CN107753673A - A kind of pharmaceutical composition with anti-trioxypurine effect and preparation method thereof and purposes - Google Patents
A kind of pharmaceutical composition with anti-trioxypurine effect and preparation method thereof and purposes Download PDFInfo
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- CN107753673A CN107753673A CN201610696842.4A CN201610696842A CN107753673A CN 107753673 A CN107753673 A CN 107753673A CN 201610696842 A CN201610696842 A CN 201610696842A CN 107753673 A CN107753673 A CN 107753673A
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- 239000004334 sorbic acid Substances 0.000 description 1
- 235000010199 sorbic acid Nutrition 0.000 description 1
- 229940075582 sorbic acid Drugs 0.000 description 1
- WNIFXKPDILJURQ-UHFFFAOYSA-N stearyl glycyrrhizinate Natural products C1CC(O)C(C)(C)C2CCC3(C)C4(C)CCC5(C)CCC(C(=O)OCCCCCCCCCCCCCCCCCC)(C)CC5C4=CC(=O)C3C21C WNIFXKPDILJURQ-UHFFFAOYSA-N 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 239000004575 stone Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 229960003329 sulfinpyrazone Drugs 0.000 description 1
- MBGGBVCUIVRRBF-UHFFFAOYSA-N sulfinpyrazone Chemical compound O=C1N(C=2C=CC=CC=2)N(C=2C=CC=CC=2)C(=O)C1CCS(=O)C1=CC=CC=C1 MBGGBVCUIVRRBF-UHFFFAOYSA-N 0.000 description 1
- 239000006228 supernatant Substances 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 238000012353 t test Methods 0.000 description 1
- 238000010257 thawing Methods 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 208000001072 type 2 diabetes mellitus Diseases 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/82—Theaceae (Tea family), e.g. camellia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- 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
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
- A61K36/605—Morus (mulberry)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/716—Clematis (leather flower)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/884—Alismataceae (Water-plantain family)
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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Abstract
The invention belongs to medicine, health products or field of food, and in particular to a kind of pharmaceutical composition with anti-trioxypurine effect and preparation method thereof and purposes.The bulk drug of the pharmaceutical composition includes：The parts by weight of Tea Polyphenols 3 78, the parts by weight of Radix Clematidis extract 1 38, the parts by weight of atractylodes chinensis 1 30, the parts by weight of mulberry-leaf extract 1 28, the parts by weight of Alisma extract 1 26.The present invention takes into full account the composition and the mutual proportioning of each bulk drug of bulk drug, each bulk drug is cooperated under specific proportioning, collective effect, so as to play the effect of anti-trioxypurine；The pharmaceutical composition, not only acted on significant anti-trioxypurine, and toxic side effect is smaller, security is higher；The pharmaceutical composition, only including 5 kinds of bulk drugs, composition is simple, cost is relatively low.
Description
Technical field
The invention belongs to medicine, health products or field of food, and in particular to a kind of drug regimen with anti-trioxypurine effect
Thing and preparation method thereof and purposes.
Background technology
Gout be by monosodium urate salt (MSU) deposit caused by crystal correlation arthropathy, with purine metabolic disturbance and
(or) hyperuricemia caused by underexcretion is directly related, clinic is mainly shown as that hyperuricemia, gouty are acute
Arthritis recurrent exerbation, gouty chornic arthritis and tophus, gouty nephropathy and kidney calculus urate etc..Gout refers in particular to urgency
Property characteristic arthritis and chronic gout stone disease, mainly include acute attack arthritis, tophus is formed, tophaceous is slow
Property arthritis, urate nephropathy and uric acid lithangiuria, severe one may occur in which that joint is disabled and renal insufficiency；In addition, gout
Often with diseases such as Central obesity, hyperlipidemia, hypertension, type II diabetes and cardiovascular diseases.At present, China's hyperuricemia
Patient reached 1.2 hundred million, patient with gout has exceeded 75,000,000 people, and annual just with 0.97% speed increase.Gout is
As the second largest metabolism class disease after diabetes, the life and health of the mankind is seriously endangered.
At present, the representative drugs of clinical treatment gout have colchicin, steroid antiinflammatory drugs, hormone, promotion uric acid
Eccritic (such as probenecid, Sulfinpyrazone and Benzbromarone) and suppression uric acid synthetic drug (allopurinol, Febustat), it is led
To pass through following two mechanism of action：Suppress uric acid synthesis and promote uric acid excretion.However, said medicine exist tolerance compared with
Low, the shortcomings of side effect is more.
Chinese patent literature CN104940484A is disclosed：A kind of Chinese medicine for treating gout, is made up of following bulk drugs：It is grey
20 parts of art, 25 parts of golden cypress, 15 parts of arisaema cum bile, 20 parts of cassia twig, 20 parts of notopterygium root, 15 parts of safflower, 20 parts of Radix Angelicae Sinensis, 25 parts of Radix Codonopsis, umbellate pore furgus
15 parts, 25 parts of Poria cocos, 20 parts of rhizoma alismatis, 20 parts of the root of fangji, 20 parts of the root of Chinese clematis, 20 parts of peach kernel is big living 15 parts, 20 parts of the root of Dahurain angelica.On however,
State composition and the shortcomings of raw material composition is complicated, cost of material is higher be present, so as to limit its application.
