(4) Those taking antidepressants such as psychotropic medicines

(5) those with pregnancy, history of epilepsy, alcohol, substance abuse and dependence

(6) Patients with dysuria caused by nerve injury such as spinal tuberculosis and spinal cord injury

(7) Patients who can not determine the therapeutic effect (dementia, overseas departure, etc.)

(8) Patients with stress urinary incontinence without symptoms of overactive bladder

(9) Patients with a treatment duration of less than 30 days and those with a log record of less than 2 months

3. Initial investigation

OABSS (overactive bladder syndrome score) questionnaire, which is proven to have reliability and validity in the study of irritable bowel, has been widely accepted, Respectively.

4. Treatment contents

The herbal mixed extracts prepared in Examples 1 and 2 were administered for 2 months.

5. Evaluation Method

Changes in the number of urine were evaluated through the urination log. All statistical analyzes were performed using Sas 9.2, the Wilcoxon signed rank sum test was used to determine the effect on OABSS, and the Friedman test was used to determine the effect on the 7-day mean number of urination.

6. Results

(1) Effect on OABSS (comparison between pre-treatment and 2 months)

The data for 10 subjects excluding the missing values were analyzed, and the average decrease value of the OABSS score is shown in Table 1 (p = 0.0039).

[Table 1]

(2) Influence on the average number of urination on 7 days

Fourteen patients who were checked for urinary frequency at the end of treatment, one month, and two months after treatment were analyzed. The results are shown in Table 2 below (p <0.0001).

[Table 2]

When the mixed herbal extract of the present invention was administered to patients suffering from overactive bladder, the OABSS score was reduced by about 3.0 and the average number of voiding times per day decreased by about 2 times or more only by short-term treatment for 2 months. In addition, the average number of 7 - day urination was not significantly different between the 1 - month and 2 - month treatments.

Therefore, the herbal medicine mixed extract of the present invention exhibits an action and effect that can treat, prevent or ameliorate the symptoms of overactive bladder.

&Lt; Preparation example of pharmaceutical preparation >

(1) Formulation Example 1: Preparation of powder

Herbal medicine mixed extract 2 g

Lactose 1 g

The above components are mixed and packed in airtight bags to prepare powders.

(2) Formulation Example 2: Preparation of tablets

Herbal medicine mixed extract 100 mg

Corn starch 100 mg

Lactose 100 mg

Magnesium stearate 2 mg

After mixing the above components, tablets are prepared by tableting by a conventional method for producing tablets.

(3) Formulation Example 3: Preparation of capsules

Herbal medicine mixed extract 100 mg

Corn starch 100 mg

Lactose 100 mg

Magnesium stearate 2 mg

After mixing the above components, they are filled into gelatin capsules by a conventional method for producing gelatin to prepare tablets.

(4) Formulation Example 4: Preparation of liquid preparation

Herbal medicine mixed extract 100 mg

10g per isomerization

Mannitol 5 g

Purified water quantity

Each component is added to and dissolved in purified water according to a conventional method for producing a liquid preparation, the components are mixed, purified water is added, and the solution is filled in an ampule and sterilized to prepare a liquid preparation.

&Lt; Preparation example of health functional beverage >

(1) Production Example 1

To 1000 ml purified water prepared by sterilization, 3.6 g of the herbal mixed extract prepared in Preparation Example is added. 1000 mg of citric acid, 2 g of plum concentrate, 100 g of oligosaccharide and 1 g of taurine are added, and the mixture is stirred at 85 캜 for about 60 minutes and heated. The resulting solution was filtered and sterilized in a sterilized 2 L container, sealed and then stored in a refrigerator to prepare a health functional beverage of the present invention.

(2) Production example 2

0.4 g of the herbal composition-mixed extract was dissolved in 100 ml of a soft beverage syrup such as cider.

(3) Production example 3

Preparation Example 1 was repeated except that 0.25 g of the herbal composition-mixed extract was added to 100 ml of various kinds of spot drink.

