CN105997979A - Medicine composition, medicine containing medicine composition for regulating uric acid content in blood and application thereof - Google Patents
Medicine composition, medicine containing medicine composition for regulating uric acid content in blood and application thereof Download PDFInfo
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- CN105997979A CN105997979A CN201610493666.4A CN201610493666A CN105997979A CN 105997979 A CN105997979 A CN 105997979A CN 201610493666 A CN201610493666 A CN 201610493666A CN 105997979 A CN105997979 A CN 105997979A
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- A61K33/24—Heavy metals; Compounds thereof
- A61K33/32—Manganese; Compounds thereof
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
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- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
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- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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Abstract
The invention provides a medicine composition, a medicine containing the medicine composition for regulating the uric acid content in blood and application thereof. The medicine composition includes a main drug, wherein the main drug includes alkaline mineral salt and optimal natural herb extract, wherein the alkaline mineral salt is one or more of soluble potassium salt, soluble sodium salt, soluble ferric salt, soluble calcium salt, soluble manganese salt and soluble magnesium salt; the natural herb extract is one or more of algal polysaccharides, lutein, anthocyanin, anisaldehyde and fructan. According to the medicine composition, addition of the alkaline mineral salt is advantageous to improve the solubility of uric acid crystal precipitation and promote drainage of uric acid; the natural herb extract is a natural ingredient, has low toxic and side effects, and is beneficial to improvement of physiological functions of a human body; and the alkaline mineral salt and natural herb extract are combined and synthesized, so that the regulating effect of the medicine composition for regulating the uric acid in blood can be improved. Therefore, the medicine composition has low toxic and side effects, and has the advantage of effectively regulating the uric acid content in blood.
Description
Technical field
The present invention relates to field of medicaments, in particular to a kind of pharmaceutical composition, the regulation uric acid in blood concentration comprising it
Medicine and application.
Background technology
Uric acid in human body there are about 1200 milligrams, newly-generated about 600 milligrams of every day, drains 600 milligrams simultaneously, is in balance
State.Due to the most a lot of human diet's not science, living habit is irregular, it is easier to metabolic arthritis phenomenon occur, its person in middle and old age
People is the main foreigner tourists of metabolic arthritis disease owing to the body function of self is more weak.The too much uric acid of internal generation has little time excretion or uric acid
Excretion mechanism degeneration can cause internal uric acid to be detained too much, and when uric acid in blood concentration is more than 7 milligram/deciliter, human body fluid becomes
Acid can affect the normal function of human body cell, will cause gout if ignoring for a long time.The hyperuricemia patients ill initial stage belongs to nothing
Symptom hyperuricemia, does not i.e. have the clinical symptoms, only blood test such as arthritis, metabolic arthritis stone or renal calculus and just can send out
Existing serum Uric Acid Concentration is high.But when the uric acid formation acicular crystal deposits of hypersaturated state is in knuckle synovia, uric acid in blood
Concentration is higher may result in acute metabolic arthritis arthritis.More seriously, it is deposited on kidney when urate crystal and produces pathological changes
Time, urate nephropathy (i.e. gouty nephropathy) can be caused.
Gout is to produce too much or cause because urate excretion is bad uric acid in blood to raise due to uric acid, and urate crystal is deposited on pass
The repeated relapsing arthritis disease caused in joint synovial membrane, synovial bursa, cartilage and hetero-organization thereof, this is a kind of lifelong participation disease.Nothing
Renal function injury or the patient with gout of joint deformity, typically can maintain orthobiosis and work through effective treatment, more not interfere with
Life-span.If but malpractice, the recurrent exerbation of acute arthritis can cause bigger misery.There is the patient of joint deformity and nephrolith
Quality of life can be affected by certain.Renal function injury severe patient, curative effect is poor, so once finding that the state of an illness will be as early as possible
Treatment.Untreated gouty arthritis, its order of severity and the speed of development also have very big difference.Some patient lifetime is only
Have and show effect several times, but great majority are not if treated, along with show effect repeatedly, frequency and degree be gradual increasing the weight of.Someone adds up
The life-span of patient with gout is short compared with ordinary person 5 years, but this has relation with the situation of individuality and the effect for the treatment of completely.When articular cartilage disappears
Lose, subchondral bone matter corrode and periarticular tissue infiltration, cause gradual invalid time, minority serious symptom person is within several years, i.e.
The heavy damage in huge tophus and joint can be produced, and affecting Most patients life is due to kidney and cardiovascular disease etc.
The existence of complication.
In the selection that suppression uric acid in blood concentration is high, mainly there are western medicine and two kinds of methods for the treatment of by Chinese herbs.Western medicine has rush urine
The medicine of the benzbromarone of acid excretion, probenecid and suppression uricopoiesis has allopurinol, and the shortcoming of these medicines is toxic and side effects
Greatly, it is eaten for a long time and health can be caused secondary injury.And the drug effect of existing Chinese medicine preparation is the most clearly.Based on the problems referred to above
Existence, it is necessary to research and develop a kind of safety and high medicine of curative effect taken for regulating internal uric acid concentration.
Summary of the invention
Present invention is primarily targeted at and a kind of pharmaceutical composition, the medicine regulating uric acid in blood concentration comprising it are provided and answer
With, to solve, existing uric acid regulating drug toxic and side effects is big or the problem of weak curative effect.
To achieve these goals, one aspect of the invention provides a kind of pharmaceutical composition, and this pharmaceutical composition includes principal agent,
Principal agent includes basic mineral salt, and basic mineral salt is selected from soluble potassium salt, soluble sodium salt, soluble ferric iron salt, solubility
One or more in calcium salt, soluble manganese salt and solubility magnesium salt.
Further, by weight, basic mineral salt includes the soluble potassium salt of 40～180 parts, 30～120 parts solvable
Property sodium salt, the soluble ferric iron salt of 1～4 part, the soluble calcium salt of 110～250 parts, the soluble manganese salt of 0.2～2.5 part and 2～25
The solubility magnesium salt of part.
