WO2010050179A1 - 5-アミノレブリン酸若しくはその誘導体、又はそれらの塩を有効成分とする成人病の予防・改善剤 - Google Patents
5-アミノレブリン酸若しくはその誘導体、又はそれらの塩を有効成分とする成人病の予防・改善剤 Download PDFInfo
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- WO2010050179A1 WO2010050179A1 PCT/JP2009/005651 JP2009005651W WO2010050179A1 WO 2010050179 A1 WO2010050179 A1 WO 2010050179A1 JP 2009005651 W JP2009005651 W JP 2009005651W WO 2010050179 A1 WO2010050179 A1 WO 2010050179A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- iron
- ala
- adult diseases
- aminolevulinic acid
- sodium
- Prior art date
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- ZGXJTSGNIOSYLO-UHFFFAOYSA-N 88755TAZ87 Chemical compound NCC(=O)CCC(O)=O ZGXJTSGNIOSYLO-UHFFFAOYSA-N 0.000 title claims abstract description 124
- 229960002749 aminolevulinic acid Drugs 0.000 title claims abstract description 116
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 title claims abstract description 91
- 201000010099 disease Diseases 0.000 title claims abstract description 87
- 239000003795 chemical substances by application Substances 0.000 title claims abstract description 19
- 150000003839 salts Chemical class 0.000 title claims abstract description 13
- 230000000069 prophylactic effect Effects 0.000 title claims abstract 4
- 239000004480 active ingredient Substances 0.000 title description 6
- 239000000203 mixture Substances 0.000 claims abstract description 33
- 206010012601 diabetes mellitus Diseases 0.000 claims abstract description 27
- 235000013305 food Nutrition 0.000 claims abstract description 27
- 238000000034 method Methods 0.000 claims abstract description 26
- 230000006872 improvement Effects 0.000 claims abstract description 22
- JHYAVWJELFKHLM-UHFFFAOYSA-H tetrasodium;2-hydroxypropane-1,2,3-tricarboxylate;iron(2+) Chemical compound [Na+].[Na+].[Na+].[Na+].[Fe+2].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O JHYAVWJELFKHLM-UHFFFAOYSA-H 0.000 claims abstract description 16
- 239000000463 material Substances 0.000 claims abstract description 14
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- 235000020824 obesity Nutrition 0.000 claims abstract description 12
- 208000031226 Hyperlipidaemia Diseases 0.000 claims abstract description 11
- 206010020772 Hypertension Diseases 0.000 claims abstract description 11
- 208000008035 Back Pain Diseases 0.000 claims abstract description 10
- 208000010228 Erectile Dysfunction Diseases 0.000 claims abstract description 10
- 201000001881 impotence Diseases 0.000 claims abstract description 10
- 150000002506 iron compounds Chemical class 0.000 claims abstract description 10
- 208000001145 Metabolic Syndrome Diseases 0.000 claims abstract description 8
- 201000000690 abdominal obesity-metabolic syndrome Diseases 0.000 claims abstract description 8
- 208000001647 Renal Insufficiency Diseases 0.000 claims abstract description 7
- 201000006370 kidney failure Diseases 0.000 claims abstract description 7
- 238000002360 preparation method Methods 0.000 claims abstract description 5
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims description 82
- 229910052742 iron Inorganic materials 0.000 claims description 40
- 150000003278 haem Chemical class 0.000 claims description 18
- 230000009245 menopause Effects 0.000 claims description 8
- QPCDCPDFJACHGM-UHFFFAOYSA-N N,N-bis{2-[bis(carboxymethyl)amino]ethyl}glycine Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(=O)O)CCN(CC(O)=O)CC(O)=O QPCDCPDFJACHGM-UHFFFAOYSA-N 0.000 claims description 7
- 208000019423 liver disease Diseases 0.000 claims description 7
- 230000005976 liver dysfunction Effects 0.000 claims description 7
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 claims description 6
- QGZKDVFQNNGYKY-UHFFFAOYSA-O Ammonium Chemical compound [NH4+] QGZKDVFQNNGYKY-UHFFFAOYSA-O 0.000 claims description 5
- 239000011640 ferrous citrate Substances 0.000 claims description 5
- 235000019850 ferrous citrate Nutrition 0.000 claims description 5
- KXFFQVUPQCREHA-UHFFFAOYSA-K sodium;2-hydroxypropane-1,2,3-tricarboxylate;iron(2+) Chemical compound [Na+].[Fe+2].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KXFFQVUPQCREHA-UHFFFAOYSA-K 0.000 claims description 4
- 229920002307 Dextran Polymers 0.000 claims description 3
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- 238000008416 Ferritin Methods 0.000 claims description 3
- PMVSDNDAUGGCCE-TYYBGVCCSA-L Ferrous fumarate Chemical compound [Fe+2].[O-]C(=O)\C=C\C([O-])=O PMVSDNDAUGGCCE-TYYBGVCCSA-L 0.000 claims description 3
- 229910021578 Iron(III) chloride Inorganic materials 0.000 claims description 3
- 102000010445 Lactoferrin Human genes 0.000 claims description 3