Therefore, study that new therapeutic effect is good, toxic side effect is small, raw material composition is simple, cost of material is relatively low, the side of preparation
The medicine of the easier treatment gout of method is significant.
The content of the invention
Therefore, the present invention provides, a kind of therapeutic effect is good, toxic side effect is small, raw material composition is simple, cost of material is relatively low, system
The pharmaceutical composition of the easier treatment gout of Preparation Method, and then its preparation method and purposes are provided.
In order to solve the above technical problems, the present invention is achieved through the following technical solutions：
The present invention provides a kind of pharmaceutical composition, and its bulk drug includes：Tea Polyphenols 3-78 parts by weight, Radix Clematidis extract 1-
38 parts by weight, atractylodes chinensis 1-30 parts by weight, mulberry-leaf extract 1-28 parts by weight, Alisma extract 1-26 parts by weight.
Preferably, aforementioned pharmaceutical compositions of the present invention, its bulk drug include：Tea Polyphenols 8-73 parts by weight, root of Chinese clematis extraction
Thing 5-34 parts by weight, atractylodes chinensis 4-27 parts by weight, mulberry-leaf extract 3-25 parts by weight, Alisma extract 3-24 parts by weight.
It is further preferred that aforementioned pharmaceutical compositions of the present invention, its bulk drug includes：
Tea Polyphenols 32-71 parts by weight, Radix Clematidis extract 7-30 parts by weight, atractylodes chinensis 6-25 parts by weight, mulberry leaf carry
Take thing 3-16 parts by weight, Alisma extract 3-16 parts by weight.
It is further preferred that aforementioned pharmaceutical compositions of the present invention, its bulk drug includes：The parts by weight of Tea Polyphenols 32, the root of Chinese clematis
The parts by weight of extract 22, the parts by weight of atractylodes chinensis 25, the parts by weight of mulberry-leaf extract 16, the parts by weight of Alisma extract 5；Or
The parts by weight of Tea Polyphenols 41, the parts by weight of Radix Clematidis extract 30, the parts by weight of atractylodes chinensis 16, the weight of mulberry-leaf extract 10
Measure part, the parts by weight of Alisma extract 3；Or
The parts by weight of Tea Polyphenols 57, the parts by weight of Radix Clematidis extract 11, the parts by weight of atractylodes chinensis 13, the weight of mulberry-leaf extract 3
Measure part, the parts by weight of Alisma extract 16；Or
The parts by weight of Tea Polyphenols 71, the parts by weight of Radix Clematidis extract 7, the parts by weight of atractylodes chinensis 6, the weight of mulberry-leaf extract 7
Part, the parts by weight of Alisma extract 9.
It is further preferred that aforementioned pharmaceutical compositions of the present invention,
The Radix Clematidis extract is prepared in accordance with the following methods：Take the dry root of Chinese clematis, heating and refluxing extraction at least 1
Secondary, the ethanol water that each volume fraction for adding at least 2 times weight is at least 10% extracts at least 0.5 hour, and merging carries
Liquid is taken, is concentrated, dries, produces；
The atractylodes chinensis is prepared in accordance with the following methods：Take dry rhizoma atractylodis, heating and refluxing extraction at least 1 time,
The ethanol water that each volume fraction for adding at least 2 times weight is at least 10% extracts at least 0.5 hour, merges extraction
Liquid, concentrate, dry, produce；
The mulberry-leaf extract is prepared in accordance with the following methods：Take dry mulberry leaf, heating and refluxing extraction at least 1 time,
The water of at least 2 times weight of addition extracts at least 0.5 hour every time or the volume fraction of at least 2 times weight of addition is at least every time
1% ethanol water extracts at least 0.5 hour, merges extract solution, concentrates, and dries, produces；
The Alisma extract is prepared in accordance with the following methods：Take dry rhizoma alismatis, heating and refluxing extraction at least 1 time,
The water of at least 2 times weight of addition extracts at least 0.5 hour every time or the volume fraction of at least 2 times weight of addition is at least every time
10% ethanol water extracts at least 0.5 hour, merges extract solution, concentrates, and dries, produces.
It is further preferred that aforementioned pharmaceutical compositions of the present invention,
The Radix Clematidis extract is prepared in accordance with the following methods：Take the dry root of Chinese clematis, heating and refluxing extraction 1~5
Secondary, the ethanol water that the volume fraction for adding 4~16 times of weight every time is 10%~95% extracts 0.5~4 hour, and merging carries
Liquid is taken, is concentrated, dries, produces；
The atractylodes chinensis is prepared in accordance with the following methods：Take dry rhizoma atractylodis, heating and refluxing extraction 1~5 time, often
The ethanol water that the secondary volume fraction for adding 4~16 times of weight is 10%~95% extracts 0.5~4 hour, merges extract solution,
Concentration, dry, produce；
The mulberry-leaf extract is prepared in accordance with the following methods：Take dry mulberry leaf, heating and refluxing extraction 1~5 time, often
The secondary water for adding 4~16 times of weight extract 0.5~4 hour or add every time the volume fraction of 4~16 times of weight for 1%~
50% ethanol water extracts 0.5~4 hour, merges extract solution, concentrates, and dries, produces；
The Alisma extract is prepared in accordance with the following methods：Take dry rhizoma alismatis, heating and refluxing extraction 1~5 time, often
The secondary water for adding 4~16 times of weight extract 0.5~4 hour or add every time the volume fraction of 4~16 times of weight for 10%~
95% ethanol water extracts 0.5~4 hour, merges extract solution, concentrates, and dries, produces.
