CN1829453A - Alimentation composition and use thereof - Google Patents
Alimentation composition and use thereof Download PDFInfo
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- CN1829453A CN1829453A CNA2004800220398A CN200480022039A CN1829453A CN 1829453 A CN1829453 A CN 1829453A CN A2004800220398 A CNA2004800220398 A CN A2004800220398A CN 200480022039 A CN200480022039 A CN 200480022039A CN 1829453 A CN1829453 A CN 1829453A
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Abstract
A nutrient composition or combination of compositions for the treatment or prophylaxis of infections, in particular HIV/AIDS, and for the enhancement of immunity, based on selenium in synergistic combinations with biologically absorbable sources of glutathione, alkalinity enhancing components, a source of sulphur, an anti-mutagenic compound and for oral use, gastrointestinal absorption enhancers. Special uses relate to reducing risks of mother-to-child transmission and treating HIV-positive pregnant women. Preferred further ingredients include anti-inflammatory compounds and nutrients which control homocysteine.
Description
Technical field
The present invention relates to based on the bond of the nutritional supplement composition of selenium or composition and in human or animal's antiviral therapy and/or prevention and/or strengthen purposes in the immune system.
Background technology
Being widely current of HIV/AIDS is one of disaster maximum on the human history.According to estimates, by 2015, whole world population nearly 20% with infected, 200,000,000 5 thousand ten thousand people are in heaven in AIDS.According to up-to-date report, all of country of African community youthful 70% are now infected, and in many African countries, the total population infection rate is 20-40%, and merciless up-trend is arranged.These numerals have been emphasized the seriousness of problem, especially in Africa.They have also shown the measure that this epiphytotics mercilessness of counterattack of being adopted so far wreaks havoc especially is invalid.
Antiretroviral drugs, for example AZT and other medicines have some effects for this virus, but benefit only is temporary transient, and they spread for the whole world of this disease and have very little effect or without any effect, reason is understandable.These reasons comprise fearful side effect and especially they have quickened the generation of new multidrug resistant disease strain, improve thereby the problem of making (1) is complicated.Also have, this virus can not be eradicated fully, and patient keeps HIV+ in its remaining life.This has two very important other real shortcomings.At first, especially under African environment, patient has been given them can be by drug therapy by the impression of " healing ", and this encourages them to carry out unconfined, unshielded sexual behaviour.
Also have, because patient is not cured (they keep HIV+), the final effect of drug therapy is the infection population that increases in the population, and therefore in the long term, this makes this problem worse generally.
In addition, these medicines are very expensive, therefore are not suitable for infecting in many third world countries general crowd's use of this virus.
Therefore, use for being convenient to, especially the method for using in third world's situation exists urgent need.
The applicant recognizes an observation of being done many years ago perhaps, and hypotrophy is the main hazard factor that AIDS takes place.Yet, the definite character of related shortage is not clear always, before about 10 years, the international research personnel when the forward position, especially the HD Foster of doctor E.W.Taylor of Georgia university and University of British Columbia professor concentrates on notice on the essential trace mineral selenium.First sign that may relate to selenium comes the disease epidemiologic observation in vogue of comfortable some sub-Saharan countries.In these national AIDS incidences generally is very high, about 20-40%, and in quick increase (2,3 and 5) of the great majority of these countries.
Yet Senegal is an exception that merits attention.The incidence here is about 1%, and static basically constant (2).Though the educational plan of senegalese relevant AIDS has put in place for some time (3), this only provides the illusion of protection, because similarly plan is not successfully carried out in other Sub-Sahara country.With other African country, compare with Uganda (5) such as Botswana (4), Senegal be rich in Selenium in Soil the dry Cretaceous period and early stage Eocene epoch sea bed.By many required mineral selenium are provided, senegalese soil and food chain have produced for the human immune system advantageous environment.Except selenium, provide the sufficient supplies of calcium and magnesium at this national food chain, its effect also is not realized so far.As if except helping patient AIDS, this environment also provides the protection to these national many other infection that the people suffered.
It is also known that, selenium plays basic role in the growth of many viruses and sudden change, noteworthy is in the conversion of the normal harmless Coxsackie virus of Chinese Keshan County, and wherein, virus is mutated into the stronger form of virulence in the presence of rare low content Selenium in Soil.This has caused cardiomyopathy popular at this county.The government interference that the form of the soil of selenium supplement and food is rich in employing makes this epidemic disease be under control (6).
In addition, in western countries, between low Selenium in Soil level and AIDS incidence, there is similarly relation as the U.S..This relation is strong and stable, makes to adopt the substituted index of HIV/AIDS incidence as the Selenium in Soil content in those countries that failing to obtain Selenium in Soil analysis on Content numeral at the atlas of the world of one of the many country variants in the world nearest Selenium in Soil content.
The concern of senegalese high Se content and this high concentration that may get in touch between the low disease incident of this country has been stimulated in the past in 10 years the further investigation of this relation, and the most important discovery relevant with the application is as follows:
* a long time ago, just know that patient AIDS has extremely low selenium level, but be assumed that this only is another side effect that is caused by viral-induced catabolism state in the prerequisite activity of Taylor.Taylor studies show that, selenium is far from so patient's AIDS effect.
Human host and HIV virus all need selenium to grow;
In the host, selenium plays a part main antioxidant, and this has especially protected the destruction of host's immune system with opposing free radical and virus; Therefore alleviated oxidation stress.
Encoding viral contains the enzyme-glutathione peroxidase (GPx) of selenium, therefore competes obtainable selenium supply with the host;
In addition, virus uses selenium as growth regulator.When the selenium supply was abundant, virus replication was slow, and therefore this disease is made slow progress or do not made progress fully.(this occurs in Senegal, and there, this sick incidence is static substantially, though chaotic sexual behaviour is not different from other African country in this area.This also occurs in for a long time-even for many years-keep in the asymptomatic HIV positive patients); With
When selenium deficiency, viral with this signal that is interpreted as breeding (otherwise owing to selenium deficiency faces death), thus spread to contiguous cell.This represents the rapid progress and the therefore generation of clinical AIDS of the disease of HIV positive patients.Taylor has proposed adjusting albumen, even may start virus replication and the existence of " master switch " that start when selenium deficiency.
* this is consistent with patient AIDS of the selenium deficiency discovery higher 20 times than those patients' of selenium abundance the possible death rate (Chem Biol Interact 1994,91:181).
This selenium theory why also explained the Congo and other African country with by its evolution be the anthropoid cape Strain contact number of human HIV strain after century, in the past 20 years only, AIDS just becomes the main clinical problem.This is owing to the following fact, and the gradual consumption of selenium level in the soil has reached critical low-level up to now.Can know by instruction of the present invention and to see that consuming in the time of many other important minerals has become cofactor.Plant does not need selenium, does not therefore comprise selenium in the works in soil application.Acid rain and agrological excessive utilization are other cofactors.Before clinical AIDS takes place, be not only the existence that needs virus.
Selenium state among the crowd has determined that who will be by virus infections.This has created and can not prevent crowd's the chance that adequately protects under the situation about contacting, and is applicable to most of populations.
These observations show that selenium supplement is delivered medicine to patient AIDS should be useful to them.It further shows, by selenium supplement being delivered medicine to the crowd of ill risk, should reduce disease incidence rate.Yet, the present invention is based on the idea that independent Selenium Supplement is not enough to recover effective blood selenium level (selenium blood level) and immunocompetence.Therefore; the present invention has instructed selenium and other nutrients administering drug combinations that the application is provided to recover patient's AIDS immunocompetence; therefore suppressed known opportunistic infections (this also is the characteristic feature of this state), usually also be used to protect by many other and infect the African that tormented and other crowd's immune system.This idea obtains by the exhaustive analysis of a large amount of clinical datas of collecting from the public and the clinical observation of oneself.Based on more detailed research, these observations have caused the understanding to the cooperative effect of not knowing in the past to exist.
Summary of the invention
Opposite with the above-mentioned background technology, the present invention has instructed the combination of various factors, these factors must be used, so that in following situation, obtain maximum effectiveness: the inhibition of virus replication and/or sudden change and/or raising human or animal's immune system, thereby reduce the possibility of virus infections simultaneously, or under situation about having infected, reduce the possibility of acquired resistance.
The synergistic effect of the combination results that the present invention instructed, reason is:
A) this combination benefit of obtaining has surpassed the summation of the benefit that can be obtained by single factor;
B) using under the invalid or inadequate situation of any one factor separately, this combination is effective.
For example, the applicant has been found that the combination of selemium nutrition replenishers and glutathione (GSH) system nutritious supplementary pharmaceutical works in coordination with.
Though hereinafter, emphasized the application of the present invention in the importance of HIV/AIDS, but it should be understood that, the present invention can have wider application on humans and animals, not only in ART and prevention, and relating to other virus, for example Ebola virus (ebola), Coxsackie virus (Keshan disease) are on hepatitis viruse and the common immunology.
According to an aspect of the present invention, provide the bond of nutrients supplement composition or composition, it comprises:
A) one or more biology can absorb and acceptable selenium compound, itself and one or more strengthen the material synergistic combination that physiology selenium absorbs, described material especially is selected from following one or more:
B) can absorb on one or more physiology and acceptable glutathione (GSH) source or precursor;
C) can absorb on one or more physiology and acceptable blood basicity improves component;
D) physiology can absorb and acceptable sulphur source;
E) one or more physiology can absorb and acceptable anti-mutagenesis compound;
And under the situation of composition for oral administration,
F) the stomach and intestine absorption enhancer of one or more selenium,
And/or in bond, do not need and a) synergistic g):
G) one or more stomach and intestine protective agents.
More particularly, these one or more selenium compounds are selected from selenocysteine, selenomethionine, methylselenocysteine (MSC), methyl selenomethionine, alkali metal selenite, Selenicel, in conjunction with the albumen of selenium, the selenium analog of sulfur-containing amino acid, the amino acid complex of selenium, the material that in commerce, is called " selenoaminoacid chelate ", with the selenium of coral calcium complexing, the analog of above-mentioned substance and derivative, and the bond of multiple above-mentioned substance.In general, the organic compound of selenium is preferred.Though the common dosage that elemental selenium is replenished is 100-200 μ g every day, under many patients' AIDS situation, preferably need at least 400 μ g.This is owing to the following fact, in many patients HIV/AIDS, selenium absorb do not resemble the collator effective.As long as every day, dosage was no more than 800-1000 μ g, just there is not toxicity.
Normally used organic selenium source is a methylselenocysteine, methyl selenomethionine, selenium yeast and " selenoaminoacid chelate ".The latter can obtain on market with this title, but it is catachrestic, because selenium does not form chelate.The applicant finds that for the application's purpose, the former two all is the compounds that are fit to.The applicant finds that also methylselenocysteine (MSC) is the higher compound of bioavailability in these two kinds.Therefore, MSC is preferred compound, is particularly useful for treating clinical AIDS with intravenous administration formulation according to the present invention.MSC is the essential component of glutathione peroxidase, as previously explained, the not oxidized infringement of known its protection cell (Alt Complem Therap 2000,6:342) also antiviral for purpose of the present invention, especially anti-HIV.
Be known that MSC be the selenium of pre-anti-cancer one of effective form (Nutrition andCancer 2001,40:12).
With regard to the activity of selenium compound, there is parallel relation in the present invention's instruction between cancer prevention and AIDS prevention and treatment.
