KR20030035482A - Compositin of Korean Red Ginseng Including Oriental Herbs for Improving Sexual Function and Manufacturing Method the Same and Its Use - Google Patents

Abstract

PURPOSE: A method of preparing a complex of Ginseng Radix rubra, Lycii Fructus, Rubi Fructus, Schizandrae Fructus, Cuscutae Semen and Torilidis Fructus is provided. The complex exhibits excellent penile erection enhancing and sustaining effects when orally administered to a rabbit and a mouse and a patient having erectile dysfunction without causing any adverse effects. CONSTITUTION: A complex contains a Ginseng Radix rubra extract and a herbal extract in a ratio of 10 to 20:90 to 80. The herbal extract contains 0.5% by weight of Lycii Fructus extract, 0.3 to 6.0% by weight of Rubi Fructus, 0.1 to 3.0% by weight of Schizandrae Fructus, 0.5 to 8.0% by weight of Cuscutae Semen and 0.3 to 6.0% by weight of Torilidis Fructus. The Ginseng Radix rubra extract and herbal extract are obtained by: adding 5 to 40 times with purified water to the Ginseng Radix rubra; extracting it at 70 to 100deg.C for 6 to 10hr 2 to 5 times; centrifuging an extract; and then concentrating it under reduced pressure at 40 to 70cmHg.

Description

Red Ginseng Including Oriental Herbs for Improving Sexual Function and Manufacturing Method the Same and Its Use}

The present invention relates to a red ginseng extract for improving oral sexual function, a use thereof and a method for preparing the red ginseng extract, which are mixed with these herbal extracts obtained by hot water extraction from Goji, Bokbunja, Tosa, Schisandra chinensis and casualty. The red ginseng complex of the present invention is a component extracted from natural products, and since red ginseng is generally known to be good for the body, it is safe for the human body, and thus may be provided as a food or drug for preventing and improving sexual dysfunction.

Most patients with male sexual dysfunction do not have a form of severe erectile dysfunction. Medically, erectile dysfunction is when insertion is not possible in more than 75% of sexual life, and is the most serious form of male sexual dysfunction. However, most sexual dysfunction patients do not fall into this category. In other words, if all subjects who feel subjective to their sexual function are included in the male sexual dysfunction category, the drug to be developed should be ideally in the category of the improvement of sexual dysfunction rather than the nature of the erectile dysfunction drug. Intracavernosal vasodilator injection, vacuum penis aspirator, and penile implant implantation, which are the three major treatments for male sexual dysfunction centered on erectile dysfunction, are most effective in the diagnosis and treatment of erectile dysfunction. It is a universal diagnosis and treatment that is widely used. The reason is that in terms of effectiveness, it is superior to other medical treatments, and most patients want medical treatment rather than surgical treatment. However, this method is the biggest problem that many patients drop out of treatment despite high treatment success rate. In 218 patients who were followed for at least 1 year, intra-cavernous self-administration using triple drug therapy showed 78% of patients' satisfaction, similar to other reports, but a final dropout rate of 49.5%. Many patients are reluctant to choose this type of therapy because of their relatively good therapeutic results, but inconvenient to use and dependent on mechanical devices. Penis implantation is also guaranteed with high success rate, but should be performed only in a limited group of patients due to invasiveness, high cost, and equipment failure.

As can be seen from the above, the most preferred treatment for male sexual dysfunction patients should be easy to use and non-invasive form like oral medication. Recently, the methods developed to meet the limitations of existing treatments and the desperate desire of patients for non-invasive treatments are intra-urethral injection of vasodilators and various oral drugs. Intraurethral injection of vasodilator was developed to reduce pain and fear following injection, but its effect is low, and it is also invasive to some extent. . Therefore, the most preferred treatment for erectile dysfunction patients at this time is oral medication. Most oral erectile dysfunction drugs developed so far have been pointed out that the mechanism is unclear, low effect and significant side effects.

Viagra, which has been recently developed and attracts much attention, is distinguished from conventional drugs in that its mechanism of action is scientific and its therapeutic results are good. The development of Viagra is a breakthrough in the treatment of erectile dysfunction in which penile cavernous self-injection has been predominant. Competitive development of similar drugs is expected in the future. However, Viagra is relatively specific to the cavernous corpus cavernosum, but side effects due to effects on other organs such as the retina, cardiovascular system, and gastrointestinal system have been reported, and even death has been reported.

Choi et al., Although a limited subject group, suggested that Korean red ginseng had a therapeutic effect over placebo and trazodone in patients with erectile dysfunction. In addition, Choi et al recently reported the efficacy of red ginseng in erectile dysfunction patients through a multinational study of three Southeast Asian countries, Korea, China and Singapore. In foreign countries, studies on the positive effects of ginseng on other human organs such as the cardiovascular system, peripheral circulatory system, and respiratory system and their active ingredients have been conducted continuously, but studies on the effects of improving sexual function have been insufficient. Choi and Lee's report is the only foreign report. However, ginseng extract is not a clinical study but its effect is mediated through NO (nitric oxide), the most important neurotransmitter for the relaxation of the corpus cavernosum in rabbits. It is an animal experiment study that reported. As mentioned above, many studies have been conducted on the positive effects of Korean red ginseng on the whole human body, but there are few studies on the improvement of male sexual function, and the few clinical papers published are insufficient to reveal the clinical effects objectively. There are many noodles.