It is further preferred that aforementioned pharmaceutical compositions of the present invention,
The Radix Clematidis extract is prepared in accordance with the following methods：Take the dry root of Chinese clematis, heating and refluxing extraction 1~3
Secondary, the ethanol water that the volume fraction for adding 8~12 times of weight every time is 30%~85% extracts 0.5~2 hour, and merging carries
Liquid is taken, is concentrated, dries, produces；
The atractylodes chinensis is prepared in accordance with the following methods：Take dry rhizoma atractylodis, heating and refluxing extraction 1~3 time, often
The ethanol water that the secondary volume fraction for adding 8~12 times of weight is 30%~85% extracts 0.5~2 hour, merges extract solution,
Concentration, dry, produce；
The mulberry-leaf extract is prepared in accordance with the following methods：Take dry mulberry leaf, heating and refluxing extraction 1~3 time, often
The secondary water for adding 8~12 times of weight extract 0.5~2 hour or add every time the volume fraction of 8~12 times of weight for 1%~
30% ethanol water extracts 0.5~2 hour, merges extract solution, concentrates, and dries, produces；
The Alisma extract is prepared in accordance with the following methods：Take dry rhizoma alismatis, heating and refluxing extraction 1~3 time, often
The secondary water for adding 8~12 times of weight extract 0.5~2 hour or add every time the volume fraction of 8~12 times of weight for 30%~
85% ethanol water extracts 0.5~2 hour, merges extract solution, concentrates, and dries, produces.
It is further preferred that aforementioned pharmaceutical compositions of the present invention,
The Radix Clematidis extract is prepared in accordance with the following methods：Take the dry root of Chinese clematis, heating and refluxing extraction 2 times,
The ethanol water that the volume fraction for adding 10 times of weight every time is 55% extracts 1.5 hours, merges extract solution, concentrates, and dries,
Produce；
The atractylodes chinensis is prepared in accordance with the following methods：Take dry rhizoma atractylodis, heating and refluxing extraction 2 times, every time
The ethanol water that the volume fraction for adding 10 times of weight is 55% extracts 1.5 hours, merges extract solution, concentrates, and dries, i.e.,
；
The mulberry-leaf extract is prepared in accordance with the following methods：Take dry mulberry leaf, heating and refluxing extraction 2 times, every time
The ethanol water that the volume fraction that the water of 10 times of weight of addition extracted 1.5 hours or added every time 10 times of weight is 15% carries
Take 1.5 hours, merge extract solution, concentrate, dry, produce；
The Alisma extract is prepared in accordance with the following methods：Take dry rhizoma alismatis, heating and refluxing extraction 2 times, every time
The ethanol water that the volume fraction that the water of 10 times of weight of addition extracted 1.5 hours or added every time 10 times of weight is 65% carries
Take 1.5 hours, merge extract solution, concentrate, dry, produce.
The present invention also provides a kind of preparation method of aforementioned pharmaceutical compositions, comprises the following steps：
Tea Polyphenols, Radix Clematidis extract, atractylodes chinensis, mulberry-leaf extract and the rhizoma alismatis extraction of selected parts by weight are taken respectively
Thing, grind, be well mixed, produce.
The present invention also provides a kind of preparation including aforementioned pharmaceutical compositions or is prepared including above-mentioned preparation method
Pharmaceutical composition preparation,
Described pharmaceutical composition adds customary adjuvant, and according to common process, clinically acceptable tablet, capsule is made
Agent, powder, mixture, pill, granule, solution, syrup, soft extract, emplastrum, suppository, aerosol, ointment, injection
Agent, beverage, biscuit, candy or cake.
The customary adjuvant is：Filler, disintegrant, lubricant, suspending agent, adhesive, sweetener, flavouring, anti-corrosion
Agent, matrix etc..Filler includes：Starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose etc.；Collapse
Solution agent includes：Starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, PVPP, low substitution hydroxyl
Third cellulose, cross-linked carboxymethyl cellulose are received；Lubricant includes：Magnesium stearate, lauryl sodium sulfate, talcum powder, dioxy
SiClx etc.；Suspending agent includes：Polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methyl cellulose etc.；Bonding
Agent includes, starch slurry, polyvinylpyrrolidone, hydroxypropyl methyl cellulose etc.；Sweetener includes：Saccharin sodium, aspartame, sugarcane
Sugar, honey element, enoxolone etc.；Flavouring includes：Sweetener and various essence；Preservative includes：Parabens, benzoic acid,
Sodium benzoate, sorbic acid and its esters, benzalkonium bromide, the fixed, eucalyptus oil of acetic acid chloroethene etc.；Matrix includes：PEG6000、
PEG4000, insect wax etc..