Further, principal agent also includes natural plant extracts, and natural plant extracts is selected from Sargassum polysaccharides, phylloxanthin, cyanine
One or more in element, anisaldehyde and levan, preferably basic mineral salt with the weight ratio of natural plant extracts is
183～582: 49～235.
Further, by weight, natural plant extracts include the Sargassum polysaccharides of 5～30 parts, the phylloxanthin of 2～20 parts,
The anthocyanidin of 5～40 parts, the anisaldehyde of 2～30 parts and the levan of 35～115 parts.
Further, principal agent include the soluble potassium salt of 60～160 parts, the soluble sodium salt of 40～95 parts, 1.5～3 parts can
Dissolubility iron salt, the soluble calcium salt of 130～230 parts, the soluble manganese salt of 0.5～2.0 part, the solubility magnesium salt of 4～18 parts, 10～
The Sargassum polysaccharides of 25 parts, the phylloxanthin of 5～15 parts, the anthocyanidin of 10～35 parts, the anisaldehyde of 5～25 parts and 50～100 parts
Levan.
Further, one or more in potassium citrate, potassium acetate, potassium chloride and potassium amino acid of soluble potassium salt；Excellent
Selection of land, one or more in sodium citrate, sodium acetate, sodium chloride and amino acid sodium of soluble sodium salt；Preferably, may be used
One or more in ferric citrate, iron acetate, iron chloride and aminoacid ferrum of dissolubility iron salt；Preferably, soluble calcium salt
One or more in calcium citrate, calcium acetate, calcium chloride and amino acid calcium；Preferably, soluble manganese salt is selected from Fructus Citri Limoniae
One or more in acid manganese, manganese acetate, manganese chloride and manganese amino acid；Preferably, solubility magnesium salt is selected from magnesium citrate, vinegar
One or more in acid magnesium, magnesium chloride and amino acid-magnesium chelate.
Further, Sargassum polysaccharides is the extract of plant A, and plant A is selected from Brown algae, Thallus Laminariae (Thallus Eckloniae), Cauda cervi dish, Macrocystis pyrifera (L.) Ag., bead
One or more in algae, yellow tang, Fucus Vesiculosus, Eucheuma gelatinosum and Thallus Gracilariae；Preferably, phylloxanthin is the extract of plant B,
Plant B is in Flos Tagetis Erectae, Herba Spinaciae, Semen Maydis, cabbage mustard, Germinatus Phragmitis, Caulis et Folium Lactucae sativae, broccoli, Fructus Mangifera Indicae, Fructus actinidiae chinensis and Radix Dauci Sativae
One or more；Preferably, anthocyanidin is the extract of plant C, plant C selected from blackberry, blue berry, cranberry, Fructus Fragariae Ananssae,
One or more in Lycium ruthenicum Murr., Fructus Mori, Fructus Vitis viniferae and Fructus Myricae rubrae；Preferably, anisaldehyde is the extract of plant D, and plant D selects
One or more in Fructus Anisi Stellati, Fructus Foeniculi, vanilla bean；Preferably, levan is the extract of plant E, plant E
One or more in Jerusalem artichoke, Bulbus Lilii, Germinatus Phragmitis, Semen Tritici aestivi, Radix Asparagi, Bulbus Allii Cepae and Dahlia Pinnata Cav..
Further, pharmaceutical composition also includes adjuvant, and adjuvant is selected from filler, disintegrating agent, binding agent, correctives, strong color
Agent, lubricant, stabilizer, emulsifying agent, co-emulsifier, pH adjusting agent, preservative, water-soluble base, oil-soluble substrate and
One or more in capsule casing material.
Further, one or more in microcrystalline Cellulose, mannitol, sorbitol and dextrin of filler；Preferably,
One or more in carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose and polyvinylpolypyrrolidone of disintegrating agent；Preferably, viscous
Mixture is selected from hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose, polyvidone, methylcellulose, hydroxypropyl cellulose, ethyl
One or more in cellulose, gelatin and carbomer；Preferably, during correctives is selected from simple syrup, xylitol, sucrose
Plant or multiple；Preferably, toner is rectified selected from caramel color, curcumin, carotene, phylloxanthin, Carthamus yellow, Fructus Citri Limoniae
One or more in Huang, sunset yellow and D C Yellow No. 10；Preferably, lubricant selected from magnesium stearate, micropowder silica gel, Pulvis Talci and
One or more in magnesium laurylsulfate；Preferably, stabilizer selected from sodium alginate, starch, arabic gum, guar gum,
One or more in carrageenan, xanthan gum, agar and propylene glycol alginate；Preferably, emulsifying agent is selected from polyoxyethylene ether, tells
Temperature 80, polysorbate60, polysorbate40, polysorbas20, this Pan 80, this Pan 60, this Pan 40, this Pan 20 and OP-10 (alkyl phenol
Polyoxyethylene ether) in one or more；Preferably, co-emulsifier is selected from ethanol, ethylene glycol, n-butyl alcohol, glycerol, PEG200
With one or more in PEG400；Preferably, pH adjusting agent is selected from hydrochloric acid, acetic acid, sulphuric acid, citric acid, lactic acid, boron
One or more in acid-sodium carbonate buffer, phosphate buffer, phosphoric acid, sodium dihydrogen phosphate, borate buffer solution；Preferably
Ground, preservative is selected from benzoic acid, sodium benzoate, sorbic acid, sodium sorbate, potassium sorbate, ethylparaben and double
One or more in sodium acetate；Preferably, water-soluble base selected from PEG2000, PEG4000, PEG6000, PEG10000,
One or more in Myrj 45 (degree of polymerization is 40), stearate, glycerol, PLURONICS F87；Preferably
Ground, one or more in olein, soybean oil, Semen Maydis oil, paraffin and Cera Flava of oleaginous base；Preferably, capsule
Shell material selected from chitosan, gelatin, glycerol, methylcellulose, CAP, polyamide, silicone rubber, poly-third
One or more in olefin(e) acid resin and polyvinyl alcohol.
On the other hand the application provides a kind of medicine regulating uric acid in blood concentration, and this medicine includes aforementioned pharmaceutical compositions.
Further, the dosage form of medicine is tablet, capsule, pill, oral liquid, syrup, granule, drop pill or powder.
