KR100672952B1 - Polygala tenuifolia extract for preventing and treating ischemic heart disease and pharmaceutical composition and health food containing the same - Google Patents

Abstract

The present invention relates to a raw paper extract (Polygala tenuifolia) extract having an efficacy for preventing or treating ischemic heart disease, and a pharmaceutical composition and health food for preventing or treating ischemic heart disease containing the same, and the extract of the present invention and a pharmaceutical containing the same Since the composition and the health food have an effect of restoring a heart that is not functioning by ischemic heart disease, it can be effectively used for the prevention or treatment of diseases related to ischemic heart disease such as angina pectoris and myocardial infarction.

Ischemic heart disease, base, angina, myocardial infarction

Description

Polygala tenuifolia extract for preventing and treating ischemic heart disease and pharmaceutical composition and health food containing the same}

1 is a graph showing a change in the recovery state of blood pressure over time during a working heartbeat for an experimental group treated with the raw paper extract of the present invention and a control group not treated with it.

Figure 2 is a graph showing the change in recovery state of the aortic ejection volume over time during the working heart rate for the experimental group treated with the raw paper extract of the present invention.

3 is a graph showing the recovery state of the coronary perfusion amount over time during the working heart rate for the experimental group and the control group treated with the raw paper extract of the present invention.

Figure 4 is a graph showing the recovery state of the cardiac output amount over time during the working heart rate for the experimental group treated with the raw paper extract of the present invention.

The present invention relates to a paper extract for preventing or treating ischemic heart disease (遠志, Polygala tenuifolia) extract, and more particularly, a paper extract for restoring the heart not functioning by ischemic heart disease, and a pharmaceutical composition containing the same And health food.

Heart disease can be classified into congenital heart disease and acquired heart disease. Acquired heart disease includes congestive heart disease (heart failure), ischemic heart disease (angina, myocardial infarction), valve disease, myocardial disease and endocardial disease, arrhythmia, cardiac neuropathy, etc. .

Ischemic heart disease, particularly ischemic heart disease, is commonly referred to as coronary artery disease. Plaque is formed by the accumulation of fat and cholesterol in the vascular lining of the coronary arteries that supply blood flow to the heart. It is a disease caused by thickening and hardening of atherosclerosis. It is a disease caused by insufficient supply of oxygen due to narrowing of the inner diameter of the coronary artery. If myocardial blood flow impairs as the blood supply deteriorates and improves repeatedly, it causes angina. If the plaque ruptures, unstable angina due to thrombus formation and part of the coronary artery are completely blocked. This can lead to acute ischemic syndromes such as myocardial infarction, which can not provide any of them.

According to the WHO statistics, 17 million people die from cardiovascular disease every year, which is the number one cause of death as the 사망 of total deaths. In the United States, about 1 million people died of cardiovascular disease in 1998, which was the number one cause of death, with ischemic heart disease accounting for 51% (Topal, 1998). Ischemic heart disease is the number one cause of death in the US for ages 65 and older, and second place of death in the 45-64 year-old population, with cancer. Deaths due to ischemic heart disease continue to increase with an increase in the elderly population. This ischemic heart disease is currently the leading cause of death among developed countries, with 12 million patients in the United States alone, 2 of 5 deaths due to ischemic heart disease, and 80% of sudden deaths in Gumi caused by ischemic heart disease. It is reported. In Korea, ischemic heart disease is the leading cause of death, and the mortality rate is rapidly increasing due to westernization of diet, high smoking rate and increased stress.

As an agent for treating ischemic heart disease, sympathetic blockers, nitrate preparations and calcium antagonists are generally used.

Among these, sympathetic blockers (also called beta-blockers) reduce heart rate and myocardial contractility by inhibiting sympathetic receptors on catecholamines in the blood, reducing myocardial oxygen demand, and in acute coronary syndrome and myocardial infarction. It is used first. This action prevents an increase in blood pressure and myocardial contractility during exercise, and therefore is known to be particularly effective for angina attacks during an exercise and angina attacks during sympathetic nervous system hyperactivity. However, when sympathetic blockers are combined with non-DPH (Dihydropyridine) calcium antagonists, bradycardia occurs and there is a risk of atrioventricular block.

