KR0148462B1 - Preparation process of brainactivating soft capsule - Google Patents

Preparation process of brainactivating soft capsule Download PDF

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KR0148462B1
KR0148462B1 KR1019950000587A KR19950000587A KR0148462B1 KR 0148462 B1 KR0148462 B1 KR 0148462B1 KR 1019950000587 A KR1019950000587 A KR 1019950000587A KR 19950000587 A KR19950000587 A KR 19950000587A KR 0148462 B1 KR0148462 B1 KR 0148462B1
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dha
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최진호
김정문
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김정문
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    • A61K36/185Magnoliopsida (dicotyledons)
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Abstract

최근들어 수험생의 학습효과 증진 및 알쯔하니머형(Alzheimer-type)노인성 치매의 예방 등 두뇌의 활성화에 대한 문제가 심각하게 대두되고 있는 실정이다.Recently, the problems of brain activation, such as improving the learning effect of the examinee and prevention of Alzheimer-type dementia, have emerged seriously.

따라서 혈액중의 저밀도리포단백(LDL)-콜레스테롤의 억제와 동맥경화지수를 감소시킬 수 있을 뿐만 아니라, 본 발명제품의 주원료로 사용되는 디에이치에이(DHA)와 대두 레시틴은 두뇌의 주요 구성성분으로서, 그리고 여러가지 두뇌를 활성화시키는 성분으로 알려져 있으며, 또한 알로에(Aloe vera)의 동물실험결과, 두뇌 활성화에 대한 효과가 인정되기 때문에 이들 알로에와 디에이치에이 성분의 두뇌 활성화를 위한 상승효과를 촉진하고 두뇌를 활성화하기 위해 본 발명의 두뇌활성제 연질캡슐을 제조하는 방법에 관한 것이다.Therefore, in addition to suppressing LDL-cholesterol in the blood and reducing arteriosclerosis index, DHA and soy lecithin, which are used as main ingredients of the present invention, are the main components of the brain. And Aloe vera's animal experiments have been shown to be effective in activating the brain, thus promoting the synergistic effects of these Aloe and D. It relates to a method for producing a soft activator soft capsule of the present invention to activate the.

본 발명품의 주원료는 알로에(Aloe vera)의 동결건조 분말과 등푸른 생선에서 추출, 정제한 고순도의 디에이치에이(DHA) 함유 어유를 혼합, 균질화한다.The main ingredient of the present invention is to mix and homogenize aloe vera freeze-dried powder and high purity DHA-containing fish oil extracted and purified from blue fish.

다음으로 여기에 대두 레시틴을 부원료로 첨가하고, 다시 천연 항산화제로서 토코페롤과 영양 강화제로서 아스코르빈산, 그리고 뇌의 에너지로서만 사용되는 포도당과 뇌의 신경세포인 아세틸콜린을 보충하는 티로신을 첨가하여 혼합, 균질화하여 식용유와 왁스 등을 배합비율에 따라 혼합, 균질화하여 조제, 성형화하여 제조된 것으로 학습능력 증진과 노인성 치매의 예방 및 개선제로 사용되는 두뇌활성제 연질캡슐의 제조방법이다.Next, soybean lecithin is added as a subsidiary ingredient, followed by tocopherol as a natural antioxidant, ascorbic acid as a nutrition enhancer, and tyrosine, which is supplemented with glucose used only as brain energy and acetylcholine, a neuron in the brain. It is prepared by mixing, homogenizing, mixing and homogenizing cooking oil and wax according to the mixing ratio. It is a manufacturing method of the brain active agent soft capsule, which is used as an improvement in learning ability and prevention and improvement of senile dementia.

Description

두뇌활성제 연질캡슐의 제조방법Preparation method of brain activator soft capsule

본 발명은 천연생약 및 건강식품으로서 난치성 질병의 예방 및 개선효과가 탁월한 것으로 알려진 알로에(Aloe vera)의 유효 약리성분을 동결, 건조하여 얻은 분말제품에 수산식품의 주요 지방산 성분의 하나로서 뇌보조성분으로 알려지고 있는 디에이치에이(docosahexaenoic acid: DHA)를 주원료로 하고, 식물성분중의 뇌보조성분으로 알려진 레시틴(lecithin) 및 천연 항산화제로서 토코페롤과 아스코르빈산을 첨가, 혼합한다.The present invention is a brain supplement component as one of the main fatty acid components of aquatic foods in powder products obtained by freezing and drying the effective pharmacological ingredients of Aloe vera, which are known to be excellent in preventing and improving intractable diseases as natural herbal medicines and health foods. The main raw material is known as docosahexaenoic acid (DHA), and tocopherol and ascorbic acid are added and mixed as lecithin and natural antioxidant, which are known as brain aids in plant components.

그리고, 다시 여기에 뇌의 에너지원인 포도당과 뇌신경성분인 아세틸 콜린을 보충하는 티로신(tyrosine)을 첨가하여 성형제로서 식용유와 왁스 등을 사용하여 두뇌의 활성화를 위한 건강 보조식품으로서 두뇌 활성제 연질캡슐의 제조방법에 관한 것이다.In addition, tyrosine, which supplements glucose and acetylcholine, which are brain energy sources, is added to it, and oil-activated soft capsules of brain activator as a health supplement for brain activation using cooking oil and wax as a molding agent. It relates to a manufacturing method.

최근 경제성장과 더불어 산업화, 공업화에 따른 환경파괴와 수질오염, 그리고 인스탄트 식품의 범람으로 우리의 건강상태가 심각한 위협을 받고 있다.With the recent economic growth, environmental damage, water pollution, and flooding of instant foods caused by industrialization and industrialization have severely threatened our health.

