KR101962894B1 - Composition for Pain Relief Comprising Natural Combined Oil - Google Patents

Abstract

The present invention is based on the finding that the amount of change in the Visual Analog Scale (VAS) value of a subject having anti-vasoconstrictive pain (VAS) by using a natural oil complex oil of virgin, fir leaf, It is an invention that can reduce.
The pain relieving composition containing the natural oil complex oil according to the present invention is a natural pain relieving composition comprising a combination oil of natural products, fir, top, and peppermint, a change in the VAS value of a subject having an anti- The pain can be significantly reduced.

Description

 TECHNICAL FIELD The present invention relates to a pain relieving composition comprising a natural product complex oil,

The present invention relates to a pain relief composition comprising a natural product complex oil. More specifically, the use of a natural oil complex oil of fir leaves, fir leaves, upper legs, and peppermint leaves a significant change in the visual analog scale (VAS) value of a subject having anti- In the present invention.

Pain relief is largely accomplished in two ways, one of which is the method of masking the pain from the patient, although the cause of the pain continues. This method is a method of action of many analgesics, and although such analgesics prevent the patient from feeling pain, it is required that the analgesic should be administered consecutively because it can not block the underlying cause of analgesia. Another method of more effective pain relief is to fundamentally address the causes of pain. That is, when the physiological or neurotransmitter of pain is relieved, the sense of pain is reduced.

On the other hand, oral painkillers such as painkillers are generally administered orally, but currently developed oral painkillers have a tendency to cause various side effects such as liver damage, kidney damage, gastrointestinal injury, poisoning and weight gain . In addition, in the case of a pain-relieving agent for oral administration, since it has to be absorbed through the digestive system before entering the bloodstream, it takes some time until the efficacy is demonstrated. Parenteral administration methods such as intravenous infusion or intramuscular injection have been proposed to solve the problem of delay in oral administration, but these methods are not convenient and costly, There is a problem that it is very inconvenient to carry out.

Therefore, attempts have been made to administer pain relievers in a local, especially transdermal, mode, and attempts have been made to develop drugs and / or pharmaceutical compositions suitable for transdermal administration.

Up to now, the development of a pain relief agent for percutaneous administration using a chemical agent has been mainly performed, which can provide pain relief in a short period of time, but has a problem of irritating the skin. Recently, attempts have been made to develop hypotonic transdermal pain relieving agents for skin. However, since the kinds and effects of the natural herbal ingredients are various, when the natural herbal ingredients are mixed, There is a lack of research on whether it can be done.

As a related art related to this, Non-Patent Document 0001 as described below, " Study on analgesic action of anti-inflammatory and anti-inflammatory action ", but the false-positive effect activates analgesic and antiinflammatory action by activating the lowering pain control system through PGE ₂ synthesis and NO production It is only disclosed that it exerts. Further, Patent Document 0001 discloses " a herbal composition for pain relief comprising various kinds of herbal extracts such as white bacillus ". However, since the pain relieving herbal composition is applied to muscles or joints, it exhibits effects such as mere blood communication, improvement of blood circulation, relaxation of muscles and joints, and pain relief, and has not reached a satisfactory level.

The present inventors have conducted a long study to present a variation of the pain assessment (VAS) value of a subject having anti-vasospasm using a combination oil of natural products, fir leaf, upper and lower meats, It was completed.

Patent Registration No. 10-1551375 (Feb.

 Study on analgesic and anti-inflammatory mechanism of virulence (2005. 12. Doctoral thesis of Kyungwon University)

The present invention relates to a natural product which can alleviate pain by presenting a change amount of pain assessment (VAS) value of a subject having an anti-obsessive-compulsive pain (anti-肩 背痛) using a natural oil, a combination oil of a fir leaf, To provide a composition comprising a complex oil.

The present invention provides a pain relief composition comprising a natural product complex oil comprising 25% by weight of a fake oil, 30% by weight of a fir leaf oil, 25% by weight of a peppermint oil, and 20% by weight of a topical oil.

Means for solving the other specific problems according to the present invention are described in the detailed description of the invention.

The pain relieving composition comprising the natural oil complex oil according to the present invention can be used as a pain relieving composition containing a natural oil, a fir leaf, an upper limb and a mint oil mixture, And the amount of pain is significantly reduced by presenting the amount of change.