The maximum importance of selenium is to guarantee that effectively the glutathione (GSH) in the patient body is effective.This can pass through GSH system nutritious supplementary pharmaceutical, and the replenishers that especially improve the replenishers of blood GSH level and/or effectively strengthen the GSH system are realized.In some cases, GSH itself can administration.Yet it is impaired that many patients absorb the ability of GSH itself, and for this reason, the precursor of GSH generally is preferred.Therefore; preferably in (at above b)); the precursor of glutathione is selected from the acyl group cysteine; N-acetyl cysteine (NAC); N-propiono cysteine, N-butyl cysteine, lipoic acid; methyl sulfonyl methane (MSM), the bond of the analog of above-claimed cpd and derivative and multiple above-claimed cpd.
As hereinafter illustrated, a purpose of above-mentioned feature is with GSH: GSSG changes to the level and the ratio of expectation.Though N-propiono and N-butyl derivative may be more superior than the N-acetyl derivative of more extensive utilization, the latter may be a preferred compound owing to cost factor.
The applicant finds that in the patient, the existence of GSH level deficiency is reflected in the ratio reduction of oxidized form GSH (GSSG) and reduced form GSH.
These passes tie up in the following diagram and illustrate, wherein
The GSH=reduced glutathione;
The GSSG=oxidized form of glutathione; With
The GPx=glutathione peroxidase.
The accumulation of GSSG represents that the glutathione of cell produces scarce capacity.Normally, have function completely in the healthy patients of glutathione system, this ratio is basically greater than 100: 1, for example in most cells above 500: 1.The applicant finds that this ratio of many patients AIDS reduces.In some, this ratio can be low to moderate 50: 1, or even lower.Therefore, one aspect of the present invention provides the state of guaranteeing the glutathione level abundance.This state must make that also glutathione mainly remains on reducing condition.This two states can be by the glutathione precursor (for example cysteine) except capacity is provided, and (Mg Zn) reaches for the required confactor of the conversion that GSH is remained on the essential confactor of reducing condition in addition in addition.In addition, the adequate level that glutathione is remained on the required confactor of reducing condition (for example riboflavin and nicotinic acid) must exist simultaneously.
The present invention's instruction, selenium only can play a role by the enzyme GPx that contains selenium, if, contain enzyme GPx and then its clinical effectiveness of competence exertion of selenium if having relative alkali condition (for example blood pH is higher than 7.45, and urine and saliva pH are higher than 6.2) in the GSH that has a capacity and the body.The importance of blood alkali condition (will distinguish with only there being the element such as Ca and Mg) is not paid close attention in the past.This is above c) meaning.
Preferably, blood basicity improves calcium, magnesium and the potassium compound that compound is selected from raising basicity, the lactate of above-mentioned substance, citrate, tartrate, malate or other fruit hydrochlorate, calcium carbonate, magnesium carbonate, basic magnesium carbonate, magnesia, dolomite, coral calcium, the bond of the analog of above-mentioned substance and derivative and multiple above-mentioned substance.
People's blood pH (acidity) is decided by diet (with final by the mineral matter in the soil of the plant of using in the diet of growing thereon).PH value of blood normally is that 7.35 (extremely acid) are to 7.45.Alkaline blood pH value is anabolic (tissue formation) relatively, therefore promote health, and acid stronger condition is relevant with catabolism, is insalubrity therefore, especially in patient AIDS.Many eubolism processes are relevant with the acid generation, and this acid produces then by buffer system of blood and mineral matter, such as calcium and magnesium institute balance.When lacking these alkalization mineral matters, this pH calibration becomes invalid, and acid poisoning takes place the result.
The applicant has been found that these Considerations are especially relevant in patient AIDS, in these patients, the strong catabolism tendency with linked groups's loss is a prominent features.In addition, immune system (pH is higher than 7.45) performance best-of-breed functionality under alkaline relatively condition.
The applicant has found patient's AIDS extensive acid poisoning tendentiousness (blood pH is lower than 7.4, and urine and saliva pH value are lower than 5.5).
This acid poisoning state has adversely influenced immune system, therefore acquires a special sense in patient AIDS.And, except elevating blood pH, according to c) material of class also promoted gastral alkali condition.The present invention instruction, opposite with people's expection, c) immune system is not only supported in the use of the acidity of class control buffer, and has improved selenium and passed through gastrointestinal absorption, and gastrointestinal absorption usually becomes problem in patient AIDS.
The preferred dose of alkalization material can be recognized from embodiment.Especially, just lack the patient of caesium and rubidium, preferably comprise caesium and/or rubidium compound, be used to improve the pH level, especially, also have the internal pH level in conjunction with the calcium source.The present invention's instruction, basicity has special significance in the cell.
In addition, have been found that as if lithium play an important role in the mode that exceeds simple pH control.Therefore, the composition of administration or the bond of composition preferably include the lithium source, especially to be suitable for making lithium be transported to the form of cell membrane.Preferably, the lithium source is selected from following organic lithium salt: the orotic acid lithium, the aspartic acid lithium, aliphatic acid, polyunsaturated fatty acid, be present in those materials in the cell membrane phospholipid, DHA, EPA,
-leukotrienes, palmitic acid, stearic acid and be present in other sour lithium salts in the biomembrane, or the bond of lithium selenite or lithium selenate and multiple above-mentioned substance.
Lithium delivers medicine to patient AIDS with the every purpose very low dose of 5-20mg.Careful patient's monitoring is necessary, even because under this low lithium concentration, some patients still the mild toxicity side effect can occur.
For this reason, preferably use the lithium of significantly lower " ultralow " dosage of 20-500mcg lithium.Under this low dosage (itself being novel and creative), can be patient AIDS, especially has in those patients' the treatment plan of the disease complex situations of determining with the immunity AIDS relevant the agent long-term treatment as a supplement of use lithium with nervous system disorders.
Lithium salts can be easily prepares by the lithium carbonate of amount of calculation or lithium hydroxide are mixed with the pure compound form or in the hydrophilic/hydrophobic solvent mixture that is fit to organic acid.In the slow reaction of back, organic acid partly is converted into corresponding lithium salts.
This reaction in the presence of 10 times of excessive acid, is carried out in 50% ethanol medium usually, then the gained mixture is sprayed to corresponding on the residual components in the replenishers of a daily dose.
The present invention has further instructed lithium selenite (or lithium selenate) also to be suitable as selenium source in the replenishers.Lithium selenite is preferred form (LiSeO
3H
2O).It also has the attendant advantages of supplying with lithium and selenium with same dose.Therefore, dosage every day of the lithium selenite of 385mcg will be supplied with the selenium of 200mcg and the lithium of 17.6mcg.
The tripeptides that glutathione is made up of three amino acid glutamic acid, cysteine and glycine.In the middle of these, the sulfur-containing amino acid cysteine is its part as the molecule at the main active place of sulfhydryl compound.As shown in the diagram of above glutathione system, it can carry out reversible OR, thereby plays antioxidant.In addition, glutathione has other beneficial effect to patient AIDS.
The structural formula of reduced glutathione has illustrated the importance of the sulphur in the glutathione structure.
The applicant recognizes that from the viewpoint of treatment, the glutathione system that works best is the key factor of AIDS prevention and treatment, in fact is the prerequisite that comprises any form of therapy of drug therapy.Selenium applies effect by glutathione system, but this is to say that under the situation that does not have selenium, glutathione system can not work equally.Patient with low glutathione level is shown to have lower life expectancy.
A kind of method of estimating the functional activity of glutathione system is to measure reduced glutathione: the ratio of oxidized form of glutathione.This ratio is different in different cells, but in most cells, this ratio is higher than 500: 1.
The cysteine that carries sulphur atom in the glutathione molecule obtains its sulphur atom from homocysteine:
Homocysteine+serine → cysteine+ketoglutaric acid
Homocysteine derives from the methionine in the methylation reaction, and methionine and then be degraded to propiono-ScoA, in view of the above, sulphur can further be degraded to the simple sulphur compound of forming human body sulphur pond (sulphur pool).
Many reactions in these reactions are reversible in some cases, make that the sulphur in the final glutathione obtains from sulphur compound (some them the derive from diet) pond of human body.
Therefore, the sulphur compound pond of human body is significant in the glutathione that keeps enough levels.
Judge the state in human body sulphur compound pond in can draining from the every day of the sulphur compound the urine.
Normally, all blood contain 3.84-5.06mg sulphur/100ml (not comprising the sulphur that exists in the albumen) (Z Klin Med 1940,137:467).The whole body sulfur content is reported as 0.196g/100g, and the glutathione content of normal person's blood plasma is 0.91 ± 0.24 μ mol/L.Herzenbergs has investigated the correlation between glutathione level and AIDS in New York.They have pointed out that patient's glutathione level has determined the time length of their survival.Other research shows that also the homoglutathion level has significantly increased patient's AIDS time-to-live, and they can (AIDS 1992,47:1021) with immunocyte (CD4) subcellular fraction enumeration correlation.
Twenty-four-hour urine in the normal adult is drained (total sulfur) and is reported as 2.0-3.4g.
Opposite with the normal person, the applicant finds, in patient AIDS (stage of depending on disease), urinating the sulphur loss every day can be up to 8-12g, this causes a large amount of sulphur losses, accumulation in time, and this will have serious unfavorable health affected, especially unfriendly influence the sulphur pond of human body, thereby influence the ability that human body keeps sufficient glutathione level.Though this a large amount of sulphur loss can be similar to other nutrients, the for example loss of nitrogen and partly relevant with many patients' AIDS general weakness situation, but do not recognize in the past, the result of sulphur loss has other result except general tissue loss, because it has directly influenced the ability of human body opposing HIV virus.
All critical functions of above-mentioned GSH depend on the glutathione peroxidase that contains selenium (GPx) of enough levels and therefore enough existence of the selenium of level.
Therefore, recovering human body sulphur pond is one aspect of the present invention.But best by the sulphur compound of the suitable biological utilisation of administration, (MSM) obtains such as methyl sulfonyl methane on the one hand for this.
Normally, sulphur is obtained by the food (plant, animal) that we ate.Sulphur is obtained by plant that we ate, plant then obtain their sulphur from their soil of growing.Therefore, descendant's sulphur state (as the selenium state) depends on the content of these mineral in soil.
As if be enjoyably, have some parallel relation between the content of these mineral in the soil of different regions and country variant, this has relation with the geographical incidence of AIDS.
The soil content of the reduction of these and other mineral matter and destructive farming practice and other environmental factor of following the selectivity fertilising plan that does not comprise sulphur and selenium, for example acid rain is closely connected.The health consequences of many sulphur shortages of people has been described.These comprise the immune system of gastrointestinal problems and dysfunction, and these two all acquires a special sense in patient AIDS.These two problems are present among patient AIDS who lacks selenium, and clearly, the common existence that sulphur lacks will make these state deterioratings.
Therefore, according to an aspect of the present invention, a large amount of sulphur losses that patient AIDS has are corrected with the sulphur supplementary scheme that is fit to.
Methyl sulfonyl methane (MSM) is excellent sulphur supplementary source, and many other inorganic sulfur forms poisonous with possibility are opposite.