Among the known effects of Korean ginseng, the male sexual dysfunction researcher wants to pay attention to erectile dysfunction is penile blood flow enhancement, tension relaxation, stress suppression effect. To overcome the limitations of these previous studies, the inventors conducted a 3-month randomized double-blind control study in erectile dysfunction patients with objectively proven vascular dysfunction. As a result, among the indicators of the questionnaire, which is a subjective evaluation of sexual function, the total score and satisfaction items showed a statistically significant improvement in the red ginseng group. Many oral erectile dysfunction drugs, such as trazodone, yohimbine, and apomorphine, which have been developed and used before Viagra, are only 20-40% effective and often have unwanted side effects. Not a few have been used on a limited basis. In contrast, ginseng is a drug that has already been proven to have a positive effect on the overall organs of the body, so if the effect of sexual improvement is objectively acknowledged to some extent, it may have sufficient product value.

The present inventors obtained a good result by examining the relaxation effect in the corpus cavernosum of rabbits in in vitro experiments on the red ginseng complex, and confirmed the synergistic effect of penile erection as a result of oral administration to rabbits and rats in in vivo experiments. In addition, in the clinical trials for humans, the present invention was completed by finding out that no side effects are shown in the human body by performing erectile power and sexual intercourse with a sexually functional patient.

An object of the present invention is to sample the herbal extract extract containing red ginseng complex, that is, red ginseng, wolfberry, schisandra chinensis, earth and sand, casualty, etc., which prevents and improves sexual function deterioration from natural products without side effects. As a result, the relaxation effect in the cavernous corpus cavernosum of rabbits in vitro , oral administration to rabbits and rats in in vivo experiments, the synergistic effect of penile erection, and clinical trials showed internationally proven international index of erectile function (IIEF). The results of the research on erectile function were used to obtain excellent results, and its purpose is to provide a drug or food for the prevention and improvement of sexual dysfunction using the red ginseng complex.

Figure 1 shows the manufacturing process of the red ginseng complex of the present invention.

Figure 2 shows the manufacturing process of the beverage using the red ginseng complex of the present invention.

Figure 3 shows a solid formulation manufacturing process using the red ginseng complex of the present invention.

The present invention is the production of red ginseng complex containing red ginseng, wolfberry, bokbunja, Schisandra chinensis, earth and sand, casualties As an efficacy effect experiment using thisin vitro, in vivoExperiment, It consists of clinical trials.

The red ginseng complex for improving sexual function of the present invention is a red ginseng extract and herbal medicines containing red ginseng extract mixed with herbal extracts such as gojija, bokbunja, Schisandra chinensis, Tosa and Sasa, 10-20: 90-80. As a red ginseng complex for improving oral sexual function mixed in the ratio of%, the herbal extracts are 0.5-8.0% by weight: 0.3-6.0% by weight: 0.1-3.0% by weight: 0.5- 8.0% by weight: Mix in 0.3-6.0% by weight.

In the present invention, the herbal extract is investigated in the optimum amount of use in a large amount of addition bar when using the addition amount can be obtained the red ginseng complex most suitable for the purpose of the present invention.

In the method for producing a red ginseng complex for improving sexual function of the present invention, the red ginseng filtrate is extracted by adding purified water to the red ginseng, and the supernatant is concentrated under reduced pressure to prepare the red ginseng concentrate, and the cut wolfberry, bokbunja, schisandra chinensis, and earthworm porridge. After centrifuging the filtrate extracted by mixing the casualties with purified water, and extracting the supernatant from the supernatant under reduced pressure, the red ginseng complex was prepared by mixing the red ginseng concentrate and the herbal herb concentrate. Steps.

The red ginseng concentrate and the herbal medicine concentrate were added with 5 to 40 times purified water to each weight, centrifuged the filtrate extracted 2 to 5 times at 6 to 10 hours at 70 to 100 ° C, and the supernatant was 50 to 60. Concentrated under reduced pressure at 40 ~ 70cmHg at ℃ to obtain red ginseng concentrate and herbal concentrate.

Meanwhile, the present invention can be used as a food for improving sexual function in the form of solid, liquid or beverage by mixing red ginseng complex as a main ingredient and food additives and excipients allowed by food, wherein the beverage for improving sexual function is 0.05 ~ Each extract extract added with 0.07 to 5% by weight of Goji extract, 0.03 to 3% by weight of Schisandra chinensis extract, 0.07 to 5% by weight of Tosa extract, 0.03 to 4% by weight of Bokbunja extract, and 0.03 to 4% by weight of Sasa extract Vitamin B1 0.0001 to 3.0% by weight, B2 0.0001 to 3.0% by weight, C 0.001 to 5.0% by weight, B6 0.0001 to 5.0% by weight, nicotinic acid amide 0.001 to 3.0% by weight, citric acid 0.001 to 5.0% by weight, liquid fructose 1.0 to 20% by weight, 1.0 to 15% by weight per white and purified water mixed and filtered, the mixture is sterilized for 15 seconds at 95 ℃ and then filled and then sterilized for 20 minutes at 80 ℃ to prepare the packaging step Can All.