Figure 1 is a photograph of a Spa Capsule (Hydro Magic Spa Capsule 1005 product) which can perform an entire body treatment.

Hereinafter, the present invention will be described in more detail with reference to examples and application examples.

Unless otherwise defined herein, scientific and technical terms used in connection with the present invention shall have the meanings commonly understood by one of ordinary skill in the art. In addition, unless the context clearly dictates otherwise, the singular form of a term includes plural forms thereof, and plural forms of a term will also include its singular form

The pain relieving composition of the present invention is characterized by containing a natural product complex oil of 25% by weight of fake oil, 30% by weight of fir leaf oil, 25% by weight of peppermint oil, and 20% by weight of topical oil.

First, the characteristics of the herbal material used for constituting the natural product complex oil of the present invention are as follows.

It is also called paddy field, and can be extracted from rootstock and root to obtain essential oil. It is used for myalgia, arthritis, low back pain, knee and lower back pain caused by the wind (cold wind), and it has moisturizing effect and it is effective for skin itching, exothermal fever, headache. Pharmacological effects have been reported to be effective in sedation, hypnosis, analgesic, anti-inflammatory, hypotensive, anti-convulsive, anti-ulcer, sunlight allergies.

The fir is an evergreen tree of the pine tree. The essential oil obtained by extracting the leaf contains Pinen, Camphen, Pinen, Limonen and the like, and rheumatoid arthritis, It is not only effective for alleviating the skin irritation caused by various kinds of inflammatory diseases such as urethritis, pulmonary tuberculosis, gastritis, gastric ulcer, and skin pruritus such as itching, swelling, wounds, swelling and swelling, Skin troubles, psoriasis, vitiligo and skin metabolism.

Mint is also called indancho, and it can be extracted from leaves and stems to obtain essential oil. The main ingredient of peppermint is menthol, and it contains menthone, and it promotes the secretion of inflammation, inflammation, dryness, bile secretion, suppression of gastric smooth muscle, increase of mucous secretion of respiratory tract, .

The upper part of the mulberry tree is mainly dried in the spring before the leaf is cut, and it is dried and used for the lower limbs of the limbs due to insomnia. It is also used for the symptoms of swelling, hypertension and limb paralysis. , Antimicrobial action, intestinal peristaltic action, and hypotensive action have been reported.

In the present invention, natural oil complex oil including chewing gum can be extracted by various known extraction methods such as steam distillation method, cold precipitation method, organic solvent method and supercritical extraction method, but preferably using supercritical extraction method has various merits .

Supercritical extraction is an extraction method using a fluid above a critical point as an extract. Supercritical fluids have medium properties between gas and liquid, and because they have solubility properties for many materials by changing solubility of materials without phase change by simply controlling temperature and pressure, . Particularly, the carbon dioxide (CO ₂ ) has a critical temperature of 31.1 ° C. and a critical pressure of 73.8 bar, so that it can be extracted at a low temperature. Thus, it is possible to prevent heat damage to the extracted active ingredient, It can be used as a supercritical fluid solvent.

In the present invention, when a dry sample for extracting a natural product complex oil is extracted by a steam distillation method, the recovery rate of each oil is only 0.05 to 2.07%. However, if the supercritical extraction method is used, it is preferable to set the recovery rate of the oil at 50 ° C, 150-300 bar, carbon dioxide flow rate of 30 g / min and 90-180 minutes, respectively. Then, the obtained extract is dissolved in 70% alcohol or a carrier oil as a solvent, and then filtered through a 10 탆 filter. The yield of the extracted oil thus obtained was 0.31% by weight of the extract, 0.24% by weight of the fir leaf, 3.05% by weight of the top, and 4.93% by weight of the peppermint, which can be significantly elevated by the conventional distillation method.

Each of the above-obtained oils is mixed in an appropriate ratio to prepare a natural product complex oil. The ratio is 25% by weight of non-fog oil, 30% by weight of fir leaf oil, 25% by weight of peppermint oil and 20% .

