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CN109674958A - A kind of Chinese medicine composition and its preparation method and application with anti-trioxypurine - Google Patents

A kind of Chinese medicine composition and its preparation method and application with anti-trioxypurine Download PDF

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Publication number
CN109674958A
CN109674958A CN201811569969.5A CN201811569969A CN109674958A CN 109674958 A CN109674958 A CN 109674958A CN 201811569969 A CN201811569969 A CN 201811569969A CN 109674958 A CN109674958 A CN 109674958A
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parts
trioxypurine
extract
ginseng
weight
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CN109674958B (en
Inventor
叶华
罗年翠
刘光曜
孙翔
李全
王恒斌
戴晶晶
翟云良
辛艳
李小冬
楼坚伟
潘耀宗
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Leiyunshang Pharmaceutical Group Co Ltd
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Leiyunshang Pharmaceutical Group Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06Fungi, e.g. yeasts
    • A61K36/07Basidiomycota, e.g. Cryptococcus
    • A61K36/076Poria
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/25Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
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    • A61K36/488Pueraria (kudzu)
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/732Chaenomeles, e.g. flowering quince
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    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736Prunus, e.g. plum, cherry, peach, apricot or almond
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/81Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815Lycium (desert-thorn)
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    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
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Abstract

The invention discloses a kind of Chinese medicine compositions and its preparation method and application with anti-trioxypurine, it is made of 20~80 parts of Poria cocos, 20~60 parts of semen coicis, 5~20 parts of cape jasmine, 5~20 parts of peach kernel, 5~20 parts of pawpaw, 5~15 parts of rhizoma polygonati, 5~15 parts of lophatherum gracile, 5~15 parts of Radix Glycyrrhizae, 2~20 parts of fructus lycii, 30~90 parts of pueraria lobata, 20~60 parts of mulberry leaf, 2~15 parts of ginseng.Formula is scientific and reasonable for the present composition, and choosing proves there is significant anti-trioxypurine effect with common dual-purpose of drug and food raw material, through animal pharmacodynamics test and clinical test, and safe and reliable, has no toxic side effect, and patient with gout and people with high uric acid is suitble to take for a long time.