In addition, the present invention can be used as a pharmaceutical agent for the prevention or treatment of sexual dysfunction in the form of a formulation of a powder, granules, hard capsules or soft capsules by mixing the pharmaceutically acceptable excipients and adjuvants with the main ingredient red ginseng complex. At this time, the drug for improving sexual function is 0.05 ~ 3% by weight of red ginseng extract, 0.07 ~ 5% by weight of Goji extract, 0.02 ~ 3% by weight of Schisandra chinensis extract, 0.07 ~ 5% by weight of Tosa fruit extract, 0.03 ~ 4% by weight of Bokjaja extract, and 0.03 ~ 4 of Sasa extract. Mixing 4% by weight to obtain a red ginseng complex, vitamin B1 0.0001 to 3.0% by weight, vitamin B2 0.0001 to 3.0% by weight, vitamin C 0.001 to 5.0% by weight, vitamin B6 0.0001 to 5.0 weight%, nicotinic acid amide 0.001 to 3.0 weight%, citric acid 0.001 to 5.0 weight%, lactose 30 to 50 weight%, glucose 5 to 30 weight% and purified water were mixed into granules with a diameter of 0.05 to 1.5 mm. And drying the molded granules in a hot air dryer at 40 to 50 ° C., and then uniformly preparing the granules by passing 12 to 14 mesh, and extruding the granules to produce tablets or powders. Or to prepare a hard capsules by filling in hard capsules, and the red ginseng extract in 0.05 ~ 3% of the ingredients, gojija extract 0.07 ~ 5%, Schisandra chinensis extract 0.02 ~ 3%, Tosa extract 0.07 ~ 5%, Bokbunja extract 0.03 Obtaining red ginseng complex by mixing ~ 4% and filamentous extract 0.03 ~ 4%, and vitamin B1 0.0001-3.0 wt%, B2 0.0001-3.0 wt%, C 0.001-5.0 wt% , B6 0.0001 to 5.0% by weight, nicotinic acid amide 0.001 to 3.0% by weight and gelatin 68.489%, glycerin 30.7%, ethylvanillin 0.3%, titanium dioxide 0.2%, blue pigment 4 0.1%, blue pigment 1 0.02%, red Evenly mixed with 0.1% of Pigment No. 40 to soft capsule type Before and after rotational molding term after the primary drying in the dryer by Burlington finally dried in a ventilated room it can be made of a soft capsule.

In the present invention, the addition amount of the substance is limited to a numerical value, or the numerical limitation of the manufacturing conditions in the manufacturing method indicates the addition amount and the manufacturing conditions of the substance most suitable for the purpose of the present invention.

Hereinafter, the present invention will be described in the following examples. However, these do not limit the scope of the present invention.

<Example 1>: Preparation of red ginseng complex

Six-year-old red ginseng was 5-10cm in size (including body and small roots), and 10 times purified water was added to red ginseng 0.2-6.0% by weight and extracted three times at 80 ℃ for 8 hours, followed by centrifugation. Concentrated under reduced pressure at 50-60 ℃ to prepare a soluble red ginseng concentrate. In addition, as a raw material of commercial herbs, gojija, bokbunja, schisandra chinensis, earthenware and casualties 0.5-8.0% by weight: 0.3-6.0% by weight: 0.1-3.0% by weight: 0.5-8.0% by weight: 0.3-6.0% by weight After mixing well and uniformly, hot water extraction was carried out in the same manner as the preparation method of red ginseng concentrate, and these herbal medicine concentrates were obtained.

The red ginseng complex was prepared by mixing the concentrated red ginseng extract extract and the herbal medicine extract extract with 10-20%: 90-80%.

<Example 2>: Relaxation effect in the corpus cavernosum of rabbit

Table 2 shows that the red ginseng complex in the concentration of 1.25mg / ml, 2.50mg / ml, 5.0mg / ml, 7.5mg / ml, 10.0mg / ml When added, 10.3%, 26.6%, 55.4%, 71.7%, and 84.0%, respectively, showed a superior concentration-dependent effect on relaxation of penile corpus cavernosum.

Table 2. Effect of Red Ginseng Complex on Penile Corporal Relaxation Effect in Rabbits

sample Relaxation rate (%) 1.25mg / ml 2.5mg / ml 5.0mg / ml 7.5mg / ml 10.0mg / ml Red Ginseng Complex 10.3 26.6 55.4 71.7 84.0

* The relaxation rate is the result calculated as 100% when the original state is released from the contraction caused by phenylephrine (Phenylephrin).