The present invention also provides aforementioned pharmaceutical compositions, the pharmaceutical composition that above-mentioned preparation method is prepared or above-mentioned medicine
Application of the preparation of compositions in xanthine oxidase inhibitor is prepared.
The present invention also provides aforementioned pharmaceutical compositions, the pharmaceutical composition that above-mentioned preparation method is prepared or above-mentioned medicine
Application of the preparation of compositions in the medicine with anti-trioxypurine effect, health products or food is prepared.
The present invention also provides aforementioned pharmaceutical compositions, the pharmaceutical composition that above-mentioned preparation method is prepared or above-mentioned medicine
Application of the preparation of compositions in the medicine, health products or food for the treatment of gout is prepared.
Technical scheme has the following advantages that：
(1) pharmaceutical composition of the present invention, the composition and the mutual proportioning of each bulk drug of bulk drug is taken into full account, is made each
Bulk drug cooperates under specific proportioning, collective effect, so as to play the effect of anti-trioxypurine；
(2) pharmaceutical composition of the present invention, not only acted on significant anti-trioxypurine, and toxic side effect is smaller, security
It is higher；
(3) pharmaceutical composition of the present invention, only including 5 kinds of bulk drugs, composition is simple, cost is relatively low.
Embodiment
In following examples and experimental example, (1) Tea Polyphenols (polyphenol content >=98%, UV detects, and catechin content >=
60%, detection method refers to GB/T 8313-2008, purchased from Chengdu Hua Gao biological products Co., Ltd)；(2) Radix Clematidis extract
It is prepared in accordance with the following methods：Take the dry root of Chinese clematis, the volume integral of heating and refluxing extraction 2 times, every time 10 times of weight of addition
Number extracts 1.5 hours for 55% ethanol water, merges extract solution, concentrates, and dries, produces；(3) atractylodes chinensis according to
Lower section method is prepared：Dry rhizoma atractylodis, heating and refluxing extraction 2 times are taken, the volume fraction for adding 10 times of weight every time is 55%
Ethanol water extract 1.5 hours, merge extract solution, concentrate, dry, produce；(4) mulberry-leaf extract is made in accordance with the following methods
It is standby to form：Dry mulberry leaf, heating and refluxing extraction 2 times are taken, the water for adding 10 times of weight every time is extracted 1.5 hours or added every time
The ethanol water that the volume fraction for entering 10 times of weight is 15% extracts 1.5 hours, merges extract solution, concentrates, and dries, produces；
(5) Alisma extract is prepared in accordance with the following methods：Dry rhizoma alismatis is taken, heating and refluxing extraction 2 times, adds 10 times of weights every time
The ethanol water that the volume fraction that the water of amount extracted 1.5 hours or added every time 10 times of weight is 65% extracts 1.5 hours,
Merge extract solution, concentrate, dry, produce.
Embodiment 1
The bulk drug of the pharmaceutical composition of the present embodiment forms：Tea Polyphenols 32g, Radix Clematidis extract 22g, rhizoma atractylodis extraction
Thing 25g, mulberry-leaf extract 16g, Alisma extract 5g；
The preparation method of the pharmaceutical composition, comprises the following steps：Tea Polyphenols, the root of Chinese clematis extraction of selected weight are taken respectively
Thing, atractylodes chinensis, mulberry-leaf extract and Alisma extract, grind, be well mixed, produce.
The pharmaceutical composition of the present embodiment adds customary adjuvant, and according to common process, tablet is made.
Embodiment 2
The bulk drug of the pharmaceutical composition of the present embodiment forms：Tea Polyphenols 41g, Radix Clematidis extract 30g, rhizoma atractylodis extraction
Thing 16g, mulberry-leaf extract 10g, Alisma extract 3g；
The preparation method of the pharmaceutical composition, comprises the following steps：Tea Polyphenols, the root of Chinese clematis extraction of selected weight are taken respectively
Thing, atractylodes chinensis, mulberry-leaf extract and Alisma extract, grind, be well mixed, produce.
The pharmaceutical composition of the present embodiment adds customary adjuvant, and according to common process, capsule is made.
Embodiment 3
The bulk drug of the pharmaceutical composition of the present embodiment forms：Tea Polyphenols 57g, Radix Clematidis extract 11g, rhizoma atractylodis extraction
Thing 13g, mulberry-leaf extract 3g, Alisma extract 16g；
The preparation method of the pharmaceutical composition, comprises the following steps：Tea Polyphenols, the root of Chinese clematis extraction of selected weight are taken respectively
Thing, atractylodes chinensis, mulberry-leaf extract and Alisma extract, grind, be well mixed, produce.
The pharmaceutical composition of the present embodiment adds customary adjuvant, and according to common process, oral liquid is made.
Embodiment 4
The bulk drug of the pharmaceutical composition of the present embodiment forms：Tea Polyphenols 71g, Radix Clematidis extract 7g, rhizoma atractylodis extraction
Thing 6g, mulberry-leaf extract 7g, Alisma extract 9g；
The preparation method of the pharmaceutical composition, comprises the following steps：Tea Polyphenols, the root of Chinese clematis extraction of selected weight are taken respectively
Thing, atractylodes chinensis, mulberry-leaf extract and Alisma extract, grind, be well mixed, produce.