On the other hand the application provides a kind of said medicine in the medicine of the preparation treatment higher relevant disease of uric acid in blood concentration
Application.
Application technical scheme, adds the basic mineral salt such as potassium salt and sodium salt and urine can be made to alkalize, thus be conducive to
Improve uric acid crystal resolution of precipitate, promote uratic excretion and slow down the swelling in joint；Add iron salt, calcium salt, manganese salt
Be conducive to regulating the pH of human body fluid with the basic mineral salt such as magnesium salt, thus improve the health degree of human body fluid, and comprehensively regulating
Metabolism, vasodilator, reduce blood pressure, and then reach the effect being conducive to urinating.Above-mentioned basic mineral salt also has nontoxic pair
The feature of effect.Thus the pharmaceutical composition toxic and side effects of the application offer is low, and can effectively regulate the concentration of uric acid in blood.
Detailed description of the invention
It should be noted that in the case of not conflicting, the embodiment in the application and the feature in embodiment can be mutually combined.
The present invention is described in detail below in conjunction with embodiment.
As described by background technology, existing uric acid regulating drug exists that toxic and side effects is big or the problem of weak curative effect.For understanding
Certainly above-mentioned technical problem, the invention provides a kind of pharmaceutical composition, and this pharmaceutical composition includes principal agent, and this principal agent includes alkalescence
Mineral salt, above-mentioned basic mineral salt includes but not limited to soluble potassium salt, soluble sodium salt, soluble ferric iron salt, solubility
One or more in calcium salt, soluble manganese salt and solubility magnesium salt.
As it was noted above, when uric acid in blood concentration relatively Gao Shihui causes urate crystal to be deposited in human organ thus causes each
Plant disease.Potassium salt and the addition of the basic mineral salt such as sodium salt in the pharmaceutical composition that the application provides can make urine alkalize,
Thus be conducive to improving uric acid crystal resolution of precipitate, promote uratic excretion and slow down the swelling in joint.Iron salt, calcium salt,
The basic mineral salt such as manganese salt and magnesium salt there was added the pH beneficially regulating human body fluid, thus improve the health degree of human body fluid,
And comprehensively regulating metabolism, vasodilator, reduce blood pressure, and then reach the effect being conducive to urinating.Above-mentioned basic mineral salt is also
Have the advantages that to have no side effect.Thus the pharmaceutical composition toxic and side effects of the application offer is low, and can effectively regulate in blood
The concentration of uric acid.
Aforementioned pharmaceutical compositions owing to containing basic mineral salt, thus its to have toxic and side effects low and can effectively regulate blood
The feature of the concentration of middle uric acid.In a preferred embodiment, by weight, basic mineral salt includes 40～180
The soluble potassium salt of part, the soluble sodium salt of 30～120 parts, the soluble ferric iron salt of 1～4 part, the solubility calcium of 110～250 parts
Salt, the soluble manganese salt of 0.2～2.5 part and the solubility magnesium salt of 2～25 parts.By soluble potassium salt in basic mineral salt, solvable
Property sodium salt, solubility iron salt, soluble calcium salt, the consumption of soluble manganese salt and solubility magnesium salt limits has within the above range
It is beneficial to play the synergism between each component, and then improves the regulating effect to uric acid in blood concentration further.
Except above-mentioned two big constituents, those skilled in the art can also add some other composition according to actual needs to improve
Drug effect.In a preferred embodiment, above-mentioned principal agent also includes natural plant extracts, natural plant extracts include but
It is not limited to one or more in Sargassum polysaccharides, phylloxanthin, anthocyanidin, anisaldehyde and levan.
Sargassum polysaccharides is conducive to growth and the gathering of suppression crystal, thus there was added of Sargassum polysaccharides the most effectively suppresses urinary stone
Formed.Phylloxanthin and anthocyanidin are respectively provided with preferable non-oxidizability, thus there was added of above two composition beneficially improves cell generation
Thank and suppress cell ageing, thus it is the most pre-to advantageously reduce the higher infringement to human organ and cell tissue of long-term uric acid concentration
The generation of anti-complication.Anisaldehyde has certain diuresis, thus anisaldehyde there was added the discharge beneficially strengthening uric acid.
Levan may advantageously facilitate human body to the absorption of mineral the probiotic bacteria that improves human body intestinal canal, thus there was added beneficially of levan
Improve the absorption of human body food to external world, rebuild intestinal balance, and then be conducive to making human body preferably digest fat and suppress a large amount of
The generation of uric acid.Thus above-mentioned natural plant extracts there was added beneficially improve in pharmaceutical composition provided herein biological
The regulating effect of confrontation uric acid in blood concentration, simultaneously because component is all natural materials, thus the addition of said components is the most favourable
In the toxic and side effects reducing aforementioned pharmaceutical compositions further.
In a preferred embodiment, the weight ratio of basic mineral salt and natural plant extracts be 183～582: 49～
235.The weight ratio of basic mineral salt with natural plant extracts is limited and is conducive within the above range improving basic mineral salt
And the coordinative role between natural plant extracts, thus improve pharmaceutical composition provided herein further at regulation blood
The effect of middle uric acid concentration.
Preferably, natural plant extracts includes the Sargassum polysaccharides of 5～30 parts, the phylloxanthin of 2～20 parts, the cyanine of 5～40 parts
Element, the anisaldehyde of 2～30 parts and the levan of 35～115 parts.By natural plant extracts Lutein, anthocyanidin, anisaldehyde
And the consumption of levan limits and is conducive within the above range improving pharmaceutical composition provided herein further to urine in blood
The regulating effect of acid concentration.
In a preferred embodiment, principal agent include the soluble potassium salt of 60～160 parts, the soluble sodium salt of 40～95 parts,
The soluble ferric iron salt of 1.5～3 parts, the soluble calcium salt of 130～230 parts, the soluble manganese salt of 0.5～2.0 part, 4～18 parts can
Soluble magnesium salt, 10～25 parts of Sargassum polysaccharides, 5～15 parts of phylloxanthins, 10～35 parts of anthocyanidin, 5～25 parts of anisaldehydes and 50～
100 portions of levan.The consumption of component each in principal agent in pharmaceutical composition is limited and is capable of within the above range each component is worked in coordination with
The further optimization of effect, thus improve the pharmaceutical composition regulating effect to uric acid in blood concentration further.