특히, 우리의 소득증대에 따른 육식중심에 의한 영양의 과잉섭취와 기계문명의 발달에 의한 운동량의 절대부족 등이 비만을 촉진할 뿐만 아니라, 비만이 원인이 되어 동맥경화, 고혈압, 관상심장질환, 심근경색, 협심증, 뇌졸중 등의 만성 퇴행성의 성인병이 만연되고 있는 실정이다. 또한 노인들의 알츠하이머형(Alzheimer-type) 치매증 환자도 해마다 증가하고 있는 실정이다. 그밖에도 어린 학생들이 지나친 수험공부로 두뇌의 건전한 발달에도 심각한 문제로 대두되고 있다.In particular, the excessive intake of nutrition due to the increase of our income and the absolute lack of exercise due to the development of mechanical civilization not only promote obesity, but also contribute to arteriosclerosis, hypertension, coronary heart disease, Chronic degenerative adult diseases such as myocardial infarction, angina pectoris and stroke are prevalent. In addition, elderly Alzheimer-type dementia patients are increasing year by year. In addition, too many young students are taking seriously the serious development of the brain due to excessive study.

따라서 학습능률을 향상하고 두뇌활동을 촉진하여 노인성 치매를 예방하고 개선할 수 있는 두뇌의 활성제로서 연질 캡슐을 발명하는데 그 목적이 있다.Therefore, the purpose of the invention is to invent a soft capsule as an active agent of the brain that can prevent and improve dementia of the elderly by improving learning efficiency and promoting brain activity.

알로에(Aloe vera)는 소화기 궤양, 난치성 피부염, 순환기 장애, 류머티스 관절염, 간장 질환, 신장ㆍ비뇨기 염증, 호흡기 질환, 당뇨병, 빈혈 등의 예방 및 치료효과가 탁월하여 건강생약으로 많은 각광을 받고 있을 뿐만 아니라 많은 임상관련 연구결과가 속속 밝혀지고 있다.Aloe vera has received much attention as a health medicine because of its excellent preventive and therapeutic effects such as digestive ulcers, intractable dermatitis, circulatory disorders, rheumatoid arthritis, liver disease, kidney and urinary inflammation, respiratory diseases, diabetes, and anemia. However, many clinical studies are being discovered one after another.

한편, 등푸른 생선중에서 다량 함유되어 있는 디에이치에이(DHA)가 최근 머리를 좋게 한다고 하여 세계적인 화제가 되고 있으며, 또한 많은 연구가 진행되고 있다. 일본의 스즈끼 박사는 그의 논문 노화와 DHA에서 DHA는 미로법에 의한 기억 학습능력 시험을 통해 디에이치에이는 학습능률을 향상하고 뇌의 기능을 조절하는 능력을 갖고 있으며, 또한 알츠하이머형(Alzheimer-type)치매의 방지에 효과적이라고 보고했다. 이 저자의 연구에서도 두뇌의 중요 구성 지방산은 디에이치에이(DHA)라는 사실을 확인했다.On the other hand, DHA, which is contained in a large amount of blue fish, has recently become a global topic because of its good hair, and many studies have been conducted. Dr. Suzuki of Japan, in his dissertation aging and DHA in the DHA, through the maze test of memory learning ability, DH has the ability to improve learning efficiency and control brain function, and also Alzheimer-type Reported effective in preventing dementia. The author's research also confirmed that the major fatty acid in the brain is DHA.

따라서 본 발명에서는 이미 효과가 과학적으로 입증된 알로에(Aloe vera)의 유효성분의 동결건조분말과 어유중의 디에이치에이(DHA)를 주원료로 하고, 여기에 두류에서 분리한 레시틴(lecithin)과 천연 항상화제로서 토코페롤 및 아스코르빈산 등을 첨가하였다.Therefore, in the present invention, the main ingredients are lyophilized powder of Aloe vera, which has been scientifically proven, and DHA in fish oil, and lecithin and natural separated from legumes. Tocopherol, ascorbic acid, and the like were added as an antioxidant.

다시 여기에 뇌의 영양으로 이용되는 포도당과 뇌의 신경전달성분인 아세틸콜린(acetylcholine)의 기능을 보충하는 아미노산 성분으로서 티로신(tyrosine)을 첨가하여 혼합, 균질화하였다. 이것을 연질캡슐의 성형제로서 식용유와 왁스 등을 사용하여 두뇌 활성제 연질캡슐을 발명하였다.Again, the mixture was homogenized by adding tyrosine as an amino acid component that supplements the function of glucose and acetylcholine, which are neurotransmitters of the brain, to be used for nutrition of the brain. Brain activator soft capsule was invented using cooking oil, wax, etc. as a molding agent of soft capsule.

두뇌 활성제로서 연질캡슐의 제품 안정성에 대한 저장시험은 의약품의 안정성검사에 사용하는 안정성 시험법을 원용하여 40℃(±1℃), 75%RH(±5%RH)에서 3개월 간 제품의 성상, 성분변화 및 관능검사 등을 통해 분석, 평가하였다.The storage test for the product stability of soft capsules as a brain activator is based on the stability test method used to test the stability of medicines. The characteristics of the product for 3 months at 40 ° C (± 1 ° C) and 75% RH (± 5% RH) And component changes and sensory tests.

본 발명제품으로 동물시험의 재료와 그 실험방법, 그리고 실험결과는 다음과 같다.The material of the animal test, the test method, and the test result of the present invention are as follows.