On the other hand, nitrate preparations have no evidence of actually reducing progression to mortality or myocardial infarction, but are the most widely used first-line drugs with sympathetic blockers. Anti-ischemic mechanisms work through the effect of reducing preload and postload, dilatating arterial vessels, dilating bypass vessels, and reducing coronary vasospasm. It has also been reported to inhibit platelet aggregation. Usually, nitrate preparations are injected intravenously and doses are increased or decreased depending on symptoms. However, resistance may develop if a headache develops, pulse rate increases or continuous injection.

 In addition, calcium antagonists (also referred to as 'calcium blockers') have coronary vasodilation and blood pressure lowering effects, and can be broadly classified into DPH (Dihydropyridine) and non-dihydropyridine (DPH) systems. However, DPH-based preparations such as nifedipine have a strong vasodilation effect, but a weak pulse lowering effect or a weakening effect on myocardial contractility, thus increasing the myocardial oxygen demand. In fact, nifedipine has been shown to progress to myocardial infarction and increases in recurrent angina by about 16%. Therefore, nifedipine alone is dangerous and must be used with sympathetic blockers. Non-DPH-based formulations reduce the pulse rate and reduce the contractile force of the myocardium, thereby reducing the oxygen consumption of the heart. These calcium antagonists are used as second-line drugs, in patients with contraindications to sympathetic blockers, in patients with acute coronary syndrome with normal myocardial function, and in patients with angina due to coronary vasospasm.

 Drugs used for the treatment of ischemic heart disease may cause side effects such as shock death, sudden paralysis, and convulsions due to sudden blood pressure reduction or cardiac function.

Therefore, the present inventors conducted a study to solve such a conventional problem, and found that the original paper extract, which has been mainly used as a herbal medicine, restores the heart that does not function by ischemic heart disease and completes the present invention. Was done.

It is an object of the present invention to provide an extract of Polygala tenuifolia, a pharmaceutical composition containing the same, and a health food, which are safe for the human body, have an effect of preventing or treating ischemic heart disease, and are free from the risk of side effects.

In order to achieve this object, the present invention provides an extract for preventing or treating ischemic heart disease prepared by extracting the base paper with a solvent.

In addition, the present invention provides a pharmaceutical composition and health food for preventing or treating ischemic heart disease containing the extract as an active ingredient.

Jiji (遠志) is a perennial herb of the dicotyledonous rat handiwork. Flowers bloom purple in July-August and are sparsely running in the inflorescence. In oriental medicine, the root is called 'wonji' and it is used as expectorant, tonic and gangjeong. Soothing, antibacterial, expectorant, coercive, hemolytic, uterine excitatory, anticancer, etc. As it is reported, the rationale for the efficacy of the paper and its clinical application to the attending physician are already presented.

Various uses have been studied based on the pharmacological action of the above-mentioned paper. A herbal composition that can be used as an antipsychotic drug containing a raw paper extract extracted therefrom is described. In particular, there have been recent attempts to use raw paper as a pharmaceutical ingredient for the prevention of dementia-related diseases. For example, according to Korean Patent Laid-Open Publication No. 1999-74052, raw paper extract reduces the excitatory effect of glutamate on brain cells, such as overexcitation of glutamate receptors caused by stroke or damage to homeostasis of intracellular ions. It has been found that the composition of the present invention relates to a composition for the prevention and treatment of stroke containing the extract as an active ingredient, but is not mentioned at all in connection with the use for the prevention and treatment of ischemic heart disease as the present invention. none.

Hereinafter, the present invention will be described in more detail.

