CN100484555C - Application of Aloe vera L. extract in preparing medicament and health products for preventing and curing diabetes - Google Patents
Application of Aloe vera L. extract in preparing medicament and health products for preventing and curing diabetes Download PDFInfo
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Abstract
The present invention belongs to the field of biomeicine, and is especially method of applying Aloe vera extract and/or other natural medicine and/or other Western medicine in treating diabetes. The technological scheme is that Aloe vera extract is taken by diabetics in the dosage of 1-1000 mg each kilogram of body weight based on the cases of the diabetic. The Aloe vera extract may be prepared into medicine preparation or health article and taken in different modes to ensure its curative effect.
Description
Technical field
The invention belongs to biomedical sector, refer in particular to a kind of extract and/or other natural products that uses Aloe vulgaris, and/or other Western medicine are with the method for prevention and treatment diabetes.
Background technology
Since entering the new millennium as the diabetes of one of commonly encountered diseases, frequently-occurring disease just with more and more surprising speed increment.Global range, along with the improving constantly of people's living standard, the change of dietary structure, the improvement of labor intensity, and the increasing of stress state, the morbidity number of diabetes from 1993 1.35 hundred million rise to 2000 1.6 hundred million, will more rise to 2.4 hundred million by 2004.
In China, show according to nearest Epidemiological study, the onset diabetes rate of China by 0.67% before 15 years rise in recent years 3.21%, wherein type ii diabetes accounts for more than 95% of sum, and men and women's there was no significant difference.China's diabetics had reached more than 2,000 ten thousand people in 1998.Brainstrust estimates that if diabetes can not get effective control, to 2010, China's number of the infected will reach 6,000 ten thousand.In addition, the increase of onset diabetes rate is also relevant with China aged tendency of population, the age greater than 60 years old crowd in, the sickness rate of diabetes has reached 11.62%.
Belong to the Aloe of Liliaceae aloe plant, of a great variety, existing known plant is above 300 kinds.Aloe is the very high plant of a kind of medical value, as medicinal, and existing hundreds of years history.Sections such as that its applicable scope spreads all over is inside and outside, woman, youngster, skin, face, as be used for relieving constipation, antiinflammatory, immunity, antibiotic, wound and burn-healing and antiulcer and even antitumor or the like.For this reason, aloetic medicinally recorded by Martindale's Martindale-The Extra Pharmacopoeia.
Aloe is used for diabetes, can trace back to the folk remedy in the Arabia Peninsula the earliest.So far ground such as Kuwait also using a prescription of being made up of five kinds of natural products (containing Aloe), is used for the control of diabetes.And the research of Modern Significance then is the thing of nearest more than ten years.
1985, Agarwal is in attempting with the atherosis cardiopathic process of medical herbs prevention of arterial, notice that after every day, secondary was taken two kinds of natural products that comprise Aloe blood cholesterol, blood glucose and the blood fat of suffering from diabetic population among the experimenter all significantly descend.Owing to used two kinds of natural products, so we can not judge that it still is another kind of natural product or two kinds of coefficient results of natural product that the decline of diabetics blood glucose etc. should be given the credit to Aloe.To causing the mechanism of this decline, the research worker conjecture may be relevant with high fibrous matter.
1986, the blood sugar decreasing effect that statistical significance is arranged of the diabetic mice that the dry extract that Ghannam etc. have reported commercially available (Saudi Arabia) Aloe juice brings out for five type ii diabetes patients with by four oxy picolinates (alloxan).Different with the experiment of Agarwal, Ghannam etc. have only used Aloe.So people have reason to believe this blood sugar decreasing effect and stem from Aloe or a certain or certain several composition wherein.But what make us it be with some feeling of regret is to test used Aloe juice dry extract directly available from the shop, Riyadh.The resident in the Arabia Peninsula is the various aloetic leaves of riving traditionally, collects the juice that flows out, and obtains brown dry extract at air evaporation.Because available from the shop, be that those a kind of or those several aloetic juice dryings get so we are unable to find out the dry extract of the experiment of doing.But this report illustrated a kind of at least or several Aloes in contain hypoglycemic active princlple.