<Example 3>: Effect on penile erection after oral administration to rabbits

Table 3 shows the effect of red ginseng complex on rabbits after oral administration to rabbits for 7 days after oral administration of red ginseng complex to rabbits to separate the corpus cavernosum of rabbits, and then to administer acylcholine (Acethylcholine) 10 ^-4 M. In vivo experiments on penile erection were 69.5% in the control group and 96.35% in the red ginseng complex-treated test group.

Table 3. Effect of Red Ginseng Complex on Penile Erection After Oral Administration in Rabbits

sample Control Red Ginseng Complex Concentration (100 mg / kg) 69.5% 96.3%

<Example 4>: Effect on penile erection after oral administration to rats

Table 4 by removing the corpus cavernosum of the ginseng Composition 7 days after oral administration, rats in rats In order to investigate the effect on the penis balgiryeok after oral administration of red ginseng complex with the similar experiment procedure as balgiryeok human to rat Acethylcholine (10 ^- In vivo experiments confirmed that the penile erection was confirmed in vivo by administering ⁴ M), and the control group administered the red ginseng complex was 43.8%, which was about twice as effective as the control group.

Table 4. Effect of Red Ginseng Complex on Penile Erection After Oral Administration in Rats

sample Control Red Ginseng Complex Concentration (100 mg / kg) 21.4% 43.8%

<Example 5>: Clinical experiment of red ginseng complex

In order to confirm the efficacy of the red ginseng complex in vitro and in vivo experiments and to determine whether it is effective in improving sexual function in Korean male sexual dysfunction patients.

1) Selection of appropriate patient group

The purpose of this experiment is to demonstrate the effect of improving the sexual function of the red ginseng complex, the subject group in accordance with the present invention is as follows. Firstly, patients with moderate to moderate sexual dysfunction with less severe sexual dysfunction would be appropriate. Second: Given the positive effects of Korean red ginseng on aging, the elderly and older patients over 40 years of age will be appropriate.

2) setting objective criteria for determining clinical efficacy

A common problem with clinical studies to verify efficacy in sexual dysfunction patients is that the questionnaire for determining efficacy is not standardized. Therefore, this study used the international index of erectile function (IIEF) developed to evaluate the efficacy of therapeutic agents in patients with sexual dysfunction. This questionnaire, first developed by Rosen et al., Has been applied to clinical trials to evaluate the efficacy of various types of erectile dysfunction drugs. In particular, it was applied for the first time in the clinical trial of Viagra, and the national index of erectile function (IIEF) was translated into Korean, and its validity was recognized. Researchers also applied the item evaluation method in the domestic clinical trial of Viagra. A total of 15 questions about the sexual function of the IIEF, each of which is rated 1-5 points, totaling 15-75 points. The 15 questions were largely related to erection (questions 1-5, 15), climax (questions 9 and 10), sexual desire (questions 11 and 12), sexual intercourse satisfaction (questions 6-8), and overall sexual life satisfaction (questions 13 and 14). It consists of five domains. Rosen et al. Recently argued that the so-called IIEF-5, which assesses erectile power, may be an objective data for diagnosing the presence and extent of erectile dysfunction. According to their research results, 21 points of IIEF-5 can be used as a cut-off value to diagnose the presence or absence of erectile dysfunction. The group could be classified into five groups, including those with severe erectile dysfunction.

3) Design of clinical trial

Phase 4 clinical trial using randomized, double-blind, placebo controls.

4) Selection and Exclusion Criteria for Target Group

(1) Selection criteria

① Male sexual dysfunction over 45 years old

② Sexual dysfunction patients with IIEF-5 scored below 21 among patients who visited due to erectile dysfunction: erectile dysfunction that reaches here means that there is not enough erection to maintain satisfactory sexual activity or it cannot be maintained even if it is erection do.

Patients who have had a stable heterosexual relationship with one partner for at least six months

④ Patient who listened to the researcher's explanation and received the written consent before starting the clinical trial.

(2) Exclusion Criteria

① Patients with anatomical abnormalities of the genitals that can seriously impair erections

② Patients judged to be the primary diagnosis of sexual dysfunction or lowering of libido other than erectile dysfunction

③ Patients with elevated prolactin levels (more than three times the normal upper limit) or patients with low levels of free testosterone (20% lower than the normal lower limit when measured with blood collected between 9 am and 11 am)

④ Major mental disorders that are not well controlled even with treatment (including major depression or schizophrenia)

⑤ Patients with a history of major blood disease, kidney disease, or liver disease

⑥ Diabetes patients with poor control

⑦ Patients who have had a stroke or myocardial infarction in the last six months, or have had a serious cardiovascular disease, including heart failure, unstable angina or life-threatening arrhythmias in the last six months.

8. Patients who are known to have a causal relationship with erectile dysfunction, such as beta-blockers, thiazide diuretics, digoxin, and tricyclic antidepressants, may be the first to be prescribed within 2 weeks prior to the start of the trial, or may be changed to such medication during the trial. Patient

Patients undergoing vacuum physiotherapy, intracavernosal injections or other erectile dysfunction treatments (including testosterone) and are not prepared to discontinue this treatment during the clinical trial.