It is the part of sulphurite circulation, and plant and comprise people's the tissue of animal and body fluid in natural existence.The applicant recognizes that MSM is nontoxic, is free from side effects, and is the sulphur that replenishes needed by human body for patient AIDS, in the mode of bringing into play the best use of generally and correcting the overall safety that occurs in a large amount of sulphur losses among these patients particularly.
Therefore; according to the present invention, at above c) in, the organic sulfur source is selected from cysteine; methyl sulfonyl methane (MSM); sulfur-containing amino acid, cystine, lanthionine; the sulfur-bearing polypeptide; alkali metal thiosulfate, preferred sodium thiosulfate, the bond of the analog of above-mentioned substance and derivative and multiple above-mentioned substance.Sodium thiosulfate (Na
2S
2O
3) be a kind of biological sulphur source, according to the present invention, it especially can be used for increasing human body sulphur deposit.It is nontoxic, and contains the sulphur of being convenient to utilize.
Reverse transcriptase is the given title of archaeal dna polymerase that RNA is instructed, and whereby, retrovirus is translated as the DNA code with their RNA type gene " information ".Typical retrovirus, initial such as the life cycle of HIV to be incorporated into the specific cell acceptor on the host cell surface and to enter the infecting virus particle (complete virus) of host cell.After this, RNA information transcribes only to enter in virus after (integration) host cell DNA and takes place.This integration is the essential step in the retroviral life cycle.Similar process has taken place when forming new unusual (for example cancer) clone in the DNA that attacks host cell when chemical carcinogen.Be exactly under this level, such as the DNA protective agent of chlorophyllin brought into play they protective effect (anti-mutagenic effects) (Mutation Res1997,376:97).Before this integration can take place, carcinogen or virus must with DNA form adduct (Env Mol Mutations 1996,27:211).When this dna adduct of enough high percents when the key gene fragment forms, normal cell is converted into abnormal cell, this abnormal cell can become cancer cell, perhaps under the situation of virus attack, is converted into the cell of replication-competent virus.Chlorophyllin has by capturing their performance with " skeleton " of chemical carcinogen reaction, and therefore, they can form adduct with DNA, thus prevented the process that their starting cancers take place (Env Mol Mutation Res 1997,388:79).
Identical process under the situation of virus, takes place in the present invention instruction, therefore, prevents or has suppressed they and host cell (for example immunocyte DNA) fusion.
Comparative study shows that though have many performance similar compounds in natural prodcuts (for example tea), chlorophyllin is the most effective obtainable so far antimutagen.Yet, in addition, or, can use other antimutagen as selecting, especially on some cancer, brought into play the material of anti-mutagenic effects.Preferably, at above e) in, anti-mutagenesis compound is selected from chlorophyllin, indole-3-carbinol (I3C), folic acid, nicotinic acid, niacinamide, the bond of the analog of above-claimed cpd and derivative and multiple above-claimed cpd.
This nutritional preparation can also comprise amino acid supplements.
This amino acid supplements can comprise cysteine, glutamine and tryptophan.
This nutritional preparation can also comprise the compound of the absorption that increases some compound.
The applicant finds that glutamine has many useful effects in patient AIDS.In addition, it has kept the structural intergrity of intestines except synthetic (in patient AIDS, this is most important) that promote glutathione, and the latter is usually impaired in patient AIDS, to such an extent as to the degree that is called as " intestines permeability factor ".Its major function is to recover the health of the mucous membrane of GI various piece.Usually, it has reduced the gastral inflammation that usually is present among patient AIDS.
The applicant recognizes that further pipering is a kind of stimulus that has shown the gentleness of the absorption that increases some compound.
This compound that increases the absorption of some compound can be selected from L-glutamine and pipering.
Therefore, preferred meaning above f) is that wherein pipe intestinal protection agent is selected from the analog of L-glutamine, above-claimed cpd and the bond of derivative and multiple above-claimed cpd.
Equally, preferred meaning above g) is that the gastrointestinal absorption reinforcing agent of wherein selenium is selected from the analog of pipering, L-glutamine, above-claimed cpd and the bond of derivative and multiple above-claimed cpd.
Preferably, a) with b) to g) and two or more combine.
Preferably, a) with b) and c) combine.
Advantageously, a) with b) and c) and d) with e) at least a the combination.
Yet most preferably, all are a) to g) class all is provided.
It should be understood that in certain embodiments the performance of at least a compound is a) to g) more than one function of class.
The present invention further instructs, except be used to strengthen effect a) to g) the class, below should preferably be provided:
At first, because HIV/AIDS usually worsens owing to lacking specific micronutrient, thus the bond of composition or composition should preferably contain useful be selected from the mineral supplement in magnesium, manganese and the zinc and/or be selected from vitamin A, B2, B3, B6, C, carotenoid and E and above-mentioned multiple bond in the micronutrient represented of vitamin.
Secondly, because having been found that inflammatory status plays an important role in the propagation of HIV/AIDS and infection and symptom, so the bond according to composition of the present invention or composition preferably contains the material that one or more are used to regulate cytokine activity, it is selected from the material that suppresses tumor necrosis factor (TNF α) and interleukin 1 and 6, the folium urticae extract, PTX (pentoxifilline), curcumin, antioxidant, NAC, alpha-lipoic acid, the bond of the analog of above-mentioned substance and derivative and multiple above-mentioned substance.Select above-mentioned substance, to avoid upsetting the short scorching power and the anti-inflammatory equilibrium of forces of human body.For this reason, some traditional anti-inflammatory drug (for example salicylate and COX inhibitor) is not preferred.
Preferably exchange the administration of the material of ganglion cell's factor active and adjust and regulate, be no more than following highest level with the level that keeps the inflammatory agent among patient AIDS:
The proinflammatory cytokine highest level
Tumor necrosis factor (TNF α) is lower than 10pg/ml
Interleukin-6 (IL-6) is lower than 12pg/ml
Interleukin-1 ' beta ' (IL-1 β) is lower than 15pg/ml
Leukotriene B4 (LTB4) is lower than 200pg/ml
C-reactive protein (CRP) is lower than 1.5mg/L
The 3rd, because have now found that, when PD, patient's AIDS homocysteine level is increased to harmful level, the present invention has instructed and has introduced the material of homocysteine level, the especially trimethylglycine (TMG) that are used for lowering blood or the bond of material.The latter is recommended, because the inventor has been found that replenishing vitamins B6, B12 and folic acid usually are not enough to the homocysteine among patient AIDS is eased down to desired horizontal (not being higher than 8.0mmol/L).Except the above-mentioned normal health risk relevant with the homocysteine level that increases, usually since its to biomembranous detrimental effect, homocysteine has produced other problem in the HIV positive patients.Infringement to the Obstruct membrane of the fragility in these tissues has improved the possibility of viral propagation, has promoted the virus replication in patient AIDS.
The 4th, notice contain selenium the glutathione peroxidase system on meaning of the present invention importance and some amino acid of this system at virus infections, especially the observed result that is consumed among the HIV/AIDS, the present invention's instruction, the bond of composition or composition should be preferably included in the amino acid whose alternative nutrients that contains in the glutathione peroxidase system that contains selenium, it is selected from cysteine, glutamine, tryptophan, the multiple bond of the precursor of above-mentioned substance, derivative and analog and these materials.
Another key factor relates to patient's AIDS gastrointestinal health.Have extremely important relation between HIV virus, AIDS wasting syndrome and gastronintestinal system health, alimentary canal inflammation condition and gastral TNF alpha levels, this is familiar with deficiency in the past, and does not reflect in present treatment plan.The present invention is that patient's AIDS recovery is obstructed greatly under the situation that has the intestines ecological disturbance based on its one of basic guiding principles.
The present invention recognizes that probiotic supplemented may be not too effective, unless they and some other supply thing and the acidosic correction of whole body as herein described such as selenium supplement give simultaneously.
In addition, the intestines ecological disturbance lowers relevant with nutrient absorption (comprising the absorption of selenium).Therefore, by selenium and suitable the mixing with the benefit of dosage giving birth to biology for example Bacillus acidi lactici and Bifidobacterium administering drug combinations, selenium absorbs and can significantly improve.There is a class selenium to absorb patient's AIDS of extreme difference subgroup.We find that in the major part of this group, problem is caused by the enteron aisle ecological disturbance.
Between chamber content (luminal content), intestinal mucosa (being stained with normal useful gastral microorganism) and alimentary canal associated lymphoid tissue (GALT), there is important exchange, and makes this mechanism become the important decisive factor of overall general immunity.In fact, the immunocyte element that GALT has (cell elements) than all other lymphoid tissues in the human body Duo several times (Surgery, 1988,104:917).This system is subjected to the influence of the inflammatory conditions of alimentary canal wall unfriendly, the result, the TNF alpha levels raises, this so that promoted HIV virus duplicating via the NF-k beta system.Therefore, TNF α is the reason that causes the early stage key step of virus replication.According to the present invention, this process can be controlled with three kinds of basic modes:
Aforesaid, by controlling aforesaid TNF alpha levels
Offer suitable mixing or normal benefit is given birth to biological by the special aliment that is used in special impaired those acid-sensitive objects of inducting among patient AIDS, so that suppress the enteric cavity inflammation, and by providing simultaneously and proinflammatory cytokine, TNF α for example, selenium with inverse relationship.
By the effect of selenium with further control virus replication and assistance probio is provided.
In the baby of contact HIV, the microorganism of suitable type is provided, for example, the freeze-drying culture medium that especially contains the baby milk acidfast bacilli is important.Generally, probio can administration (preferably as tablet, capsule, Caplet), perhaps as the major part administration (referring to embodiment) of the anti-AIDS replenishers of multicomponent, or as multivitamin/mineral preparations administration, perhaps they can be prepared as patient's AIDS beneficial living replenishers separately.In this respect, the present invention has further instructed the introducing in probio source.
At last, according to a specific importance of the present invention, the bond of said composition or composition and various above-mentioned instruction be applied to before the childbirth, during or treat the HIV positive pregnant women afterwards, so that lower their HI virus load, and/or strengthen their immune system and/or alleviate or postpone the beginning of AIDS symptom and/or reduce the risk of mother-to-baby transmission (MTCT) and/or opposing to the fetus and the neonatal influence of mother-to-baby transmission (MTCT), and/or the ewborn infant for the treatment of this women.
Except those of above further instruction, the bond of said composition or composition preferably includes multivitamin/mineral preparations, and preparation specifically is used to resist HIV positive pregnant women and/or positive mother of neonatal HIV and baby's thereof shortage characteristics.
According to an embodiment, the bond of said composition or composition is or comprises non-enteron aisle selenium prescription, and in three uses in the middle of the month in the end of gestation, especially uses in the living phase process of enclosing of HIV positive pregnant women.
According to another embodiment, the bond of said composition or composition is or comprises non-enteron aisle selenium prescription, and uses in the positive mother's of HIV ewborn infant, especially uses in postnatal preceding 3 middle of the month.