The pharmaceutical composition of the present embodiment adds customary adjuvant, and according to common process, granule is made.
Comparative example 1
The bulk drug of the pharmaceutical composition of this comparative example forms：It is tea polyphenol extract thing 5g, Radix Clematidis extract 39g, grey
Art extract 28g, mulberry-leaf extract 26g, Alisma extract 2g；
The preparation method of the pharmaceutical composition, comprises the following steps：Tea polyphenol extract thing, the Wheeling of selected weight are taken respectively
Celestial extract, atractylodes chinensis, mulberry-leaf extract and Alisma extract, grind, be well mixed, produce.
The pharmaceutical composition of this comparative example adds customary adjuvant, and according to common process, tablet is made.
Comparative example 2
The bulk drug of the pharmaceutical composition of this comparative example forms：It is tea polyphenol extract thing 7g, Radix Clematidis extract 35g, grey
Art extract 31g, mulberry-leaf extract 2g, Alisma extract 25g；
The preparation method of the pharmaceutical composition, comprises the following steps：Tea polyphenol extract thing, the Wheeling of selected weight are taken respectively
Celestial extract, atractylodes chinensis, mulberry-leaf extract and Alisma extract, grind, be well mixed, produce.
The pharmaceutical composition of this comparative example adds customary adjuvant, and according to common process, tablet is made.
Experimental example 1Research of the present composition to the In-vitro Inhibitory Effect of xanthine oxidase
1st, experiment material
Xanthine oxidase, xanthine, phosphate buffer (K2HPO4、KH2PO4), hydrochloric acid, sodium hydroxide, methanol, acetic acid
Ammonium, acetic acid, thermostat water bath, vortex oscillator, liquid-transfering gun (1mL, 200 μ L, 100 μ L), Agilent 1260-VWD etc..
2nd, experimental method
2.1 solution are prepared
2.1.1 phosphate buffer PB preparation
Prepare K in advance2HPO4(weigh 5.23g K2HPO4It is dissolved in 400mL water) and KH2PO4Solution (weighs 1.02g
KH2PO4It is dissolved in 100mL water), then accurately measure 324mL K2HPO4With 76mL KH2PO4, be well mixed after, produce 50mM,
PH7.5 phosphate buffer PB, the need testing solution as blank control group.
If after preparing, pH value is not met, then according to acid-base value K2HPO4And KH2PO4Solution is finely adjusted.
2.1.2 the preparation of allopurinol solution
Weigh allopurinol 5mg and be dissolved in 1mL DMSO and mother liquor is made, 1.5 μ g/mL, 10 are diluted to PB after being completely dissolved
μ g/mL, packing 1mL/ pipes are preserved to -20 DEG C of refrigerators, the need testing solution as positive controls.
1 pipe is respectively taken during experiment, without dilution, is directly used after defrosting.
Wherein, for the allopurinol solution that concentration is 1.5 μ g/mL as allopurinol low dose group, concentration is 10 μ g/mL's
Allopurinol solution is as allopurinol high dose group.
2.1.3 the preparation of xanthine oxidase solution
By the enzyme amount and volume shown in xanthine oxidase product packaging, 100U/L is diluted to PB, after preparing
Packing 8mL/ pipes preserve in -20 DEG C of environment.
1 pipe is taken every time, it is standby to be diluted to 25U/L with PB.
2.1.4 the preparation of hydrochloric acid
1mL concentrated hydrochloric acids are measured, is added in pure water, is settled to 10mL, produces 1M hydrochloric acid.
2.1.5NaOH the preparation of solution
1g NaOH are weighed, are dissolved in pure water, are settled to 25mL, produce 1M NaOH solution.
2.1.6 the preparation of substrates xanthine solution
4.56mg xanthine accurately is weighed, is put in 50mL volumetric flasks, adds 150 μ L 1M sodium hydroxides, PB 30mL, ultrasound
Hydrotropy, after xanthine is all dissolved to clear, scale is settled to PB, produces 600 μM of xanthine solution.
2.1.7 the preparation of need testing solution
The pharmaceutical composition of 20mg embodiments 1-4 preparations is weighed respectively, is added to 1.5mL centrifuge tubes, is then added 1mL
DMSO ultrasonic dissolutions mix into mother liquor, 50 μ L mother liquors of absorption and 950 μ L PB, produce the solution for reagent thing 1-4, respectively as
The need testing solution of experimental group 1-4 groups.
The pharmaceutical composition of 20mg comparative examples 1-2 preparations is weighed respectively, is added to 1.5mL centrifuge tubes, is then added 1mL
DMSO ultrasonic dissolutions mix into mother liquor, 50 μ L mother liquors of absorption and 950 μ L PB, produce control drug 1-2 solution, respectively as
The need testing solution of control group 1-2 groups.
Weigh respectively 20mg Tea Polyphenols, 20mg Radix Clematidis extracts, 20mg atractylodes chinensis, 20mg mulberry-leaf extracts and
20mg Alisma extracts, add to 1.5mL centrifuge tubes, then add 1mL DMSO ultrasonic dissolutions into mother liquor, draw 50 μ L mother liquors
Mixed with 950 μ L PB, control drug 3-7 solution is produced, respectively as the need testing solution of control group 3-7 groups.