I. 실험재료I. Experimental Materials

1. 동물실험1. Animal Experiment

본 실험에 사용한 실험동물은 스프래규 도우리산(Sprague Dawley : SD) 웅성 랫트를 한국화학연구소에서 구입하여 2주일간 예비사육한 다음, 체중 90±10g의 랫트를 선별하여 각 그룹당 10마리씩으로 하여 7주동안 동물실험을 하였다.The experimental animals used for this experiment were Sprague Dawley (SD) male rats purchased from the Korea Research Institute of Chemistry and pre- bred for 2 weeks, and then rats weighing 90 ± 10 g were weighed 10 rats per group for 7 weeks. Animal experiments were conducted.

이때 동물실의 사육조건은 온도(22±2℃), 습도(65±3%RH)가 자동조절되는 동물 사육실에서 혈액중의 콜레스토롤과 저밀도리포단백(LDL)-콜레스토롤의 함량 및 동맥경화지수에 미치는 알로에 및 디에이치에이(DHA)의 상승효과를 평가하였다.At this time, the conditions of breeding in the animal room were the content of cholesterol and low density lipoprotein (LDL) -cholesterol in the blood in the animal breeding room where temperature (22 ± 2 ℃) and humidity (65 ± 3% RH) are automatically controlled. The synergistic effects of Aloe and DHA on atherosclerosis were evaluated.

그리고 두뇌활성의 간접적인 평가방법으로서 활성산소종인 프리 라디칼에 의해 생성되는 과산화지질에 의한 신경관련세포의 기능적 손상 및 활성산소의 제거효소의 활성에 미치는 알로에 및 디에이치에이(DHA)의 상승효과를 비교, 평가하였다.And as an indirect assessment of brain activity, the synergistic effects of Aloe and DHA on the functional damage of neuronal cells and the activity of free radical scavenging enzymes caused by lipid peroxide produced by free radicals, a free radical species, Compare and evaluate.

2. 사용시약2. Reagent

본 발명제품개발에 사용할 알로에(Aloe vera)제품은 김정문 알로에 (주)에서 할애받은 동결건조 분말을 사용하였고, 혈액중의 활성산소종(reactive oxygen species : ROS)으로서 프리 라디칼에 의해 생성되는 과산화지질의 생성에 사용할 시약 및 프리 라디칼의 제거효소로서 수퍼옥시드 디스무타아제(SOD)의 활성 측정에 사용할 효소는 모두 시그마제 특급 시약을 사용하였으며, 그 밖의 관련시약도 모두 특급시약을 사용하였다.The aloe vera product used in the development of the present invention uses a freeze-dried powder devoted by Kim Jung Moon Aloe Co., Ltd., and lipid peroxide produced by free radicals as reactive oxygen species (ROS) in the blood. The reagent to be used for the production and the enzyme to be used for the determination of the activity of superoxide dismutase (SOD) as free radical scavenging enzyme were used as the sigma-express reagent, and all other related reagents were used as the special reagent.

II. 실험방법II. Experiment method

1. 실험사료의 조제1. Preparation of experimental feed

본 실험에 사용한 동물사료는 탄수화물로서 콘스타치(corn starch) 44.0%와 설탕 13.3%로서 전부 57.3%로 하였고, 단백질로서는카제인(casein) 18.0%, 지질로서는 돼지기름(lard)을 16.0%가 되도록 첨가하였으며, 그 밖에 셀루로오스 3.0%, 무기질과 비타민은 미국 에이아이엔(AIN)의 동물실험용 제품을 각각 1.0%와 3.5%가 되도록 첨가하였고, DL-메티오닌 0.3%, 콜린클로라이드(choline chloride) 0.2%도 첨가, 조제하여 사용하였다.Animal feed used in this experiment was 44.0% of corn starch and 13.3% of carbohydrate, 57.3% of total carbohydrate, 18.0% of casein for protein, and 16.0% of lard for lipid. In addition, cellulose (3.0%), minerals and vitamins were added to 1.0% and 3.5% of AIN's animal test products, respectively, DL-methionine 0.3% and choline chloride 0.2% It was added and prepared and used.

또한, 콜레스테롤의 억제효과를 규명하기 위하여 실험사료에 콜레스테롤 0.5%와 소디움콜레이트(Na-cholate) 0.2%을 첨가하여 고콜레스테롤혈증을 유도하였다. 그리고, 알로에 1.0% 첨가군은 탄수화물중의 콘스탄치의 양을 1.0%줄이고, 디에이치에이(DHA) 3.0% 첨가군은 지질중의 돼지기름(lard)을 3.0% 줄이며, 알로에+디에이치에이(Aloe+DHA)첨가군은 알로에 1.0%와 디에이치에이 3.0%를 각각 줄여서 조제사료를 제조하였다.In addition, hypercholesterolemia was induced by adding 0.5% cholesterol and 0.2% sodium cholate (Na-cholate) to the experimental feed to investigate the inhibitory effect of cholesterol. In addition, the 1.0% aloe group reduced the amount of constant in carbohydrates by 1.0%, and the 3.0% group of DHA reduced 3.0% of the lipid in pig fat (lard). The Aloe + DHA) group prepared a diet by reducing 1.0% of aloe and 3.0% of aH.

2.효과검정을 위한 동물실험2. Animal testing for effect test

아무것도 첨가하지 않는 대조군, 알로에 1.0% 첨가군, 디에이치에이(DHA) 3.0% 첨가군, 그리고 알로에와 디에이치에이 혼합(1.0%+3.0%) 첨가군의 조제사료를 매일 평량으로 하여 자유 섭식시키고 물론 자유로이 섭취시켰다.Free-feeding the prepared foods of the control group which added nothing, the aloe 1.0% group, the DHA 3.0% group, and the aloe and DH mixed (1.0% + 3.0%) group as a basis weight daily Of course it was taken freely.