In aforementioned pharmaceutical compositions, soluble potassium salt, soluble sodium salt, soluble ferric iron salt, soluble calcium salt, soluble manganese salt,
Solubility magnesium salt can select compound commonly used in the art.In a preferred embodiment, soluble potassium salt include but not
It is limited to one or more in potassium citrate, potassium acetate, chlorate and potassium amino acid；Preferably, soluble sodium salt is selected from Fructus Citri Limoniae
One or more in acid sodium, sodium acetate, sodium chloride and amino acid sodium；Preferably, soluble ferric iron salt is selected from ferric citrate, vinegar
One or more in acid ferrum, iron chloride and aminoacid ferrum；Preferably, soluble calcium salt is selected from calcium citrate, calcium acetate, chlorine
Change one or more in calcium and amino acid calcium；Preferably, soluble manganese salt is selected from manganese citrate, manganese acetate, manganese chloride and ammonia
One or more in base acid manganese；Preferably, solubility magnesium salt is in magnesium citrate, magnesium acetate, magnesium chloride and amino acid-magnesium chelate
One or more.Above-mentioned soluble-salt has that source is wide, price is low and the feature such as good water solubility, thus selects above-mentioned solubility
The composition of the pharmaceutical composition that salt provides as the application is conducive to improving the dissolubility of pharmaceutical composition, and then is conducive to improving it
The drug effect of unit dose, also helps the cost reducing aforementioned pharmaceutical compositions simultaneously.
Be conducive to promoting medicine further as it was noted above, add a certain amount of natural plant extracts in aforementioned pharmaceutical compositions
The compositions regulating effect to uric acid in blood concentration.The acquisition pattern of above-mentioned biotic component has multiple, and those skilled in the art can
To select according to practical situation.In a preferred embodiment, Sargassum polysaccharides is the extract of plant A, plant A
Include but not limited in Brown algae, Thallus Laminariae (Thallus Eckloniae), Cauda cervi dish, Macrocystis pyrifera (L.) Ag., chlorella, yellow tang, Fucus Vesiculosus, Eucheuma gelatinosum and Thallus Gracilariae
One or more；Preferably, phylloxanthin is the extract of plant B, plant B include but not limited to Flos Tagetis Erectae, Herba Spinaciae, Semen Maydis,
One or more in cabbage mustard, Germinatus Phragmitis, Caulis et Folium Lactucae sativae, broccoli, Fructus Mangifera Indicae, Fructus actinidiae chinensis and Radix Dauci Sativae；Preferably, anthocyanidin is
The extract of plant C, plant C include but not limited to blackberry, blue berry, cranberry, Fructus Fragariae Ananssae, Lycium ruthenicum Murr., Fructus Mori, Fructus Vitis viniferae and
One or more in Fructus Myricae rubrae；Preferably, anisaldehyde is the extract of plant D, plant D include but not limited to Fructus Anisi Stellati,
One or more in Fructus Foeniculi, vanilla bean；Preferably, levan is the extract of plant E, and plant E includes but do not limits
One or more in Jerusalem artichoke, Bulbus Lilii, Germinatus Phragmitis, Semen Tritici aestivi, Radix Asparagi, Bulbus Allii Cepae and Dahlia Pinnata Cav..By extracting from existing plant
Sargassum polysaccharides, phylloxanthin, anthocyanidin, anisaldehyde and levan, be conducive to the poison pair reducing aforementioned pharmaceutical compositions further to make
With.
Aforementioned pharmaceutical compositions is prepared as during some particular dosage form needing to add some adjuvants, as filler, disintegrating agent, binding agent,
Correctives, rectify toner, lubricant, stabilizer, emulsifying agent, co-emulsifier, pH adjusting agent, preservative, water-soluble base,
One or more in oleaginous base and capsule casing material.There was added of filler beneficially regulates effectively containing under Unit Weight in dosage form
Amount.It is preferably filled with agent and includes but not limited to one or more in microcrystalline Cellulose, mannitol, sorbitol and dextrin.
Disintegrating agent there was added the disintegrative beneficially improving medicament, thus shorten the release time of drug effect.Preferably disintegrating agent include but
It is not limited to one or more in carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose and polyvinylpolypyrrolidone.
There was added the adhesion beneficially improved between each component and then obtain required dosage form of binding agent.Correctives is generally with special
Taste, beneficially improve the mouthfeel of medicine thereby through there was added of correctives.Preferably binding agent includes but not limited to hydroxypropyl first
Base cellulose, sodium carboxymethyl cellulose, polyvidone, methylcellulose, hydroxypropyl cellulose, ethyl cellulose, gelatin and card
One or more in ripple nurse.
That rectifys toner there was added the color beneficially adjusting preparation.Preferably rectify toner and include but not limited to simple syrup, xylitol, sucrose
In one or more.
Lubricant there was added the molding effect beneficially improving preparation.Preferred emollient includes but not limited to magnesium stearate, micropowder silicon
One or more in glue, Pulvis Talci and magnesium laurylsulfate.
Stabilizer there was added the stability beneficially improving medicament.Preferred stabilizer include but not limited to sodium alginate, starch, Ah
Draw one or more in primary glue, guar gum, carrageenan, xanthan gum, agar and propylene glycol alginate.
There was added of emulsifying agent beneficially improves the intermiscibility of various components in medicine, is conducive to improving the synergism between various component,
And then be conducive to improving the drug effect of medicament.Preferred emulsifier includes but not limited to polyoxyethylene ether, Tween 80, polysorbate60, tween
40, the one in polysorbas20, this Pan 80, this Pan 60, this Pan 40, this Pan 20 and OP-10 (alkylphenol polyoxyethylene)
Or it is multiple.
The intermiscibility that there was added each component of raising beneficially further of co-emulsifier.Preferably co-emulsifier include but not limited to ethanol,
One or more in ethylene glycol, n-butyl alcohol, glycerol, PEG200 and PEG400.