Similarly, 1987, Al-Awadi etc. reported that the Aloe extractum of one of five kinds of components can increase the glucose tolerance of normal mice and diabetic mice effectively when the employed five kinds of natural product mixtures of Kuwait's diabetics are studied.
Nineteen ninety, be still Saudi scholar Ajabnoor has confirmed Ghannam to the diabetic mice experimental result of model induced by alloxan with the component of the effluent of Aloe Barbadensis Miller and hardship wherein experiment discovery, be to contain the effectively component of blood sugar lowering in the Aloe, its mechanism may be to stimulate the synthetic or uelralante of β cell.
But just 1 year (1991), the experimental result that Mexico scholar Roman-Ramas etc. delivers reported that but Aloe Barbadensis Miller does not have effective blood sugar decreasing effect.
Still in 1991, Al-Awadi attempted to disclose aloetic blood sugar lowering mechanism with the diabetic mice that STZ (streptozotocin) brings out on the basis of research in 1987.Blood sugar decreasing effect to the small part that studies show that five kinds of natural products that comprise Aloe stems from the inhibitory action to the liver glucose heteroplasia.
1994, the experiment of Koo but had opposite discovery, and Koo has reported that a kind of health product that contain Aloe gel are not to reduce but the blood glucose of the diabetic mice of rising model induced by alloxan.
In addition, people such as Hikino are in 1985, and people such as Beppu have reported respectively in 1993 from being derived from a kind of Aloe kind (A.arborescens) of Japan, have middlely separated two kinds of components that show hypoglycemic activity.
Calendar year 2001, Okyar etc. reported they respectively from the exudate of the pulp of the normal saline extraction barbados aloe leaf of phosphate-buffered or dilution barbados aloe leaf with investigate this two parts thing respectively I type that normal mice and STZ are brought out, the situation that influences of type ii diabetes Mus blood glucose.Their experiment shows that the pulp of Aloe Barbadensis Miller has hypoglycemic activity to I type and type ii diabetes, but the exudate of Aloe Barbadensis Miller then can not blood sugar lowering, and blood glucose on the contrary raises.
Only be understood that the complexity of Aloe to blood sugar influence research with above-mentioned simple brief summary.We have reason to believe that the animal model of aloetic kind, the place of production, collection position, extracting method and used diabetes all may influence result of study.
Goal of the invention
The object of the invention provide a kind of aloe vera extract aspect preparation prevention and treatment diabetes medicine and the application in the health product.To determine to utilize the curative effect of aloe vera extract in the treatment diabetes, provide a kind of medicine or health product and application process thereof of new treatment diabetes.
The aloe vera extract of indication of the present invention is refered in particular to the aloe vera extract of using Chinese invention patent CN1065015A to be extracted.
The present invention can be according to factors such as diabetics age, ethnic group, health status, sex, diet, the state of an illness, the course of disease, administration time, route of administration and medication combined uses, every day used aloe vera extract total amount between per kilogram of body weight 1.0mg to 1000mg.
Wherein every day used aloe vera extract total amount between per kilogram of body weight 5.0mg to 500mg.
The optimal amts of used aloe vera extract is between every day per kilogram of body weight 10～250mg.
Take after aloe vera extract made pharmaceutical formulation or health-care preparation.
Pharmaceutical formulation or health-care preparation can the side of loosing or with unit dosage form for using.
Described unit dosage form be one by aloe vera extract and other medicinal or food with the mixture of raw material, adjuvant or carrier.
Described unit dosage form can contain or not contain other natural product or natural extracts.
Described unit dosage form also can contain or not contain other reactive compound.