매일 오후 5시 30분에 체중과 전일 평량하여 투여한 조제사료의 잔량을 측정하여 매일의 사료 섭취량을 계산하였다.Daily feed intake was calculated by measuring the weight of the formula and the amount of the rations administered at 5:30 pm every day and the basis weight.

3.콜레스테롤 함량의 측정3. Measurement of cholesterol content

총 콜레스테롤의 함량은 Rudel등(1973)의 방법에 따라 오르토-프탈알데히드(o-phthaladehyde)법으로 측정하여 표준 검량선에 의하여 혈청중의 총콜레스테롤의 함량을 측정하였다. 그리고 저밀도리포단백(LDL)-콜레스테롤의 함량은 노마(Noma)등(1978)의 방법에 따라 다음과 같이 측정하였다.The total cholesterol content was measured by the ortho-phthaladehyde method according to the method of Rudel et al. (1973) and the total cholesterol content in serum was measured by a standard calibration curve. And the content of low density lipoprotein (LDL) -cholesterol was measured according to the method of Noma (Noma et al. (1978)) as follows.

① HDL+LDL-콜레스테롤의 측정 : 혈청 100㎕을 시험관에 넣고 소디움 헤파린/소디움 클로라이드 시약(sodium heparin/sodium chloride : 150㎎+4g/1000㎖ DW) 4.0㎖을 첨가하여 혼합하여 실온에서 15분간 방치한 다음 이 시험관에 다시 암버라이트(Amberlite) IRA-400을 0.5g씩 놓고 혼합하여 10분간 방치한다.① Measurement of HDL + LDL-cholesterol: 100 μl of serum is added to the test tube and 4.0 ml of sodium heparin / sodium chloride (150 mg + 4 g / 1000 ml DW) is added to the mixture and left to stand at room temperature for 15 minutes. Then, add 0.5 g of Amberlite IRA-400 to the test tube, mix and leave for 10 minutes.

10분이 지난 후 700xg에서 10분간 원심분리시켜 상징액을 2㎖씩 새로운 시험관에 옮긴 다음 2.0M 피시에이(PCA) 용액을 2.0㎖씩 첨가, 혼합한 다음, 다시 700xg에서 15분간 원심분리한다.After 10 minutes, centrifuge at 700xg for 10 minutes, transfer 2 ml of the supernatant to a new test tube, add 2.0 ml of 2.0 M fish (PCA) solution, mix, and then centrifuge at 700xg for 15 minutes.

② HDL-콜레스테롤의 측정 : 혈정 100㎕을 시험관에 넣고 소디움 헤파린/칼슘 클로라이드/닉켈 클로라이드 시약(sodium heparin/chlcium chloride/sodium heparin/calcium chloride/nickel chloride : 300㎎+60mM+2.0mM/1000㎕DW) 4.0㎕을 첨가, 혼합하여 실온에서 30분간 방치한 다음, 700xg에서 15분간 원심분리시킨다.② Measurement of HDL-cholesterol: 100 μl of blood serum is placed in a test tube, sodium heparin / calcium chloride / nickel chloride reagent (sodium heparin / chlcium chloride / sodium heparin / calcium chloride / nickel chloride: 300mg + 60mM + 2.0mM / 1000μlDW) ) 4.0 µl is added, mixed and allowed to stand at room temperature for 30 minutes, followed by centrifugation at 700xg for 15 minutes.

이때 얻어진 상징액 2.0㎖씩을 새로운 시험관에 옮긴 다음 여기에 2.0M PCA용액 2.0㎖씩을 첨가, 혼합하여 다시 700xg에서 15분간 원심분리한다.Transfer 2.0 ml of the supernatant obtained at this time to a new test tube, add 2.0 ml of 2.0 M PCA solution to each test tube, and mix and centrifuge again at 700xg for 15 minutes.

③ LDL-콜레스테롤의 결정 : 위①②에서 전처리한 두 가지를 원심분리한 다음, 상징액은 버리고 잔사에 발색시약(50g of sulfosalicylic acid/1000㎖ of acetic acid/acetic acid anhydride/C-sulfuric acid=35/65/10) 2.0㎖씩을 첨가, 혼합하여 실온에서 10분간 방치한 다음, 스펙트로포토메터의 625nm에서 흡광도를 측정, 표준 검량선에 의해 정량하여 계산에 의하여 LDL-콜레스테롤을 정량하였다.③ Determination of LDL-cholesterol: Centrifuge the two pretreated in the above ①②, discard the supernatant and color the reagent (50g of sulfosalicylic acid / 1000mL of acetic acid / acetic acid anhydride / C-sulfuric acid = 35 /). 65/10) 2.0 ml each was added and mixed, and the mixture was left at room temperature for 10 minutes, and then absorbance was measured at 625 nm of the spectrophotometer. The LDL-cholesterol was quantified by quantification using a standard calibration curve.

4. 동맥경화지수의 계산4. Calculation of arteriosclerosis index

성인병의 초기증상으로 알려진 동맥경화중의 발병지표로서 널리 활용되고 있는 동맥경화지수(atherogeinc index:AI)는 Haglund등(1991)의 방법에 따라 총콜레스테롤에서 고밀도리포단백(HDL)-콜레스테롤을 뺀 다음, 다시 HDL-콜레스테롤로 나눈 값으로 계산하였다.The atherosclerosis index (AI), which is widely used as an index of atherosclerosis, known as an early symptom of adult disease, was obtained by subtracting HDL-cholesterol from total cholesterol in accordance with the method of Haglund et al. (1991). Again, it was calculated by dividing by HDL-cholesterol.