- 108010063045 Lactoferrin Proteins 0.000 claims description 3
- 102000004338 Transferrin Human genes 0.000 claims description 3
- 108090000901 Transferrin Proteins 0.000 claims description 3
- JVOGSHDZLOJKKR-MXFMKSRJSA-I [Na+].[Na+].[Na+].[Mg++].CCc1c(C)c2cc3[n-]c(c(C)c3C=C)c(C)c3nc(C[C@H]3CCC([O-])=O)c(CC([O-])=O)c3[n-]c(cc1n2)c(C)c3C([O-])=O Chemical compound [Na+].[Na+].[Na+].[Mg++].CCc1c(C)c2cc3[n-]c(c(C)c3C=C)c(C)c3nc(C[C@H]3CCC([O-])=O)c(CC([O-])=O)c3[n-]c(cc1n2)c(C)c3C([O-])=O JVOGSHDZLOJKKR-MXFMKSRJSA-I 0.000 claims description 3
- MDXRFOWKIZPNTA-UHFFFAOYSA-L butanedioate;iron(2+) Chemical compound [Fe+2].[O-]C(=O)CCC([O-])=O MDXRFOWKIZPNTA-UHFFFAOYSA-L 0.000 claims description 3
- VEPSWGHMGZQCIN-UHFFFAOYSA-H ferric oxalate Chemical compound [Fe+3].[Fe+3].[O-]C(=O)C([O-])=O.[O-]C(=O)C([O-])=O.[O-]C(=O)C([O-])=O VEPSWGHMGZQCIN-UHFFFAOYSA-H 0.000 claims description 3
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- 229960001645 ferrous gluconate Drugs 0.000 claims description 3
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- BAUYGSIQEAFULO-UHFFFAOYSA-L iron(2+) sulfate (anhydrous) Chemical compound [Fe+2].[O-]S([O-])(=O)=O BAUYGSIQEAFULO-UHFFFAOYSA-L 0.000 claims description 3
- PVFSDGKDKFSOTB-UHFFFAOYSA-K iron(3+);triacetate Chemical compound [Fe+3].CC([O-])=O.CC([O-])=O.CC([O-])=O PVFSDGKDKFSOTB-UHFFFAOYSA-K 0.000 claims description 3
- VRIVJOXICYMTAG-IYEMJOQQSA-L iron(ii) gluconate Chemical compound [Fe+2].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O VRIVJOXICYMTAG-IYEMJOQQSA-L 0.000 claims description 3
- YOBAEOGBNPPUQV-UHFFFAOYSA-N iron;trihydrate Chemical compound O.O.O.[Fe].[Fe] YOBAEOGBNPPUQV-UHFFFAOYSA-N 0.000 claims description 3
- CSSYQJWUGATIHM-IKGCZBKSSA-N l-phenylalanyl-l-lysyl-l-cysteinyl-l-arginyl-l-arginyl-l-tryptophyl-l-glutaminyl-l-tryptophyl-l-arginyl-l-methionyl-l-lysyl-l-lysyl-l-leucylglycyl-l-alanyl-l-prolyl-l-seryl-l-isoleucyl-l-threonyl-l-cysteinyl-l-valyl-l-arginyl-l-arginyl-l-alanyl-l-phenylal Chemical compound C([C@H](N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CS)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C=CC=CC=1)C(O)=O)C1=CC=CC=C1 CSSYQJWUGATIHM-IKGCZBKSSA-N 0.000 claims description 3
- 229940078795 lactoferrin Drugs 0.000 claims description 3
- 235000021242 lactoferrin Nutrition 0.000 claims description 3
- LQPLDXQVILYOOL-UHFFFAOYSA-I pentasodium;2-[bis[2-[bis(carboxylatomethyl)amino]ethyl]amino]acetate Chemical compound [Na+].[Na+].[Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CCN(CC(=O)[O-])CCN(CC([O-])=O)CC([O-])=O LQPLDXQVILYOOL-UHFFFAOYSA-I 0.000 claims description 3
- UEUXEKPTXMALOB-UHFFFAOYSA-J tetrasodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O UEUXEKPTXMALOB-UHFFFAOYSA-J 0.000 claims description 3
- 239000012581 transferrin Substances 0.000 claims description 3
- DKKCQDROTDCQOR-UHFFFAOYSA-L Ferrous lactate Chemical compound [Fe+2].CC(O)C([O-])=O.CC(O)C([O-])=O DKKCQDROTDCQOR-UHFFFAOYSA-L 0.000 claims description 2
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- 235000007144 ferric diphosphate Nutrition 0.000 claims description 2
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- 229940036404 ferric pyrophosphate Drugs 0.000 claims description 2
- ATEAWHILRRXHPW-UHFFFAOYSA-J iron(2+);phosphonato phosphate Chemical compound [Fe+2].[Fe+2].[O-]P([O-])(=O)OP([O-])([O-])=O ATEAWHILRRXHPW-UHFFFAOYSA-J 0.000 claims description 2
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Definitions
- the present invention relates to an agent for improving / preventing adult diseases comprising 5-aminolevulinic acid (hereinafter also referred to as “ALA”) or a derivative thereof, or a salt thereof as an active ingredient.
- ALA 5-aminolevulinic acid
- oral, intravenous injection, sublingual tablet The present invention relates to a composition for preventing and improving adult diseases such as diabetes, hyperlipidemia and hypertension administered by intraperitoneal administration, enteral infusion, transdermal agent, suppository, and the like, and a method for prevention and improvement.
- statin drugs For hyperlipidemia, health foods that suppress fat absorption and cholesterol metabolism inhibitors (so-called statin drugs) meet market needs, but statin drugs are said to lead to arteriosclerosis in the body. It is known to significantly lower cholesterol and at the same time suppress the supply of ubiquinone, etc. related to basal metabolism. Epidemiologically, the risk of myocardial infarction is slightly reduced, but on the other hand, the incidence of cancer is increased. The results of increasing the mortality rate have been reported and are considered problematic.