The pH that there was added beneficially regulating agent of pH adjusting agent.Preferably pH adjusting agent include but not limited to hydrochloric acid, acetic acid, sulphuric acid,
In citric acid, lactic acid, boric acid-sodium carbonate buffer, phosphate buffer, phosphoric acid, sodium dihydrogen phosphate, borate buffer solution
One or more.
Preservative there was added the effect duration beneficially extending pharmaceutical composition.Preferred preservative includes but not limited to benzoic acid, benzene first
One or more in acid sodium, sorbic acid, sodium sorbate, potassium sorbate, ethylparaben and sodium diacetate.
Water-soluble base is mostly polymer substance, water-soluble base there was added the release effect beneficially improving preparation.Preferably water
Soluble base includes but not limited to that PEG2000, PEG4000, PEG6000, PEG10000, Myrj 45 are (poly-
Right is 40), stearate, glycerol, one or more in PLURONICS F87.
There was added of oil-soluble substrate beneficially improves medicine penetration power in skin.Preferably oleaginous base includes but not limited to oleic acid
One or more in glyceride, soybean oil, Semen Maydis oil, paraffin and Cera Flava.
For some specific dosage form, such as capsule etc., needing to add a certain amount of capsule casing material, this is conducive to releasing in desired location
Put the effective ingredient in medicine.Preferably capsule casing material includes but not limited to chitosan, gelatin, glycerol, methylcellulose, acetic acid
One or more in cellulose phthalate, polyamide, silicone rubber, polyacrylic resin and polyvinyl alcohol.
Another aspect of the present invention additionally provides a kind of medicine regulating uric acid in blood concentration, and this medicine includes that said medicine combines
Thing.To have toxic and side effects low for the pharmaceutical composition provided due to the application, and can effectively regulate the concentration of uric acid in blood, because of
And the medicine of the regulation uric acid in blood concentration comprising aforementioned pharmaceutical compositions is equally reached effectively regulation uric acid in blood concentration
Effect.
Aforementioned pharmaceutical compositions can be prepared as different dosage forms according to the difference of route of administration.The dosage form of aforementioned pharmaceutical compositions
Include but not limited to tablet, capsule, pill, oral liquid, syrup, granule, drop pill and powder.
Another aspect of the present invention additionally provides a kind of said medicine medicine at the preparation treatment higher relevant disease of uric acid in blood concentration
Application in thing.To have toxic and side effects low for the pharmaceutical composition provided due to the application, and can effectively regulate uric acid in blood
Concentration, thus the medicinal application comprising aforementioned pharmaceutical compositions equally can in time treating uric acid in blood concentration higher disease
Reach effectively to regulate the effect of uric acid in blood concentration.When the synthesis of uric acid in blood increases or discharges minimizing, blood can be caused
Middle uric acid concentration is too high, and uric acid is deposited in joint, cartilage and kidney with the form of sodium salt, can cause gouty arthritis, kidney
The disease such as dysfunction and renal calculus.
In the application, the preparation method of aforementioned pharmaceutical compositions is as follows: sieved by needed raw material, weighs required weight portion the most respectively
Each component, each component mixing and stirring that finally will weigh up, required dosage form made by the optional adjuvant that adds.
Being described in further detail the present invention below in conjunction with specific embodiment, these embodiments are it is not intended that limit institute of the present invention
Claimed scope.
Embodiment 1
The composition of pharmaceutical composition: 60g potassium citrate, 40g sodium citrate, 1.5g ferric citrate, 130g calcium citrate, 0.5g
Manganese citrate, 4g magnesium citrate, 25g Sargassum polysaccharides, 15g phylloxanthin, 35g anthocyanidin, 25g anisaldehyde and 100g levan.
Preparation method: above-mentioned each component is sieved, then each component of weight needed for accurate weighing, after mixing and stirring, system
Piece agent.
Embodiment 2
The composition of pharmaceutical composition: 72g potassium citrate, 72g sodium citrate, 3g ferric citrate, 215g calcium citrate, 1.4g
Manganese citrate, 7g magnesium citrate, 14g Sargassum polysaccharides, 7g phylloxanthin, 14g anthocyanidin, 7g anisaldehyde, 86g levan and
600gPEG 4000、600gPEG 6000。
Preparation method: above-mentioned each component sieved, then each component of weight needed for accurate weighing, after mixing and stirring, adds
Enter PEG4000 and PEG6000 to drip and make drop pill and cool down.
Embodiment 3
The composition of pharmaceutical composition: 147g potassium citrate, 49g sodium citrate, 2g ferric citrate, 148g calcium citrate, 1g lemon
Lemon acid manganese, 15g magnesium citrate, 20g Sargassum polysaccharides, 10g phylloxanthin, 30g anthocyanidin, 20g anisaldehyde, 60g levan,
4g simple syrup, 2g sodium benzoate, 2g sodium alginate, 1.5g xanthan gum, hydrochloric acid (pH value of solution is adjusted to 4.0) and 3000g
Sterilized water.
Preparation method: above-mentioned each component is sieved, each component of weight needed for accurate weighing；The each component weighed up is dissolved into nothing
In bacterium water, adding simple syrup, sodium benzoate, sodium alginate, xanthan gum, the pH value of solution is adjusted to 4.0 by dropping hydrochloric acid,
Then sterilization filling, makes oral liquid.
Embodiment 4
The composition of pharmaceutical composition: 98g potassium citrate, 87g sodium citrate, 2.3g ferric citrate, 173g calcium citrate, 1.1g
Manganese citrate, 5.8g magnesium citrate, 17g Sargassum polysaccharides, 9g phylloxanthin, 23g anthocyanidin, 14g anisaldehyde, 70g levan,
50g microcrystalline Cellulose (PH-101 type, Shanghai Kai Yin Chemical Co., Ltd.), 12g hydroxypropyl methyl cellulose, 15g crosslinking is poly-
Dimension ketone and capsule material (capsule material is made up of the edible Gelatinum oxhide that weight ratio is 1: 4: 1, methylcellulose, sterilized water).