(4) Production example 4

Except that 0.15 g of the herbal mixture was added to 100 ml of the beverage prepared by using juice of various fruits, vegetables, seaweeds, beans, natural medicines, etc. or its extract concentrate (apple juice, tomato juice, kelp juice or ginseng juice) Was prepared in the same manner as in Preparation Example 1.

(5) Production example 5

The preparation was carried out in the same manner as in Preparation Example 1, except that 0.5 g of the herbal mixture-containing extract was added to 100 ml of the fatigue eliminating drink.

(6) Production example 6

The preparation was carried out in the same manner as in Preparation Example 1, except that 0.5 g of the herbal mixture-containing extract was added to 100 ml of the alcoholic beverage.

Claims (10)

delete delete delete delete delete delete delete Wherein the herbal medicine contains 10 to 80 parts by weight of licorice, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of rich ginseng, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of peony powder and 50 to 200 parts by weight of sulfur powder;
Wherein the herbal medicine contains 10 to 80 parts by weight of licorice, 10 to 80 parts by weight of Angelica gigantis, 10 to 80 parts by weight of rich Angeliaceae, 10 to 80 parts by weight of Angelicae radix, 10 to 80 parts by weight of peanut, 50 to 200 parts by weight of sulfur, 10 to 80 parts by weight of sewage syrup;
Wherein the herbal medicine contains 10 to 80 parts by weight of licorice, 10 to 80 parts by weight of Angelica gigantis, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of Angelica keiskei koidz. 10 to 80 parts by weight of peony powder, 50 to 200 parts by weight of sulfur powder,
Wherein the herbal medicine contains 10 to 80 parts by weight of licorice, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of rich ginseng, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of peony powder and 50 to 200 parts by weight of sulfur, and the medicinal herb is a mixed medicinal herb extract which is extracted with an extraction solvent selected from water, C1 to C4 alcohols or a mixture thereof;
Wherein the herbal medicine contains 10 to 80 parts by weight of licorice, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of rich ginseng, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of peony and 50 to 200 parts by weight of sulfur, wherein the herbal medicine is a mixture of herbal medicines which is hydrothermally extracted with an extraction solvent selected from water, C1 to C4 alcohols or a mixture thereof
Wherein the pharmaceutical composition comprises at least one herbal medicine mixed extract selected from the group consisting of:
Wherein the herbal medicine contains 10 to 80 parts by weight of licorice, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of rich ginseng, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of peony powder and 50 to 200 parts by weight of sulfur powder;
Wherein the herbal medicine contains 10 to 80 parts by weight of licorice, 10 to 80 parts by weight of Angelica gigantis, 10 to 80 parts by weight of rich Angeliaceae, 10 to 80 parts by weight of Angelicae radix, 10 to 80 parts by weight of peanut, 50 to 200 parts by weight of sulfur, 10 to 80 parts by weight of sewage syrup;
Wherein the herbal medicine contains 10 to 80 parts by weight of licorice, 10 to 80 parts by weight of Angelica gigantis, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of Angelica keiskei koidz. 10 to 80 parts by weight of peony powder, 50 to 200 parts by weight of sulfur powder,
Wherein the herbal medicine contains 10 to 80 parts by weight of licorice, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of rich ginseng, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of peony powder and 50 to 200 parts by weight of sulfur, and the medicinal herb is a mixed medicinal herb extract which is extracted with an extraction solvent selected from water, C1 to C4 alcohols or a mixture thereof;
Wherein the herbal medicine contains 10 to 80 parts by weight of licorice, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of rich ginseng, 10 to 80 parts by weight of Angelica keiskei, 10 to 80 parts by weight of peony and 50 to 200 parts by weight of sulfur, wherein the herbal medicine is a mixture of herbal medicines which is hydrothermally extracted with an extraction solvent selected from water, C1 to C4 alcohols or a mixture thereof
Wherein the active ingredient is selected from the group consisting of a herbal medicine mixed extract selected from the group consisting of:
The health functional food according to claim 9, which is a health functional drink.