Base paper extract according to the present invention can be extracted with water, lower alcohol, hexane, ethyl acetate or a mixed solvent thereof. More preferably, the organic solvent may be prepared by an organic solvent extraction method for separating volatile or nonvolatile materials. It consists of extracting with lower alcohol, hexane, ethyl acetate or a mixed solvent thereof, filtering the filtrate to concentrate and freeze drying. The lower alcohol is selected from the group consisting of methanol, ethanol and butanol. As the extraction process, methods such as cold needle extraction, ultrasonic extraction, filtration, reflux extraction, and vacuum concentration may be used. In addition, extraction methods commonly used may be used. In addition, the raw paper extract may also be prepared by hot water extraction to separate soluble substances using hot hot water. Hot water extraction is preferably made for 1 to 3 hours at a temperature of 80 to 100 ℃, it is composed of a step of filtration and concentration and lyophilization after adding water to the base paper. Concentration and freezing can also be used in a variety of commonly known methods.

<Example 1> Preparation of raw paper extract by hot water extraction

500 g of polygala tenuifolia dried powder was added to a flask containing 1 L of tertiary distilled water, followed by hot water extraction at 100 ° C. for 1 hour, and the filtrate was filtered with gauze and concentrated under reduced pressure (Eyela. Japan). To prepare a raw paper extract of the present invention. As a result, 115 g of dry extract was obtained.

<Example 2> Preparation of Raw Paper Extract by Organic Solvent Extraction

After 2 liters of ethanol aqueous solution was added to 1 kg of the dried paper powder, 3 liters of extract was obtained by extracting twice with ultrasonic waves for 15 minutes using a sonicator which is commonly used for extracting herbal medicines. The collected extract was filtered with filter paper, and the filtrate was concentrated under reduced pressure (Eyela. Japan) at 45 ° C. and 1 atm, followed by freeze drying to prepare the extract of the present invention. As a result, 92 g of dry extract was obtained.

First, an acute toxicity test was conducted to examine human stability of the extract.

Test Example 1 Acute Toxicity in Rats

Acute toxicity test was performed using 6-week-old specific pathogen-free (SPF) SD rats. Five animals per group were suspended in 0.5% methylcellulose solution, respectively, and the original extracts of the present invention were administered once orally at a dose of 5 g / kg, 10 g / kg and 20 g / kg, respectively. After administration of the test substance, the mortality, clinical symptoms, and weight change of the animals were observed according to the usual methods, and hematological and blood biochemical tests were performed. The necropsy was performed to visually observe the abdominal and thoracic organ abnormalities.

As a result, no significant clinical symptoms or dead animals were noted in all animals treated with the test substance, and no toxic changes were observed in weight changes, blood tests, blood biochemical tests, and autopsy findings. As a result, the raw paper extracts of the present invention do not show a toxic change up to 20 g / kg in rats, therefore, the oral administration intermediate dose (LD ₅₀ ) was determined to be a safe substance of 20 g / kg or more of the raw paper extract.

As a result of the toxicity test of oral administration, intraperitoneal administration and subcutaneous injection to rats according to a conventional method according to a conventional method, 50% lethal dose (LD ₅₀ ) by intraperitoneal administration toxicity test was at least the base extract It turns out to be a safe substance of more than 20 g / kg.

Then, blood pressure, aortic ejection, coronary perfusion, and cardiac ejection change over time were measured to determine the therapeutic ability of the extract.

Experimental Example 2 Test for Ischemic Heart Disease in Myocardial Infarction-Induced Rats

(1) Preparation of experimental group

① Separation of the Heart

A male rat (Sprague-Dawley strain) having a weight of about 250 to 300 gm prepared in advance has a temperature of 24 to 26 ° C., and controls a lamp of a feeding room at an interval of 12 hours by an automatic power supply in an environment having a relative humidity of 50 to 60%. It was provided for free intake of water and feed in the cage. All experiments were conducted in accordance with animal test ethics regulations. After fasting for about 2 hours before the experiment, pentobarbital was injected by intraperitoneal injection of 5 mg / 100 gm of body weight to induce anesthesia. The anesthetized rat was tied to the extremities and fixed on the bench. The incision was made in the inguinal area to expose the femoral vein and 100 units of heparin per 100 gm of body weight were injected into the femoral vein. 60 seconds after heparin injection, the sternum of the rat was medianly dissected and the heart was extracted and immersed in 4 ° C saline to induce cardiac arrest. When the heart was stopped, the airway and esophagus around the heart were removed, and then the catheter was inserted into the aorta and the left atrium. After the ligation of both pulmonary gates, the lung tissue was isolated and an incision scar was left in the main pulmonary artery to prevent the perfusion fluid from filling in the right ventricle.