On the meaning of the health status of keeping the HIV positive pregnant women and the mother-to-baby transmission (MTCT) of avoiding HIV, particularly importantly, comprise one or more glutathione sources and/or strengthen the combination of material and one or more materials that alkalize of the activity of glutathione oxidation-reduction system.Preferably, prepare this one or more alkalization material to obtain the daily dose scope according to following table:
| Compound | Mother (mg) | Baby's (mg/kg body weight) | ||
| Scope | Preferably | Scope | Preferably | |
| Calcium is (as GaGO 3) magnesium is (as MgCO 3) alkaline MgCO 3Magnesium is (as citrate, alkalescence) calcium (as citrate, alkalescence) calcium (as double-glycine salt) potassium citrate Ca is (as CaCO 3) Mg is (as MgCO 3) alkaline Mg is (as alkaline MgCO 3) Mg (as alkaline citrate) | 100-1500 20-500 20-500 20-500 100-1500 100-1200 500-3000 100-1500 20-500 20-500 20-500 | 300-800 100-300 100-300 100-300 300-800 300-600 500-1500 300-800 100-300 100-300 100-300 | 1.5-25 0.3-7.5 0.3-7.5 0.3-7.5 1.5-25 1.5-20 7.5-45 1.3-25 0.3-7.5 0.3-7.5 0.3-7.5 | 5-15 1.5-5.0 1.5-5.0 1.5-5.0 5-15 5.0-20 7.5-23 5-15 1.5-5.0 1.5-5.0 1.5-5.0 |
| Ca, as citrate (alkalescence) Ca, as double-glycine salt (bisglyuriate) potassium citrate | 100-1500 100-1200 500-3000 | 300-800 300-600 500-1500 | 1.5-25 1.5-20 7.5-45 | 5.0-15 5.0-10 7.5-22.5 |
Above dosage range also is the preferable range of the patient except pregnant woman and baby.
This aspect of the present invention is intended to alleviate fetus and neonatal spreading rate and the effect of MTCT to them based on the principle that additional consideration and factor are applied to the treatment of HIV positive pregnant women.
The spreading rate of MTCT is 15-30% (average 25%), and is low unexpectedly.Propagate to take place in uterus (to propagate), in birth process and pass through breast milk postpartum through placenta.Great majority are propagated and to be occurred in conceived late period and in birth process.Some factors of increase propagating are: mother's virus load, mother's clinical, immunity and nutritional status can damage the existing of immune other factors breaking of (for example medicine, external chemicals) and the film in birth process.
Based on observing and the anatomizing of data, the present invention instructs, and trophic factor is the same at least with virus load important in child's the vertical transmission mother.They can pass through several mothers of influence propagation and the risk factor of fetus, such as mother and child's immune state, and the effect of viral development speed, virus quantity of discharging in genital secretion and the viral secretory in the breast milk reduce to propagate.The other factors that nutrition is worked comprises that reducing low birth weighs and keep mother and child's intestines and stomach integrality.Shown that virus is present in the human body most liquid secretion (blood, serum, lymph, breast milk, seminal fluid, vaginal fluid etc.).At period of gestation with especially before childbirth, childbirth neutralization childbirth after-stage, fetus contacts in a large number with this type of secretion, and based on this, people expect that spreading rate is near 100%.Yet under actual conditions, average spreading rate only is 20-30%, in some researchs, it is reported to be low to moderate 10%.This has caused being used for by using the idea that inventive principle mentioned above reduces spreading rate:
Reduce the quantity of the virus of health conveying;
Change and shifted the viral tissue and the composition of body fluid,
Thereby reduce the risk of fetus or infections in infants,, reduce its seriousness if infect.
In conceived process, selenium level and other important protectiveness blood constituent are transferred to the fetus from the pregnant woman, thereby have improved the ability that the anti-HIV of fetus infects, and have reduced these levels of pregnant woman simultaneously.This transfer of important nutrients from mother to baby and the low selenium level that is caused continue in puerperal earlier month, and cause with mother of bottle-feeding and compare, the AIDS death rate of the increase of seeing in mother of lactication.Our observation has shown the high selenium level in first Ruzhong.Thereby the baby is supplied as cost with the selenium of sacrificing mother self and is protected.
Virus is response selenium level one of in two ways.When the selenium level was hanged down, virus responded by increasing propagation, caused the fast-developing AIDS completely that arrives in the HIV positive patients.When this level was high, virus multiplication was suppressed, even reached virus and can keep the state of dormancy for a long time.
Therefore, by originally increase selenium level of baby as cost with parent, mother has guaranteed that the baby can resist virus multiplication, has increased the risk that himself develops into clinical AIDS simultaneously.
The degree that this protective effect works obviously depends on mother's selenium reserves level, and when reserves were low, the baby was not adequately protected, as taking place under the situation that infects the baby in the birth of 20-25%.
Following table has been summed up preferred day administration scope, prepares in view of the above according to composition of the present invention.
| Compound | Adult/mother | The baby, every kg | ||
| Scope | Preferably | Scope | Preferably | |
| Selenium source (mcg) methylselenocysteine (mg) selenomethionine (mg) sodium selenite (mg) ferment compound (mg) amounts to (mg) NAC of folic acid (mg) chlorophyllin (mg) L-Trp (mg) Glu (mg) Cys (mg) nicotinic acid (niacinamide) | 50-1000 50-1000 50-600 50-1000 50-1200 0.02-10 50-1000 50-3000 50-30000 50-2000 5-500 50-3000 | 100-500 100-500 100-400 100-500 400-800 1-5.0 100-500 500-1500 500-5000 300-600 20-100 300-1000 | 1.0-15 1.0-15 1.0-8.0 1.0-15 1-17 0.0003-0.14 1-15 1-40 1-400 1-28 0.07-7 1-40 | 2-7 2-7 2-5 2-7 5-12 0.014-0.07 2-7 10-20 10-70 4-8 0.3-1.5 4-14 |
| (NAC) (mg) (mg) (mg) (mg) (mg) (mg) alpha-lipoic acid (mg) calcium d-Panthotenate (mg) L-BETAIN (mg) PTX (mg) folium urticae extract (mg) cesium chloride humic acid fulvic acid of vitamin A (IU) ascorbic acid (mg) indole-3-carbinol (mg) beta carotene (mg) pyridoxine (mg) vitamin C (mg) cobalamin (mcg) betaine (TMG) of potassium citrate (mg) sodium thiosulfate (mg) quercetin (Quercitin) of vitamin E (TE) methyl sulfonyl methane (mg) riboflavin (mg) zinc (separate sources) of magnesium (separate sources) of calcium (separate sources) | 100-1500 20-500 10-1000 50-5000 2-100 5-60 500-10000 500-5000 60-1500 5000- 25000 50-5000 50-1000 5-100 5-30 50-3000 1-100 100-3000 100-1200 10-1000 100-3000 100-800 400-1200 50-5000 10-500 5-500 | 300-800 100-300 20-100 100-1000 5-20 10-40 700-2000 700-2000 600-1200 10000- 20000 200-1500 100-400 10-50 5-30 100-2000 5-50 500-1500 500-900 100-600 500-2000 400-600 700-900 100-2000 50-200 30-200 | 1.4-20 0.3-7 0.14-14 1-70 0.03-1.4 0.07-0.9 7-140 7-70 0.9-21 70-350 1-70 1-14 0.1-1.4 0.04-1.4 1.0-40 0.014-1.4 1.4-20 1.4-10 0.1-10 1.4-30 1.4-12 5.7-17 0.7-70 0.1-7 0.07-7 | 4-11 1.4-5 0.3-1.4 2-14 0.07-0.3 0.14-0.6 10-28 10-28 9-17 140-280 3-20 1.4-7 0.2-1.0 0.07-0.42 1.4-28 0.07-0.7 0.7-10 5.0-12 1.0-6.0 7-20 5-8 10-13 1.5-30 0.7-3 0.3-3 |
| The living replenishers 1-5 of benefit * 10 9Biology/dosage (mg) lithium selenite (mg) (LiSeO 3·H 2O) lithium selenate (mg) (LiSeO 4 ·H 2O) Li, as PUFA compound (mg) Li, as Orotate (mg) | 100-1200 50-1000 50-1000 10-500 1-30 | 400-800 100-400 100-400 20-200 5-15 | 1.4-18 0.7-15 0.7-15 0.15-7 0.014-0.4 | 5.7-12 1.4-6 1.4-6 0.3-3 0.07-0.2 |
The preferred composition of another of composition is the whey concentrate.
Bond great majority according to nutritional supplement composition of the present invention or composition are the form of oral administration, for example oral Galenic formula form (galenic form), or be used for the composition introduced at food or feed or beverage or the bond preparation of composition as prefabricated.
Oral Galenic formula form can be a liquid, for example syrup, or solid, powder for example, pill, tablet, optional dressing, particle, capsule.Under the situation of using dressing, they can be prepared and be used for time-delay release purpose.
Scope of the present invention is included in this based composition of introducing in food or feed or the beverage, for example to be selected from the form of the material in the following material: be rich in corn flour, tapioca starch, baked wheat flour, bread and mahewu (mahew) at composition defined above (mahewu is the pasty food in Africa, and the lactic fermentation by starch (usually from corn flour or cornstarch) prepares).。
Also comprise the form that is suitable for parenterai administration, for example be suitable for the composition as above definition of the form of intravenous injection or perfusion or intramuscular injection.
Mainly be suitable for pre-preventing virus infection and prevent disease proceeded in the metainfective clinical more serious stage according to the oral application of preparation of the present invention.
These preparations generally need just occur effect after a while, and therefore, they may be not suitable for treating clinical patient and end-stage patients especially.
In these patients, may need drug therapy, but should remember, as long as in patient, have the condition that is beneficial to virus multiplication, so finally can be successful without any treatment.The major reason why virus multiplication carries out in out of contior mode in these patients is common low blood selenium and the glutathione concentrations of seeing in these patients.
According to the present invention, by sharply increasing the suitable selenium preparation and the blood concentration of glutathione under these conditions, medicine (and other) treatment can become more effective, and in many cases it in addition itself can constitute effective treatment.
Yet, can not before patient's last death, in the obtainable short time blood levels be elevated to the level of expectation usually.This is especially suitable under the situation of glutathione, and glutathione can not be used for improving blood levels like this.The common precursor (for example, the N-acetyl cysteine) that is used for generating in the cell of glutathione reacts lentamente, can not be used in obtainable finite time glutathione being brought up to the level of expectation usually.Therefore the present invention has also instructed, and under these conditions, it is very effective adopting the glutathione intravenous administration that the blood glutathione is elevated to aspiration level rapidly.
According to an aspect of the present invention, the intravenous administration of glutathione is used to the blood levels that obtains to expect.For example, in fact, have been found that slow (for example 20 minutes) injection of the sterile solution of the 400mg glutathione in the salt solution that is dissolved in 20ml is effective (referring to embodiment) for this purpose.In the serious patient, may need to inject repeatedly.
According to another aspect of the present invention, but the sterile solution of the selenium source of the biological utilisation that use is fit to (for example, be dissolved in the L-methylselenocysteine or the L-methyl selenomethionine of 1mg of the sterile saline solution of 10ml) come under these conditions blood selenium level to be elevated to fast the level (for example, surpassing 160mcg/L) of expectation.In addition, selenium can come administration by the intramuscular approach.In this case, the solution that is used for intramuscular administration is by being dissolved in oiliness with one or more of above selenium compound or aqueous medium prepares.
According to a further aspect of the invention, use the combination (preferably with gene protection agent and pH conditioning agent, i.e. basicity improving agent combination) of selenium and glutathione.In serious patient AIDS, particularly advantageous is to be used in combination one of this preparation and antiretroviral drugs.
If especially under the situation of Galenic formula form or exist to need keep preferably in independent dosage unit that is used in combination or preparation, to comprise heterogeneity under the situation of the reason that some component separates.