On the other hand, in the pain relief composition containing the natural product complex oil of the present invention, the complex oil may be contained in a proportion of 0.5 to 3.0% by weight, preferably 1.0 to 2.0% by weight, based on the pain relief composition . When the content of the complex oil is less than 0.5% by weight, a significant effect of pain relief can not be expected. When the content of the compound oil is more than 3.0% by weight, the effect is not increased remarkably due to the increase of the content, Not suitable.

In a preferred embodiment of the present invention, the components contained in the pain relieving composition comprising the natural product complex oil are not limited to the complex oil of the chewing gum, fir leaf, peppermint and upper body used as the active ingredient of the present invention, Various components may be included.

In addition, the pain relieving composition comprising the natural oil complex oil of the present invention can be prepared into any formulation conventionally produced in the art. In addition to the composition of the present invention, a skin- Or in the form of adjuvants which can be applied topically or systemically.

Suitable formulations of the pain relief composition comprising the natural product complex oil include, for example, solutions, gels, solid or kneaded anhydrous products, emulsions obtained by dispersing oil phase in aqueous phase, suspensions, microemulsions, microcapsules, (Liposome), in the form of a non-ionic follicular dispersion, in the form of a cream, skin, lotion, powder, ointment, spray or conceal stick. It can also be prepared in the form of a foam or an aerosol composition further containing a compressed propellant.

Further, the pain relieving composition comprising the natural oil complex oil of the present invention may further contain, in addition to the complex oil such as a chewing gum, a fat substance, an organic solvent, a solubilizing agent, a thickening agent and a gelling agent, a softening agent, an antioxidant, a suspending agent, a stabilizer, ), Perfumes, surfactants, water, ionic or nonionic emulsifiers, fillers, sequestering and chelating agents, preservatives, vitamins, blocking agents, wetting agents, essential oils, dyes, pigments, hydrophilic or lipophilic active agents, lipids Or any other ingredient conventionally used in cosmetics, such as, for example, cosmetics or dermatological sciences. And the above ingredients may be introduced in amounts commonly used in the dermatology field.

The product to which the pain relief composition containing the natural product complex oil of the present invention can be added includes, but is not limited to, a skin lotion, a skin softener, a skin toner, a convergent lotion, a softening longevity, a nutritional lotion, an astringent, , Moisture Lotion, Nutrition Lotion, Body Cream, Massage Cream, Nourishing Cream, Moisture Cream, Hand Cream, Essence, Nutrition Essence, Pack, Soap, Shampoo, Cleansing Foam, Cleansing Lotion, Cleansing Cream, Body Lotion, Body Cleanser, Treatment , Serum, milky lotion, press powder, loose powder, eye shadow, and the like.

According to another embodiment of the present invention, the composition comprising the natural product complex oil of the present invention can be used as a pain relief food composition. When the composition of the present invention is prepared as a food composition, it contains not only a natural oil complex oil such as a hardening oil as an active ingredient but also a component which is ordinarily added at the time of manufacturing a food. Examples thereof include protein, carbohydrate, fat, Seasoning and flavoring agents. Examples of the above-mentioned carbohydrates are monosaccharides such as glucose, fructose, and the like; Disaccharides such as maltose, sucrose, oligosaccharides and the like; And polysaccharides such as dextrin, cyclodextrin and the like, and sugar alcohols such as xylitol, sorbitol and erythritol. Natural flavors such as tau martin, stevia extract (e.g., rebaudioside A, glycyrrhizin, etc.) and synthetic flavors (saccharine, aspartame, etc.) can be used.

When the food composition of the present invention is prepared as a drink, it may further contain citric acid, liquid fructose, sugar, glucose, acetic acid, malic acid, juice, mulberry extract, jujube extract, licorice extract etc. in addition to the complex oil of the present invention .

Hereinafter, the present invention will be described in more detail with reference to Examples and Experimental Examples. It is to be understood by those skilled in the art that these embodiments are only for illustrating the present invention and that the scope of the present invention is not construed as being limited by these embodiments.

<Examples> Production of natural oil complex oil

Clean washing and drying of Aralia cordata, fir needle, upper limbs and by the peppermint prepared by each 2㎏ supercritical extractor was charged into the (renewed autoclave products) in supercritical fluid for two hours at 300bar, 50 ℃ carbon dioxide (CO ₂₎ And extracted from the supercritical state to produce a natural oil such as a fake oil. The yields of each oil were 0.31%, 0.24%, 3.05%, and 4.93%, respectively.