- anti-hypertensive agents that lower blood pressure with various inhibitors in addition to the old calcium antagonists are on the market and are a big market, but it is only a coping therapy and is not an approach to remove the root cause.
- antihypertensive drugs the efficacy of taking them has been discussed for epidemiological efficacy and side effects.
- liver dysfunction it is known that treatment with interferon is effective for viral liver dysfunction, but there is no effective means for reducing general liver function that is not viral. Rely on folk remedies. A certain effect is known empirically, such as bear's gall developed from herbal medicine, but the action mechanism and even the active ingredient is not specified. Although many health foods are sold as effective against blemishes and turmeric, the effect has not been proven. Further, a liver function improving agent mainly composed of protoporphyrin sodium has been used for a long time, but it is said that the effect is not sufficient, and photoinjury is known as a side effect.
- dialysis is often performed in the treatment, but it artificially performs the function of the kidney and is the best coping therapy, and has nothing to do with improving the function of the kidney.
- the improvement of kidney function depends on nutrients and folk remedies as well as liver. Dialysis is also the biggest factor in the rise in medical costs.
- Obesity is said to be the culprit of all adult diseases, but it is disliked, but there are no appropriate medicines, diet health foods and exercise that suppress absorption and digestion are recommended, and a huge market is formed.
- the burden is great not only financially but also mentally. Even if you take the same amount of meals, you will definitely gain fat as you age, but this is because absorption and digestion do not increase with age, and lack of exercise is not the main cause and basal metabolism is reduced. . There is no known approach to eliminate obesity by improving basal metabolism.
- Viagra As for erectile dysfunction, Viagra has developed an effective medicine that has improved the lives of many patients suffering from erectile dysfunction, but its mechanism of action is vasodilation, which causes physical erections when administered. It is not an erection associated with the original emotion, but at the same time causes risks such as heart disease. Even in this field, folk remedies such as corn and rhino horns, fur seals, and supine are widely used. However, they are not scientific at all, and there are many known examples that cause health problems. In other words, there is no known fundamental approach that focuses on the phenomenon of erection weakening with age.
- Menopause is generally said to be a combination of symptoms such as malaise and depression caused by hormonal imbalance in postmenopausal women, but recently men also have menopause and symptoms such as malaise and depression are similar to women. Is known to appear. In severe cases, hormone replacement therapy is administered to both men and women, but in women, the risk of breast cancer and uterine cancer increases with long-term administration, and the risk of myocardial infarction and stroke increases. It is regarded as a problem. For men, increased risk of prostate cancer is also regarded as a problem.
- Stiffness such as stiff shoulders and back pain is not a disease name but a symptom, but many people suffer from stiff shoulders and back pain as they age, such as acupuncture, jiu jitsu, massage, spa treatments, poultices, etc.
- Drugs are a big industry. Although there are many causes of stiffness such as stiff shoulders and low back pain, one of the main causes is stagnation of blood flow, and existing treatments and drugs are focused on improving this blood flow. It is clear from the large number of people who suffer from these symptoms associated with aging that various methods have been proposed but no effective means have yet been found.
- adult diseases are caused by basal metabolism that decreases with age as a common cause and distant cause, and basal metabolism falls. It can be redefined as the retention of sugar and fat in the blood, the leakage of active oxygen due to the failure of the energy production system, and the accumulation of genetic abnormalities caused by it. Therefore, the fundamental treatment and prevention of adult disease is how to keep the basic metabolism healthy, but as we have already seen, Western medicine deals with each phenomenon of adult disease with biochemical inhibitors. It is an attempt to try and is only a coping therapy, not a radical cure. It has a basic philosophy that it is important for oriental medicine and traditional medicine to maintain a fundamental basal metabolism, but as specific measures, it does not go beyond breathing, gymnastics, and the use of traditional medicinal herbs. The effect is not enough.
- ALA is known as an intermediate of the pigment biosynthetic pathway and is widely present in animals, plants and fungi, and is usually biosynthesized from succinyl CoA and glycine by 5-aminolevulinate synthetase. Although it itself has no photosensitizing action, it is said to induce protoporphyrin IX (PpIX) through the pigment biosynthesis pathway. Since it has been reported that skin cancer can be treated by applying ALA and irradiating light (for example, see Non-Patent Document 1), there are methods for diagnosing and treating lesions at various sites using ALA.
- PpIX when ALA or a derivative thereof or a salt thereof (hereinafter also referred to as “ALA”) is administered into the body, PpIX, which is considered to have tumor affinity, is biosynthesized and accumulated in tumor cells. PpIX photoirradiates surrounding oxygen molecules by photoirradiation, and the singlet oxygen produced as a result is considered to have a cytocidal effect due to its strong oxidative power. It has been proposed (see, for example, Patent Documents 1 to 3).
- bladder cancer can be detected by filling the bladder with a sensitizer solution containing ALAs from the urethra, irradiating light after a certain period of time, and observing fluorescence with a cystoscope
- a sensitizer solution containing ALAs from the urethra irradiating light after a certain period of time
- one or more compounds selected from 5-aminolevulinic acid, salts thereof, and ester derivatives thereof and iron compounds are effective.