2.1.8 the reaction and termination of enzyme and substrate
Experimental group 1-4 groups sequentially add the μ L of xanthine oxidase (XOD) solution 400 and experimental group in 1.5mL centrifuge tubes
The μ L of need testing solution 200 of 1-4 groups, it is molten that control group 1-7 groups sequentially add xanthine oxidase (XOD) in 1.5mL centrifuge tubes
The μ L of liquid 400 and the μ L of the need testing solution of control group 1-7 groups 200, blank control group sequentially add xanthine in 1.5mL centrifuge tubes
The μ L of oxidizing ferment (XOD) solution 400 and blank control group the μ L of need testing solution 200, positive controls low dose group and high dose
Group sequentially adds the μ L of xanthine oxidase (XOD) solution 400 and positive controls low dose group and high agent in 1.5mL centrifuge tubes
The μ L of need testing solution 200 of amount group；Then, each group carries out following experimental implementation：It is placed in 37 DEG C of water-baths and is incubated 10min,
Add the μ L of xanthine (XAN) solution 400 and start reaction, after 37 DEG C of water-baths react 10min, 80 μ L 1M hydrochloric acid of addition terminate anti-
Should, the rear 70-75 μ L 1M NaOH solutions that add adjust pH to neutrality.
2.1.9 centrifugation and upper machine testing
Then the need testing solution that each group is disposed draws 600 μ L of supernatant extremely after 12000rpm normal temperature centrifuges 10min
In liquid phase bottle, the uric acid level of HPLC detection each group need testing solutions is carried out.
3rd, experimental data detection and processing
Data processing is carried out using the softwares of SPSS 20.0, group difference uses one-way analysis of variance, calculated with Excel
Average and SD.
Xanthine oxidase inhibiting rate is calculated according to below equation：Inhibiting rate=[(the uric acid level of blank control group-confession examination
The uric acid level of product solution)/blank control group uric acid level] * 100.
4th, experimental result
Each group is as shown in table 1 to the specific experiment result of the inhibiting rate of xanthine oxidase.
Specific experiment result of each group of table 1 to the inhibiting rate of xanthine oxidase
| Group | Inhibiting rate (%) |
| Positive controls low dose group | 32.4 |
| Positive controls high dose group | 92.1 |
| 1 group of experimental group | 44.2 |
| 2 groups of experimental group | 42.6 |
| 3 groups of experimental group | 45.8 |
| 4 groups of experimental group | 47.5 |
| 1 group of control group | 23.7 |
| 2 groups of control group | 22.9 |
| 3 groups of control group | 57.6 |
| 4 groups of control group | 18.6 |
| 5 groups of control group | 45.3 |
| 6 groups of control group | 19.4 |
| 7 groups of control group | 20.3 |
As shown in Table 1：(1) experimental group 1-4 groups and 3 groups of control group, 5 groups of inhibiting rates to xanthine oxidase are above sun
Inhibiting rate of the property control group low dose group to xanthine oxidase；This shows, 3 groups of experimental group 1-4 groups and control group, 5 groups have
There is significant xanthine oxidase inhibitory activity；
(2) 1 group of control group, 2 groups, 4 groups, 6 groups, that 7 groups of inhibiting rates to xanthine oxidase are below positive controls is low
Inhibiting rate of the dosage group to xanthine oxidase；This shows, 1 group of control group, 2 groups, 4 groups, 6 groups, 7 groups without significant xanthine oxidase
Change enzyme inhibition activity.
5th, experiment conclusion
Pharmaceutical composition prepared by embodiment 1-4, has significant inhibitory action to xanthine oxidase.
Experimental example 2The research of present composition anti-trioxypurine effect
1st, experiment material
Healthy male KM mouse 150, body weight 15-18g, provided by Shanghai Ling Chang bio tech ltd；By every
After cage 5 only carries out point cage processing, raised 4 days in barrier system endoadaptation.
2nd, experimental method
2.1 experiment packet
140 mouse that body weight is concentrated are chosen from 150 mouse and are divided into 14 groups by body weight stochastic averagina, every group 10,
Respectively blank control group, model control group, positive controls, experimental group 1-4 groups, control group 1-7 groups.
2.2 medication
Laundering period carries out gastric infusion, every morning gavage 1 time to mouse immediately later, and continuous gavage is administered 7 days.
Experimental group 1-4 groups give the embodiment 1-4 composition 200mg/kg of preparation respectively, are suspended respectively with pure water；
Control group 1-2 groups give the comparative example 1-2 composition 200mg/kg of preparation respectively, are suspended respectively with pure water；Control group 3-7
Group gives Tea Polyphenols 200mg/kg, Radix Clematidis extract 200mg/kg, atractylodes chinensis 200mg/kg, mulberry-leaf extract respectively
200mg/kg and Alisma extract 200mg/kg, is suspended with pure water respectively；Positive controls give Febustat 1.0mg/
Kg, it is suspended with pure water；Blank control group and model control group use pure water gavage.