(3) the number of target groups and their basis;

Non-parametric verification was performed for statistical analysis of this study. In order to secure statistical stability, the final evaluable number of subjects was set to 15 persons in the dosing group and the placebo group, and the number of subjects was set to 20 or more in each group in consideration of the number of expected dropouts.

(4) Clinical trial period

Most of the subjects were using conventional erectile dysfunction drugs (oral erectile dysfunction such as Viagra or intracavernosal vasodilator self-injection). Therefore, these patients needed a four-week period for discontinuing the use of conventional erectile dysfunction and evaluating basal sexual function, followed by an eight-week dosing period, for a total of 12 weeks.

(5) randomization

This study was conducted through randomized double blind method. To this end, the clinical sample provider divided the placebo and the 8-week medication for each patient into four weeks. The investigator prepared a randomization table with the number indicating the drug. A randomized number assigned to each drug was assigned by a doctor unrelated to the clinical trial, and each drug was recorded as a test drug or a placebo and sealed. At the end of the trial, the number tags were opened to evaluate the clinical efficacy of each drug.

(6) Clinical trial method (dose, administration method, follow-up period, combination therapy)

An overview of the clinical trials was randomized to subjects in the same placebo group and the Korean red ginseng complex group. All subjects took 7 capsules of red ginseng complex (0.25 g per capsule) three times after meals (or equivalent placebo).

<Select Subject>: Visit 1

When the patient's symptoms were questioned and the information including the patient's age and the degree of sexual dysfunction was judged to be appropriate for the study, the preliminary information on the clinical study was provided, including the description of placebo and compensation.

. The IIEF Korean Questionnaire (IIEF-K) was completed to confirm whether the total score of IIEF-5 is included in the selection criteria.

. Other selection / exclusion criteria were reviewed. If the above questionnaire and questionnaire were found to be a requirement to be the subject of this study, the following tests were conducted.

. Obtain demographic information.

. Medical history was obtained, including concomitant medications.

. Sufficient physical examinations were performed, including height, weight and genital examination.

. Blood pressure and heart rate in the sitting position were measured.

. Blood was collected for laboratory safety testing, including general blood tests and general chemical tests.

. I explained how to write and write a participant's journal.

<Start of Double Blind (0 weeks)>: Visit 2

. If the investigator judges that it is certain that the subject cannot or will not continue to accurately and accurately record the data required for the study.

. Subject's laboratory test results do not meet the selection criteria

. Subject does not meet selection criteria for other reasons

All subjects received a four week dose of Korean Red Ginseng Complex or equivalent dose of placebo and the behavior / procedures at the visit for subjects who could begin double blind treatment were as follows.

. Concomitant medications and adverse events were recorded.

. Blood pressure and heart rate were measured in the sitting position.

. Subjects were given a study drug and a participant log to be taken for 4 weeks and medication instructions were provided.

<Interim Evaluation (4 weeks)> Visit 3

. Subjects were asked to return unused clinical trials.

. Concomitant medications and adverse events were recorded.

. Blood pressure and heart rate were measured in the sitting position.

. Participant logs were reviewed and the next medication and participant log provided.

. IIEF-K was written.

At any point after randomization, the adverse events were recorded for those who were dropped from the trial for any reason, if they were dropped out due to side effects.

: A physical examination was done.

: The reason for dropping out from the clinical trial was recorded.

: A medication record column and a subject summary column of the subject case record table were prepared.

<End of medication visit (8 weeks)> Visit 4

. Subjects were asked to return unused clinical trials.

. We reviewed the quantity of participants returned and whether they were participants.

. Concomitant medications and adverse events were recorded.

. Blood pressure and heart rate were measured in the sitting position.

. Termination physical examinations, including body weight measurements, were performed.

. Blood was collected to conduct a laboratory safety test.

. Subjects were asked to complete an IIEF-K and a comprehensive efficacy assessment questionnaire.

The Comprehensive Effectiveness Questionnaire answered 'Yes' or 'No' to the question 'Did the treatment you have received improved your erection?' To assess the subject's overall satisfaction with the efficacy of the test drug. It is an item.

<Clinical Inspection Items>

1) Validation

① Questionnaire about erectile function (IIEF-K)

② Comprehensive Effectiveness Evaluation Question

③ Participant

2) safety evaluation

① Evaluate safety and tolerability through questions that do not lead to answers

② Regular laboratory test result

Hematological tests: Hemoglobin, hematocrit, total RBC, total WBC including differential count, and platelet count were performed at the first and final visits.

General Chemistry Test (Serum / Plasma): General liver function and blood glucose tests were performed at the first and final visits.

Liver dysfunction: Moderate liver dysfunction and severe liver dysfunction were defined as follows.