5. 과산화지질의 함량 및 에스오디(SOD)활성측정5. Determination of lipid peroxide content and SOD activity

혈청중에서 생성된 과산화지질(malondialdehyde:MDA)의 함량은 Yagi(1987)의 방법에 따라 형광광도계로써 532nm 에서 측정하여 표준 검량선에 의해 말론디알데히드(MDA)의 생성량을 측정하였다.The content of malondialdehyde (MDA) produced in serum was measured at 532 nm with a fluorophotometer according to the method of Yagi (1987), and the amount of malondialdehyde (MDA) was measured by a standard calibration curve.

그리고 뇌를 비롯한 장기의 생리적 기능저하와 성인병의 발병 및 세포활성의 손상, 그리고 생체노화의 중요한 지표로 널리 사용되고 과산화지질의 함량은 혈청을 사용하여 발명자의 방법에 따라 측정하였다. 20%초산, 8.1%에스디에스(SDS) 및 1.2%티비에이(TBA:pH3.5)를 사용하여 532nm에서 스펙트로포토메터로써 측정한다.In addition, it is widely used as an important indicator of physiological impairment of the organs including the brain, the development of geriatric disease, damage to cellular activity, and bioaging, and the content of lipid peroxide was measured according to the inventor's method using serum. Measured with spectrophotometer at 532 nm using 20% acetic acid, 8.1% SDS and 1.2% TV (TBA: pH3.5).

또한 활성산소종의 제거효소중에서 가장 중요한 수퍼옥시드 디스무타아제(superoxide dismurase:SOD) 활성의 측정은 Oyanagui(1984)의 방법에 따라 정량하였다.In addition, the measurement of superoxide dismurase (SOD) activity, which is the most important among the reactive oxygen species removal enzymes, was quantified according to the method of Oyanagui (1984).

혈청을 인산칼륨 완충액으로서 100배 희석하여, 그중의 100㎕을 시험관에 넣고, 여기에 증류수 500㎕, 시약 A(3mM hydroxylamine/3mM hypoxanthine) 200㎕과 시약 B(7.5mU/㎖ xanthine oxidase with 0.1mM EDTA-2Na) 200㎖를 넣어 볼텍스에서 잘 혼합한 다음, 수조상(37℃)에서 40분간 정치한다.The serum was diluted 100-fold as potassium phosphate buffer, and 100 μl of this was placed in a test tube, where 500 μl of distilled water, 200 μl of reagent A (3 mM hydroxylamine / 3 mM hypoxanthine) and reagent B (7.5 mU / ml xanthine oxidase with 0.1 mM). 200 ml of EDTA-2Na) was added, mixed well in a vortex, and then left in a water bath (37 ° C.) for 40 minutes.

이 반응액에 다시 반응액, 시약 C(300㎎ of sulfanilic acid/5.0㎎ of N-1-naphthyle-thylenediamine in 500㎖ of 16.7% acetic acid) 2.0㎖을 넣어 잘 혼합하여 실온에서 20분동안 정치한 다음, 분광광도계의 550nm에서 흡광도를 측정하여 표준검량선에 의거 혈청중의 수퍼옥시드 디스무타아제(SOD)활성을 측정하였다.To this reaction solution was added reaction solution, 2.0 ml of Reagent C (300 mg of sulfanilic acid / 5.0 mg of N-1-naphthyle-thylenediamine in 500 ml of 16.7% acetic acid), and the mixture was mixed well and allowed to stand at room temperature for 20 minutes. Next, the absorbance was measured at 550 nm of the spectrophotometer, and the superoxide dismutase (SOD) activity in serum was measured according to a standard calibration curve.

III.실험결과III.Experimental Results

첫째로, 성인병의 예방 및 개선효과를 설명하면 다음과 같다.First, the prevention and improvement effect of the adult disease is described as follows.

성인병의 발병인자로 알려진 혈액중의 총 콜레스테롤 저밀도리포단백(LDL)-콜레스테롤의 함량, 그리고 동맥경화중의 발병지표로서 사용되는 동맥경화지수(atherogenic index)를 비교하여 보면 표 1과 같다.Table 1 shows a comparison of the total cholesterol low density lipoprotein (LDL) -cholesterol content in the blood, which is known to be a cause of adult disease, and the atherosclerotic index used as an index of development during atherosclerosis.

혈청중의 총 콜레스테롤의 함량을 비교하여 보면 대조군(100%) 대비 알로에 1.0% 첨가군은 82.5%, 디에이치에이 3.0% 첨가군은 71.9%인데 반해 알로에와 디에이치에이 혼합(1.0%+3.0%) 첨가군은 69.5%로서 현저한 상승효과가 인정되었다.Compared with the total cholesterol content in serum, 82.5% added Aloe 1.0% and 71.9% added DH 3.0% compared to the control group (100%), while aloe and DC mixed (1.0% + 3.0%). ), The addition group was 69.5%, a significant synergistic effect was recognized.

특히, 성인병의 발병지표로서 널리 사용되고 있는 혈액중의 LDL-콜레스테롤의 함량을 비교하여 보면 대조군 대비(100%) 알로에 1.0% 첨가군이 83.0%, 디에이치에이 3.0% 첨가군이 66.8%인데 반해 알로에와 디에이치에이(DHA) 혼합(1.0%+3.0%) 첨가군이 60.5%로서 현저한 상승효과가 인정되었다.In particular, comparing the content of LDL-cholesterol in the blood, which is widely used as an indicator of the development of adult diseases, compared to the control group (100%), aloe 1.0% added group was 83.0% and DH 3.0% added group was 66.8%. A significant synergistic effect was recognized as 60.5% in the group containing WHA mixed (1.0% + 3.0%).