② extracorporeal circulation of the heart

[Preparation and Principle of In Vitro Circulation System]

The extracorporeal circulation circuit of the rat heart used in this experiment is a non-working Langendorff persusion system devised by Wengeldorf, a workable extracorporeal circulation devised by Neeley, Chain, etc. Attach the heart perfusion system at the same time.

The 'non-working extracorporeal circulation device' is a circuit that flows back into the aorta with a water pressure of 100 cm H ₂ O in an aortic reservoir having a height of 100 cm above the heart, and maintains the heart function by coronary perfusion due to the reflux circulation. It is called 'non-working heart' because there is no cardiac extraction. This non-working heart is used at the beginning of the experiment and during the first 15 minutes of recovery after induction of myocardial infarction, leading to recovery of the heart against enzyme deficiency during cardiac extraction and myocardial infarction. The 'workable extracorporeal circulation device' refers to a left heart preperation that is circulated in the left atrium with a 20 cm H ₂ O water pressure through an atrial bubble trap 20 cm above the heart, and introduced into the left atrium. Perfusate flows through the left ventricle in a left atrial reservoir at a height equal to 100 cm H ₂ O water pressure per heartbeat, 20-30 mL per minute (this is the amount of aortic ejection). Electrical pacin is not used for heart rate. This workable heart is used for 20 minutes before the induction of myocardial infarction and 15 minutes after the Wengeldorf in vitro circulatory system after the induction of myocardial infarction. In this experiment, aortic ejection fluid and coronary perfusion fluid are not used for recirculation.

The heart prepared in ① was connected to the modified Langendorff perfusion system of the in vitro circulatory system prepared as described above, followed by a 15 minutes extracorporeal circulation to remove the blood components in the heart and intracellular interstitial solution. The substrate concentrations of the perfusate were parallel. Left atrial bushings were also performed at this time. In addition, at this time, a control value of heart rate, maximum aortic systolic pressure, and coronary perfusion amount was determined.

Wegeldorf continued her extracorporeal circulation and at the same time perfused the left atrium and converted to a working heart. The left atrial and aortic vessels were closed 15 minutes after working heart before induction of myocardial infarction.

③ Injection of raw paper extract and myocardial infarction

After the left atrial and aortic tube closure by ②, 50 ml of the original extract prepared in Example 1 at a concentration of 1 mg / 1 ml was injected through an injection cap for about 3 minutes at a pressure of 65 cm H ₂ O. Inject into the coronary artery to allow the drug to enter the entire heart. To prevent dryness of the heart surface, 37 ° C physiological saline is added to the heart surface, and then the cardiac localization method is used in combination with the heart chamber. The water jacket was kept in a warm jacket, the myocardium was kept at 37 ± 1 ° C throughout the entire procedure, and the left atrial and aortic vessels were closed to prevent myocardial infarction for 5 minutes. Induced.

After induction of myocardial infarction, cardiac ischemia was stopped and Wegeldorf circulation was performed for 15 minutes with 37 ° C perfusion. Coronary perfusion fluid at this time was not recycled.

After 15 minutes of non-working circulation, Wegeldorf's circulation was continued while left atrial perfusion was carried out and changed to working heart, and the recovery state of cardiac function was measured for 60 minutes. At this time, if myocardial injury is in a state of impairment of recovery, it is not induced to non-working circulation so that it can be measured and observed under the same conditions.

(2) preparation of control group

Except for the fact that myocardial infarction was induced using a perfusion solution without the original extract, a series of procedures in preparation of the experimental group were performed.