Described unit dosage form is the health product of tablet or capsule or drop or pill or powder or unguentum or cream or solution or suspensoid or opacifiers or injection or implant or patch or varnish or spray or arbitrary form.
Pharmaceutical formulation or health-care preparation are with oral or injection or suction or tract or skin penetrates or administration such as implantation.
In numerous Aloe kinds, Aloe vulgaris, has cultivation and application has been arranged in foods and cosmetics as Guangdong, Guangxi, Yunnan, Hainan, Fujian, Sichuan, Guizhou etc. in some provinces, China south.In addition, this kind also is one of comparatively general Aloe kind of external plantation, research and use.The present invention use another reason of Aloe vulgaris be the inventor since nineteen ninety is carried out the Aloe case study, set up the scientific research planting base of special Aloe vulgaris already.Can guarantee the verity of the medical material of studying and the concordance of quality from the medical material source like this.
Except invention the uniqueness in Aloe kind, the place of production of using, Chinese invention patent " the extraction process for purification of cosmetics and medicinal aloe " (China Patent No. CN1065015A) is followed in strictness of the present invention, and the fresh Folium Aloe of gathering extracts by the technology of patent regulation and be refining.
In order to prove conclusively the quality of the aloe vera extract that obtains through said method, we open all components in the extract and obtain corresponding high pressure liquid chromatography figure, ultraviolet spectrogram and mass spectrum with high performance liquid chromatogram one mass spectrometer separation.
The present invention uses outstanding diabetes model, bull Zucker diabetic mice, the oral glucose tolerance test show that the extract of Aloe vulgaris has the obvious functions of blood sugar effect.
In addition, the tablet of making in the health product mode that contains this extract is that diabetics result on probation shows that this extract can reduce the blood glucose of diabetics effectively, and 26 routine patients' total effective rate is 84.6%.Observe simultaneously also clinically that patient's giddy, dim eyesight, polyphagia can be eliminated or improve to this extract, symptom such as feel sick.
The invention provides the medicine that contains aloe vera extract or health product in order to treatment or prevent diabetes and other disease.
The present invention contains the medicine of aloe vera extract or health product in treating diabetes or prevention process, can be independent use, also can be to unite use with another kind of, two kinds or more kinds of medicine or health product.This to unite use can be administration simultaneously, also can be with different precedence administrations.Here saidly uniting use, can be to unite use with other Western medicine, also can be to unite use with other natural drugs.
Medicine or the health product that contain aloe vera extract of the present invention can also can penetrate or drug delivery implant through injection, suction, tract, skin in the oral administration absorption.
When oral, every day used aloe vera extract total amount between per kilogram of body weight 1.0mg to 1000mg.In general, should be between 5.0mg to 500mg, and optimum range should be between 10-250mg.
Every day, administration number of times was decided according to sick the kind.In most cases, no more than four times of every day.Should be pointed out that dosage may be subjected to multiple factor affecting, unite use etc. as age, body weight, ethnic group, health status, sex, diet, the state of an illness, the course of disease and administration time, approach and medicine.So final dosage regimen should be decided according to patient's concrete condition by the doctor.
Medicine or health product that the present invention contains aloe vera extract can use each quasi drugs or health product production technology to carry out the processing of preparation or health product.Corresponding preparations and health product can be selected for use according to character, use object and function, the market bearing capacity of preparation and health product and meet the medicinal of country pharmacopeia, health product standard or relevant regulations or health product adjuvant, condiment or material.
Dosage forms such as medicine that contains aloe vera extract of the present invention or health product can tablets, capsule, drop, pill, powder, unguentum, cream, solution, suspensoid, opacifiers, injection, implant, patch, varnish, suppository, spray are used.The use approach can oral administration or through injection, suction, tract, skin penetrate, administration such as implantation.
Beneficial effect compared with prior art
Compare with background technology, the present invention has following advantage at least:
1, only uses Aloe, do not contain any other natural product;
2, only use Aloe vulgaris, do not contain any other Aloe kind;
3, the place of production is clear and definite;
4, the collection position is clear and definite, promptly fresh Aloe Barbadensis Miller.