또한 동맥경화증의 발병지표로 사용되는 동맥경화지수를 비교하여 보면 대조군(100%) 대비 알로에 1.0% 첨가군이70.3%, 디에이치에이 3.0%, 첨가군이 65.9%인데 비해 알로에와 디에이치에이 혼합(1.0%+3.0%) 첨가군이 63.4%로서 약간의 상승효과가 나타났다.In addition, when comparing the atherosclerosis index used as an indicator of atherosclerosis, the mixture of aloe and DH was mixed compared to the control group (100%), compared with 70.3%, 3.0%, and 65.9%, respectively. The addition group (1.0% + 3.0%) was 63.4%, showing a slight synergistic effect.

이상의 실험결과를 종합해 볼때 알로에(Aloe vera)나 디에이치에이(DHA) 단독 투여 보다 알로에와 디에이치에이를 혼합하여 투여하는 것이 성인병의 예방 및 개선효과가 뛰어나다는 것을 알 수가 있다.In conclusion, it can be seen that a combination of Aloe and DH is more effective in preventing and improving adult diseases than Aloe vera or DHA alone.

둘째로, 신경세포의 손상 및 방어효소의 활성에 대해 설명하면 다음과 같다.Second, the nerve cell damage and defense enzyme activity is described as follows.

뇌신경세포를 포함한 각 장기의 조직세포의 기능적 손상에 직접 관계하는 것으로 알려진 활성산소종(ROS)으로서 강력한 프리 라디칼(free radical)에 의해 생성되는 것으로 알려진 혈청중의 과산화지질로서 말론디알데히드(MDA)의 함량변화 및 이들 프리 라디칼의 제거효소중에서 가장 강력한 수퍼옥시드 디스무타아제(SOD)의 활성을 비교하여 보면 표2와 같다.Malondialdehyde (MDA) as a lipid peroxide in serum known to be produced by strong free radicals, which is known to be directly involved in the functional damage of tissue cells of each organ including brain nerve cells. Table 2 shows a comparison of the content of and the activity of the most powerful superoxide dismutase (SOD) among the free radical scavenging enzymes.

신경조직등의 세포의 기능적 손상에 영향을 미칠 것으로 예측되는 강력한 프리 라디칼에 의해 생성되는 과산화지질로서 말론디알데히드(malondialdehyde:MDA)의 생성 및 이들 프리 라디칼의 제거효소로서 수퍼옥시드 디스무타아제(superoxide dismutase : SOA)의 활성에 미치는 알로에(1.0%) 및 디에이치에이(3.0%), 그리고 이들 혼합물(1.0+3.0%)의 첨가효과를 비교하여 보면 표2와 같다.Production of malondialdehyde (MDA) as a lipid peroxide produced by strong free radicals predicted to affect functional damage of cells such as neural tissues, and superoxide dismutase as an enzyme for removing these free radicals. The effects of aloe (1.0%) and DH (3.0%), and mixtures (1.0 + 3.0%) on the activity of superoxide dismutase (SOA) are shown in Table 2.

말론디알데히드의 생성에 미치는 영향을 보면 알로에나 디에이치에이를 전연 첨가하지 않은 대조군(100%) 대비 알로에 1.0% 첨가군은 93.3%, 디에이치에이 3.0% 첨가군은 89.4%인데 반해 알로에와 디에이치에이 혼합(1.0%+3.0%) 첨가군은 84.4%나 현저히 과산화지질(MDA)의 생성을 억제함을 알 수 있었다.The effect on the production of malondialdehyde was 93.3% for Aloe 1.0% and 89.4% for DM 3.0%, compared to the control group (100%) without Aloe or DC. It was found that the addition of HA (1.0% + 3.0%) significantly inhibited the production of lipid peroxide (MDA) by 84.4%.

또한 이들 프리 라디칼의 제거효소로서 수퍼옥시드 디스무타아제(SOD)의 활성은 대조군(100%) 대비 알로에 1.0% 첨가군은 105.2%, 디에이치에이 3.0% 첨가군은 114.6%인데 반해 알로에와 디에이치에이 혼합(1.0%+3.0%) 첨가군은 121.9%로서 알로에나 디에이치에이(DHA) 단독 투여보다 상승적으로 수퍼 옥시드 디스무타아제(SOD)의 활성을 효과적으로 증가함을 알 수 있었다.In addition, the activity of superoxide dismutase (SOD) as a free radical scavenger was 105.2% in the group added with 1.0% aloe and 114.6% in the group added 3.0% compared to the control group (100%), while Aloe and D. The group of H (1.0% + 3.0%) added was 121.9%, which showed synergistically increasing the activity of superoxide dismutase (SOD) synergistically compared to the administration of Aloe or DHA alone.

따라서 알로에와 디에이치에이 혼합물(1.0%+3.05)로서 알로하(Aloha)의 투여가 알로에나 디에이치에이 단독투여보다 효과적으로 신경세포의 손상을 가져오는 프리 라디칼에 의해 생성되는 과산화지질(malondialdehyde:MDA)의 생성을 효과적으로 억제할 뿐만 아니라 이들 유독한 프리 라디칼의 방어효소인 수퍼옥시드 디스무타아제(superoxide dismutase:SOD)의 활성을 효과적으로 증가시키게 된다.Therefore, the administration of Aloha as a mixture of Aloe and DH (1.0% + 3.05) results in malondialdehyde (MDA) produced by free radicals that cause neuronal damage more effectively than Aloe or DH alone. In addition to effectively inhibiting the production of superoxide dismutase (SOD), the protective enzyme of these toxic free radicals effectively increases.

이상의 결과를 종합해 볼 때 알로에(Aloe vera)와 디에이치에이(DHA)를 1:3으로 혼합하여 만든 본 발명제품인 연질캐슐은 총 콜레스테롤 및 저밀도리포단백(LDL)-콜레스테롤의 함량을 효과적으로 억제하여 동맥경화지수를 효과적으로 감소함으로써 성인병의 예방과 개선효과가 뚜렷할 것이다.In summary, the soft carcass of the present invention made by mixing Aloe vera and DHA in 1: 3 effectively suppresses total cholesterol and low density lipoprotein (LDL) -cholesterol content. By effectively reducing the arteriosclerosis index, the prevention and improvement of adult disease will be evident.