Each of the natural oils obtained above is mixed in an appropriate ratio to prepare a natural product complex oil. The ratio is 25% by weight of essential oil, 30% by weight of fir leaf oil, 25% by weight of peppermint oil and 20% .

&Lt; Comparative Example 1 &

Jojoba oil (100% purity) in a transparent liquid state was purchased from Healing Nature Co., Ltd. and used.

&Lt; Comparative Example 2 &

1: 1: 1: 1: 1: 1.6 in a weight ratio of 1: 1: 1: 1: 1: The extracts were heated at 150 ℃ for 2 hours, dried and then extracted with hot water.

&Lt; Preparation Example > Preparation of body cream

Body creams were prepared according to the composition of the following table in Table 1. First, the water phase and the oil phase were weighed and heated to 70 to 75 DEG C, respectively. The water phase was uniformly mixed using an emulsifier, and the oil phase was added to the oil phase. After the emulsification, the stabilizer was metered and administered. The speed of the emulsifier was reduced while stirring with an emulsifier, and the emulsion was cooled to 35 to 40 ° C. After the additives were weighed and dosed 4 times, the mixture was gradually stirred to distribute the additives evenly. The mixture was degassed under reduced pressure and aged at room temperature for about 3 days to prepare a body cream.

Body cream composition table Water (% by weight) Oil phase (% by weight) Compound oil   1.00 Compound oil  1.00 glycerin 10.00 Lanette O  2.00 Silicone derivative  0.20 Olive M 1000  1.00 Microcide-C  0.20 Tego care 450  2.00 EDTA-2Na  0.01 Puresyn 4  2.00 Keltrol F (1%)  5.00 TCG-M  8.00 Sepiplus 400  0.30 DC 200 / 6cs  2.50 TEA  0.10 Lipex Shea  1.00 Di water Remainder Vitamin E  0.50 D-P  0.10 BHT  0.02 TEA  0.10 Di Water  Remainder

<Experimental Example> Effectiveness test of natural oil complex oil

The efficacy of the compounded oils according to Examples of the present invention and Comparative Examples 1 and 2 was tested by VAS measurement. The visual analog scale (VAS) is a test method to determine the degree of pain in a patient. It records 10 points of no pain at one end with a line of 10cm length, records the most imaginable pain at the end of the other piece (10 points) . Patients should fill in the appropriate score for the pain they feel at the time of the measurement. Although this method can not compare one patient to another, it is a measurement that has the advantage of being able to pinpoint how the pain is changing for the same patient. The detailed conditions for testing other efficacy are as follows.

1. Selection criteria for subjects

 1) Target disease and indications: Attachment pain (Pain at the junction between the upper and lower limbs, upper and lower limbs,

 2) Selection criteria of subjects

① Men and women aged between 19 and 65

② Those who have the pain from the shoulder part, the shoulder part to the upper part,

     - sprain and torsion of the cervical vertebra / thoracic / shoulder joints [S134 / S233 / S434]

     - myofascial syndrome, neck / shoulder part / shoulder joint [M79180C / M79110 / M7911E]

     - Miscellaneous pains, neck / shoulder parts / shoulder joints / scapula [M79188C / M79118 / M79118E / M79118C]

     - Other pain, neck / neck thoracic spine [M5482 / M5483]

     - Thoracic pain, light thoracic / thoracic [M5463 / M5464]

③ A person with three or more points on visual analog scale

④ Those who are able to communicate with the researcher and follow the test compliance

⑤ Prior to participating in the test, he / she should be fully informed about the purpose of the examination, the contents of the test, the characteristics of the test product, etc. and voluntarily decided to participate in the human test and agreed in writing

 3) Exclusion criteria for subjects

① Those with major shoulder injury and history of surgery

② Those who have traumatic diseases (fracture, tendon rupture, muscle rupture, dislocation, subluxation)

③ patients with severe neurological symptoms, such as bone diseases (osteomyelitis, bone tumors, osteosarcoma, bone cancer), spinal and spinal diseases (cervical disc herniation, cervical discitis, cervical intervertebral stenosis neuromuscular)

④ Those who have internal medicine diseases (visceral pain, rheumatoid arthritis, panchost syndrome), kidney and liver diseases, hematopoietic diseases