Ten blood pressure, aortic ejection, coronary perfusion, and cardiac ejection were measured for 10 groups. 1 is a measurement of the change in the recovery state of blood pressure over time during the working heart rate for the experimental group and the control group, the results shown in Table 1 as a numerical value represents the mean blood pressure and the standard error. ** in FIG. 1 indicates that the probability of occurrence by chance is 1% or less ((P) <0.01) compared to the control group. 2 is a change in the recovery state of the aortic ejection volume over time during the working heart rate in the experimental group and the control group, the results shown as a numerical value in Table 1 shows the average ejection volume and the standard error per minute. 3 is a measurement of the change in the recovery state of coronary perfusion amount over time in the working heart rate for the experimental group and the control group, the results shown in Table 1 shows the average perfusion amount and standard error per minute Indicates. 4 is a change in the recovery state of the cardiac output volume over time during the working heart rate in the experimental group and the control group, the results shown as a numerical value in Table 1 shows the average ejection volume and the standard error per minute. 2 to 4, * has a probability of 5% or less caused by chance compared to the control group ((P) <0.05) and ** has a probability of 1% or less caused by chance compared to the control group ((P) < 0.01).

Control Experimental group Time (min) Blood pressure (mmHg) Aortic ejection volume (ml / min) Coronary Perfusion Volume (ml / min) Cardiac output (ml / min) Blood pressure (mmHg) Aortic ejection volume (ml / min) Coronary Perfusion Volume (ml / min) Cardiac output (ml / min) 20 93.70 ± 1.00 70.30 ± 1.17 22.90 ± 0.82 92.20 ± 1.47 91.80 ± 1.74 70.00 ± 1.50 21.33 ± 1.86 91.33 ± 1.50 25 93.50 ± 0.87 67.00 ± 1.32 23.30 ± 0.75 90.30 ± 1.51 91.50 ± 1.29 68.10 ± 1.79 22.33 ± 2.91 90.43 ± 1.78 30 93.80 ± 1.14 66.70 ± 0.94 22.00 ± 0.97 88.70 ± 1.28 90.70 ± 1.82 67.30 ± 1.99 24.00 ± 1.73 91.30 ± 1.97 35 92.30 ± 1.18 66.20 ± 1.22 22.80 ± 0.39 89.00 ± 1.26 89.70 ± 1.98 67.00 ± 0.90 21.33 ± 0.88 88.33 ± 1.01 70 64.30 ± 1.11 34.70 ± 1.01 13.80 ± 0.53 48.50 ± 1.11 76.60 ** ± 2.14 43.67 ± 3.48 18.33 ** ± 1.20 62.00 ** ± 3.47 80 63.70 ± 1.16 34.90 ± 1.15 13.90 ± 0.81 48.80 ± 1.31 75.90 ** ± 2.11 46.00 ** ± 3.46 19.50 ** ± 1.33 65.50 ** ± 3.43 90 59.00 ± 1.30 32.40 ± 1.38 12.70 ± 0.72 45.10 ± 1.64 74.60 ** ± 2.02 44.67 ** ± 4.91 20.50 ** ± 2.19 65.17 ** ± 4.89 100 58.60 ± 1.46 31.70 ± 1.12 13.40 ± 1.14 45.10 ± 1.68 74.50 ** ± 2.66 45.67 ** ± 4.48 23.00 ** ± 1.20 68.67 ** ± 4.45 110 54.10 ± 1.12 32.40 ± 1.40 12.90 ± 0.67 45.30 ± 1.61 74.90 ** ± 1.81 50.00 ** ± 3.21 24.00 ** ± 1.86 74.00 ** ± 3.18 120 51.60 ± 1.01 31.70 ± 1.64 13.80 ± 0.88 45.50 ± 1.55 74.00 ** ± 2.71 52.00 ** ± 3.10 23.00 ** ± 0.80 75.00 ** ± 3.08 ① *: Probability (P) <0.05 compared with the control group ** **: Probability (P) <0.01 compared with control group ③ Each value is mean ± standard error

As can be seen from Table 1, the blood pressure, aortic ejection, coronary perfusion and cardiac ejection in the experimental group treated with the extract were significantly increased from 10 minutes when compared with those of the control group. .