Another aspect of the present invention comprises using as the composition of above definition and explanation or the bond of composition and suppresses virus replication and/or sudden change and/or be used to improve human or animal's immune system and/or prevention or treatment HIV/AIDS.
This type of purposes can be used as the part of regional regimen.It can also be designed to combine application with common antiviral and/or antiretroviral drugs treatment.
Resisting the outburst of serious disease or potential serious disease or be very popular, on the certain sense such as HIV/AIDS, the present invention plans to use combination, if suitably, the strategy of extensive use health care and acute nursing is used.
For this reason, the present invention has considered various regional situations, in this scope, allows each situation that difference is arranged.
More particularly, use according to the bond of composition of the present invention or composition comprises following feature: for the HIV/AIDS that is controlled in the regional population popular, this crowd is layered as a plurality of different risk group, and according to providing the bond of different components or composition to the different risk orders of magnitude in serious HIV positive person's the risk range at low-risk=low disease incident.
More particularly, the crowd is layered as following at least 5 risk group:
1.) low-risk, low disease incident group, the HIV incidence is minimum.
2.) normal risk group: the HIV state of the general individuality of failing to understand, but, be considered to have average infection risk by on average.
3.) HIV positive person, its still essentially no AIDS symptom, and its CD4 counting is more than the level that needs the antiretroviral drugs treatment.
4.) have the clinical HIV positive person that low CD4 counts, observed the symptom of the definite opportunistic infections of AIDS within it.
5.) the CD4 counting is lower than the serious HIV positive patients of 200/mcl.
At first, end in this scope, formation risk group 1.) adventurous crowd carries out the prevention administration of the bond of composition or composition, uses to be designed for the dosage regimen that keeps with regard to the effective nutrient health level of the cost of material as herein described and principle in target group's maximum number member:
(1) is used to make overall immune power maximization and infection risk is minimized; And
(2) and if when infecting (for example HIV infects) when taking place, make the progress that infects Symptomatic disease condition reduce to minimum or postpone.
Secondly, risk group 2.) be beginning in the intermediate range of this scope, it comprises no disease (HIV feminine gender) person who lives in the society, in described society, risk level is judged as normally according to the level of disease incident.This group has comprised the very big part of population generally; for this reason; nutritional intervention provides actual drug type protection only; yet; people can/should examine situation closely; if considerable infection rate has taken place significantly, individuality can to immune state (cd4 t cell counting), viral count and symptom may occur identify and test.In this case, representative group 3.) more effective/more the high dose system should be applied to infected individuals and may be applied to a large amount of regional populations at least.The victim who determines should be subjected to proportionately monitoring and treating (for example depending on whether they are asymptomatic HIV positive patients) separately and with their clinical state.As long as CD4 counting is more than certain level, based on related counting with run into the real danger that the multidrug resistant disease strain occurs, retrovirus drug therapy will be debatable.In this group, suitable nutritional intervention is especially valuable.
4.) under the situation of group, depend on the seriousness of symptom and the parameter that can measure, should use acute treatment.
To the degree that notes abnormalities, mainly be limited to auxotrophy, they use the principle of the present invention instruction and treat, and second purpose is that the immune state (with regard to the cd4 t cell counting) with patient remains on more than the critical level of being recognized.Think at present and what accept extensively is that cd4 t cell counting is being equal to or less than 200CD4T cell/mm
3The time be critical low-level.In this stage, except nutritional intervention (advanced prescription), need the antiretroviral drugs treatment.
Acute treatment
In HIV/AIDS expert, what accept extensively at present is, when the blood cd4 t cell is counted approaching or is reached above-mentioned 200 critical level, should start conventional ART, this treatment is carried out with the combination of three kinds of medicines that comprise at least a viral inhibitors, RTI and at least a protease usually, but do not do so before this, no matter viral count how.This knowledge is adhered in the present invention's instruction, but in addition above-mentioned principle is applied to Selenium Supplement level and other trophic level, and the especially combination of selenium, GSH and blood basicity if found shortage, preferably includes these parameters of monitoring and takes positive correct action.
According to the present invention, the effectiveness of this conventional therapy can be by giving to work in coordination with raising by the nutritional supplementation system of the present invention's instruction simultaneously.Under situation about being fit to, this allows to use the common drug than low dosage, and with less and not too serious side reaction.
As for 5.) group, exist life-threatening CD4 counting to be lower than the serious HIV positive patients of 200/mcl, this group must be as 4.) treat organizing, but may need vein to give glutathione in addition and/or intramuscular gives selenium and other nutrients.
In using above-mentioned instruction, importantly remember, though a)-g) each of above-mentioned each factor has good effect in some (not being whole) patients, but when all using simultaneously, obtained maximum efficiency.Therefore, another novel aspect of the present invention is to recognize to have only just to obtain whole effects when they are all used simultaneously.Therefore, Selenium Supplement has certain effect for certain percentile patient separately, when correcting the acid poisoning that in fact always is present among all patients AIDS, expection can obtain better effect, because dominant pH value of blood is sensitively depended in the enzyme reaction (glutathione peroxidase) based on this of selenium effect.Involving under the situation of other factors, having similar cooperative effect.
The present invention further instructs, because above-mentioned reason, positive conceived mother of HIV and their neonate have constituted the special risk group in above-mentioned classification.Their treatment needs special consideration, and this is because the risk of disease fast development increases.Especially, make more extensive and frequent use as Selenium Supplement teaching herein and other nutraceutical non-enteron aisle mode.
In principle, also use the present invention's general instruction in addition.Yet the control of homocysteine level is particular importance, because infect even without HIV, and level carrying out property decline in conceived process of the vitamin of control homocysteine, thereby homocysteine level raises simultaneously.These effects infect by HIV and worsen, and must eliminate, especially because these effects are also propagated the neonate to this mother's birth.
Relevant with anti-inflammatory treatment of the present inventionly be taught in particular importance in HIV positive pregnant women and their the neonatal treatment, so that blocking-up or reduce the approach that virus is propagated by cell membrane.
Equally, being controlled among positive women of HIV and their neonate by the acid of the present invention instruction than under the situation of other HIV positive patients even more important.
On the meaning of HIV/AIDS, the present invention has special significance in its influence to the effect of reverse transcriptase.
HIV and other retrovirus contain the gene information of the rna form that stores in albumen and lipid icosahedral capsid (icosahedral shell).This spherical virus particle is further wrapped up by the coating that the glycoprotein molecule by the special coding of virus in the double-layer of lipoid of the plasma membrane that derives from host cell is formed.The albumen that this virus merges peplos by the interaction of the diathesis membrane receptor surperficial with being arranged in host cell (for example CD4 immunocyte) penetrates host cell.In case in host cell inside, new, atypical dna molecular is synthesized in host cell nuclear by the enzyme of the archaeal dna polymerase that is called RNA at first and instructs.This enzyme was called as reverse transcriptase afterwards.Therefore the integration of viral RNA and host cell nuclear is the part of HIV life cycle.
Using the antimutagen inhibition such as chlorophyllin is important step.The rna gene group of HIV contains several genes, and several albumen of also encoding, all these protein all stimulate to be transcribed and translate.
The existence of these the many stimulus of the quick formation of permission mutated viruses strain and the quick variation of virus envelope protein is to be difficult to form one of the effective vaccine of these diseases of fight or reason of medicine why.Though these effort must continue, the present invention is supposition therefore, and the more instant solution of HIV/AIDS problem should be sought on the antiviral mechanism of glutathione type at enhancing host immune system and the interior of it in addition.
HIV virus belongs to the retrovirus group, and it is carried at the gene information that RNA goes up coding, and the people's cell that carries in the nucleus with dna encoding with genetic code wherein is opposite.Before HIV virus can be duplicated in human body cell and breed, it must become DNA " language " from rna transcription with its gene-code.This process is called as reverse transcription.The process that reverse transcription can be used as the gene mutation of virus induction is observed.For the record that takes a turn for the worse, virus must closely contact with the DNA of host cell.When environment and other carcinogen enter in the genetic material in people's cell with when bringing out sudden change and cause cancer, similar contact has taken place.The first line of defence of defending many chemical carcinogens is the medicament that prevents gene mutation.The many of these medicaments are present in the natural prodcuts, comprise the phyllins that are called chlorophyllin.
Chlorophyllin is chlorophyllous modified soluble form, and it was used as anti-inducer matter many years in cancer research.Therefore, has the mass data of the anticancer and anti-mutagenic effects of handling chlorophyllin (for example referring to Environm Mol Mutagen 1997,30:468).In the prior art, do not carry out the Study on Effect of chlorophyllin to clinical AIDS.
Disclosed key studies show that in 1986, chlorophyllin be than the more effective anti-mutagenesis compound of all other known anticancer compounds at that time (Mutation Research, 1986,173:111).Therefore, this studies confirm that chlorophyllin suppresses the outstanding effectiveness of lethal gene sudden change of being caused by compound.
Surprisingly, have now found that effectively chlorophyllin has also suppressed retroviral sudden change and viral growth with other anti-inducer matter in treatment of cancer, though have no reason to guess this effect.Really, can understand that from further research and consideration the anti-mutagenesis of chlorophyllin is given by two kinds of different mechanism with the viral growth inhibitory action.At first, chlorophyllin by forming adduct with carcinogen chemistry with chemical carcinogen qualitative response such as some heterocyclic amine, thereby prevented they with the reaction of nuclear DNA material (Cancer Letters 1996,107:223).Yet chlorophyllin also combines with DNA in the genetic material, thereby has prevented that it from being destroyed by mutagens.The present invention's instruction, the DNA in the chlorophyllin protection normal cell is not attacked by HIV with similar mechanism.
Indole-3-carbinol (I3C) is another naturally occurring DNA protective agent and antimutagen, and it has been proved to be and can have prevented to reach 90% chemically induced cancer.Studies show that further I3C has reduced 67-82% with the dna damage of various tissues.Its main mode of action be prevent various carcinogens and DNA form adduct (Food Chem Toxicol 2000,38:15).According to the present invention, the DNA in the I3C protection normal cell is not attacked by HIV with similar mechanism.
Folic acid supplement has shown the cancer that can prevent the people, especially colon cancer and breast cancer in several researchs.This can also track as the gene protection under the situation of above-mentioned other two kinds of compounds.
Nicotinic acid (niacinamide) (10) as one man has been reported among patient AIDS (9) and has seriously consumed.The fact that niacinamide can protect the DNA in the cell not to be damaged that several researchs are verified.These researchs only limit to the aging protective effect of the anti-brain cell of nicotinic acid in patient AIDS (8) and the beneficial effect of niacinamide replenishers.Yet, do not investigate nicotinic acid or niacinamide to viral-induced dna damage in these researchs, especially to the protective effect of the dna damage relevant with HIV.
The shortage of cysteine, glutamine and tryptophan also helps the main clinic symptoms (Townsend Letter, in April, 2002, the 76th page) of AIDS.Therefore, but clinical patient's AIDS optimal treatment must not only comprise the selenium of biological utilisation form, and also has these necessary amino acid.Applicant and other people have been found that patient's AIDS deficiency of tryptophan has caused pellagra sample symptom, comprises depression.