⑤ Persons with previous history of symptoms of angina, myocardial infarction, acute infectious disease within 3 months

⑥ People who are exposed to the general taboo of hot springs in the following situations: those who have a temperature above 38 ℃, who complain of upper respiratory infection, sore throat, skin rash, drinking status, early and late pregnancy, active tuberculosis, Respiratory failure, acute stroke, hemorrhagic disease

⑦ Those who are taking medications that may affect clinical trials such as corticosteroids and anticonvulsants within the last week

⑧ Women who are pregnant or lactating and women who are pregnant

⑨ Those who participated in clinical trials of intervention and treatment within 3 months prior to commencement of clinical trial

⑩ Any person other than the above who is deemed difficult to perform the test at the discretion of the tester

 4) Number of target subjects: 15 subjects in the experimental group and 15 subjects in the control group (Placebo)

 2. Clinical Test Methods

 1) Outline of clinical trial

Prospective, double blind, randomization, single center clinical trials

② Registered subjects will have a total of 2 fragrance dry inhalation therapy and spa program at the institution every 2 ~ 4 days for 1 week.

 2) How to use products for clinical tests

The duration of the test per subject is 1 to 3 weeks in total. The subjects will be visited three to four times during the period of the trial. The test product will be administered in the order of aroma dry inhalation therapy and Vishwa Spa program water treatment.

① fragrance dry inhalation therapy

   Two drops of oil according to the examples and the comparative example are dropped on the gauze, and 5 breaths are performed in front of the subject's nose 5 cm. Then, the breath is first sucked through general suction for 5 minutes.

② Vishwa Spa Program

  It is possible to realize the treatment according to the characteristics of the person's body. When the set temperature is reached, the fumigation system automatically stops. When the temperature goes down again, the fumigation is automatically turned on. (Taiwan product name: Hydro Magic Spa Capsule 1005, see drawing 1).

 3. Clinical examination item and observation method

 1) Inspection items

① Subject Basic Information

   Record the gender and date of birth of the subject in Visit 1 and record basic information about the subject such as past history and drug dosage. At visits 2, 3 and 4, investigate the disease / illness and drug use after the last visit.

② Signs of vitality: After taking 5 minutes of stabilization, measure blood pressure and pulse every visit, then record. (If visits 1 and 2 are carried out on the same day, the same test value is used for visit 1.)

③ Confirmation of selection exclusion criteria: Visit 1 and confirm before random assignment.

④ Pregnancy test (only for pregnant women): It is performed at visit 1.

⑤ Scent dry inhalation therapy: It is carried out at visit 2, 3.

⑥ Implementation of Spa Program: Visit 2 or 3.

⑦ Assessment of Pain Level (VAS): Visits 1, 2 and 4.

 2) Inspection method

① Evaluation of pain (VAS)

   The subjects were asked to indicate the degree of pain felt by the subjects at visit 1, 2, and 4 directly on the 10 cm segment below, and measure their length. Clinical test The degree of pain improvement is evaluated by comparing the degree of pain before and after use of the product.

3) Clinical Trial Procedures

① Primary performance (visit 1)

   - Acquisition of written consent and screening test

  - demographic surveys, signs of vitality, history and previous drug dosing, pregnancy test

  - Evaluation of Pain (VAS)

② Secondary performance (visit 2, Baseline, simultaneous with 1st performance)

  - Assign random number and registration number

  - Measurement of signs of vitality

  - Evaluation of Pain (VAS)

  - Fragrance dry inhalation therapy enforcement

  - Spa program enforcement

③ Third performance (visit 3 or 4 days ± 2)

  - Measurement of signs of vitality

  - Fragrance dry inhalation therapy enforcement

  - Spa program enforcement

④ Fourth performance (visit 4, 6 days ± 3)

  - Measurement of signs of vitality

  - Evaluation of Pain (VAS)

 4. Evaluation and Interpretation

The VAS values measured at the baseline of visit 2 and the mixed crude oil of the test product example and the comparative example 1 jojoba oil and the herbal extract of the comparative example 2 were applied to the test subjects and the control group (Mean, standard deviation, median, minimum, and maximum values) for the variation of the VAS values measured in step 4 are presented.