또한, 뇌 등의 조직세포에 혈루를 촉진하고 세포독성인 프리라디칼의 생성억제에 효과적일 뿐만아니라, 세포독성물질인 프리 라디칼의 제거효소의 활성을 효과적으로 촉진함으로써 두뇌의 활동을 활성화시킬수가 있다.In addition, it is effective in promoting blood flow to tissue cells such as the brain and inhibiting the production of cytotoxic free radicals, and effectively activating the activity of the free radical scavenger, a cytotoxic substance.

세째로, 두뇌활성제 시제품의 안정성 시험은 다음과 같이 실시한다.Third, the stability test of the brain activator prototype is performed as follows.

A.두뇌활성제 시제품의 제조A. Preparation of Brain Activator Prototype

본 발명제품으로서 시제품은 상기의 동물실험의 결과에서 입증된 알로에(Aloe vera)와 디에이치에이(DHA)의 구성비율(1:3)을 기초로 하여 실험동물에 투여한 양을 사람의 양으로 환산하여 조제하였다.As a prototype of the present invention, the amount administered to a test animal based on the composition ratio (1: 3) of Aloe vera and DHA (DHA), which is proved in the results of the above animal experiment, is determined by the human amount. It prepared in conversion.

두뇌활성제 시제품은 이미 효과가 과학적으로 입증된 알로에(Aloe vera)의 유효성분의 동결건조 분말 8.0중량부와 어유(魚油)중에서 분리한 고순도의 디에이치에이(DHA:31/0%이하) 24.0 중량부를 주성분으로 하고, 여기에 뇌보조성분으로 밝혀진 두류(豆類)에서 분리한 레시틴(iecithin) 1.0 중량부, 그리고 천연 항상화제로서 토코페롤 1.0 중량부 및 아스코르빈산 0.5 중량부를 첨가, 혼합하였다.Brain Activator Prototype is 8.0 parts by weight of lyophilized powder of Aloe vera, which has been scientifically proven effective, and 24.0 parts by weight of high purity DHA isolated from fish oil (DHA: 31/0% or less). As a main component, 1.0 parts by weight of lecithin (iecithin) isolated from a soybean found as a brain aid component, and 1.0 parts by weight of tocopherol and 0.5 parts by weight of ascorbic acid were added and mixed as a natural homeostatic agent.

여기에 뇌의 에너지로서만 이용되는 포도당(glucose) 8.0중량부와 뇌의 신경전달성분인 아세틸 콜린(acetylcholine)의 기능을 보충하는 것으로 알려진 아미노산 성분으로서 티로신(tyrosine) 0.3 중량부를 첨가하여 혼합, 균질화하였다.It is mixed and homogenized by adding 8.0 parts by weight of glucose, which is used only as brain energy, and 0.3 parts by weight of tyrosine, an amino acid component known to supplement the function of acetylcholine, a neurotransmitter component of the brain. It was.

이것을 연질캡슐의 성형제로서 식용유와 왁스 등 57.2 중량부를 사용하여 두뇌활성제 연질캡슐을 제조하였다.Brain softener was prepared by using 57.2 parts by weight of cooking oil and wax as a molding agent of the soft capsule.

두뇌활성제로서 연질캡슐의 제품 안정성에 대한 저장시험은 의약품의 안정성 검사에 사용하는 안정성 시험법을 원용하여 실시하였다.The storage test for the product stability of the soft capsule as a brain activator was carried out using the stability test method used to test the stability of the drug.

B. 시제품의 안정성 시험B. Stability Test of Prototype

두뇌 활성제 연질캡슐 시제품의 안정성 시험은 의약품 안정성과 유효기간 설정에 관련된 시험법을 원용하여 40℃(±1℃), 75%RH(±5%RH)의 확대조건하에서 3개월 간 본 시제품을 롯트당 20캡슐식 5롯트의 성상 및 성분변화를 분석, 평가하였다.The stability test of the brain activator soft capsule prototype was conducted using a test method related to drug stability and shelf life, and the product was tested for 3 months under extended conditions of 40 ° C (± 1 ° C) and 75% RH (± 5% RH). The characteristics and compositional changes of 5 lots of 20 capsules per sugar were analyzed and evaluated.

본 시제품을 40℃(±1℃), 75%RH(±5%RH)의 확대조건하에서 3개월 간 저장시험을 통해 주기적으로 분석, 평가하여 본 결과, 표 3에서 보는 바와 같이 시제품의 성장 및 성분변화는 전체 실험롯트에 전혀 나타나지 않았다. 따라서 본 발명제품의 시제품의 안정성은 충분히 인정되기 때문에 유통기간중의 안정성은 충분히 보장되는 것이다.The prototype was analyzed and evaluated periodically through storage test for 3 months under 40 ℃ (± 1 ℃) and 75% RH (± 5% RH) expansion conditions. No component changes were seen in the whole lot. Therefore, since the stability of the prototype of the present invention is sufficiently recognized, the stability during the distribution period is sufficiently ensured.

따라서, 상기의 두뇌활성제의 생리적 효과와 시제품 제조 및 안정성 시험결과를 기초로 하여 두뇌활성제 연질캡슐을 제조하였다.Therefore, based on the physiological effects of the brain activator and the preparation of the prototype and stability test results, the brain activator soft capsule was prepared.