The applicant knows, it may be a problem that selenium absorbs, at least in some patients, and patient AIDS particularly.In these patients, therefore pay particular attention to the amount and the type of the selenium compound that in supplementary scheme, uses.In addition, the applicant finds that the compound (for example glutamine) of the condition of the cell in the improvement alimentary canal internal layer and the material (for example pipering) of improvement gastrointestinal absorption can be used for improving selenium and absorb.
The object of the invention is to solve following state of at least a portion or purpose:
1) glutathione system of best-of-breed functionality;
2) existence of native compound, this compound prevent or stop virus to combine with host's DNA, thereby protection host gene material is avoided virus attack;
3) supply with other nutrients of capacity, these nutrients are also by encoding viral and its critical shortage thereby may take place in patient AIDS;
4) but the selenium of the selenium compound by utilizing the difference biological utilisation replenishes and introduce the step that makes selenium absorb normalization among those patients that become problem and guarantee enough blood selenium levels by absorbing at selenium;
5) AIDS is extensive cachectic catabolism disease that muscle and tissue loss take place.Therefore, limiting these losses must be primary therapeutic purposes with substituting the tissue that loses.In addition, the applicant is surprised to find except the common measure that reaches this purpose (improve nutrition, high quality protein, general many minerals and vitamins replenish), and the loss of sulphur is an importance of tissue loss; And/or
6) being lost among patient AIDS of sulphur is especially severe, because the biosynthesis of this hint sulfur-containing amino acid cysteine and methionine reduces, these two is important in patient AIDS.
Therefore, the HIV/AIDS that the objective of the invention is to control among a large amount of crowds (especially young man) in the third world countries is popular, in these countries, because economy and logistics factor, can not adopt the institutionalization nursing of expensive medication and high request.In some modification of this application, formulated product is so that except suppressing the AIDS virus replication, and also as nutritious supplementary pharmaceutical, it has solved in the many shortages that occur among the target group some to this product.In order to cover wide as far as possible target demographic part and economic cause, the invention provides different formulations of the present invention to be used for different people's notch portion.
The specific embodiment
By non-limiting example the present invention is described now.
A) AIDS in a large amount of populations of prevention
Very clear, this prescription must be that cost is effective.This product will with the form of the pill of taking to be fit to preparation or tablet per diem benchmark deliver medicine to those population at risks.This product can also by with methods known in the art and operation to be rich at basic food, for example bread, corn flour, soy meal or any food that other is fit to come administration.
Embodiment 1
Every day dosage:
Selenium:
Selenium (as 0.1% ferment compound) 0.20mg
Total elemental selenium 0.20mg
The glutathione source:
N-acetyl cysteine 200mg
Riboflavin 5mg
Niacinamide 20mg
Folic acid 1.0mg
Trace quantity mineral source 200mg
The acidity hierarchy of control:
Calcium carbonate 500mg
Magnesium carbonate 400mg
Tablet prepares by common mode according to operation well known in the art.
Instruction: on an empty stomach every day one to two tablet of tablet.
Embodiment 2
Be used for preventing AIDS (simplifying prescription) the crowd
Selenium (as 0.1% ferment compound) 200 μ g
Niacinamide 20mg
Folic acid 1mg
Calcium carbonate 400mg
Trace quantity mineral source 100mg
Embodiment 3
Be used for preventing AIDS (reinforcing formulation) the crowd
Selenium:
Selenium (as 0.1% ferment compound) 0.3mg
Selenium (as amino acid complex) 0.1mg
Total selenium 0.4mg
Glutathione:
L-cysteine 400mg
MSM 200mg
Riboflavin 5mg
Niacinamide 20mg
Antimutagen
Folic acid 1.0mg
The acidity hierarchy of control:
Calcium carbonate 500mg
Basic magnesium carbonate 400mg
Trace minerals
Seawater extract (or soil trace element of purifying) 300mg
B)
Be used for the treatment of the asymptomatic patient (asymptomatic HIV positive patients) who contacts HIV virus
Embodiment 4
Every day dosage:
Selenium:
Selenium (as 0.2% amino acid complex) 0.2mg
Selenium (as 0.1% selenium yeast) 0.2mg
Total selenium 0.4mg
The glutathione source:
N-acetyl cysteine 300mg
L-cysteine 500mg
Riboflavin 5mg
Niacinamide 20mg
MSM 200mg
Gene protection agent (anti-mutagenesis compound):
Folic acid 5.0mg
Chlorophyllin 300mg
Antiinflammatory:
Quercetin 300mg
Mineral matter:
Calcium carbonate 500mg
Basic magnesium carbonate 200mg
Trace minerals:
Seawater extract 300mg
Vitamin:
Pyridoxine (as the pyridoxine hydrochloride) 5mg
Vitamin E (as the d-alpha-tocopherol acetate) 20mg TE
Probio:
The mixture 500mg of the living enteric microorganism of benefit
Embodiment 5
Be used for prophylactic treatment HIV positive patients (reinforcing formulation)
Every day dosage:
Selenium:
Selenium (as 0.2% amino acid complex) 0.1mg
Selenium (as selenium yeast) 0.3mg
Total selenium 0.4mg
The glutathione source:
L-cysteine 400mg
Riboflavin 5mg
Nicotinic acid 20mg
MSM 300mg
DNA protective agent (anti-mutagenesis compound):
Chlorophyllin 300mg
Folic acid 5mg
Homocysteine control:
Betaine 300mg
Antiinflammatory:
Quercetin 500mg
Mineral matter (acidity controlling agent):
Potassium citrate 400mg
Calcium carbonate 500mg
Magnesium (as oxide) 200mg
The trace mineral sources:
Zinc oxide 30mg
Manganese (as citrate or sulfate) 5mg
Vitamin:
Pyridoxine (as hydrochloride) 5mg
D-alpha-tocopherol acetate (vitamin E) 20mg TE
Probio:
The freeze-dried mixture 500mg of enteron aisle probiotic microorganisms
Operation instruction: 6-10 sheet every day, divided dose, administered at empty stomach are used.
This product can be with the beverage of tablet, capsule, Caplet, powder, special preparation or the form administration of food or any carrier that other is fit to.
C) be used for the treatment of clinical AIDS
Embodiment 6
Every day dosage:
Selenium:
Selenium (as selenomethionine) 0.26mg (=0.1mg Se)
Selenium (as 0.1% selenium yeast) 100mg (=0.1mg Se)
Selenium (as amino-acid chelate, 0.2%) 100mg (=0.2mg Se)
Selenium (complexing as coral calcium) 500mg (=0.01mg Se)
Total selenium 0.41mg
Lithium is as Orotate 5mg
The glutathione source:
Alpha-lipoic acid 400mg
N-acetyl cysteine 600mg
L-cysteine 400mg
Riboflavin 5mg
MSM 500mg
Niacinamide 40mg
Gene protection agent (anti-mutagenesis compound):
Chlorophyllin 300mg
Indole-3-carbinol (I-3-C) 500mg
Folic acid 5mg
Homocysteine control:
Betaine (trimethylglycine) 300mg
The basicity improving agent:
Calcium (200mg) is as coral calcium 1000mg
Basic magnesium carbonate 300mg
Potassium citrate 400mg
The pipe intestinal protection agent:
L-glutamine 1000mg
The probiotic's culture based mixtures 300mg of freeze-drying
The cell factor control system:
Folium urticae extract 1% 500mg
Quercetin 1000mg
Additional nutrient thing and antioxidant:
Zinc oxide (=30mg zinc) 37.34mg
Pyridoxine HCl 12.2mg
D-alpha-tocopherol acetate 30mg
Ascorbic acid 200mg
Dosage: 10-12 sheet every day, divided dose, administered at empty stomach are used.
Annotate: this prescription is fit to be used in combination with patient's AIDS drug therapy, and expection can be strengthened the most effect in these medicines.
Embodiment 7
The serious nutritional deficiency of correcting patient AIDS (does not comprise selenium; Except selenium preparation with external administration)
L-tryptophan 500mg
L-cysteine 500mg
L-glutamine 500mg
Zinc (as amino-acid chelate) 30mg
Vitamin:
Vitamin B1 (thiamine) 10mg
Pyridoxine (vitamin B6) 5mg
Vitamin E (as the d-alpha-tocopherol acetate) 30TE
Nicotinic acid 50mg
Vitamin A 4000mcgRE
Beta carotene 30mg
D-calcium pantothenate 20mg
Ascorbic acid 500mg
Cobalamin 100mcg
Folic acid 5mg
Riboflavin 5mg
Biotin 0.2mg
Manganese (as citrate or sulfate) 5.0mg
Vitamin C 300mg
Magnesium (as oxide) 100mg
Operation instruction: 4-6 sheet every day, divided dose, every day, administered at empty stomach was used.
This product can be with tablet, capsule, Caplet, form of powder administration, or introduces in the food that is fit to or as specialty beverages.
The administration of product according to the present invention in whole population
The control that HIV/AIDS is popular need be treated the entire population.Because tangible reason, this is impossible with common drug.In the past, education and sociological method have also been failed largely, mainly are because they depend on the enthusiastic cooperation of the individuality in the dangerous population.Remaining selection scheme is that anti-AIDS preparation is administered into suitable carrier, food for example, and drinking water is in the beverage of special preparation etc.
The present invention especially is suitable for this type of purpose because of underlying cause:
According to product of the present invention is tasteless to a great extent.
The effect of product only just can be seen (several weeks are to the several months) after long term administration, this makes it be particularly suitable for this class administration.
The amount that daily requirement is few relatively.
Product is stable.
Product is nontoxic, even when by child's permanent consumption.
Product has other health advantages except suppressing the HIV virus multiplication.For example, the selenium in preparation works as powerful antioxidant, and this has especially protected immune system, thereby has increased the resistance of many other infection that target demographic is suffered.
The most tangible carrier that is used for the administration product is to add product to by target demographic some basic foods that everyone consumed such as in the corn flour.
Enrichment is according to product of the present invention in corn flour
Following non-limiting examples has illustrated the purposes of prescription enrichment in corn flour of the present invention:
According to corn flour additive of the present invention (MFA)
Embodiment 8
Corn flour additive (low-level) (MFA)
Annotate: this product is used for low-risk population
Following ingredients is fully mixed, to prepare additive:
| Additive | Daily dose | ％ | The 1kg additive |
| Selenium 0.1%AAC, (=200 μ g Se) folic acid niacinamide riboflavin NAC calcium carbonate, (=108mg Ca) magnesia, (=40mg Mg) | 200mg 2.0mg 10mg 2mg 50mg 270mg 66mg 600mg | 33.3 0.33 1.67 0.33 8.33 45 11 | 333g 3.3g 16.7g 3.3g 83.3g 450g 110g 1000g |
In order to prepare the corn flour of enrichment, the MFA of 200g is added in the corn flour of 100kg.
Embodiment 9
Corn flour additive (high level) (MFA-H)
Annotate: this product purpose is used for excessive risk population.
| Additive | Daily dose | ％ | The 1kg additive |
| Selenium AAC 0.1% (=400 μ g Se) L-cysteine riboflavin folic acid calcium carbonate (=500mg Ca) magnesia (=100mg Mg) | 0.4mg 400mg 5mg 2mg 750mg 166mg | 0.032 16.01 0.5 0.16 60.05 13.29 | 0.32g 160g 4.0g 1.6g 600.5g 132.9g |
| Pyridoxine HCl (=5mg vitamin B6) niacinamide NAC | 6.1mg 20mg 100mg 1449.5mg | 0.49 1.6 8.06 | 4.9g 16g 80.6g 1000g |
In order to prepare the corn flour of enrichment, the additive of 417g fully is mixed in the corn flour of 100kg.