- Hair growth agents see, for example, Patent Document 4
- rough skin prevention / improving agents see, for example, Patent Document 5
- An object of the present invention is to provide a pharmaceutical composition that can improve or prevent adult diseases by improving basal metabolism that decreases with aging, that is, a therapeutic agent for adult diseases caused by existing biochemical reaction inhibition type
- the improvement of basal metabolism is the mechanism of action, so to speak
- the rejuvenation of metabolism is the mechanism of action, there are no side effects, and no drug resistance of adult disease occurs, and the prevention and treatment method of adult disease using it Is to provide.
- ALA is said to be one of the organic compounds produced by the lightning energy of the atmosphere on the primitive earth 3.6 billion years ago.
- a tetrapyrrole compound consisting of 8 molecules of ALA has a very long resonance system and a very high molecular symmetry. Therefore, energy can be held, for example, light energy can be absorbed.
- protoporphyrin IX is accumulated in cancer by ALA administration, and cancer diagnostic and therapeutic agents combined with light irradiation are famous. Photodynamic diagnosis and photodynamics, respectively. It has been already put into practical use. Again, ALA is known as a toxic rather than killing cancer cells, and no one has anticipated an improvement or prevention effect on adult disease by improving basal metabolism.
- ALA is biosynthesized in the mitochondria by the condensation of glycine and succinyl CoA by aminolevulinate synthase.
- the biosynthesized ALA is once transferred to the cytoplasm, and two molecules are condensed by aminolevulinate dehydrogenase (porphobilinogen synthase) in the cell chamber to form a pyrrole ring, thereby forming porphobilinogen.
- the four porphobilinogen molecules form a porphyrin ring to form a tetrapyrrole structure, which is sequentially converted by an enzyme in the cytoplasm to become coproporphyrinogen III.
- Coproporphyrinogen III is taken up into mitochondria by ABC transporter, and is sequentially oxidized to protoporphyrin IX, and divalent iron is coordinated by ferrochelatase to become heme and cytochrome.
- Heme and cytochrome are constituent elements of the complexes II, III, and IV constituting the electron transport system, and cytochrome C directly carries electrons from the complexes III to IV.
- life of a person is defined by the life of the electron transport system, particularly the enzyme activity of Complex IV.
- the reaction centers of this electron transfer system are cytochrome and heme derived from ALA.
- ALA preferably ALA and iron
- basal metabolism is the most important mechanism of action. I thought.
- ALA preferably ALA and iron
- the TCA circuit works only when the electron transfer system is activated. If the TCA cycle works, acetyl CoA as a substrate is required, and sugar is consumed in the glycolysis system, so it is estimated that it leads to improvement of diabetes.
- ALA preferably ALA and iron
- the TCA circuit works only when the electron transfer system is activated. It was speculated that if the TCA cycle works, acetyl CoA as a substrate is required, and fatty acids are consumed by ⁇ -oxidation, leading to improvement of hyperlipidemia. Fatty acids are taken into the mitochondria as acyl CoA and undergo ⁇ -oxidation in the mitochondria.
- a fatty acid synthesis reaction occurs in the cytoplasm, but the consumption of sugar can be suppressed by administration of ALA and iron, so that the synthesis of fatty acid can also be expected to decrease.
- NO which is a vasodilator
- ALA preferably ALA and iron
- the degradation of toxic substances which is an important function of liver function, is caused by P450 having heme derived from ALA, preferably ALA and iron as the reaction center It is presumed that the mechanism of action is that toxic resolution is improved by administration of ALA, preferably ALA and iron.
- the target adult disease is renal failure (renal dysfunction)
- renal dysfunction in addition to improving basal metabolism and blood flow by vasodilation, the increase in heme and cytochrome induced by administration of ALA, preferably ALA and iron, It is considered that the action mechanism is to activate the activity of the ion pump, which is an important role of
- the target adult disease is obesity
- the most effective mechanism is that the heme and cytochrome of the electron transport system are enhanced by administering ALA, preferably ALA and iron, and so-called basal metabolism is improved. Conceivable. It seems that the improvement of basal metabolism makes it easier to resume exercise, which has been difficult due to aging, to help improve obesity.
- ALA has an action to increase the secretion of male hormone that decreases with age.
- the rate-limiting step of male hormone metabolism is hydroxylation by cytochrome P450scc in mitochondria, and it is presumed that the activity of the enzyme is improved by administration of ALA, preferably ALA and iron.
- ALA is presumed to have an important effect of increasing the secretion of sex hormones that decrease with age.
- the rate-limiting step of sex hormone metabolism is hydroxylation by cytochrome P450scc in mitochondria for both male and female hormones, and it is presumed that the activity of the enzyme is improved by administration of ALA, preferably ALA and iron.
- ALA preferably ALA and iron administration
- improved basal metabolism and blood vessel dilatation have led to significant therapeutic effects Inferred.
- the present inventors are a number of biochemists who understand what is an adult disease, what is an aging phenomenon, what is aging, and why a decrease in basal metabolism associated with aging occurs. Tackling the fundamental problems that have been avoided, and reducing mitochondrial activity, more specifically, weakening of the mitochondrial electron transport system reduces energy acquisition efficiency and thus reduces the activity of the TCA circuit, As a result, hypothesis is that it may cause absorption of adult diseases such as diabetes, hyperlipidemia, obesity, and metabolic syndrome. The present inventors have further thought deeply, and the decrease in the activity of the electron transport system is not due to the decrease in the ability of ALA to produce mitochondria with aging of heme compounds or cytochromes corresponding to the electron path of the electron transport system.