Description

A kind of Chinese medicine composition and its preparation method and application with anti-trioxypurine
Technical field
The present invention relates to a kind of compositions, in particular to a kind of to have effects that the Chinese medicine composition of anti-trioxypurine and its preparation side Method and application, belong to pharmaceutical technology field.
Background technique
Uric acid is the final product that purine substance is metabolized in vivo, by hypoxanthine and xanthine in xanthine oxidase Catalytic action under generate, while generating peroxide radical.In body stable uric acid level be related to uric acid generation, It absorbs, the balance between metabolism and decomposition.The generation of uric acid caused by purine metabolic disturbance increases or underexcretion can be led Cause hyperuricemia.It is generally acknowledged that blood uric acid Yan Shui Ping≤417 μm ol/L will induce hyperuricemia or a series of other Symptom such as urarthritis and hyperuricemic nephropathy etc..The modern medicine morbidity of clear gout and hyperuricemia are straight Correlation is connect, is a kind of serious metabolic disease for endangering human health.Urarthritis is since internal uric acid increases cause Lithate is set to be deposited on joint capsule, synovial membrane, cartilage, kidney, a kind of tissue disease damage and inflammatory caused by subcutaneous, its hetero-organization anti- It answers, is mainly shown as arthroncus, pain recurrent exerbation, joint joint stuffiness.Blood uric acid raising is the weight of urarthritis Want feature.
As the improvement of people's living standards, the variation of dietary structure, sugar, albumen, fat intake obviously increase, pain Wind and the disease incidence of hyperuricemia increase year by year.China's prevalence of gout in general population up to 0.84%, there are about 12,000,000 people, Wherein 95% is male patient, and the ratio between men and women is about 20:1;There are about 1.2 hundred million (to account for about total population by China hyperuricemia person 10%), male's high incidence age is 50~59 years old, and women is after menopause.Currently, western medical treatment common drug have it is non-steroid anti-inflammatory Medicine, colchicin, glucocorticoid, probenecid, benzene Australia Ma Long, allopurinol etc., these drugs are mostly anti-inflammatory analgesic medicine, though energy Rapid pain relief terminates the acute attack of gout, prevents the formation of urarthritis and gouty kidney stone, but this kind of Drug all has serious side effect, and the damage that such as gastrointestinal tract can be caused different degrees of causes hepatic and renal function abnormal when serious, long Phase, which takes, can cause bone marrow suppression, necrosis of liver cells and neurotoxicity etc..
Gout category Chinese medicine " numbness disease " scope, Han dynasty Zhang Zhongjing propose the name of disease of " severe and migratory arthralgia " in " Synopsis Golden Chamber ".Because of pain Pain traverses general joint and gains the name, and because progression of the disease speed is fast, therefore also known as " severe and wadering arthralgia ".Chinese medicine think gout be because Liver, Dyssplenism influence kidney, and kidney cannot be generated normally in catharsis aqueous body fluid, cause organism metabolic disorder, wet, phlegm, silt, in turbid poison It is raw, so as to cause gout.Have some researchs that anti-trioxypurine product is prepared using Chinese medicine dual-purpose of drug and food material as raw material at present.It is right A kind of health preserving tea and preparation method thereof with the strong kidney function effect of anti-trioxypurine, protect liver is disclosed than file CN106720797A.It contains There are 20-30 parts of pueraria lobata, 20-28 parts of semen coicis, 20-25 parts of lophatherum gracile, 15-25 parts of Poria cocos, 10-15 parts of Radix Glycyrrhizae, fresh Rhizoma Imperatae 10- 15 parts, 8-15 parts of mulberry leaf, 5-10 parts of fructus lycii, 5-10 parts of Cordyceps militaris.The health preserving tea can be clearing heat and detoxicating, significant anti-trioxypurine, however its Treatment cycle is partially long, efficient relatively low, and after treatment in 1 month, effective percentage is only 25% or so.
Against the above deficiency, present invention combination gout pathogenesis and anti-trioxypurine mechanism scientific composition, by Poria cocos, coix lacryma-jobi Benevolence, cape jasmine, peach kernel, pawpaw, rhizoma polygonati, lophatherum gracile, Radix Glycyrrhizae, fructus lycii, pueraria lobata, mulberry leaf, ginseng totally 12 kinds of medicinal and edible Chinese medicines into Row combination can significantly inhibit uric acid and generate, promote uric acid excretion, and anti-trioxypurine effect is more preferably.It is special for effective component dissolution simultaneously Point alcohol extracting or extraction process by water is respectively adopted, active constituent content and bioavilability greatly improve, can significantly shorten treatment cycle, Therapeutic efficiency is improved, achieves better progress compared to existing Chinese medicine compound prescription.
Summary of the invention
Goal of the invention: the purpose of the invention is to overcome the deficiencies of the prior art and provide one kind to have effects that anti-trioxypurine Chinese medicine composition and preparation method thereof.The Chinese medicine composition of anti-trioxypurine provided by the invention selects medicine and food raw materials, prescription Rationally, anti-trioxypurine significant effect.
Technical solution: in order to achieve the goal above, the technical scheme adopted by the invention is as follows:
