CN112237591B - Anti-gout composition containing folic acid - Google Patents

Anti-gout composition containing folic acid Download PDF

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CN112237591B
CN112237591B CN201910655067.1A CN201910655067A CN112237591B CN 112237591 B CN112237591 B CN 112237591B CN 201910655067 A CN201910655067 A CN 201910655067A CN 112237591 B CN112237591 B CN 112237591B
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gout
essence
folic acid
acid
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CN112237591A (en
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白洁
黄晓杰
于多
邢厚恂
王滨燕
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Shenzhen Ausa Pharmaceutical Co ltd
Shenzhen Ausa Pharmed Co ltd
Shenzhen Changqing Medical Science Research Institute
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents

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Abstract

The invention discloses a composition with gout resisting effect, which consists of 100-1500 mg of celery seed extract, 20-1000 mu g of folic acid components and a proper amount of auxiliary materials. The composition provided by the invention is used for gout patients, has the effects of preventing, relieving or treating gout, and has a function synergistic effect among the components.

Description

Anti-gout composition containing folic acid
Technical Field
The invention relates to a composition, in particular to a composition product suitable for gout patients to prevent, relieve or treat gout. The invention belongs to the field of medicine.
Background
Gout (Gout) is a crystal-related arthropathy caused by deposition of mono-natriuretic urate, and is directly related to hyperuricemia caused by purine metabolic disorder or reduced uric acid excretion. Gout is especially acute gouty arthritis and chronic tophus diseases, which are often accompanied by hyperlipidemia, hypertension, diabetes, arteriosclerosis, coronary heart disease and the like. At present, the incidence rate of gout worldwide increases year by year, and few effective medicines with few adverse reactions are used at present. Data from the national health and nutrition survey (NHANES) show that the prevalence of gout in the united states rises from 2.64% in 1988-1994 to 3.76% in 2007-2010. A big data based on the health record of 120 ten thousand english population showed that the prevalence of gout in the uk in 2012 was about 2.49%. At present, the prevalence rate of gout in China is 1% -3%, and the gout is on the trend of rising year by year. The acute onset of gouty arthritis is mainly due to rapid fluctuations in blood uric acid levels. Is an inflammatory reaction caused by sodium urate crystallization: sudden elevation of serum uric acid: the uric acid crystal is precipitated in the synovial fluid to form needle-shaped urate; ② sudden reduction of blood uric acid: the tophus dissolves on the surface and releases insoluble needle crystals. The urate microcrystals can chemotaxis leukocytes, release inflammatory factors (such as IL-1) and hydrolases after phagocytosis → cause necrosis → release of more inflammatory factors → cause lysis of articular cartilage and soft tissue injury → acute attack. Although the gout treatment rate is higher in China, most doctors and patients pay attention to the acute gout treatment only due to irregular treatment, and the uric acid reduction and the complication prevention in the intermittent period are neglected, so that the uric acid reduction for a long time cannot be adhered to, and the standard reaching rate is great.
The existing medicines for treating gout are mainly divided into the following two categories: anti-inflammatory agents: including colchicine, non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, adrenocorticoids, glucosamine, IL-1 inhibitors, etc.; uric acid lowering drugs: has uricosuric and uric acid production inhibiting effects. Acute gout, mainly using anti-inflammatory drugs; in the chronic stage, uric acid lowering drugs are mainly used, and the common drugs comprise allopurinol and have adverse reactions such as liver and bone marrow toxicity; non-purine selective xanthine oxidase inhibitor febuxostat (febuxostat), although current clinical data indicate that adverse reactions are much more or less severe, related studies show that patients have a higher incidence of cardiovascular events. Although some western medicines for preventing and treating gout exist clinically, the symptoms of gout are controlled, more clinical data show that the selection of medicines is limited due to the limitation of the existing medicines, adverse reactions and few varieties of medicines for treating gout, so that gout is not well prevented and treated. The development of high-efficiency and low-toxicity anti-gout products becomes a problem to be solved urgently at present.
Disclosure of Invention
The invention aims to provide a safe and effective composition for resisting gout for gout patients, which has the effects of preventing gout attack, relieving pain and treating gout, can be used for daily health care of the gout patients, and is safe and free of side effects.
In order to achieve the purpose, the invention adopts the following technical scheme:
a safe and effective composition for gout patients to resist gout is composed of the following components:
(1) 100-1500 mg of celery seed extract