AST / ALT Alkaline Phosphatase Total Bilirubin

Moderate ≥1.5 x ULN ≥1.5 x ULN ≥1.5 x ULN

Severe ≥3.0 x ULN ≥3.0 x ULN ≥2.0 x ULN

The upper limit of normal (ULN) was defined as the upper limit of normal value if the baseline measurement was normal, and as the upper limit of the baseline measurement if abnormal.

3) Validation Variable

Primary efficacy endpoints: Responses to questions 3 and 4 of the IIEF-K (these questions are about the achievement of subjects' successful sexual intercourse).

Secondary validity assessment variables: responses to questions other than questions 3 and 4 of the IIEF-K.

Comprehensive Validity Question: Sexual Success Rate from Participant Log

<Evaluation evaluation>

① Primary validity evaluation variable: Response to questions 3 and 4 of IIEF-K

Among the items of IIEF-K, the question of the frequency of successful insertion (question 3) and the question of maintenance of erection (question 4) were the primary efficacy evaluation variables. In the administration group, questions 3 and 4 increased significantly from 2.9 ± 1.3 and 2.2 ± 1.1 before dosing, respectively, to 4.2 ± 1.3 and 3.4 ± 1.2, respectively (p <0.05). However, in the placebo group, significant differences in questions 3 and 4 were not found before and after drug administration.

Secondary validity assessment variables: responses to questions other than questions 3 and 4 of the IIEF-K.

The total score of IIEF-K was significantly increased from 40.5 ± 12.5 points before administration to 51.4 ± 12.5 points after administration (p <0.05). Among the domains of sexual function evaluation, item scores on erectile ability, sexual satisfaction, and overall sexual life satisfaction also increased significantly after administration. However, item scores for climax and sexual desire did not show significant changes despite drug administration. In the placebo group, no significant differences were found between the IIEF-K scores and the sexual function assessments before and after drug administration.

<Comprehensive Validity Question>

In a comprehensive efficacy assessment questionnaire asking subjective assessments of whether the drug administered during the trial improved erection, 12 of 14 dose groups (85.7%) and 2 of 14 placebo groups (14.3%) A significant difference could be confirmed by answering 'Yes' (p <0.05).

-Success rate of sexual intercourse obtained from participant log

The success rate of sexual intercourse in the dosing group increased significantly from 14.9 ± 28.5% before dosing to 32.6 ± 31.6% after dosing. In the placebo group, no significant difference was found between before and after drug administration.

-Safety assessment

Blood pressure and heart rate did not show any change in both groups. The laboratory tests, which consisted of general blood tests and liver function tests, showed no significant differences before and after the clinical trial. The 28 subjects who completed the study did not report any adverse events associated with drug use.

<Interpretation of Clinical Test Results>

The red ginseng complex has been objectively proven to be a placebo-improving effect on sexual dysfunction in Korean patients. In particular, this clinical trial secured objectivity by using an internationally recognized questionnaire (IIEF) as a measure of efficacy of sexual dysfunction drugs. The results showed that red ginseng complex significantly increased the frequency of successful insertion (question 3) and retention of erection (question 4), which were variables of primary efficacy evaluation. In addition, red ginseng composites significantly increased item scores on erection, sexual intercourse satisfaction, and overall sexual life satisfaction among IIEF-K's total score and sexual function evaluation. Among the areas of sexual function evaluation, there were no changes in the item scores for sexual desire and climax, and the red ginseng complex did not affect the sexual desire and mainly focused on improving the erection. The effect was confirmed. In the overall efficacy evaluation item, which was another secondary efficacy evaluation variable, the group taking red ginseng complex showed a significantly higher response rate (85.70% vs 14.3%) than the placebo group, and the personal variation in the success rate of sexual intercourse was significantly higher in the test drug taking group. The improvement was confirmed. No adverse effects related to drug use were identified in the subjects who had completed the clinical trial, and their effects on drug use could not be confirmed in blood pressure, heart rate, and laboratory test findings.

Table 5. Results of comparing the effects of the group (red ginseng complex) and placebo group with international foot function before and after administration

Item Dosing group (n = 14) Placebo group (n = 14) Before dosing After dosing value Before dosing After dosing value Question 3 2.9 ± 1.3 4.2 ± 1.3 0.001 3.3 ± 1.3 3.3 ± 1.3 0.387 Question 4 2.2 ± 1.1 3.4 ± 1.2 0.001 1.9 ± 1.3 1.9 ± 1.2 0.165 sum 40.5 ± 12.5 51.4 ± 12.5 <0.001 36.1 ± 10.6 35.6 ± 10.9 0.925 Foot function 15.0 ± 5.3 21.4 ± 6.1 <0.001 14.4 ± 5.1 14.3 ± 5.1 0.794 Climax 7.4 ± 3.0 8.2 ± 2.3 0.074 6.1 ± 2.7 6.0 ± 2.9 0.837 sexual desire 6.0 ± 1.7 6.6 ± 1.3 0.166 5.1 ± 1.4 4.8 ± 1.6 0.209 Sexual satisfaction 7.2 ± 2.6 9.7 ± 2.3 0.001 6.6 ± 2.2 6.7 ± 2.3 0.861 Overall Satisfaction 4.6 ± 1.7 5.8 ± 1.8 0.032 3.8 ± 1.1 3.6 ± 0.9 1.000

The figures are mean ± SD.