- the present invention provides (1) a composition for preventing / ameliorating adult diseases characterized by containing 5-aminolevulinic acid (ALA) or a derivative thereof, or a salt thereof, and (2) further containing an iron compound.
- the composition for preventing or improving adult diseases according to the above (1) wherein the iron compound is ferrous citrate, sodium ferrous citrate, sodium iron citrate, iron citrate Ammonium, ferric pyrophosphate, heme iron, dextran iron, lactate iron, ferrous gluconate, DTPA iron, sodium diethylenetriaminepentaacetate, ammonium diethylenetriaminepentaacetate, sodium ethylenediaminetetraacetate, ammonium ethylenediaminepentaacetate, Triethylenetetraamine iron, dicarboxymethyl sodium iron glutamate, dicarboxymethyl Ammonium iron glutamate, lactoferrin iron, transferrin iron, ferric chloride, iron sesquioxide, iron chlorophyllin sodium, ferritin iron, ferr
- the adult disease is selected from the group consisting of metabolic syndrome, diabetes, hyperlipidemia, hypertension, liver dysfunction, renal failure, obesity, erectile dysfunction, climacteric disorder, stiff shoulder, and back pain.
- the composition for preventing / ameliorating adult diseases according to any one of (1) to (3) above, characterized in that it is one or more types, or (5) any one of (1) to (4) above A food or food material for adult disease prevention / amelioration characterized by the addition of the composition of (6) above, or a composition according to any one of (1) to (4) above,
- the present invention relates to a method used for preparation, and (7) a method for preventing / ameliorating adult diseases characterized by administering the composition described in any one of (1) to (4) above.
- the adult disease prevention / amelioration composition (prevention / amelioration agent) of the present invention is not particularly limited as long as it contains ALA composed of ALA, its derivatives or salts thereof as an active ingredient or main component.
- the ALA is also referred to as ⁇ -aminolevulinic acid and is a kind of amino acid represented by the formula HOOC— (CH 2 ) 2 — (CO) —CH 2 —NH 2 .
- These ALAs can be produced by any known method such as chemical synthesis, production by microorganisms, production by enzymes, and the like.
- examples of ALA derivatives include those having an ester group and an acyl group of ALA, preferably a methyl ester group and a formyl group, a methyl ester group and an acetyl group, and a methyl ester group and n.
- -Illustrate combinations of propanoyl group, methyl ester group and n-butanoyl group, ethyl ester group and formyl group, ethyl ester group and acetyl group, ethyl ester group and n-propanoyl group, ethyl ester group and n-butanoyl group Can do.
- ALAs as salts of ALA or its derivatives, for example, hydrochloride, hydrobromide, hydroiodide, phosphate, nitrate, sulfate, acetate, propionate, toluenesulfonate Acid addition of succinate, oxalate, lactate, tartrate, glycolate, methanesulfonate, butyrate, valerate, citrate, fumarate, maleate, malate, etc. Examples thereof include metal salts such as sodium salts, potassium salts, and calcium salts, ammonium salts, and alkylammonium salts. These salts are used as a solution at the time of use, and the action thereof is preferably the same as that of ALA. These salts may form a hydrate or a solvate, and can be used alone or in combination of two or more.
- an adult disease refers to a lifestyle-related disease whose long-standing lifestyle is deeply involved in the onset, metabolic syndrome, diabetes, hyperlipidemia, hypertension, liver dysfunction, renal failure, obesity, erectile dysfunction, Menopause, stiff shoulders, back pain and the like can be preferably exemplified.
- the adult disease prevention / amelioration composition of the present invention preferably contains an iron compound as an active ingredient.
- the iron compound in the present invention is not particularly limited as long as it is a compound having iron in the molecule.
- ferrous acid sugar-containing iron oxide, iron acetate,
- Monoiron and sodium iron citrate are preferred. These iron compounds may be used alone or in combination of two or more.
- the iron compound contained in the composition for preventing / ameliorating adult diseases of the present invention usually has a molar ratio of 0 to 100 times, preferably 0.1 to 8 times the dose of ALA. .
- the adult disease prevention / amelioration composition of the present invention is useful as an adult disease prevention / amelioration agent, and can be used as an oral administration type or an intravenous injection type.
- Examples of the dosage form of the preventive / improving agent for oral administration include powders, granules, tablets, capsules, syrups, suspensions, etc. May include injections, infusions and the like.
- the composition for preventing / ameliorating adult diseases of the present invention is prepared as an aqueous solution such as an injection, it is preferably prepared with care so that the aqueous solution does not become alkaline in order to prevent decomposition of ALAs. When it becomes alkaline, decomposition of the active ingredient can be prevented by removing oxygen.
- optional components such as other medicinal ingredients, nutrients, and carriers can be added to the preventive / improving composition of the present invention as necessary.
- an optional component for example, crystalline cellulose, gelatin, lactose, starch, magnesium stearate, talc, vegetable and animal fats, fats and oils, gums, polyalkylene glycols and the like, pharmaceutically acceptable ordinary carriers and binders
- Various formulation ingredients such as stabilizers, solvents, dispersion media, extenders, excipients, diluents, pH buffers, disintegrants, solubilizers, solubilizers, isotonic agents, etc. it can.
- Desirable methods of administration of the preventive / ameliorating agent for adult diseases of the present invention include oral administration including sublingual administration and intravenous administration including infusion, transdermal administration using a suppository, suppository, and the like.