(2) 200-1000 mg folic acid component
(3) Auxiliary material
In the composition, preferably, the content of the celery seed extract in the composition is 200-1000 mg, and the content of the folic acid component in the composition is 200-800 μ g.
In the invention, the celery seed extract comprises one or more substances such as volatile oil, unsaturated fatty acid, flavonoid substance, butyl phthalides, amino acid, dietary fiber, coumarin derivative and the like extracted from celery seeds.
In the present invention, the folic acid compounds include folic acid, 5-methyltetrahydrofolic acid, leucovorin calcium, L-methylfolic acid, folate, active metabolites of folic acid or folate, and substances that can release/generate folic acid in vivo, i.e., various folic acid forms including synthetic and plant extract sources.
The composition can be prepared into oral preparations such as common tablets, chewable tablets, soft capsules, hard capsules, powder, granules, solid beverages and the like.
In the invention, the auxiliary materials are selected from one or a combination of more of a filling agent (dispersing agent), a suspending agent, a wetting agent, an adhesive, a disintegrating agent, a lubricant, a flavoring agent, a stabilizing agent, an embedding substance, a coating premixing agent and an edible pigment.
The filler (dispersing agent) comprises one or more of starch, soluble starch, dextrin, maltodextrin, potato starch, corn starch, wheat starch, D-mannitol, calcium hydrophosphate, anhydrous calcium hydrophosphate, maltose, xylitol, sorbitol, microcrystalline cellulose, isomaltulose, milk powder, low-substituted hydroxypropyl cellulose, sucrose, glucose, lactose, pregelatinized starch, edible vegetable oil, polyethylene glycol and the like.
The suspending agent comprises one or more of beeswax, insect wax, lecithin, glyceryl monostearate, ethyl cellulose and the like, the wetting agent comprises purified water and ethanol, and the adhesive comprises one or more of hydroxypropyl methyl cellulose, povidone, hydroxypropyl cellulose, sodium carboxymethyl cellulose, starch, methyl cellulose, ethyl cellulose, gelatin, polyethylene glycol, pregelatinized starch, sucrose, glucose and the like.
The disintegrating agent comprises one or more of starch, carboxymethyl starch sodium, crospovidone, croscarmellose sodium, low-substituted hydroxypropyl cellulose, sodium bicarbonate, citric acid and the like, and the lubricant comprises one or more of magnesium stearate, stearic acid, talcum powder, silicon dioxide, hydrogenated vegetable oil, polyethylene glycol, sodium dodecyl sulfate, glyceryl behenate, sodium stearyl fumarate and the like.
The flavoring agent comprises one or more of fruit powder, edible essence, high-intensity sweetener, sour agent and the like, wherein the fruit powder comprises one or more of orange powder, lemon powder, cherry powder, apple powder, strawberry powder, kiwi fruit powder, orange powder, seabuckthorn fruit powder, green plum fruit powder, mango fruit powder, mulberry fruit powder, hawthorn fruit powder, watermelon fruit powder, pineapple fruit powder, blueberry fruit powder, honey peach fruit powder, hami melon fruit powder, grape fruit powder, vanilla fruit powder, pomegranate fruit powder, rose fruit powder and the like.
The edible essence comprises one or more of vanilla essence, sweet orange essence, milk essence, apple essence, grape essence, strawberry essence, pineapple essence, honey peach essence, hami melon essence, lemon essence, cherry essence, sweet corn essence, banana essence, grape essence, rose essence, blackcurrant essence, green apple essence, mango essence, green mango essence, orange essence, fragrant orange essence, snow pear essence, strawberry essence, green plum essence, blueberry essence, waxberry essence, grapefruit essence, pineapple essence, guava essence, passion fruit essence, kiwi fruit essence, cherry essence, kiwi fruit essence, watermelon essence, papaya essence, hami melon essence, durian essence, lychee essence, hawthorn essence, olive essence, mulberry essence and the like.
The high-power sweetener comprises sucralose, aspartame, mogroside, neotame and stevioside, the sour agent comprises citric acid, malic acid, lactic acid, tartaric acid and fumaric acid, the edible pigment comprises caramel color, gardenia yellow, curcumin, chlorophyll, capsicum orange, capsanthin, grape skin red, carmine and aluminum lake thereof, sunset yellow and aluminum lake thereof, brilliant blue and aluminum lake thereof, indigo blue and aluminum lake thereof, beet red, natural amaranth, gardenia blue, plant carbon black, iron oxide red, black bean red, quinoline yellow, lycopene, monascus red, yellow iron oxide, cocoa shell color, safflower yellow, monascus yellow and the like.
The stabilizer comprises vitamin E, dibutyl hydroxy toluene (BHT), Butyl Hydroxy Anisol (BHA) and vitamin C, and the embedding substance comprises one or more of beta-cyclodextrin, alpha-cyclodextrin, gamma-cyclodextrin, dextrin, starch, edible modified starch, sucrose, maltodextrin, gum arabic and the like.