Preparation method: above-mentioned each component sieved, then each component of weight needed for accurate weighing, after mixing and stirring, adds
Enter microcrystalline Cellulose, hydroxypropyl methyl cellulose and polyvinylpolypyrrolidone, be sufficiently mixed prepared capsule 's content.By gelatin, methyl
Cellulose and sterilized water weigh according to above-mentioned usage ratio, are prepared as capsule material glue.Capsule 's content is loaded in Capsules and make
Become hard capsule.
Embodiment 5
The composition of pharmaceutical composition: 70g potassium citrate, 70g sodium citrate, 3g ferric citrate, 215g calcium citrate, 1.4g
Manganese citrate, 7g magnesium citrate, 14g Sargassum polysaccharides, 7g phylloxanthin, 14g anthocyanidin, 7g anisaldehyde, 90g levan,
45g mannitol, 3.8g sucrose, 2g caramel color, 12g magnesium stearate and 10g micropowder silica gel.
Preparation method: above-mentioned each component sieved, then each component of weight needed for accurate weighing, after mixing and stirring, adds
Enter mannitol, sucrose, caramel color and magnesium stearate and micropowder silica gel, pulverize, sieve, mix after make powder.
Embodiment 6
The composition of pharmaceutical composition: 160g potassium citrate, 95g sodium citrate, 3g ferric citrate, 230g calcium citrate, 2g lemon
Lemon acid manganese, 18g magnesium citrate, 10g Sargassum polysaccharides, 5g phylloxanthin, 10g anthocyanidin, 5g anisaldehyde, 50g levan and 50g
Dextrin.
Preparation method: above-mentioned each component sieved, then each component of weight needed for accurate weighing, after mixing and stirring, adds
Enter dextrin and make granule.
Embodiment 7
The composition of pharmaceutical composition: 60g potassium citrate, 50g sodium citrate, 3g ferric citrate, 150g calcium citrate, 2g lemon
Lemon acid manganese, 4g magnesium citrate, 20g Sargassum polysaccharides, 15g phylloxanthin, 10g anthocyanidin, 10g anisaldehyde, 50g levan,
600g Semen Maydis oil, 14g polysorbate60,22g Si Pan 80,5g ethanol and capsule material (capsule material by weight ratio be 2: 1: 1 edible
Gelatin, glycerol, sterilized water form).
Preparation method: above-mentioned each solid constituent sieved, then each principal agent component of weight needed for accurate weighing, add required weight
The Semen Maydis oil mix and blend of amount, adds polysorbate60, this Pan 80 and ethanol mix homogeneously, prepares capsule 's content.By gelatin,
Glycerol and sterilized water weigh according to above-mentioned usage ratio, are prepared as capsule material glue.Glue and capsule Dissolve things inside extrude soft through pellet press
Capsule, wall thickness is 0.7mm.
Embodiment 8
The composition of pharmaceutical composition: 40g potassium citrate, 30g sodium citrate, 1g ferric citrate, 110g calcium citrate, 0.2g
Manganese citrate, 2g magnesium citrate, 30g Sargassum polysaccharides, 20g phylloxanthin, 40g anthocyanidin, 30g anisaldehyde, 115g levan,
36g microcrystalline Cellulose, 12g polyvidone, 8g magnesium stearate and 5g Pulvis Talci.
Preparation method: above-mentioned each component sieved, then each component of weight needed for accurate weighing, after mixing and stirring, adds
Enter microcrystalline Cellulose, polyvidone and magnesium stearate and tablet made by Pulvis Talci.
Embodiment 9
The composition of pharmaceutical composition: 180g potassium citrate, 120g sodium citrate, 4g ferric citrate, 250g calcium citrate, 2.5g
Manganese citrate, 25g magnesium citrate, 5g Sargassum polysaccharides, 2g phylloxanthin, 5g anthocyanidin, 2g anisaldehyde, 25g levan, 50g
Microcrystalline Cellulose, 15g methylcellulose and 18g magnesium laurylsulfate.
Preparation method: above-mentioned each component sieved, then each component of weight needed for accurate weighing, after mixing and stirring, adds
Enter microcrystalline Cellulose, methylcellulose and magnesium laurylsulfate and make tablet.
Embodiment 10
The composition of pharmaceutical composition: 40g potassium citrate, 30g sodium citrate, 1g ferric citrate, 110g calcium citrate, 0.2g
Manganese citrate, 2g magnesium citrate, 42g sorbitol, 16g methylcellulose and 17g magnesium laurylsulfate.
Preparation method: above-mentioned each component sieved, then each component of weight needed for accurate weighing, after mixing and stirring, adds
Enter sorbitol, methylcellulose and magnesium laurylsulfate and make tablet.
Embodiment 11
The composition of pharmaceutical composition: 40g potassium citrate, 140g sodium citrate, 5g ferric citrate, 280g calcium citrate, 3g lemon
Lemon acid manganese, 10g magnesium citrate and, 40g microcrystalline Cellulose, 11g carbomer and 20g micropowder silica gel.
Preparation method: above-mentioned each component sieved, then each component of weight needed for accurate weighing, after mixing and stirring, adds
Enter microcrystalline Cellulose, carbomer and micropowder silica gel, make tablet.
Detection test
1) animal experiment
The pharmaceutical composition that embodiment 1～11 prepares all is configured to, with sterilized water, the solution that principal agent valid density is 10mg/mL,
It is easy to be administered.
Material: uric acid detection kit, Bioengineering Research Institute is built up in Nanjing.
After normal male Kunming mouse overnight fasting, it is randomly divided into following 13 groups by body weight, normal group, model group, treatment 1
Group, treat 2 groups, treat 3 groups, treat 4 groups, treat 5 groups, treat 6 groups, treat 7 groups, treat 8 groups, treatment 9
Group, treat 10 groups, treat 11 groups, often group 8.Normal group gives normal feedstuff and feeds, and model group, treatment 1-11 group are given
Give high yeast feed (20% yeast extract+80 normal feedstuff)+200mg/kg Oteracil Potassium, cause hyperuricemia model.Building
While mould, each group of mice injects a kind of medicine, treat 1～11 group by intravenous mode correspondingly inject embodiment 1～
The drug solution (dosage 1mL/100g once a day) of 11, normal group and the normal saline of model group equal intravenous injection equivalent.Even
Continuous administration 4 weeks.At the end of medication the 0th, 1,2,4 weeks, in batches after being administered 3 hours, eyeball takes blood 0.5mL, room temperature
Lower standing, after 1 hour, is centrifuged 20 minutes under 3000rpm rotating speed, takes serum uric acid detection kit and measures uric acid level,
Experimental result is as shown in table 1.