Embodiment 10
Multivitamin/the mineral supplements that is used for patient AIDS
| Composition | Active matter dosage every day: | Material | The QTY material |
| Selenium folic acid niacinamide Glu vitamin A thiamine riboflavin pyridoxine vitamin C vitamin E magnesium calcium zinc pantothenic acid copper | 0.4mg 1.0mg 30mg 1000mg 3000IU 2mg 2mg 5mg 100mg 20RE 100mg 300mg 20mg 5mg 1mg | 0.2% amino-acid chelate folic acid niacinamide Glu Type500CWS 500IU/mg thiamine .HCl riboflavin pyridoxine .HCl Type EC coated Roche d-alpha-tocopherol acetate magnesia calcium carbonate zinc oxide calcium d-Panthotenate copper sulphate .5H2O | 200mg 1.0mg 30mg 1000mg 6mg 2.3mg 2mg 6.1mg 111.1mg 23.1mg 164mg 750mg 25mg 5.4mg 3.93mg |
Dosage: 2, every day 2 times, take during dining
Embodiment 11
The soybean type that is used for patient AIDS is strengthened protein beverage
| Composition | Active matter | Material | The QTY material |
| Soybean selenium folic acid L-cysteine calcium magnesium pyridoxine | Soy meal 200 μ g 1mg 100mg 100mg 50mg 2mg | Soymilk powder selenium AAC 0.2% folic acid Cys calcium carbonate magnesia pyridoxine .HCl | 10g 0.1g 1mg 100mg 250mg 83mg 2.4mg |
Dosage: in one glass of milk, fruit juice or water, mix the 2-3 teaspoon.
Other embodiment
The application of following non-limiting example explanation the present invention in different population clusters and different clinical settings.
Embodiment 12
Parenterai administration according to product of the present invention
A. prepare the solution that every liter of physiological saline contains following ingredients and be used for intravenous administration:
| Preferably | Scope | |
| L-methylselenocysteine GSH riboflavin niacinamide folic acid saleratus alpha-lipoic acid | (40.5mg=10mg selenium) 20.0mg 100mg 250mg 100mg 500mg 400mg | 5-200mg 10-500mg 10-1000mg 20-1000mg 10-500mg 100-2000mg 100-800mg |
After each composition is dissolved in solvent, solution is transferred to pH7.4, this solution comes degerming according to technology known in the art with filtration then.
After filtration, sterile solution is assigned to dark 20ml phial or is used in other dark container that is fit to of sterile liquid storage under 4 degrees centigrade.This solution contains (every 20ml phial) following active ingredients:
L-methylselenocysteine 0.81mg (200mg Se)
L-glutathione 0.4mg
Riboflavin Tetrabutyrate .0mg
Niacinamide 5.0mg
Folic acid 2.0mg
Saleratus 10mg
Alpha-lipoic acid 8mg
For administration, a phial (20ml) dilutes with the 20ml sterile saline solution, 20-25 minute slow intravenous injection of time of this mixture.In the incipient stage, 1-2 phial be administration 3 times weekly by this way, altogether 2 weeks.After this, and depend on patient's state, dose frequency can reduce to 1-2 time weekly.Said preparation should come administration by the personnel of practising medicine.
B. the solution that the physiological saline for preparing every 200ml contains following ingredients is used for the intramuscular injection administration of product:
| Example | Scope | |
| L-methylselenocysteine GSH riboflavin niacinamide folic acid saleratus alpha-lipoic acid | (40.5mg=10mg selenium) 20.0mg 100mg 250mg 100mg 500mg 400mg | 5-200mg 10-500mg 10-1000mg 20-1000mg 10-500mg 100-2000mg 100-800mg |
After each composition is dissolved in solvent, solution is transferred to pH7.4, this solution comes degerming according to technology known in the art with filtration then.
After filtration, sterile solution is assigned to dark 5ml phial or is used in other dark container that is fit to of sterile liquid storage under 4 degrees centigrade.
This solution contains (every 5ml phial) following active ingredients:
L-methylselenocysteine 0.81mg (200mcg Se)
L-glutathione 0.4mg
Riboflavin Tetrabutyrate .0mg
Niacinamide 5.0mg
Folic acid 2.0mg
Saleratus 10mg
Alpha-lipoic acid 8mg
For administration, a phial (5ml) comes administration with dark intramuscular injection.In the incipient stage, 1-2 phial be administration 3 times weekly by this way, altogether 2 weeks.After this, and depend on patient's state, dose frequency can reduce to 1-2 time weekly.Said preparation should come administration by the personnel of practising medicine.
Embodiment 13
Be used for the treatment of the selenium prescription that HIV infects the pregnant woman: after the end of gestation reached in three months
Every day dosage:
Selenium:
Selenium (as 0.2% amino acid complex) 0.1mg
Selenium (as 0.1% ferment compound) 0.2mg
Selenium (as selenomethionine) 0.1mg
Total selenium 0.4mg
The glutathione source:
L-cysteine 400mg
MSM (methyl sulfonyl methane) 400mg
Riboflavin 5mg
Niacinamide 50mg
Antimutagen:
Folic acid 5.0mg
The acidity hierarchy of control:
Potassium citrate 400mg
Calcium carbonate 500mg
Basic magnesium carbonate 500mg
Be used to control homocysteine:
Trimethylglycine
500mg
2760.8mg
Prepare tablet or capsule or Caplet according to operation well known in the art.
Operation instruction: every day the 4-5 sheet, divided dose, administered at empty stomach is used.
Embodiment 14
The neonatal selenium prescription that is used for the treatment of the positive mother's birth of HIV
The daily dose of per kilogram of body weight
Selenium:
Selenium (as methylselenocysteine) 5.0mcg
The glutathione source:
N-acetyl cysteine 3.0mg
Riboflavin 0.07mg
Niacinamide 0.3mg
Alpha-lipoic acid 25mg
Antimutagen:
Folic acid 0.05mg
The control homocysteine level:
Vitamin B6 0.05mg
Cobalamin 3.0mcg
Trimethylglycine (betaine) 10mg
Glucose: 50mg
Tablet disintegrant: 50mg
Prepare the rapid disintegration tablet that every tablet contains above amount according to operation well known in the art.
Operation instruction: dissolving requisite number purpose tablet (determining by body weight) in breast milk of collecting or infant formula makes total every day dosage to be no less than the mode administration of 3 feedings.Therefore, baby's daily requirement of body weight 5kg 5 tablets of tablets that are dissolved in the milk altogether.This dosage should use once to feed and give 1 so, feeds 5 times mode administration on the 1st.
Embodiment 15
Multivitamin/the mineral preparations (combining) that is used for the HIV positive pregnant women with embodiment 12
Every day dosage:
The normally devoid component of patient AIDS:
Vitamin A 1500mcg RE
Beta carotene 20mg
Pyridoxine 25mg
Ascorbic acid 500mg
Vitamin E 50mgTE
Cobalamin 50mcg
Folic acid 5mg
Alpha-lipoic acid 300mg
Quercetin 500mg
Magnesium (as oxide) 200mg
Zinc (as oxide) 50mg
Additional collaborative component:
Thiamine (as hydrochloride) 10mg
Riboflavin 5mg
Nicotinic acid 30mg
D-calcium pantothenate 20mg
Biotin 0.2mg
Embodiment 16
The quick disintegration multivitamin/mineral formulations that is used for the baby:
Per kilogram of body weight every day:
The normally devoid vitamin of the positive baby of HIV:
Vitamin A 20mcg RE
Beta carotene 0.2mg
Pyridoxine 0.3mg
Ascorbic acid 10mg
Vitamin E 0.7mgTE
Cobalamin 0.7mcg
Folic acid 0.07mg
Alpha-lipoic acid 2.0mg
Quercetin 5.0mg
Inose 1.0mg
L-carnitine 5.0mg
Magnesium (as chelate) 3mg
Zinc (as chelate) 0.7mg
The collaborative compound:
Thiamine 0.1mg
Riboflavin 0.07mg
Niacinamide 0.3mg
D-calcium pantothenate 0.2mg
Biotin 0.002mg
Embodiment 17
The nutritious supplementary pharmaceutical that is used for HIV+ women
Every day dosage:
Whey protein concentrate 40g (=28g albumen)
Soymilk powder 100g (=12g albumen)
Chinese sorghum ground rice 100g
Sweetener is an amount of
Flavouring agent
In right amount
240g
List of references
1.Foster HD″The real cause of AIDS″，Trafford Publishing，Victoria，Canada，2002
2.UNAIDS/WHO Epidemiological fact sheets，2000，updated。
3.Seattle Post Intelligentser, August 12 calendar year 2001.
4.AIDS in Botswana, Economist, August 12 calendar year 2001.
5.AIDS, Unhappy Anniversary, Economist, December calendar year 2001, the 76th page
6.Cheng Y-Y, Qian P-C, Internat Symp on Environm Life Elements andHealth, Bejing, 1988, the 241 pages
7.Biol Trace Elem Res 1997，56：43。
8.Passwater R，″Selenium as food and Medicine″，Keats Publishing，NewCanaan，Connecticut。
9.Med Hyp 1999，53：375。
10.Chem Biol Interact 1994，91：199。
Following claim is considered to a part of this disclosure. Employed term " comprises " or " comprising " has its habitual non-limiting implication in this paper and the claim, and this represents can comprise other project of specifically not mentioning except any project that this term relates to.
Claims (45)
1. the bond of nutritional supplement composition or composition, it comprises:
A) one or more biologically can absorb and acceptable selenium compound;
It is characterized in that a) and one or more synergistic combination that strengthens the material that physiology selenium absorb that described material especially is selected from one or more in the following material:
B) can absorb on one or more physiology and acceptable glutathione (GSH) source or its precursor;
C) can absorb on one or more physiology and acceptable blood basicity improves component;
D) can absorb on the physiology and acceptable sulphur source;
E) can absorb on one or more physiology and acceptable anti-mutagenesis compound;
And under the situation of composition for oral administration,
F) the stomach and intestine absorption enhancer of one or more selenium,
And/or in bond, do not need and a) synergistic g):
G) one or more stomach and intestine protective agents.
2. the bond of composition as claimed in claim 1 or composition, wherein these one or more selenium compounds are selected from selenocysteine, selenomethionine, methylselenocysteine (MSC), the methyl selenomethionine, the alkali metal selenite, Selenicel, the material that in commerce, is called " selenoaminoacid chelate ", in conjunction with the albumen of selenium, the selenium analog of sulfur-containing amino acid, the amino acid complex of selenium, with the selenium of coral calcium complexing, the analog of above-mentioned substance and derivative, and the bond of multiple above-mentioned substance.
3. the bond of composition as claimed in claim 1 or 2 or composition; wherein glutathione source or glutathione precursor are selected from the acyl group cysteine; N-acetyl cysteine (NAC); N-propiono cysteine; N-butyl cysteine; lipoic acid, methyl sulfonyl methane (MSM), the bond of the analog of above-mentioned substance and derivative and multiple above-mentioned substance.