According to the invention, the celery seed extract with synergistic screening function and the vitamin folic acid are scientifically formulated, and the purposes of preventing gout attack, relieving pain and treating gout are achieved by selecting the optimal dosage of the components of the composition. Compared with the existing products, the composition is a safer and more effective composition product, the action effect of the composition product is also obviously better than the single application effect of the components, and the composition product has unexpected synergistic effect on improving the health condition of gout patients. Can be used for daily health care of gout patients, is safe without side effect, and has the function of auxiliary prevention of cardiovascular diseases.
Embodiments of the present invention are further described below with reference to examples.
Detailed Description
Example 1: tablet preparation (1000 tablets amount) of the composition of the invention
The formula is as follows:
Figure BDA0002136619960000041
the preparation method comprises the following steps: preparing polyvidone K30 into binder with 50% ethanol solution, adding semen Apii Graveolentis extract into the binder, and stirring. Mixing 5-methyltetrahydrofolic acid, sucralose and pregelatinized starch, sieving, adding milk essence, carboxymethyl starch sodium and dextrin, mixing, adding prepared binder containing semen Apii graveolentis extract, making into soft mass, granulating with 24 mesh sieve, drying at 55 deg.C for 2 hr, grading with 24 mesh sieve, adding magnesium stearate, mixing, and tabletting. And (3) preparing the coating premix into a solution, and coating plain tablets to obtain the tablets of the composition.
Example 2: tablet preparation (1000 tablets amount) of the composition of the invention
The formula is as follows:
Figure BDA0002136619960000042
Figure BDA0002136619960000051
the preparation method comprises the following steps: preparing polyvidone K30 into binder with 50% ethanol solution, adding semen Apii Graveolentis extract into the binder, and stirring. Mixing folic acid, sucralose and pregelatinized starch, sieving, adding milk essence, carboxymethyl starch sodium and dextrin, mixing, adding prepared binder containing semen Apii graveolentis extract, making into soft mass, granulating with 24 mesh sieve, drying at 55 deg.C for 2 hr, grading with 24 mesh sieve, adding magnesium stearate, mixing, and tabletting. The coating premix is prepared into solution, and tablets of the composition are prepared by coating the tablets.
Example 3: hard capsule preparation (1000 granules of quantity) of the composition of the invention
The formula is as follows:
Figure BDA0002136619960000052
the preparation method comprises the following steps: mixing folic acid with 20% microcrystalline cellulose, sieving, adding the celery seed extract, mixing the obtained raw material mixture with the rest amount of microcrystalline cellulose in an equivalent increasing manner, adding lactose and magnesium stearate, mixing, filling by using a full-automatic capsule filling machine, and polishing to obtain the hard capsule of the composition. 1-4 granules are taken daily.
Example 4: hard capsule preparation (1000 granules) of the composition of the invention
The formula is as follows:
Figure BDA0002136619960000053
Figure BDA0002136619960000061
the preparation method comprises the following steps: mixing folinic acid and 20% microcrystalline cellulose, sieving, adding the celery seed extract, mixing the obtained raw material mixture with the rest amount of microcrystalline cellulose in an equivalent increasing manner, adding lactose and magnesium stearate, mixing, filling by using a full-automatic capsule filling machine, and polishing to obtain the hard capsule of the composition. The daily dosage is 1-2 tablets.
Example 5: chewable tablet preparation (1000 tablets amount) of the composition of the invention
The formula is as follows:
Figure BDA0002136619960000062
the preparation method comprises the following steps: preparing hydroxypropyl methylcellulose E5 into adhesive with 60% ethanol solution, adding semen Apii Graveolentis extract into the adhesive, and stirring. Mixing folic acid with microcrystalline cellulose, sieving, adding stevioside, lemon essence, milk powder and xylitol, mixing, adding the prepared binder containing vitamin K to prepare a soft material, granulating by using a 24-mesh sieve, drying for 2 hours at 55 ℃, granulating by using the 24-mesh sieve, adding magnesium stearate, mixing, and tabletting to obtain the chewable tablet of the vitamin composition. The daily dose is 1-2 tablets
Example 6: solid beverage preparation (1000 parts) of the composition according to the invention
The formula is as follows:
Figure BDA0002136619960000063
Figure BDA0002136619960000071
the preparation method comprises the following steps: grinding the raw materials into fine powder, mixing, and making into powder. The daily dosage is 1-4 bags.
Example 7: in order to prove that the composition has the effect of resisting the gout, the following experiments are designed, mainly including the detection of the activities of serum uric acid and xanthine oxidase of experimental animals, and the efficacy of the composition is investigated.