After the 7th day morning gastric infusion 0.5 hour, intraperitoneal injection is carried out to each group mouse hyperuricemia is carried out to make
Mould.Wherein, blank control group intraperitoneal injection 0.5% sodium carboxymethylcellulose (CMC-Na) solution；Model control group, positive control
Group, experimental group 1-4 groups and control group 1-7 groups inject 300mg/kg Oteracil Potassiums (OA), are dissolved with CMC-Na solution.
3rd, experimental data detection and processing
3.1 Testing index
After hyperuricemia modeling 1.5 hours, each group mouse extracts eyeball and taken a blood sample, and blood sampling capacity is not less than 0.5mL,
Blood specimen collection is placed about 1 hour after room temperature, is treated that blood solidification completely centrifuges 10 minutes under the conditions of 3500rpm/4 DEG C, is taken
Serum is under equal conditions multiple from 5 minutes, then takes 0.2mL serum to detect UA values by Biochemical Analyzer.
3.2 statistical analysis
Data processing is carried out using the softwares of SPSS 20.0, group difference uses one-way analysis of variance, calculated with Excel
Average and SD.
4th, experimental result
After administration 7 days, influence of each group to hyperuricemia mice serum uric acid level is as shown in table 2.
Influence of the table 2 to uric acid level in hyperuricemia mice serum
Note：##Expression is compared with blank control group, P<0.01；**Expression is compared with model control group, P<0.01；*Represent and
Model control group is compared, P<0.05 (t-test inspections)
As shown in Table 2：(1) compared with blank control group, the uric acid in serum of model control group mouse significantly raises (P<
0.01), this shows hyperuricemia model modeling success；
(2) compared with model control group, the reduction that the uric acid in serum of experimental group 1-4 group mouse is horizontal has conspicuousness poor
Different (P<0.01 or P<0.05)；
(3) compared with model control group, the uric acid in serum level of control group 1-7 group mouse also has a certain degree of drop
It is low, but there was no significant difference；
(4) reduction effect of the experimental group 1-4 groups to uric acid in serum is better than reduction of the control group 3-7 groups to uric acid in serum
Effect, also superior to reduction effect of the control group 1-2 groups to uric acid in serum.
5th, experiment conclusion
Pharmaceutical composition prepared by embodiment 1-4, each bulk drug cooperates under specific proportioning, collective effect, tool
There is significant anti-trioxypurine to act on.
Experimental example 3The research of present composition preliminary toxicity and security
1st, laboratory apparatus and material
KM mouse (are provided) by Shanghai Ling Chang bio tech ltd；
Biochemical Analyzer (BECKMAN COULTER AU480).
2nd, experimental method
2.1 experiment packet
The KM mouse (being provided by Shanghai Ling Chang bio tech ltd) 66 of health, male and female half and half, body weight 15-
18g, is randomly divided into 4 groups, male and female half and half, respectively blank control group, experimental group 1-3 groups, blank control group 6, experimental group 1-3
Group every group 20.
2nd, medication
Experimental group 1-3 groups：Fasting 12 hours before administration, the embodiment 1-3 pharmaceutical compositions of preparation are given respectively, use pure water
It is suspended, by Cmax, gavage 30mL/kg of maximum volume, 10g/kg is finally administered.
Blank control group：Gavage is carried out with isometric physiological saline.
The equal successive administration of each group 14 days.
3rd, experimental data detects
3.1 Testing index
(1) successive administration observes and records the weight of animals, intoxication conditions and death condition after 14 days；
(2) after administration observation in the 14th day terminates, each group mouse extracts eyeball and taken a blood sample, and blood sampling capacity is not less than 0.5mL,
Blood specimen collection is placed about 1 hour after room temperature, is treated that blood solidification completely centrifuges 10 minutes under the conditions of 3500rpm/4 DEG C, is taken
Serum is under equal conditions multiple from 5 minutes, then takes 0.2mL serum to detect alanine aminotransferase (ALT) by Biochemical Analyzer
Value, glutamic-oxalacetic transaminease (AST) value, creatinine (CRE) value；
(3) during testing, dissection is carried out to the animal being poisoned to death and does histopathologic examination, organ whether there is hyperemia, gone out
Blood, oedema or other changes, and the internal organs to changing do histopathologic examination；
(4) after experiment terminates, pathological examination observation index is carried out to survival mice and (refers to the Ministry of Public Health《Health food is examined
Test and assessment technique enforcement of regulations handbook (2003 editions)》, as shown in table 3).
The MAIN OUTCOME MEASURES of the rodent acute toxicity testing of table 3
3.2 statistical analysis
Data processing is carried out using the softwares of SPSS 20.0, group difference uses one-way analysis of variance.
4th, experimental result
The body weight of each group mouse, alanine aminotransferase (ALT) value, glutamic-oxalacetic transaminease (AST) value, the tool of creatinine (CRE) value
Body experimental result is as shown in table 4.
The body weight of each group mouse of table 4, alanine aminotransferase (ALT), glutamic-oxalacetic transaminease (AST), the experiment knot of creatinine (CRE)
Fruit
(1) as shown in Table 4：Compared with blank control group, the body weight of experimental group 1-3 group mouse, alanine aminotransferase (ALT)
Value, glutamic-oxalacetic transaminease (AST) value, creatinine (CRE) value are without significant difference；
(2) during testing, blank control group, experimental group 1-3 groups do not occur the phenomena of mortality, and activity is normal, and hair is normal,
Breathing is had no, is urinated, defecation and glandular secretion are abnormal；
(3) after experiment terminates, each group mouse is dissected, blank control group, experimental example 1-3 groups are showed no macroscopic pathology
Change.