Example 6 Preparation of Beverage

Based on the results of the red ginseng complex, the sensory test was carried out by adding red ginseng, wolfberry, bokbunja, Schisandra chinensis and filamentous extract extracts by 0.05% to 15% by weight. Results: To 0.05-3% by weight of red ginseng extract, 0.07-5% by weight of Goji extract, 0.02-3% by weight of Schisandra chinensis extract, 0.07-5% by weight of Tosa extract, 0.03-4% by weight of Bokbunja extract, and 0.03-4% by weight of filamentous extract Each extract extract (Table 1) and nutritional supplements vitamins B1, B2, C, B6, nicotinic acid amide, etc. are added at different concentrations, to enhance palatability and organoleptic properties, and to provide nutrition and refreshment. Vitamin B1 0.0001 to 3.0% by weight, vitamin B2 0.0001 to 3.0% by weight, vitamin C 0.001 to 5.0% by weight, vitamin B6 0.0001 to 5.0% by weight, nicotinic acid amide 0.001 to 3.0% by weight, citric acid 0 Table 1 shows the results of selecting an optimum blending component and a ratio table in which .001 to 5.0% by weight, liquid fructose 1.0 to 20% by weight, 1.0 to 15% by weight of white sugar, and an appropriate amount of purified water were mixed.

Table 1. Composition and Contents of Red Ginseng Complex

Ingredient Compounding content (% by weight) Red Ginseng Extract 0.05-3 Goji Extract 0.07-5 Schisandra chinensis extract 0.02 to 3 Tosa Extract 0.07-5 Casualty extract 0.03 to 4 Bokbunja Extract 0.03 to 4 Vitamin B1 0.0001 to 3.0 Vitamin B2 0.0001 to 3.0 Vitamin B6 0.0001 to 5.0 Vitamin C 0.001 to 5.0 Nicotinic acid amide 0.001-3.0 Citric acid 0.001 to 5.0 Liquid fructose 1.0 to 20 Baekbaekdan 1.0-15 Purified water Quantity

Example 7 Preparation of Solid Form

In consideration of organoleptic properties and workability of the manufacturing process, when red ginseng, gojijaja, bokbunja, Schisandra chinensis and filamentous extract extract were added by 0.05% to 15% by weight, the red ginseng extract 0.07 to 5% Each extract extract and vitamin B1 0.0001-3.0% by weight, vitamins by weight, 0.02-3% by weight of Schisandra chinensis extract, 0.07-5% by weight of Tosa extract, 0.03-4% by weight of Bokbunja extract, 0.03-4% by weight of filamentous extract B2 0.0001-3.0 wt%, Vitamin C 0.001-5.0 wt%, Vitamin B6 0.0001-5.0 wt%, Nicotinic acid amide 0.001-3.0 wt%, Citric acid 0.001-5.0 wt%, Lactose 30-50 wt%, Glucose 5-30 wt% The optimum blending component and ratio which mixed% were selected. 5% of sterile purified water was added to the mixture, followed by mixing to form granules having a diameter of 1 to 2 mm with a reverse rotating granulator. The molded granules were dried in a hot air dryer at 40 to 50 ° C., and then passed through 12 to 14 mesh to uniformly prepare granules. The granules prepared as described above were extruded by a suitable amount into tablets or powders, or filled into hard capsules to prepare hard capsules. In addition, gelatin 68.489%, glycerin 30.7%, ethylvanillin 0.3%, titanium dioxide 0.2%, blue pigment No. 4 0.1%, blue pigment No. 1 0.02%, red pigment No. 40 0.1% is uniformly mixed with the above ingredients. After filling and molding into a soft capsule type, it was first dried in a rotary tumbler dryer and finally dried in a ventilation chamber to prepare a soft capsule.

To evaluate the efficacy of red ginseng complexes in vitro experiments were obtained good results in the corpus cavernosum of rabbit in the relaxation effect experiment was also a result of oral administration to the rabbit and rat in in vivo experiments confirm the synergistic effect balgiryeok penis. In addition, the clinical trials of Korean patients with erectile dysfunction were tested objectively using the internationally proven international index of erectile function (IIEF). Therefore, according to the present invention, the formulations and ratios of the above formulations of beverage formulations, granules, hard capsules and soft capsule formulations are used to prevent and treat sexual functions that are safe and effective for middle-aged and elderly patients without severe erectile dysfunction. As a result, the effect can be increased.