The efficacy variable is the change in VAS for Visit 4 (6 days ± 3) versus Visit 2 (Baseline). Therefore, we use the Student't-test to compare the distribution of the variable values unless they deviate significantly from the normality assumption. If the normality assumption is not satisfied, use the Wilcoxon rank sum test.

In the first step, a corresponding sample t-test is conducted to test the significance of the changes in the VAS scores of visit 4 versus visit 2 for the test group (simple oil) and the control group (jojoba oil, herbal extract). At this time, if the test group and the control group show statistically significant pain reduction effect, the second step is carried out.

The second step is to compare the changes in the VAS scores of visit 4 versus visit 2, the primary efficacy variable between the test and control groups, using the Student't-test or the Wilcoxon rank sum test.

5. Validity Results

 1) VAS variation of visit 4 versus baseline 2

The validity test variable of this study is VAS variation of baseline (visit 2) and final evaluation time (visit 4), and the mean, standard deviation, minimum value, and maximum value of the VAS variation are presented. The validity was evaluated by analyzing the test group and the control group, and the results are shown in [Table 3].

In the comparison between the test group and the control group in the first visit 2 (baseline), there was no difference in the VAS data between these groups with P1 = 0.490 and P2 = 0.298. In each group, the changes in the test group showed the most significant decrease from 6.22 to 4.11 in the experimental group. In the control group 1, 4.23 to 3.35 and in the control group 2, the pain decreased significantly from 5.01 to 3.89.

Compared with the control group, the mean value of the VAS change before and after the test was -2.11 ± 0.19 in the test group, -0.88 ± 0.43 in the control group 1, and -1.12 ± 0.32 in the control group.

 VAS variation of visit 2 and visit 4 Test group Control 1 Control group 2 P1 P2 Average Standard Deviation Average Standard Deviation Average Standard Deviation Visit 2 6.22 1.17 4.23 1.02 5.01 1.20 0.490 0.298 Visit 4 4.11 1.32 3.35 1.36 3.89 1.45 0.225 0.192 Variation -2.11 0.19 -0.88 0.43 -1.12 0.32 0.072 0.059

* P1, P2: Students' t-test

 2) Conclusion

In the case of VAS, the subject's subjective pain was quantified and the pain was significantly reduced after the clinical trial compared to before the clinical trial. In the comparison between the VAS groups, the mean values of the mixed oils in the test group were -2.11 ± 0.19, -0.88 ± 0.43 in the control group 1, and -1.12 ± 0.32 in the control group.

Based on the validity evaluation, the test group showed the most significant effect as compared with the control group 1 and 2, and it was confirmed that there was a statistically significant change. As a result, the validity and stability It was possible to confirm.

It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the invention as defined in the following claims And changes may be made without departing from the spirit and scope of the invention. Many embodiments other than the above-described embodiments are within the scope of the claims of the present invention.

Claims (6)

25% by weight of essential oil, 30% by weight of fir leaf oil, 25% by weight of peppermint oil, and 20% by weight of topical oil as active ingredients,
Wherein the natural oil complex oil is extracted and mixed with supernatant extraction method using carbon dioxide (CO ₂ ) as a supercritical fluid from false leaves, fir leaves, peppermint leaves, and upper limbs.
delete The method according to claim 1,
The extraction is performed by setting the carbon dioxide flow rate at 50 g / min at 150 to 300 bar and then extracting it for 90 to 180 minutes, dissolving the obtained extract in a 70% alcohol as a solvent, and then filtering with a filter. Composition.
The method according to claim 1 or 3,
The composition may further comprise at least one of a fatty substance, an organic solvent, a solubilizing agent, a thickening and gelling agent, a softening agent, an antioxidant, a suspending agent, a stabilizer, a foaming agent, a fragrance, a surfactant, water, Wherein the composition further comprises at least one selected from a chelating agent, a chelating agent, a preservative, a vitamin, a blocking agent, a wetting agent, an essential oil, a dye, a pigment, a hydrophilic or lipophilic active agent, and a lipid vesicle.
5. The method of claim 4,
Wherein the natural oil complex oil comprises 0.5 to 3.0% by weight based on the total weight of the natural composition.
A pain relieving composition comprising the natural oil complex oil according to any one of claims 1 to 3 as an active ingredient.

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