5, processing and extracting method are clear and definite;
6, extract quality is controlled;
7, animal model is better.
Animal model in the background information all is the insulin cells that destroy normal mice with four oxy picolinates or STZ, causes normal mice glycometabolic unusual suddenly.The pathological process of this and people's diabetes, especially type ii diabetes has than big-difference.Zucker diabetic mice used in the present invention, several weeks are raised in the birth back, are exactly type ii diabetes.The American Studies personnel study the mechanism of diabetes and the drug effect of antidiabetic drug with this kind Mus.
Clinical research data is arranged, and certain sample number is arranged.
In the background information, use merely Aloe extract study its to the patient influence the blood sugar lowering report arranged again simultaneously have only Ghannam (1996), its result is from five type ii diabetes patients.
The specific embodiment
Embodiment one, the high-pressure liquid phase of aloe vera extract---mass spectral analysis
Materials and methods
Reagent: trifluoracetic acid, acetonitrile are all available from U.S. Sigma-Aldrich company; Instrument: HPLC-ESI-MS hewlette-packard; High pressure liquid chromatograph post: Zorbax SB-Phenyl; Method: high pressure liquid chromatograph linear gradient elution: 0 minute, 100% water (containing 0.1% trifluoracetic acid); 60 minutes, 100% acetonitrile; UV-detector detects, and detects wavelength 232nm; Mass spectrograph detects, 75 volts of Fragmentor of band cation detector.
Result and discussion
Extract obtains comparatively ideal separation, about 30 separated opening of component.Wherein there is the relative amount of 6 components to surpass 4.5%.The retention time of these 6 components is respectively: 16.8 minutes; 17.8 divide; 23.5 divide; 25.0 divide; 25.3 divide; 25.8 divide.
Embodiment two; Aloe vera extract is to the influence of Zucker diabetic mice oral glucose tolerance test
Materials and methods
Tried Mus: the male Zucker diabetic mice in 7 weeks is available from U.S. Genetic Models, Inc.Hyperglycemia generally appears in the Zucker diabetic mice when 7 weeks.Every Mus is all weighed when arriving laboratory and measures glucose content with the conclusive evidence hyperglycemia from the afterbody blood drawing.
Aloe vera extract: extract by our laboratory, prove conclusively with HPLC-ESI-MS; Aloe vera extract is a dirty-green.During experiment, the adding distil water wiring solution-forming.
Experimental technique
3-1. oral glucose tolerance test in 1 hour
Tried Mus and the equal overnight fasting of contrast Mus.Raised the Aloe vulgaris aqueous solution to trying the Mus stomach morning of test day respectively, and contrast Mus stomach is raised the equal-volume distilled water.After one hour, give respectively and tried Mus and contrast the Mus stomach to raise equal-volume 50% D/W.Respectively at 0 minute, 30 minutes, 45 minutes, 60 minutes, the blood sugar level of being tried Mus and contrast Mus was detected in 90 minutes and 120 minutes.
3-2. oral glucose tolerance test on the 4th
After the oral glucose tolerance test, tried Mus and contrasted Mus all to have a rest a week for the first time.Take food therebetween and drink water all unrestricted.
After one week, tried Mus respectively at the morning, afternoon each stomach raise Aloe vulgaris aqueous solution (be divided into equate two parts with single dose); The contrast Mus then in the corresponding time stomach raise the equal-volume distilled water.After continuous three days, overnight fasting.Raised the Aloe vulgaris aqueous solution to trying the Mus stomach the 4th day morning respectively, and contrast Mus stomach is raised the equal-volume distilled water.After one hour, give respectively and tried Mus and contrast the Mus stomach to raise equal-volume 50% D/W.Respectively at 0 minute, 30 minutes, 45 minutes, 60 minutes, the blood sugar level of being tried Mus and contrast Mus was detected in 90 minutes and 120 minutes.