Table 1
Compare with model group, * P < 0.05.
The Serum experiments data of analytical table 1 model group understand, and when testing 1 week, model group serum uric acid raises, the 2nd Zhou Shida
Arrive peak, although within the 4th week, serum uric acid level has declined, but still much higher than normal group data, and this metabolic arthritis is described
Mass formed by blood stasis model has continuous stability, designs very successful.Treat 1～11 group of serum uric acid value when the 1st week and reach peak,
But the respectively less than numerical value (P < 0.05) of model group.When the 2nd week, the uric acid level treating 1～11 group all declines to a great extent.4th
In week, the uric acid level treating 1～7 group is as good as with normal group；Though the uric acid level treating 8～11 groups has decline, but slightly above normal group
Uric acid level.Simultaneously by the comparison for the treatment of group 8～11, add in pharmaceutical composition natural extract be conducive to making itself and
Mineral salt plays synergism, and then improves drug effect.To sum up analyze, illustrate that the embodiment medicine for the treatment of 1～11 group is respectively provided with and press down
Urina Hominis (processed) acid is formed, and promotes urate excretion, reduces the effect of serum uric acid, and treats the embodiment drug component of 1～7 group
Proportioning more optimize.
2) clinical trial
The effect of the present invention is further described in detail by the clinical trial carried out below in conjunction with hospital.
330 hyperuricemia patients being divided into 11 groups, takes the pharmaceutical composition that embodiment 1～11 prepares respectively, every day is the most each
1 time, take 30 days continuously.Uric acid level before and after detection patient on medication, judges the curative effect of medicine of the present invention with this.Table
2 is each embodiment therapeutic effect to human body hyperuricemia.
Table 2
| Embodiment | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 |
| Patient's number | 30 | 30 | 30 | 30 | 30 | 30 | 30 | 30 | 30 | 30 | 30 |
| Uric acid declines patient's number | 28 | 28 | 29 | 28 | 29 | 29 | 29 | 26 | 25 | 25 | 26 |
| Effective percentage (%) | 93.3 | 93.3 | 96.7 | 93.3 | 96.7 | 96.7 | 96.7 | 86.7 | 83.3 | 83.3 | 86.7 |
Knowable to the data of table 2,11 embodiment medicines are all notable to the therapeutic effect of hyperuricemia, and treated effect is more than
80%.During clinical trial and followed the tracks of the concrete condition of patient.The following is two concrete cases.
Wu, man, 55 years old, before taking medicine of the present invention, serum uric acid level was 528 μm ol/L, and big toe has an intense pain.
Taking the embodiment of the present invention 1 medicine, the most each 1 time, each 1, take continuously 3 days, toe pain symptom has been alleviated.
After taking medicine 1 month, the Level of Serum Uric Acid of Wu reduces to 457 μm ol/L, toe no longer pain, after taking medicine 2 months, and serum uric acid level
It is 411 μm ol/L, returns to normal.
Remaining certain, man, 53 years old, before Drug therapy, serum uric acid level was 611 μm ol/L, and big toe has an intense pain and with slight swollen
Large deformation, takes the medicine of the embodiment of the present invention 4 sooner or later, and each 1, after taking medicine continuously 4 days, the symptom of toe pain is delayed
Solve.After taking medicine 1 month, the serum Uric Acid Concentration of patient is 489 μm ol/L, and toe pain symptom substantially alleviates, and takes medicine 3 continuously
After Yue, the serum uric acid level of patient returns to normally, is 404 μm ol/L.
The foregoing is only the preferred embodiments of the present invention, be not limited to the present invention, for those skilled in the art
For, the present invention can have various modifications and variations.All within the spirit and principles in the present invention, any amendment of being made, etc.
With replacement, improvement etc., should be included within the scope of the present invention.
Claims (12)
1. a pharmaceutical composition, it is characterised in that described pharmaceutical composition includes that principal agent, described principal agent include basic mineral salt,
Described basic mineral salt is selected from soluble potassium salt, soluble sodium salt, soluble ferric iron salt, soluble calcium salt, soluble manganese
One or more in salt and solubility magnesium salt.
Pharmaceutical composition the most according to claim 1, it is characterised in that by weight, described basic mineral salt includes
The soluble potassium salt of 40～180 parts, the soluble sodium salt of 30～120 parts, the soluble ferric iron salt of 1～4 part, 110～250
Soluble calcium salt, the soluble manganese salt of 0.2～2.5 part and the solubility magnesium salt of 2～25 parts of part.
Pharmaceutical composition the most according to claim 1 and 2, it is characterised in that described principal agent also includes natural plant extracts,
One or more in Sargassum polysaccharides, phylloxanthin, anthocyanidin, anisaldehyde and levan of described natural plant extracts,
The most described basic mineral salt is 183～582: 49～235 with the weight ratio of described natural plant extracts.
Pharmaceutical composition the most according to claim 3, it is characterised in that based on described weight portion, described extracted form natural plant
Thing include the described Sargassum polysaccharides of 5～30 parts, the described phylloxanthin of 2～20 parts, the described anthocyanidin of 5～40 parts, 2～
The described anisaldehyde of 30 parts and the described levan of 35～115 parts.
Pharmaceutical composition the most according to claim 4, it is characterised in that described principal agent includes 60～160 parts described solvable
Property potassium salt, the described soluble sodium salt of 40～95 parts, the described soluble ferric iron salt of 1.5～3 parts, 130～230 parts described
Soluble calcium salt, the described soluble manganese salt of 0.5～2.0 part, the described solubility magnesium salt of 4～18 parts, the sea of 10～25 parts
The fruit of polysaccharides, the phylloxanthin of 5～15 parts, the anthocyanidin of 10～35 parts, the anisaldehyde of 5～25 parts and 50～100 parts gathers
Sugar.