In addition, the blood pressure, aortic ejection, coronary perfusion, and cardiac output before and after ischemic shock were induced in the control group and the experimental group were measured, and the value was measured before the ischemic shock. The measured value after ischemic shock is shown in Table 2 in terms of percentage.

Control group (%) Experimental group (Unit:%) Time (min) Blood pressure Aortic ejection volume Coronary perfusion Cardiac output Blood pressure Aortic ejection volume Coronary perfusion Cardiac output Before ischemic shock To 20 100 100 100 100 100 100 100 100 After ischemic shock 10 68.4 52.0 61.1 53.8 84.2 64.2 82.4 68.2 20 68.1 52.3 62.5 54.1 83.4 67.6 87.7 72.0 30 63.1 48.6 57.1 50.0 82.0 65.6 92.2 71.6 40 62.7 47.5 60.3 50.0 81.9 67.1 103.5 75.5 50 58.0 48.6 58.0 50.2 82.3 73.5 108.0 81.4 60 55.2 47.5 62.1 50.5 81.4 76.4 103.5 82.5

As can be seen from Table 2, in the experimental group treated with the raw paper extract of the present invention, the blood pressure, the aortic ejection amount, the coronary artery ejection amount, and the cardiac ejection amount after the ischemic shock show a value almost recovering the value before the ischemic shock. From this, it can be seen that the extract extract is effective in treating ischemic heart disease.

A pharmaceutical composition for treating ischemic heart disease may be prepared by using the base extract as an active ingredient, which is safe for the human body and has an effect of preventing or treating ischemic heart disease. Raw paper extract can be administered orally or parenterally during clinical administration and can be used in the form of general pharmaceutical preparations.

That is, the raw extract of the present invention may be administered in various oral and parenteral dosage forms in actual clinical administration, and when formulated, diluents such as fillers, extenders, binders, wetting agents, disintegrating agents and surfactants that are commonly used, or Formulated using excipients.

Solid preparations for oral administration include tablets, pills, powders, granules and capsules, and the like, which may be used in the extract of at least one excipient such as starch, calcium carbonate, sucrose, lactose and gelatin. The mixture is prepared. In addition to simple excipients, glidants such as magnesium stearate, talc and the like are also used.

Liquid preparations for oral administration include suspensions, solvents, emulsions, and syrups. In addition to the commonly used simple diluents, water and liquid paraffin, various excipients such as wetting agents, sweeteners, fragrances and preservatives are available. Etc. may be included.

Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations and suppositories. As the non-aqueous solvent and the suspension solvent, propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like can be used. As the base of the suppository, witepsol, macrogol, tween 61, cacao butter, laurin, glycerol and gelatin may be used.

Dosage units may contain, for example, one, two, three or four times the individual dosage, or they may contain 1/2, 1/3 or 1/4 times. The individual dosage preferably contains an amount in which the effective drug is administered at one time, which usually corresponds to all, 1/2, 1/3 or 1/4 times the daily dose.

In the pharmaceutical composition for the treatment of ischemic heart disease, the effective dose of the base paper extract is 30 to 700 mg / kg, preferably 100 to 500 mg / kg, and may be administered 1-6 times a day. However, the dosage level for a particular patient may vary depending on the weight, age, sex, health status, diet, time of administration, administration method, excretion rate, severity of the disease, and the like of the patient.

In addition, it is possible to prepare a health food for treating ischemic heart disease using the base extract as an active ingredient. When the extract of the present invention is used as a food, the extract may be added as it is or used with other food or food ingredients, and may be appropriately used according to a conventional method. The blending amount of the active ingredient can be suitably determined according to the purpose of its use (prevention, health or therapeutic treatment). In general, the extract of the present invention may be added in an amount of 0.01 to 1% by weight, preferably 0.1 to 1% by weight based on the raw materials in the manufacture of food or beverage. An effective dose of the extract of the present invention may be used in accordance with the effective dose of the pharmaceutical composition, but may be less than the above range in the case of long-term intake for the purpose of health and hygiene or health control, Since there is no problem in terms of safety, it is certain that it can be used in an amount above the above range. There is no particular limitation on the kind of food. Examples of the food to which the substance can be added include dairy products including meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gums, ice cream, various soups, drinks, tea, drinks, Alcoholic beverages and vitamin complexes; and folk remedies for the purpose of blood donors, nourishing agents, skin whitening agents and the like. In addition, it can be used in various oriental medicine prescriptions such as bulmangsan, ginseng yangyoungtang, guibitang.