Result and discussion
Table 1. aloe vera extract is to the influence of Zucker diabetic mice oral glucose tolerance test in two hours
| Time | Tried Mus blood glucose (mM) | Contrast Mus blood glucose (mM) |
| 0 30 45 60 90 120 | 6.06.98.26.86.96.4 | 4.25.47.19.87.96.1 |
Table 2, aloe vera extract is to the influence of Zucher diabetic mice oral glucose tolerance test on the 4th
| Time | Tried Mus blood glucose (mM) | Contrast Mus blood glucose (mM) |
| 0 30 45 60 90 120 | 5.76.76.25.85.95.4 | 5.7 6.4 7.3 10.610.05.8 |
The result of table 1 and table 2 has convincingly demonstrated the hypoglycemic activity of aloe vera extract.We therefrom can obtain following preliminary conclusion:
1, no matter be 1 hour or the 4th day oral glucose tolerance test, all can significantly the descend blood sugar level of Zucker diabetic mice of aloe vera extract;
2, compare with the contrast Mus, no matter tried Mus at one hour or in the 4th day oral glucose tolerance test, glycemic peaks descends soon and early;
3, compare with oral glucose tolerance test in a hour, the 4th day blood sugar decreasing effect is more obvious.This shows following two fermentation at least:
(i) glycemic peaks descends sooner, and in one hour metabolic test, glycemic peaks descended later on since 45 minutes, and in test on the 4th, glycemic peaks then just descended later on since 30 minutes;
(ii) compare with the contrast Mus, glycemic peaks is lower.In test in a hour, tried the Mus glycemic peaks and be about 1/2.5th of contrast Mus glycemic peaks; And in test on the 4th, tried the Mus glycemic peaks and be about 1/5th of contrast Mus peak value.
The explanation of such result of the test, similar with most of Chinese medicines, the aloe vera extract blood sugar decreasing effect can be along with the prolongation of Time of Administration, and is more effective.This discovery undoubtedly to diabetes this with old age artificial main chronic disease treatment positive effect is arranged.
Embodiment three, and aloe vera extract is to the therapeutical effect of diabetics
The object of observation: be diagnosed as II type (non-insulin-depending type) diabetics.
Diagnostic criteria: according to the diabetes diagnosis standard of nineteen ninety World Health Organization's proposition, secondary fasting glucose 〉=7.8mmol/L or 2 hours after the meal blood glucose 〉=11.1mmol/L; The examination of sugar in urine positive is with polydipsia, polyuria, polyphagia, symptom such as lose weight.
Therapeutic scheme:
Medicine is formed: the aloe vera extract sheet, every contains extract 100mg.
Usage and consumption: every day is early, middle and late respectively obeys 1 time, each 3-4 sheet, and one month is a course of treatment, serious symptom person formerly can reduce gradually with the blood sugar lowering Western medicine, until inactive.
Criterion of therapeutical effect: formulate by the academic meeting criterion of therapeutical effect of the 5th diabetes of China.
(i) produce effects: fasting glucose drops to the following or fall of normal 5.5mmol/L〉4.5mmol/L, and transference cure, glucose in urine is qualitative on an empty stomach turns out cloudy.
(ii) effective: fasting glucose descends〉3mmol/L, symptom obviously alleviates, the qualitative former positive person's plus sige of glucose in urine reduces on an empty stomach〉2.
(iii) invalid: symptom does not have obvious change, fasting glucose decline＜3mmol/L.
Result and discussion
The results are shown in Table 3.