- the amount of ALA contained in the preparation may be 0.1 mg to 1000 mg per day per adult in terms of ALA hydrochloride, preferably 0.3 mg to 300 mg, more preferably 1 mg to 100 mg.
- the desirable administration time of the agent for preventing / ameliorating adult diseases of the present invention is not particularly limited, and it may be morning or evening, but when the dose is large, it is better to administer it in multiple doses.
- the adult disease prevention / amelioration composition of the present invention can also be used in combination with other adult disease prevention, improvement and treatment agents.
- the administration preventive / improving composition of the present invention is an additive, sometimes synergistic, because existing pharmaceuticals in the field are inhibitors of specific reactions and differ from the mechanism of action of this drug that enhances basal metabolism. Can be expected.
- the food or food material for prevention / amelioration of adult diseases of the present invention is not particularly limited as long as the composition for preventing / ameliorating adult diseases of the present invention is added, and the composition of the present invention containing ALAs Can be used as a food or food material for preventing or ameliorating adult diseases.
- the method of use of the present invention is not particularly limited as long as it is a method of using the composition for preventing / ameliorating adult diseases of the present invention described above for the preparation of a preventive / ameliorating agent for adult diseases.
- Examples of the method of using the composition of the present invention containing ALAs include a method of preparing an oral administration type or intravenous injection type preventive / improving agent by blending the above-mentioned optional components with ALAs. .
- the method for preventing / ameliorating adult disease of the present invention is not particularly limited as long as it is a method for administering the composition for preventing / ameliorating adult disease of the present invention, and the administration method is orally as described above. Administration, intravenous injection, and transdermal administration can be mentioned.
- the food or food material for prevention / amelioration of adult disease of the present invention is characterized by adding ALA, and is labeled as being used for prevention / amelioration of adult disease
- a method for producing a food or food material for preventing or ameliorating adult diseases characterized by adding ALA to a food or food material is characterized by adding ALA to a food or food material.
- Examples of the food or food material for preventing or improving adult diseases of the present invention include, for example, various beverages such as yogurt, drink yogurt, juice, milk, soy milk, liquor, coffee, tea, sencha, oolong tea, sports drink, Baked confectionery such as cookies, bread, cake, jelly, rice crackers, Japanese confectionery such as sheep crab, bread and confectionery such as frozen confectionery, chewing gum, noodles such as udon and soba, fish paste products such as kamaboko, ham and fish sausage , Miso, soy sauce, dressing, mayonnaise, sweeteners, dairy products such as cheese, butter, tofu, konjac, other boiled fish, dumplings, croquettes, salads it can.
- Adult disease prevention / improvement means that the use of ALAs is for adult diseases, such as food or food material packaging containers or instructions that indicate that it is effective in preventing or improving adult disease. It means that it is aimed at prevention and improvement.
- a 61-year-old man took a capsule containing 5 mg of aminolevulinic acid phosphate (5-aminolevulinic acid phosphate) and 2.87 mg of sodium ferrous citrate each morning and evening and improved the following biochemical values in 2 weeks.
- Lipid metabolism, liver function, and sugar metabolism are all improved.
- lipid metabolism was improved to a normal value, and a clear therapeutic effect was shown. From this example, it was shown that ALA administration is effective for various adult diseases.
- body temperature was measured with a female thermometer, an increase of 0.1 to 0.2 ° C. was observed before and after ingestion. After 3 months of ingestion, the body weight decreased from 79 kg to 74 kg, 5 kg, and improvement of white hair and wrinkles was also observed. This indicates that administration of aminolevulinic acid is effective for adult diseases such as metabolic syndrome.
- a 46-year-old woman suffering from coldness took a capsule containing 5 mg of aminolevulinic acid phosphate and 2.87 mg of sodium ferrous citrate a day, and felt warmth in the extremities after 2 days and improved coldness and no constipation. It was. This indicates that aminolevulinic acid administration is effective for cooling and constipation.
- a 55-year-old woman suffering from climacteric disorder took 2 capsules a day containing 5 mg of aminolevulinic acid phosphate and 23 mg of ferrous sodium citrate, and he felt improvement in physical fitness and skin rejuvenation from around 1 week of ingestion. Symptoms of menopause such as hot flashes and frustration disappeared. This shows that administration of aminolevulinic acid is effective for menopause.
- a 47-year-old man suffering from stiff shoulders applies 1% each by weight of aminolevulinic acid phosphate and DTPA iron (diethylene / triamine / penta / acetic acid) -Fe once a day to the area of low back pain or stiff shoulders for 1 week I lost my stiff shoulders.
- DTPA iron diethylene / triamine / penta / acetic acid
- a decrease in ALP is a good change that improves liver function, and a decrease in total protein, albumin, and creatinine means an increase in protein metabolism. Furthermore, the decrease in total cholesterol, HDL-cholesterol, and LDL-cholesterol was a good change toward improving lipid metabolism.
- An increase in sodium is presumed to be related to sodium excretion from the cells and predicts improved renal function.
- FIG. 1 shows the blood glucose level when ALA 30 mg and iron citrate 276 mg were administered
- FIG. 2 shows the glucose tolerance test results
- FIG. 3 shows the transition of neutral fat during this period
- FIG. 4 shows the history of insulin secretion. Shown in The experiment was conducted with 10 animals in each group.