5th, experiment conclusion
Pharmaceutical composition prepared by embodiment 1-3, under conditions of heavy dose of gavage, not only has no obvious signs of toxicity,
And hepatic and renal function is had no significant effect, toxic side effect is smaller, and security is higher.
To sum up, from experimental example 1-3：(1) pharmaceutical composition of the present invention, each bulk drug phase interworking under specific proportioning
Close, collective effect, so as to play the effect of anti-trioxypurine；(2) pharmaceutical composition of the present invention, not only make with significant anti-trioxypurine
With, and toxic side effect is smaller, security is higher.
Obviously, above-described embodiment is only intended to clearly illustrate example, and is not the restriction to embodiment.It is right
For those of ordinary skill in the art, can also make on the basis of the above description it is other it is various forms of change or
Change.There is no necessity and possibility to exhaust all the enbodiments.And the obvious change thus extended out or
Among changing still in the protection domain of the invention.
Claims (9)
1. a kind of pharmaceutical composition, it is characterised in that its bulk drug includes：Tea Polyphenols 3-78 parts by weight, Radix Clematidis extract 1-
38 parts by weight, atractylodes chinensis 1-30 parts by weight, mulberry-leaf extract 1-28 parts by weight, Alisma extract 1-26 parts by weight.
2. pharmaceutical composition according to claim 1, it is characterised in that its bulk drug includes：Tea Polyphenols 8-73 parts by weight,
Radix Clematidis extract 5-34 parts by weight, atractylodes chinensis 4-27 parts by weight, mulberry-leaf extract 3-25 parts by weight, Alisma extract 3-
24 parts by weight.
3. pharmaceutical composition according to claim 2, it is characterised in that its bulk drug includes：Tea Polyphenols 32-71 weight
Part, Radix Clematidis extract 7-30 parts by weight, atractylodes chinensis 6-25 parts by weight, mulberry-leaf extract 3-16 parts by weight, rhizoma alismatis extraction
Thing 3-16 parts by weight.
4. pharmaceutical composition according to claim 3, it is characterised in that its bulk drug includes：
The parts by weight of Tea Polyphenols 32, the parts by weight of Radix Clematidis extract 22, the parts by weight of atractylodes chinensis 25, the weight of mulberry-leaf extract 16
Part, the parts by weight of Alisma extract 5；Or
The parts by weight of Tea Polyphenols 41, the parts by weight of Radix Clematidis extract 30, the parts by weight of atractylodes chinensis 16, the weight of mulberry-leaf extract 10
Part, the parts by weight of Alisma extract 3；Or
The parts by weight of Tea Polyphenols 57, the parts by weight of Radix Clematidis extract 11, the parts by weight of atractylodes chinensis 13, the parts by weight of mulberry-leaf extract 3,
The parts by weight of Alisma extract 16；Or
The parts by weight of Tea Polyphenols 71, the parts by weight of Radix Clematidis extract 7, the parts by weight of atractylodes chinensis 6, the parts by weight of mulberry-leaf extract 7, pool
Rush down the parts by weight of extract 9.
5. the preparation method of the pharmaceutical composition described in a kind of any one of claim 1-4, it is characterised in that including following step
Suddenly：
Tea Polyphenols, Radix Clematidis extract, atractylodes chinensis, mulberry-leaf extract and the Alisma extract of selected parts by weight are taken respectively,
Grinding, it is well mixed, produces.
6. including the preparation of the pharmaceutical composition described in claim any one of 1-4 or including the preparation described in claim 5
The preparation for the pharmaceutical composition that method is prepared, it is characterised in that
Described pharmaceutical composition adds customary adjuvant, according to common process, be made clinically acceptable tablet, capsule, dissipate
Agent, mixture, pill, granule, solution, syrup, soft extract, emplastrum, suppository, aerosol, ointment, injection, drink
Material, biscuit, candy or cake.
7. the medicine that the pharmaceutical composition described in claim any one of 1-4, the preparation method described in claim 5 are prepared
Application of the preparation of pharmaceutical composition described in composition or claim 6 in xanthine oxidase inhibitor is prepared.
8. the medicine that the pharmaceutical composition described in claim any one of 1-4, the preparation method described in claim 5 are prepared
The preparation of pharmaceutical composition described in composition or claim 6 is preparing medicine, health products or food with anti-trioxypurine effect
Application in product.
9. the medicine that the pharmaceutical composition described in claim any one of 1-4, the preparation method described in claim 5 are prepared
The preparation of pharmaceutical composition described in composition or claim 6 is in the medicine, health products or food for the treatment of gout is prepared
Using.
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Cited By (1)
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| CN107184859A (en) * | 2017-07-25 | 2017-09-22 | 江西熙帝生物科技有限公司 | A kind of composition with three high drop and anti-trioxypurine |
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| CN107184859A (en) * | 2017-07-25 | 2017-09-22 | 江西熙帝生物科技有限公司 | A kind of composition with three high drop and anti-trioxypurine |
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