Table 3 aloe vera extract is observed the diabetics effective percentage
From our preliminary clinical results, aloe vera extract is for diabetes, and especially type ii diabetes has therapeutical effect really.Use separately this medicine total effective rate 84.6%, wherein effective 38%, produce effects 46%.Clinical observation confirms that the hypoglycemic effect of aloe vera extract is lasting, stable.A patient is arranged,, suffer from diabetes more than 5 years over 7 ten days, polyphagia, polydipsia, polyuria, long-term prescription shows effect repeatedly.Use after the aloe vera extract, blood glucose is well controlled, and comes normal always 2 years more.This phenomenon is consistent with our the viewed pharmacological tests of Zucker diabetic mice in embodiment two also.
Except the blood sugar decreasing effect of lasting stability, symptom such as the extract of Aloe vulgaris can also obviously improve diabetics giddy, dim eyesight, polyphagia, feel sick.This illustrates that at least aloe vera extract all is being effective aspect control of diabetes patient blood glucose and other symptom.
In addition, because this product uses for the patient with the health product form, part patient with severe symptoms does not stop former blood sugar lowering Western medicine (as acarbose etc.) immediately, but minimizing gradually, until inactive.With the process of the parallel use of former blood sugar lowering Western medicine in, the patient does not feel any discomfort.Although our sample is big not enough, this indicates that at least aloe vera extract is to use separately, also might unite use with blood sugar lowering Western medicine such as acarboses.
Among 26 patients of preliminary clinical trial, short took this product one month, long reached several years, the report that still has no adverse reaction so far.This illustrates that at least aloe vera extract may be safe.
Claims (3)
1, a kind of aloe vera extract aspect preparation prevention and treatment diabetes medicine or the application in the health product; Wherein said aloe vera extract is prepared by following method:
A, clean with tap water, use distilled water drip washing after removing earth and surface contaminants, drain, remove the barbed part tailing edge of blade edge blade flat horizontal surface horizontal direction it is cut away half, mesophyll is scraped pulp and in advance to collect with the fresh aloe leaf;
B, place the rustless steel container internal heating to closely boiling the Aloe juice of collecting, after stopping heating, add an amount of antiseptic and stir, airtight cooling back stand at low temperature to the room temperature is got the clear liquid filtration more than 24 hours, precipitation filter pressing or centrifugal back gained filtrate merge, and are enclosed within cryopreservation;
C, (b) Aloe clear liquid weight of making 1/4～1/5 gets cation exchange resin and anion exchange resin is handled activation with conventional method set by step, press sun-male-female-cloudy four posts and connect installation, cross with distilled water and again the Aloe clear liquid for preparing to be sent into exchanger after post is checked installation qualification, exchanging to the pH value that flows out the Aloe clear liquid repeatedly is 6～7, reach the aloe purificata juice that 140-160k Ω cm can collect outflow than resistance value, be enclosed within cryopreservation;
Cryopreservation and dwell temperature are 1～5 ℃.
2, according to the described aloe vera extract of claim 1 aspect preparation prevention and treatment diabetes medicine or the application in the health product, it is characterized in that medicine or health product are aloe vera extract and other mixture medicinal or food usefulness raw material, adjuvant or carrier.
3, according to the described aloe vera extract of claim 2 aspect preparation prevention and treatment diabetes medicine or the application in the health product, it is characterized in that medicine or health product are tablet or capsule or drop or pill or powder or unguentum or cream or solution or suspensoid or opacifiers or injection or implant or patch or varnish or spray.
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| TWI454261B (en) * | 2007-01-09 | 2014-10-01 | Unigen Inc | Chromones as therapeutic agents |
| KR101578070B1 (en) * | 2015-04-08 | 2015-12-16 | 김경일 | Health supplementing food for enhancing hair restoration, alleviating and improving hair loss, adjusting blood sugar, alleviating and improving gastrointestinal disorders |
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| 芦荟对运动小鼠糖代谢影响的实验研究. 唐量.陕西医学杂志，第31卷第11期. 2002 |
| 芦荟对运动小鼠糖代谢影响的实验研究. 唐量.陕西医学杂志，第31卷第11期. 2002 * |
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