4. as each the described composition of claim 1-3 or the bond of composition, wherein blood basicity improves calcium, magnesium and the potassium compound that compound is selected from raising basicity, lactate, citrate, tartrate, malate, or other tartaric acid salt of above-mentioned substance, calcium carbonate, magnesium carbonate, basic magnesium carbonate, magnesia, dolomite, coral calcium, the bond of the analog of above-mentioned substance and derivative and above-mentioned multiple material.
5. as each the described composition of claim 1-4 or the bond of composition; wherein the sulphur source is selected from cysteine; methyl sulfonyl methane (MSM); sulfur-containing amino acid; cystine, lanthionine, sulfur-bearing polypeptide; alkali metal thiosulfate, the bond of the analog of above-mentioned substance and derivative and multiple above-mentioned substance.
6. as each the described composition of claim 1-5 or the bond of composition, wherein anti-mutagenesis compound is selected from chlorophyllin, indole-3-carbinol (I3C), folic acid, nicotinic acid, niacinamide, the bond of the analog of above-claimed cpd and derivative and multiple above-claimed cpd.
7. as each the described composition of claim 1-6 or the bond of composition, wherein the pipe intestinal protection agent is selected from the L-glutamine, the bond of the analog of above material or derivative and multiple above-mentioned substance.
8. as each the described composition of claim 1-7 or the bond of composition, wherein the gastrointestinal absorption reinforcing agent of selenium is selected from the analog of pipering, L-glutamine, above-mentioned substance and the bond of derivative and multiple above-mentioned substance.
9. as each the described composition of claim 1-8 or the bond of composition, wherein a) with b) to g) and in two or more combine.
10. as each the described composition of claim 1-9 or the bond of composition, wherein a) with b) and c) combine.
11. as each the described composition of claim 1-10 or the bond of composition, wherein a) with b) and c) and d) and e) at least a combination in the two.
12. as each the described composition of claim 1-11 or the bond of composition, wherein at least a compound plays a) g) more than one function of class.
13. as each the described composition of claim 1-12 or the bond of composition, wherein a) to g) class all is provided.
14. as each the described composition of claim 1-13 or the bond of composition, it is the form of oral administration.
15. the bond of composition as claimed in claim 14 or composition, it is oral Galenic formula form.
16. the bond of composition as claimed in claim 14 or composition, it is as the bond preparation of composition of introducing in food or feed or beverage with preparation or composition.
17. the bond of composition as claimed in claim 14 or composition, it is introduced in food or feed or beverage.
18. the bond of composition as claimed in claim 14 or composition, it is the form of the material in the corn flour, tapioca starch, baked wheat flour, bread and the mahewu that are selected from each the defined composition that is rich in claim 1-13 (annotate: mahewu is the pulpous state food in Africa, and it prepares by the lactic fermentation from the starch of corn flour or cornstarch usually).
19. as each the described composition of claim 1-13 or the bond of composition, it is the form that is suitable for parenterai administration.
20. the bond of composition as claimed in claim 19 or composition, it is the form that is suitable for intravenous injection or perfusion.
21., it is characterized in that it comprises the lithium source as each the described composition of claim 1-20 or the bond of composition.
22. the bond of composition as claimed in claim 21 or composition, wherein the lithium source is selected from following organic lithium salt: the orotic acid lithium, the aspartic acid lithium, aliphatic acid, polyunsaturated fatty acid, be present in the cell membrane phospholipid those, DHA, EPA,
-leukotrienes, palmitic acid, stearic acid and be present in other sour lithium salts in the biomembrane, or the bond of lithium selenite or lithium selenate and multiple above-mentioned substance.
23. the bond of composition as claimed in claim 21 or composition is characterized in that it contains the lithium source of " ultralow " dosage unit of 20-500mcg lithium.
24. as each the described composition of claim 1-23 or the bond of composition, it is characterized in that it comprises the material that improves the internal pH level, this material is selected from potassium and magnesium compound, caesium and rubidium compound, any above-mentioned substance that combines with the calcium source and the bond of multiple above-mentioned substance.
25. as each the described composition of claim 1-24 or the bond of composition, it is characterized in that it contains humic acid and/or fulvic acid and/or biological flavone and/or GSH, the bond of the analog of above-mentioned substance and derivative and multiple above-mentioned substance.
26. as each the described composition of claim 1-25 or the bond of composition, it is characterized in that it contains with the following substances is the micronutrient of representative: be selected from the mineral supplements in magnesium, manganese and the zinc, and/or be selected from the vitamin among vitamin A, B2, B3, B6, C, carrotene and the E and the bond of multiple above-mentioned substance.
27. as each the described composition of claim 1-26 or the bond of composition, it is characterized in that it contains the material that one or more regulate cytokine activities, it is selected from the material that suppresses tumor necrosis factor (TNF α) and interleukin 1 and 6, the folium urticae extract, PTX, curcumin, antioxidant, NAC, alpha-lipoic acid, the bond of the analog of above-mentioned substance and derivative and multiple above-mentioned substance.
28., it is characterized in that it comprises the material that reduces homocysteine level in the blood or the bond of material as each the described composition of claim 1-27 or the bond of composition.
29. the bond of composition as claimed in claim 28 or composition is characterized in that it comprises trimethylglycine (TMG).
30. as each the described composition of claim 1-29 or the bond of composition, it is characterized in that it is included in contains the amino acid whose alternative nutrients that contains in the selenium glutathione peroxidase system, it is selected from cysteine, glutamine, tryptophan, the bond of the precursor of above-mentioned substance, derivative and analog and multiple these materials.
31., it is characterized in that it is used for suppressing human or animal's virus replication and/or virus mutation as each the described composition of claim 1-30 or the bond of composition.
32. as each the described composition of claim 1-31 or the bond of composition, it is used for prevention or treatment HIV/AIDS.
33. the purposes as the bond of each the described composition of claim 1-32 or composition, the immune system that it is used to suppress virus replication and/or sudden change and/or is used to strengthen the human or animal.
34. purposes as claimed in claim 33, it is used for prevention or treatment HIV/AIDS.
35. the purposes of the bond of alimentation composition or composition, the bond of described alimentation composition or composition comprises:
A) one or more biologically can absorb and acceptable selenium compound, itself and one or more following material synergistic combination:
B) can absorb on one or more physiology and acceptable glutathione (GSH) source or its precursor;
C) can absorb on one or more physiology and acceptable blood basicity improves component;
D) can absorb on the physiology and acceptable sulphur source;
E) can absorb on one or more physiology and acceptable anti-mutagenesis compound;
And under the situation of composition for oral administration,
F) the stomach and intestine absorption enhancer of one or more selenium,
And/or in bond, do not need and a) synergistic g):
G) one or more stomach and intestine protective agents,
It is characterized in that it be applied to before the childbirth, during or treat the HIV positive pregnant women afterwards, so that lower their HIV virus load, and/or strengthen their immune system and/or alleviate or postpone the beginning of AIDS symptom and/or reduce the risk of mother-to-baby transmission (MTCT) and/or opposing to the fetus and the neonatal influence of mother-to-baby transmission (MTCT), and/or the ewborn infant for the treatment of this women.
36. purposes as claimed in claim 35, the bond that it is characterized in that said composition or composition comprises one or more in the following material:
(i) one or more anti-inflammatory compounds are particularly suited for controlling proinflammatory cytokine;
(ii) control the nutrients of homocysteine level;
(iii) multivitamin/mineral preparations is especially prepared the shortage feature that is used to resist HIV positive pregnant women and/or positive mother of neonatal HIV and their baby.
37. as claim 35 or 36 described purposes, it is characterized in that being or comprising non-enteron aisle selenium prescription, and use three middle of the month, especially in the living phase process of enclosing of HIV positive pregnant women, use at the end of gestation.
38. as claim 35 or 36 described purposes, the bond that it is characterized in that said composition or composition is or comprises non-enteron aisle selenium prescription, and uses in the positive mother's of HIV ewborn infant, especially in postnatal preceding 3 middle of the month.
39. as each described purposes of claim 35-38, the bond that it is characterized in that said composition or composition comprises one or more glutathione sources and/or strengthens the combination of material and one or more materials that alkalize of the activity of glutathione oxidation-reduction system.
40. purposes as claimed in claim 39 is characterized in that preparing this one or more alkalization material to obtain the daily dose scope according to following table:
41. as each described purposes of claim 35-40, the bond that it is characterized in that said composition or composition comprises or multinomial described feature as claim 2-31.
42., it is characterized in that it is applied to treat HIV/AIDS, and further in the bond of composition or composition, comprise the probio source as each described purposes of claim 33-41.
43., it is characterized in that it is applied to treat HIV/AIDS, and further in the bond of composition or composition, comprise whey protein concentrate as each described purposes of claim 33-42.
44. purposes as claimed in claim 34, it is characterized in that, for the HIV/AIDS in control area's population popular, this population is layered as a plurality of different risk group, according to providing the bond of different components or composition to the different risk orders of magnitude in serious HIV positive person's the risk range at low-risk=low disease incident.
45. purposes as claimed in claim 44 is characterized in that the crowd is layered as following at least 5 risk group:
1.) low-risk, low disease incident group, the HIV incidence is minimum;
2.) normal risk group: the HIV state of the general individuality of failing to understand, but, be considered to have average infection risk by on average;
3.) HIV positive person, its still essentially no AIDS symptom, and its CD4 counting is more than the level that needs the antiretroviral drugs treatment;
4.) have the clinical HIV positive person that low CD4 counts, observed the symptom of the definite opportunistic infections of AIDS in it;
5.) the CD4 counting is lower than the serious HIV positive patients of 200/mcl.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ZA200304360 | 2003-06-04 | ||
| ZA2003/4360 | 2003-06-04 | ||
| ZA2003/5112 | 2003-07-01 | ||
| ZA2003/6713 | 2003-08-28 | ||
| ZA2004/0053 | 2004-01-06 |
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| CN1829453A true CN1829453A (en) | 2006-09-06 |
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| CN108853048A (en) * | 2018-07-02 | 2018-11-23 | 郑州博凯医药保健品有限公司 | Organic selenium effervescent tablet and preparation method thereof |
| CN114867466A (en) * | 2019-12-17 | 2022-08-05 | 巴克斯特国际公司 | Parenteral nutritional solution comprising a selenium source |
| WO2023016471A1 (en) * | 2021-08-10 | 2023-02-16 | 武汉远大弘元股份有限公司 | Composition, formulation, preparation method and use for glutathione precursor |
-
2004
- 2004-06-03 CN CNA2004800220398A patent/CN1829453A/en active Pending
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| CN105555150A (en) * | 2013-04-19 | 2016-05-04 | 艾克提格诺米克斯股份公司 | Composition for enhancing immunity |
| CN108853048A (en) * | 2018-07-02 | 2018-11-23 | 郑州博凯医药保健品有限公司 | Organic selenium effervescent tablet and preparation method thereof |
| CN114867466A (en) * | 2019-12-17 | 2022-08-05 | 巴克斯特国际公司 | Parenteral nutritional solution comprising a selenium source |
| WO2023016471A1 (en) * | 2021-08-10 | 2023-02-16 | 武汉远大弘元股份有限公司 | Composition, formulation, preparation method and use for glutathione precursor |
| CN115702910A (en) * | 2021-08-10 | 2023-02-17 | 武汉远大弘元股份有限公司 | Composition of glutathione precursor, preparation method and application |
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