- the administration of ALA and iron lowers blood glucose levels, improves sugar-adding ability, improves lipid metabolism, and restores insulin secretion, which is effective for diabetes and high-fat plasma.
- ALA and iron activate the mitochondrial electron transport system and improve the rotation of the linked TCA cycle. Consumption is considered to have improved.
- FIG. 5 shows changes in fasting blood glucose when this patient was ingested with 25 mg of ALA phosphate per day and iron citrate 0.5 times as much as ALA in molar ratio.
- Fasting blood glucose changes greatly with the diet of the previous day, etc., and rises and falls, but on average it decreases by about 15 mg / dl in one month as shown in the supplementary line, which may be effective in improving diabetes Recognize.
- HbA1c decreased to 5.9 after 5 months from the start of intake, and to 5.2 after 8 months, and was completely withdrawn from diabetes.
- the results are shown in FIG.
- FIG. 8 shows changes in HbA1c during this period.
- the intake period is indicated by a thick arrow.
- Ingestion improves HbA1c.
- HbA1c rose when it stopped, it became clear that it was an effect of ALA.
- FIG. 9 shows the results of stratification of healthy subjects into a group in which HbA1c before ingestion is higher than 4.8 and a group of 4.8 or lower. As can be seen from FIG. 9, the group with HbA1c exceeding 4.8 shows a slight downward trend, but the group with 4.8 or lower has a tendency to increase rather than the normal group. It turns out that it is a high effect. Similarly, FIG.
- FIG. 10 shows changes in blood glucose levels when the fasting blood glucose at the start is stratified into a group of 90 or more and a group lower than 90. As is clear from FIG. 10, a moderate decrease is seen in the higher group even in the normal range, but almost no change is seen in the lower group, indicating that it is a safe effect that does not cause hypoglycemia in normal people. .
- Table 1 shows changes in ALA intake, duration, and HbA1c of 6 men with borderline diabetes. It can be seen that the HbA1c of all six people is improved and the probability of the present invention is high.
- adult diseases can be improved or prevented by improving the basal metabolism that decreases with aging.
- the present invention is different from existing therapeutic agents for adult diseases due to biochemical reaction inhibition type, and it is based on the improvement of basal metabolism, so to speak, the rejuvenation of metabolism is the mechanism of action, there are no side effects, and drug resistance of adult diseases occurs. Absent.
- the mechanism of action is different from that of existing drugs, it is also expected to increase the effect by using it together with existing drugs.
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Abstract
Description
TG 314 → 132
GOT 19 → 19
GPT 17 → 15
γ-GTP 60 → 48
HbA1c 6.2 → 5.9
脂質代謝、肝機能、糖代謝ともに改善している。とりわけ脂質代謝は正常値に改善され明らかな治療効果が示された。本例よりALA投与が各種成人病に有効であることが示された。
TC 264 → 260
LDL 192 → 173
HDL 65 → 58
本例によりALA投与が脂質代謝と肝機能に改善に有効であることが示された。
開始前 1ヶ月後 2ケ月後 3ヶ月後
HbA1c 7.4 7.2 6.9 6.8
本例によりアミノレブリン酸の投与が糖尿病の改善及び予防に有効であることが示された。
1) ALP
・2群の2週後で18.0±23.2U/L低下した(195.2±74.7 vs 177.2±55.2 U/L)。
2) 総タンパク
・2群の4週後で0.29±0.22g/dL低下した(7.28±0.48 vs 6.99±0.47g/dL)。
3) アルブミン
・3群の2週後で0.12±0.11g/dL低下した(4.43±0.26 vs 4.31±0.26g/dL)。
4) クレアチニン
・2群の4週後で0.040±0.037mg/dL低下した(0.701±0.134 vs 0.661±0.109mg/dL)。
5) 総コレステロール
・3群の2週後で13.2±15.0mg/dL低下した(204.1±21.0 vs 190.9±30.3mg/dL)。
6) HDL-コレステロール
・1群の4週後で3.7±4.9mg/dL低下した(64.6±17.3 vs 60.9±15.8mg/dL)。
・3群の2週後で2.6±2.8mg/dL低下した(67.8±12.4 vs 65.2±11.7mg/dL)。
・終了2週後で2.8±3.7mg/dL低下した(67.8±12.4 vs 65.0±11.4mg/dL)。
7) LDL-コレステロール
・3群の2週後で10.7±7.8mg/dL低下した(122.5±20.6 vs 111.8±25.9mg/dL)。