After 96 male SD rats are adaptively fed for one week, the SD rats are randomly divided into 8 groups according to body weight, each group is 12, each group is fed with high purine feed, the low, medium and high dose groups are respectively subjected to intragastric administration (the compositions prepared in the above examples 3, 2, 5 and 6) according to dose every day for 6 weeks, and the low, medium and high doses are respectively (10+0.02), (30+0.05), (100+0.08), (150+0.1) mg/kg (calculated by the content of celery seed extract and folic acid), the celery seed extract group is 30mg/kg, and the folic acid is 0.05 mg/kg. After 6 weeks, blood is collected to detect serum Uric Acid (UA), and liver is taken to prepare liver homogenate for measuring the xanthine oxidase activity of the liver. Statistical analysis: statistical processing is carried out on the test data by adopting GraphPadprism5 statistical analysis software; the data results are all as follows
Figure BDA0002136619960000073
And (4) showing. The comparison between groups was performed by ANOVA test, setting the test level as 0.05, P<0.05 statistical difference, P>0.05 had no statistical difference. The experimental results are as follows: see table below.
TABLE 1 Effect of the compositions of the present invention on uric acid and xanthine oxidase activity in rats
Figure BDA0002136619960000072
Compared with the control group, # P <0.05, # P < 0.01; p <0.05, P <0.01, compared to the set of models
The above experimental results show that the composition of the invention has the effect of significantly reducing serum Uric Acid (UA) of rats, and as can be seen from the data in the above table, the composition of the invention has a dose-effect relationship in the dosage range of (10+0.02) mg/kg to (100+0.08) mg/kg, and the effect of reducing UA increases with increasing dosage, wherein the effect of reducing UA in the medium-low dosage group (the uric acid value of the model control group is 90.75 + -5.73. mu. mol/L, the uric acid value of the composition in the medium-low dosage group is 63.76 + -13.6. mu. mol/L, and is reduced by about 27. mu. mol/L) is significantly better than that of the vegetable seed extract (the uric acid value of the model control group is 90.75 + -5.73. mu. mol/L, the uric acid value of the vegetable seed extract group is 74.18 + -14.62, and is reduced by about 16. mu. mol/L), and the uric acid of the single-use (the uric acid value of the model control group is 90.75 + -5.73. mu. mol/L, the sum of the effects of the folic acid group of 81.52 +/-9.49 which reduces about 9 mu mol/L) (16 mu mol/L +9 mu mol/L is 25 mu mol/L), the medium and high dose group (the uric acid value is 58.76 +/-13.6) is lower than that of the low and medium dose group in the composition, and the two groups have unexpected synergistic effect in the combination of the medium and high doses; while a further increase in the dosage of the composition (high dose group) also significantly reduced UA, there was no tendency for the effect of decreasing UA to increase further with further increase in dosage compared to the medium and high dose group.
The above data show that the composition of the invention has a certain dose-effect relationship in the dosage range of (10+0.02) mg/kg to (100+0.08) mg/kg, and the composition can reduce the activity of the xanthine oxidase to be enhanced along with the increase of the dose, wherein the effect of reducing the activity of the xanthine oxidase in the low-dose group (the xanthine oxidase activity in the model control group is 6.28 +/-0.89 mu mol/min, the medium-low dose group is 4.92 +/-0.97 mu mol/min, and the difference is about 1.4 mu mol/min) is obviously better than that of the celery seed extract (the xanthine oxidase activity in the model control group is 6.28 +/-0.89 mu mol/min, the celery seed extract group has the effects that the celery seed extract group has the effects of 5.50 +/-0.86 mu mol/min and the difference is about 0.8 mu mol/min and the effects of the single use of folic acid (the xanthine oxidase activity of a model control group is 6.28 +/-0.89 mu mol/min, the folic acid group has the effects of 5.85 +/-1.23 mu mol/min and the difference is about 0.4 mu mol/min) are summed (0.8 mu mol/min +0.4 mu mol/min is 1.2 mu mol/min), and the xanthine oxidase activity of a medium-high dose group (the xanthine oxidase activity is 4.76 +/-1.18) is lower than that of a low-low dose group in the composition, which shows that the two groups have unexpected synergistic effect in the medium-high dose combination; while further increasing the dosage of the composition (high dose group) can also significantly reduce xanthine oxidase activity, there is no trend toward further increase in the effect of further increasing the dosage of the composition in reducing xanthine oxidase activity compared to the medium-high dose group.

Claims (3)

1. A composition with an anti-gout effect comprises 100-300 mg of celery seed extract, 200-500 mu g of folic acid components and acceptable auxiliary materials, wherein the celery seed extract contains volatile oil extracted from celery seeds, unsaturated fatty acid, flavonoid substances, butyl benzene phthalides, amino acid, dietary fiber and coumarin derivatives, and the folic acid components comprise folic acid, 5-methyltetrahydrofolic acid, leucovorin and calcium levofolinate.
2. The composition of claim 1, wherein: the composition can be prepared into common tablets, chewable tablets, soft capsules, hard capsules, powder or granules.
3. Use of the composition of claim 1 or 2 in the manufacture of an article of manufacture for the prevention, alleviation or treatment of gout.
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