Pharmaceutical composition the most according to any one of claim 1 to 5, it is characterised in that described soluble potassium salt is selected from lemon
One or more in lemon acid potassium, potassium acetate, potassium chloride and potassium amino acid；
Preferably, described soluble sodium salt one or many in sodium citrate, sodium acetate, sodium chloride and amino acid sodium
Kind；
Preferably, described soluble ferric iron salt one or many in ferric citrate, iron acetate, iron chloride and aminoacid ferrum
Kind；
Preferably, described soluble calcium salt one or many in calcium citrate, calcium acetate, calcium chloride and amino acid calcium
Kind；
Preferably, described soluble manganese salt one or many in manganese citrate, manganese acetate, manganese chloride and manganese amino acid
Kind；
Preferably, described solubility magnesium salt one or many in magnesium citrate, magnesium acetate, magnesium chloride and amino acid-magnesium chelate
Kind.
7. according to the pharmaceutical composition according to any one of claim 3 to 5, it is characterised in that described Sargassum polysaccharides is plant A
Extract, described plant A be selected from Brown algae, Thallus Laminariae (Thallus Eckloniae), Cauda cervi dish, Macrocystis pyrifera (L.) Ag., chlorella, yellow tang, Fucus Vesiculosus, stone
One or more in Herba Astragali Sinici and Thallus Gracilariae；
Preferably, described phylloxanthin is the extract of plant B, and described plant B is selected from Flos Tagetis Erectae, Herba Spinaciae, Semen Maydis, mustard
One or more in indigo plant, Germinatus Phragmitis, Caulis et Folium Lactucae sativae, broccoli, Fructus Mangifera Indicae, Fructus actinidiae chinensis and Radix Dauci Sativae；
Preferably, described anthocyanidin is the extract of plant C, and described plant C is selected from blackberry, blue berry, cranberry, grass
One or more in the certain kind of berries, Lycium ruthenicum Murr., Fructus Mori, Fructus Vitis viniferae and Fructus Myricae rubrae；
Preferably, described anisaldehyde is the extract of plant D, and described plant D is selected from Fructus Anisi Stellati, Fructus Foeniculi, fragrant pod
One or more in blue bean；
Preferably, described levan is the extract of plant E, described plant E selected from Jerusalem artichoke, Bulbus Lilii, Germinatus Phragmitis, Semen Tritici aestivi,
One or more in Radix Asparagi, Bulbus Allii Cepae and Dahlia Pinnata Cav..
Pharmaceutical composition the most according to any one of claim 1 to 7, it is characterised in that described pharmaceutical composition also includes
Adjuvant, described adjuvant is selected from filler, disintegrating agent, binding agent, correctives, strong toner, lubricant, stabilizer, breast
One in agent, co-emulsifier, pH adjusting agent, preservative, water-soluble base, oil-soluble substrate and capsule casing material or
Multiple.
Pharmaceutical composition the most according to claim 8, it is characterised in that described filler selected from microcrystalline Cellulose, mannitol,
One or more in sorbitol and dextrin；
Preferably, during described disintegrating agent is selected from carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose and polyvinylpolypyrrolidone
Plant or multiple；
Preferably, described binding agent is selected from hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose, polyvidone, Methyl cellulose
One or more in element, hydroxypropyl cellulose, ethyl cellulose, gelatin and carbomer；
Preferably, one or more in simple syrup, xylitol, sucrose of described correctives；
Preferably, described strong toner is selected from caramel color, curcumin, carotene, phylloxanthin, Carthamus yellow, lemon
One or more in lemon Huang, sunset yellow and D C Yellow No. 10；
Preferably, described lubricant one in magnesium stearate, micropowder silica gel, Pulvis Talci and magnesium laurylsulfate or
Multiple；
Preferably, described stabilizer selected from sodium alginate, starch, arabic gum, guar gum, carrageenan, xanthan gum,
One or more in agar and propylene glycol alginate；
Preferably, described emulsifying agent is selected from polyoxyethylene ether, Tween 80, polysorbate60, polysorbate40, polysorbas20, Si Pan
80, one or more in this Pan 60, this Pan 40, this Pan 20 and OP-10；
Preferably, described co-emulsifier is in ethanol, ethylene glycol, n-butyl alcohol, glycerol, PEG200 and PEG400
One or more；
Preferably, described pH adjusting agent is selected from hydrochloric acid, acetic acid, sulphuric acid, citric acid, lactic acid, boric acid-sodium carbonate buffering
One or more in liquid, phosphate buffer, phosphoric acid, sodium dihydrogen phosphate, borate buffer solution；
Preferably, described preservative selected from benzoic acid, sodium benzoate, sorbic acid, sodium sorbate, potassium sorbate, to hydroxyl
One or more in yl benzoic acid ethyl ester and sodium diacetate；
Preferably, described water-soluble base is selected from PEG2000, PEG4000, PEG6000, PEG10000, polyoxy second
One or more in alkene stearate, stearate, glycerol, PLURONICS F87；
Preferably, described oil-soluble substrate one in olein, soybean oil, Semen Maydis oil, paraffin and Cera Flava
Or it is multiple；
Preferably, described capsule casing material selected from chitosan, gelatin, glycerol, methylcellulose, CAP,
One or more in polyamide, silicone rubber, polyacrylic resin and polyvinyl alcohol.
10. regulating a medicine for uric acid in blood concentration, described medicine includes the medicine group according to any one of claim 1 to 9
Compound.
11. medicines according to claim 10, it is characterised in that the dosage form of described medicine is tablet, capsule, pill, is administered orally
Liquid, syrup, granule, drop pill or powder.
Medicine described in 12. 1 kinds of claim 10 or 11 answering in the medicine of the preparation treatment higher relevant disease of uric acid in blood concentration
With.
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| US11357792B2 (en) | 2017-09-15 | 2022-06-14 | Dyvve Biosciences, Inc. | Method of administration and treatment |
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Application publication date: 20161012 |
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