특히 본 발명에 따른 연질캡슐 제품은 배합성분의 성장이 불포화성, 유성 및 시럽상의 연질캡슐이므로 산화방지와 품질의 안정성 및 복용의 편의를 위하여 연질캡슐 형태로 제조하는 것이 바람직하다.In particular, the soft capsule product according to the present invention is preferably prepared in the form of soft capsules for the purpose of preventing the oxidation, stability of the quality and convenience of taking since the growth of the compounding ingredients is unsaturated, oily and syrup-like soft capsules.

이하 본 발명품인 두뇌활성제 연질캡슐의 제조방법의 실시예를 설명하면 다음과 같다.Hereinafter, an embodiment of the preparation method of the brain active agent soft capsule of the present invention is as follows.

[실시예]EXAMPLE

천연생약으로 탁월한 약리효능을 갖고 있을 뿐만 아니라, 건강식품으로서도 각광을 받고 있는 알로에(Aloe vera)의 유효성분을 추출하여, 동결건조한 분말 8.0중량부와 등푸른 생선에서 추출, 정제하여 만든 고순도의 디에이치에이(DHA) 24.0 중량부를 주원료로 하고, 여기에 대두에서 분리한 레시틴 1.0 중량부를 첨가, 혼합하고, 다시 여기에 천연 항산화제로서 토코페롤 1.0 중량부와 식미 개선 및 영양 강화제로서 아스코르빈산 0.5 중량부를 첨가, 균질화한다.It is a high-purity DeHy made by extracting the active ingredient of Aloe vera, which is not only excellent natural medicinal effect, but also a well-known health food, extracted from 8.0 parts by weight of lyophilized powder and back blue fish. 24.0 parts by weight of DHA was used as the main raw material, and 1.0 parts by weight of lecithin isolated from soybean was added and mixed, and then, 1.0 parts by weight of tocopherol as a natural antioxidant and 0.5 parts by weight of ascorbic acid as a food enhancer and nutrition enhancer. Add, homogenize.

이들 혼합물에 뇌의 에너지로서만 이용되는 포도당(glucose) 8.0 중량부와, 뇌의 신경전달성분인 아세틸콜린(acetylcholine)의 기능을 보충하는 것으로 알려진 아미노산 성분으로서 티로신(tyrosine) 0.3 중량부를 첨가하여 혼합, 균질화하였다. 이것을 연질 캡슐의 성형제로서 식용유와 왁스 등 57.2 중량부를 사용하여 두뇌활성제 연질캡슐을 제조하여 포장하여서 출하한다.8.0 parts by weight of glucose, which is used only as brain energy, and 0.3 parts by weight of tyrosine as an amino acid component known to supplement the function of acetylcholine, a brain neurotransmitter, are mixed with these mixtures. , Homogenized. It is prepared by packaging 57.2 parts by weight of cooking oil and wax as a soft capsule molding agent, and packaged and shipped.

Claims (3)

알로에(Aloe vera)의 유효성분을 추출하여 동결건조한 분말과 등푸른 생선에서 통상방법으로 추출, 정제된 고순도의 디에이치에이(DHA)를 주원료로 하고, 다시 대두에서 추출, 정제한 레시틴을 첨가, 혼합하고, 다시 부원료로서 천연 항상화제로서 토코페롤과 영양 강화제로서 아스코르빈산을 첨가하여 혼합, 균질화한 다음, 여기에 아미노산 성분으로서 티로신을 첨가하여 혼합, 균질화한 다음, 성형제로서 식용유와 왁스를 사용하여 성형제조하는 것을 특징으로 하는 두뇌활성제 연질캡슐의 제조방법.Extracts the active ingredient of Aloe vera and freeze-dried powder and high-purity DHA, which is extracted and purified by conventional methods, as a main ingredient, and then extracted and refined lecithin from soybean. Then, mixed and homogenized by adding tocopherol as a natural raw material and ascorbic acid as a nutrient enhancer, and then mixing and homogenizing by adding tyrosine as an amino acid component, and then using cooking oil and wax as a molding agent. A method for producing a softening agent for brain activator, characterized in that the molding. 제1항에 있어서, 알로에(Aloe vera)에 대한 디에이치에이(DHA) 함유 어유(魚油)의 혼합비가 0.3~15.0배임을 특징으로 하는 두뇌활성제 연질캡슐의 제조방법.The method of claim 1, wherein the mixing ratio of DHA-containing fish oil to Aloe vera is 0.3 to 15.0 times. 제1항에 있어서, 알로에(Aloe vera)동결건조분말 0.5~30.0 중량부, 디에이치에이(DHA)함유 어유 1.0~50.0 중량부, 대두 레시틴 0.1~15중량부, 토코페롤 0.2~15중량부, 아스코르빈산 0.2~10중량부, 그리고 포도당 0.5~20.0중량부, 티로신 0.05~10.0중량부와 식용유 10~70 중량부를 배합하여 제조됨을 특징으로 하는 두뇌활성제 연질캡슐의 제조방법.According to claim 1, 0.5 to 30.0 parts by weight of Aloe vera freeze-dried powder, 1.0 to 50.0 parts by weight of DHA fish oil, 0.1 to 15 parts by weight of soy lecithin, 0.2 to 15 parts by weight of tocopherol, Corbin acid 0.2 ~ 10 parts by weight, glucose 0.5 ~ 20.0 parts by weight, tyrosine 0.05 ~ 10.0 parts by weight and cooking oil 10 to 70 parts by weight of the preparation method of the brain active agent soft capsule characterized in that it is prepared.
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EP1272197A2 (en) 2000-03-06 2003-01-08 Javor, Andras Combination of lecithin with ascorbic acid
EP1272197B2 (en) 2000-03-06 2012-03-28 N.V. Nutricia Combination of lecithin with ascorbic acid

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