8) Na
・3群の終了2週後で0.7±0.7mEq/L上昇した(140.4±1.6 vs 141.1±1.5mEq/L)。
図より明らかなように、ALAと鉄の投与で血糖値が下がり、糖付加能力が向上し、脂質代謝も向上してインシュリンの分泌も回復していることがわかり糖尿病、高脂血漿に有効であることがわかる。一般の糖尿病改善剤は脂質代謝を悪くするがALAと鉄はミトコンドリアの電子伝達系を活発化し、連鎖するTCA回路の回転を改善するため、いわゆる基礎代謝の改善が見られ、糖、脂質とともにその消費が改善したものと考えられる。
空腹時血糖は前日の食生活などで変化が大きく、上下はするものの、平均的には補助線に示されるよう1ヶ月で15mg/dl程度低下しており、糖尿病の改善に有効であることがわかる。
Claims (7)
- 5-アミノレブリン酸(ALA)若しくはその誘導体、又はそれらの塩を含有することを特徴とする成人病の予防・改善組成物。
- さらに、鉄化合物を含有することを特徴とする請求項1記載の成人病の予防・改善組成物。
- 鉄化合物が、クエン酸第一鉄、クエン酸第一鉄ナトリウム、クエン酸鉄ナトリウム、クエン酸鉄アンモニウム、ピロリン酸第二鉄、ヘム鉄、デキストラン鉄、乳酸鉄、グルコン酸第一鉄、DTPA鉄、ジエチレントリアミン五酢酸鉄ナトリウム、ジエチレントリアミン五酢酸鉄アンモニウム、エチレンジアミン四酢酸鉄ナトリウム、エチレンジアミン五酢酸鉄アンモニウム、トリエチレンテトラアミン鉄、ジカルボキシメチルグルタミン酸鉄ナトリウム、ジカルボキシメチルグルタミン酸アンモニウム鉄アンモニウム、ラクトフェリン鉄、トランスフェリン鉄、塩化第二鉄、三二酸化鉄、鉄クロロフィリンナトリウム、フェリチン鉄、フマル酸第一鉄、ピロリン酸第一鉄、含糖酸化鉄、酢酸鉄、シュウ酸鉄、コハク酸第一鉄、コハク酸クエン酸鉄ナトリウム、硫酸鉄、及び硫化グリシン鉄から選ばれる1種又は2種以上であることを特徴とする請求項1又は2記載の成人病の予防・改善組成物。
- 成人病が、メタボリックシンドローム、糖尿病、高脂血症、高血圧、肝機能障害、腎不全、肥満、勃起不全、更年期障害、肩こり、及び腰痛からなる群から選ばれる1種又は2種以上であることを特徴とする請求項1~3のいずれか記載の成人病の予防・改善組成物。
- 請求項1~4いずれか記載の組成物を添加したことを特徴とする成人病の予防・改善用食品又は食品素材。
- 請求項1~4いずれか記載の組成物を成人病の予防・改善剤の調製に使用する方法。
- 請求項1~4いずれか記載の組成物を投与することを特徴とする成人病の予防・改善方法。
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CN200980138548XA CN102164596A (zh) | 2008-10-27 | 2009-10-27 | 以5-氨基乙酰丙酸或其衍生物、或它们的盐作为有效成分的成人病的预防、改善剂 |
JP2010535656A JP5665544B2 (ja) | 2008-10-27 | 2009-10-27 | 5−アミノレブリン酸若しくはその誘導体、又はそれらの塩を有効成分とする成人病の予防・改善剤 |
EP09823292.9A EP2340821B1 (en) | 2008-10-27 | 2009-10-27 | Prophylactic/ameliorating agent for adult diseases comprising 5-aminolevulinic acid, derivative of 5-aminolevulinic acid, or salt of 5-aminolevulinic acid or the derivative of 5-aminolevulinic acid as active ingredient |
KR1020117009208A KR101322259B1 (ko) | 2008-10-27 | 2009-10-27 | 5-아미노레불린산 혹은 그의 유도체, 또는 그들 염을 유효성분으로 하는 성인병의 예방·개선제 |
CA2736866A CA2736866C (en) | 2008-10-27 | 2009-10-27 | Prophylactic/ameliorating agent for adult diseases comprising 5-aminolevulinic acid, its ester, or salt thereof as active ingredient |
US13/123,374 US9095165B2 (en) | 2008-10-27 | 2009-10-27 | Prophylactic/ameliorating agent for adult diseases comprising 5-aminolevulinic acid, derivative of 5-aminolevulinic acid, or salt of 5-aminolevulinic acid or the derivative of 5-aminolevulinic acid as active ingredient |
US14/707,260 US9730904B2 (en) | 2008-10-27 | 2015-05-08 | Prophylactic/ameliorating agent for adult diseases comprising 5-aminolevulinic acid, derivative of 5-aminolevulinic acid, or salt of 5-aminolevulinic acid or the derivative of 5-aminolevulinic acid as active ingredient |
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US14/707,260 Continuation US9730904B2 (en) | 2008-10-27 | 2015-05-08 | Prophylactic/ameliorating agent for adult diseases comprising 5-aminolevulinic acid, derivative of 5-aminolevulinic acid, or salt of 5-aminolevulinic acid or the derivative of 5-aminolevulinic acid as active ingredient |
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KR (1) | KR101322259B1 (ja) |
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CA2935654A1 (en) | 2010-05-06 |
EP2340821A4 (en) | 2012-10-03 |
EP2340821A1 (en) | 2011-07-06 |
CA2736866C (en) | 2016-09-06 |
US20150290159A1 (en) | 2015-10-15 |
CA2736866A1 (en) | 2010-05-06 |
JPWO2010050179A1 (ja) | 2012-03-29 |
US9730904B2 (en) | 2017-08-15 |
KR20110058902A (ko) | 2011-06-01 |
EP2340821B1 (en) | 2017-01-25 |
CN106692122A (zh) | 2017-05-24 |
JP5665544B2 (ja) | 2015-02-04 |
US20110196033A1 (en) | 2011-08-11 |
CN103800310A (zh) | 2014-05-21 |
KR101322259B1 (ko) | 2013-10-28 |
EP3192506A3 (en) | 2017-10-25 |
CA2935654C (en) | 2019-01-08 |
CN102164596A (zh) | 2011-08-24 |
EP3192506A2 (en) | 2017-07-19 |
US9095165B2 (en) | 2015-08-04 |
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