Hereinafter, although the pharmaceutical formulations and health foods containing the raw paper extracts were prepared in Formulation Examples 1 to 7, the present invention is not limited to these examples.

Preparation Example 1 Preparation of Soft Capsule

Raw paper extract prepared according to Example 1 100.0 mg, soybean oil 175.0 mg, lead 45.0 mg, coconut oil 127.5 mg, soybean phospholipid 21.0 mg, gelatin 212.0 mg, glycerin (specific gravity 1.24) 50.0 mg, di-sorbitol 76.0 mg, paraoxy 0.54 mg of methyl benzoate, 0.90 mg of paraoxybenzoate, 0.56 mg of methyl vanillin, and yellow 203 were prepared according to the method of preparing soft capsules in the Pharmacopoeia General Regulations so that an appropriate amount of ingredients was contained in 1 capsule.

Preparation Example 2 Preparation of Tablet

100.0 mg of raw paper extract prepared according to Example 1, corn starch 90.0 mg, lactose 175.0 mg, l-hydroxypropyl cellulose 15.0 mg, polyvinylpyrrolidone 90 5.0 mg and ethanol appropriately mixed raw material wet granules Granulation was carried out by the method, and 1.8 mg of magnesium stearate was added and mixed, and the tablet was compressed to 400 mg.

Preparation Example 3 Preparation of Capsule

Raw materials of 100.0 mg of raw paper extract prepared according to Example 1, 83.2 mg of corn starch, 175.0 mg of lactose and 1.8 mg of magnesium stearate were homogeneously mixed and filled to contain 360 mg in one capsule.

Preparation Example 4 Preparation of Chewing Gum

Chewing gum was prepared using a conventional method with the composition of 0.24 to 0.64% of the base paper extract prepared according to Example 1, 20% of gum base, 1% of fruit flavor, 2% of water and the balance of sugar.

Preparation Example 5 Preparation of Ice Cream

Raw paper extract prepared according to Example 1 0.24 ~ 0.64%, milk fat 10.0%, nonfat milk solids 10.8%, sugar 12.0%, starch syrup 3.0%, emulsifying stabilizer (span, span) 0.5%, fragrance (strawberry) 0.15% and Ice cream was prepared using a conventional method with the composition of the residual amount of water.

Preparation Example 6 Preparation of Drinks

0.48 to 1.28 mg of raw paper extract prepared according to Example 1, 522 mg of honey, 5 mg of chioctoamide, 10 mg of nicotinic acid, 10 mg of riboflavin hydrochloride, 2 mg of pyridoxine hydrochloride, 30 mg of inositol, 50 mg of orteic acid, and A beverage was prepared using conventional methods with a composition and content of 200 ml of water.

Preparation Example 7 Preparation of Sausage

With the composition of 0.24 to 0.64% raw paper extract prepared according to Example 1, poultry 27.5%, starch 3.5%, soy protein 1.7%, salt 1.62%, glucose 0.5%, other additives (glycerine) 0.94 to 1.34% and the remaining amount of pork Sausages were prepared using conventional methods.

As can be seen from the above, the base extract according to the present invention is a natural medicine harmless to the human body, and has an effect of restoring the heart that is not functioning by ischemic heart disease, and thus is useful for the prevention or treatment of diseases related to ischemic heart disease. Can be used.

Claims (5)

Polygala tenuifolia extract for the prevention or treatment of ischemic heart disease prepared by extracting the base paper with water or ethanol aqueous solution. delete delete A pharmaceutical composition for preventing or treating ischemic heart disease, comprising the original extract of claim 1 as an active ingredient. Health food for preventing or improving ischemic heart disease, comprising the original extract of claim 1 as an active ingredient.

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