Claims (11)

Red ginseng complex for improving sexual function of oral administration type containing red ginseng complex mixed with red ginseng extract and herbal extract The red ginseng complex for improving sexual function of the oral administration type according to claim 1, wherein the red ginseng extract and the herbal medicine extract are mixed at a ratio of 10-20: 90-80%. According to claim 1, the herbal medicine extract is a raw material for herbal medicine, gojija, bokbunja, Schisandra chinensis, earthenware, casualties 0.5-8.0% by weight: 0.3-6.0% by weight: 0.1-3.0% by weight: 0.5-8.0% by weight: 0.3-6.0% Red ginseng complex for improving sexual function of the oral administration type, characterized in that the herbal extract extracted by mixing in% After centrifuging the red ginseng filtrate extracted by adding purified water to the red ginseng, the supernatant was concentrated under reduced pressure to prepare a red ginseng concentrate, and the mixture of the cut wolfberry, bokbunja, Schisandra chinensis, earthenware and casualties was added to these herbal medicines and extracted. After centrifuging the filtrate, the supernatant is concentrated under reduced pressure to produce a herbal medicine concentrate, and the red ginseng concentrate and the herbal medicine concentrate are mixed to obtain a red ginseng complex, comprising the steps of: Manufacturing method of red ginseng complex for improving sexual function The red ginseng concentrate and the herbal herb concentrate were subjected to centrifugation of the filtrate extracted 2 to 5 times at 70 to 100 ° C for 6 to 10 hours by adding 5 to 40 times purified water to each weight. Method of producing red ginseng complex for improving oral sexual function, characterized in that the red ginseng concentrate and herbal medicine concentrate obtained by decompression concentration at 40-70 cmHg at 50-60 ℃ Method of using the red ginseng complex of any one of claims 1 to 3 as a main ingredient and mixing food additives and excipients allowed by foods as a food for improving sexual function The method of claim 6, wherein the food for improving sexual function is used as a solid, a liquid, or a beverage. 8. The beverage for sexual function improvement is 0.05-3% by weight of red ginseng extract, 0.07-5% by weight of Goji extract, 0.03-3% by weight of Schisandra chinensis extract, 0.07-5% by weight of Tosa fruit extract, and 0.03-4% by weight of Bokbunja extract. , Each extract extract added with 0.01 to 4% by weight of filamentous extract and vitamin B1 0.0001 to 3.0% by weight, B2 0.0001 to 3.0% by weight, C 0.001 to 5.0% by weight, B6 0.0001 to 5.0% by weight, nicotinic acid amide 0.001 to 3.0% by weight, citric acid 0.001 to 5.0% by weight, liquid fructose 1.0 to 20% by weight, white sugar 1.0-15% by weight and purified water, and the mixture was filtered and sterilized for 15 seconds at 95 ℃ After the sterilization for 20 minutes at 80 ℃, the method for producing a beverage using the red ginseng complex for improving sexual function, characterized in that consisting of steps Method of using the red ginseng complex of any one of claims 1 to 3 as a main ingredient as a pharmaceutical ingredient for preventing or treating hypogonadism by mixing a pharmaceutically acceptable excipient and an adjuvant 10. The agent according to claim 9, wherein the agent for preventing or treating sexual hypoplasia is a powder, granule, hard capsule, or soft capsule. The pharmaceutical composition for improving sexual function according to claim 10, wherein the red ginseng extract is 0.05 to 3% by weight of red ginseng extract, 0.07 to 5% by weight, Schisandra chinensis extract, 0.02 to 3% by weight, earthworm extract 0.07 to 5% by weight, bokbunja extract 0.03 to 4% by weight. To obtain a red ginseng complex by mixing 0.03 to 4% by weight of the filamentous extract, vitamin B1 0.0001 to 3.0% by weight, vitamin B2 0.0001 to 3.0% by weight and vitamin C 0.001 to 5.0% by weight , 0.0001 to 5.0% by weight of vitamin B6, 0.001 to 3.0% by weight of nicotinic acid amide, 0.001 to 5.0% by weight of citric acid, 30 to 50% by weight of lactose, 5 to 30% by weight of glucose, and purified water, with a diameter of 0.05 to 1.5 mm. Molding into granules, drying the molded granules in a hot air dryer at 40 to 50 ° C., and then uniformly preparing the granules through 12 to 14 mesh; and extruding the granules to tablets. Or as a powder or filled into hard capsules To prepare a hard capsule and the above ingredients, red ginseng extract from 0.05 to 3% gojija extract 0.07 to 5%, Schisandra chinensis extract 0.02 to 3%, earthworm extract 0.07 to 5%, bokbunja extract 0.03 to 4%, filamentous extract 0.03 to 4% of red ginseng complex to obtain a mixture, and the former red ginseng complex vitamin B1 0.0001 to 3.0% by weight, B2 0.0001 to 3.0% by weight, C 0.001 to 5.0% by weight, B6 0.0001 to 5.0% by weight %, 0.001 to 3.0% by weight of nicotinic acid amide, gelatin 68.489%, glycerin 30.7%, ethylvanillin 0.3%, titanium dioxide 0.2%, blue pigment 4 0.1%, blue pigment 1 0.02%, red pigment 40 0.1% After mixing uniformly by filling and molding into a soft capsule type, the first drying in a rotary tumbler dryer, and finally dried in a ventilation chamber to produce a soft capsule, characterized in that the drug using the red ginseng complex for improving sexual function Manufacturing Method