A kind of to have effects that the Chinese medicine composition of anti-trioxypurine, it is made of the raw material of following portions by weight: Poria cocos 20~80 Part, 20~60 parts of semen coicis, 5~20 parts of cape jasmine, 5~20 parts of peach kernel, 5~20 parts of pawpaw, 5~15 parts of rhizoma polygonati, lophatherum gracile 5~15 Part, 5~15 parts of Radix Glycyrrhizae, 2~20 parts of fructus lycii, 30~90 parts of pueraria lobata, 20~60 parts of mulberry leaf, 2~15 parts of ginseng.
Preferably, above-described to have effects that the Chinese medicine composition of anti-trioxypurine, it is by following portions by weight Raw material is made: 30~60 parts of Poria cocos, 30~50 parts of semen coicis, 10~15 parts of cape jasmine, 10~15 parts of peach kernel, 10~15 parts of pawpaw, 6~12 parts of rhizoma polygonati, 5~12 parts of lophatherum gracile, 5~15 parts of Radix Glycyrrhizae, 3~10 parts of fructus lycii, 40~80 parts of pueraria lobata, mulberry leaf 30~50 Part, 3~10 parts of ginseng.
Preferably, above-described to have effects that the Chinese medicine composition of anti-trioxypurine, it is by following portions by weight Raw material is made: 30 parts of Poria cocos, 30 parts of semen coicis, 10 parts of cape jasmine, 10 parts of peach kernel, 10 parts of pawpaw, 6 parts of rhizoma polygonati, 5 parts of lophatherum gracile, sweet Careless 5 parts, 3 parts of fructus lycii, 40 parts of pueraria lobata, 30 parts of mulberry leaf, 3 parts of ginseng.
Preferably, above-described to have effects that the Chinese medicine composition of anti-trioxypurine, it is by following portions by weight Raw material is made: 60 parts of Poria cocos, 50 parts of semen coicis, 15 parts of cape jasmine, 15 parts of peach kernel, 15 parts of pawpaw, 12 parts of rhizoma polygonati, 12 parts of lophatherum gracile, 15 parts of Radix Glycyrrhizae, 10 parts of fructus lycii, 80 parts of pueraria lobata, 50 parts of mulberry leaf, 10 parts of ginseng.
Preferably, above-described to have effects that the Chinese medicine composition of anti-trioxypurine, it is by following portions by weight Raw material is made: 50 parts of Poria cocos, 40 parts of semen coicis, 12 parts of cape jasmine, 12 parts of peach kernel, 12 parts of pawpaw, 8 parts of rhizoma polygonati, 10 parts of lophatherum gracile, sweet Careless 10 parts, 3 parts of fructus lycii, 60 parts of pueraria lobata, 40 parts of mulberry leaf, 5 parts of ginseng.
The preparation method with the Chinese medicine composition of anti-trioxypurine of the present invention, comprising the following steps:
(1) Poria cocos, semen coicis, cape jasmine, peach kernel, pawpaw, rhizoma polygonati, lophatherum gracile, Radix Glycyrrhizae, fructus lycii are weighed in parts by weight, Extracting in water, extract filtration, filtrate concentration, obtains extract I;
(2) pueraria lobata and mulberry leaf are weighed in parts by weight, are added methanol or ethyl alcohol to extract filtration, filtrate concentration, drying, must be extracted Object II;
(3) ginseng is weighed in parts by weight, and dry, sterilizing crushes, and obtains ginseng fine powder;
(4) it prepares preparation: extract I, extract II and ginseng fine powder being mixed, and pharmacy is added and often uses auxiliary material, is made Various preparations.
Preferably, the above-described preparation method with the Chinese medicine composition of anti-trioxypurine, including it is following Step:
(1) Poria cocos, semen coicis, cape jasmine, peach kernel, pawpaw, rhizoma polygonati, lophatherum gracile, Radix Glycyrrhizae, fructus lycii are weighed in parts by weight, Be added 6~12 times amount water extract 1~3 time, 1~3 hour every time, extracting solution filtration, concentrate the filtrate to specific gravity 1.03~ 1.10 (60 DEG C~80 DEG C), obtain extract I;
(2) pueraria lobata, mulberry leaf are weighed in parts by weight, and 20%~80% ethyl alcohol that 2~6 times of amounts are added extracts 1~3 Secondary, 1~3 hour every time, extracting solution filtration merged filtrate, is concentrated under reduced pressure into specific gravity 1.02~1.08 (60 DEG C~80 DEG C), sprays Mist is dry (120~150 DEG C of inlet air temperature, 30~60L/h of flow velocity), obtains extract II;
(3) ginseng is weighed in parts by weight, and vacuum drying, crushes at sterilizing, crosses 100 mesh~300 meshes, obtains ginseng fine powder.
(4) it prepares preparation: extract I, extract II and ginseng fine powder being mixed, and pharmacy is added and often uses auxiliary material, is made Various preparations.
Scheme more preferably, the above-described preparation method with the Chinese medicine composition of anti-trioxypurine, including with Lower step:
(1) Poria cocos, semen coicis, cape jasmine, peach kernel, pawpaw, rhizoma polygonati, lophatherum gracile, Radix Glycyrrhizae, fructus lycii are weighed in parts by weight, The water that 10 times of amounts are added extracts 3 times, and 2 hours every time, extracting solution filtration, filtrate were concentrated into specific gravity 1.05 (60 DEG C), were extracted Object I;
(2) pueraria lobata, mulberry leaf are weighed in parts by weight, and 60% ethyl alcohol that 6 times of amounts are added extracts 3 times, and 1.5 is small every time When, extracting solution filtration, filtrate merge, it is concentrated under reduced pressure into specific gravity 1.03 (60 DEG C), spray drying (140 DEG C of inlet air temperature, flow velocity 45L/h), extract II is obtained;
(3) ginseng is weighed in parts by weight, and vacuum drying, crushes at sterilizing, sieves with 100 mesh sieve, obtains ginseng fine powder.
(4) it prepares preparation: extract I, extract II and ginseng fine powder being mixed, and pharmacy is added and often uses auxiliary material, is made Various preparations.
Pharmaceutical composition of the invention can be prepared into any regular dosage form using Chinese materia medica preparation conventional method, and pharmacy is added Any one upper acceptable auxiliary material, including but not limited to tablet, capsule, syrup, pill etc.;The activity of drug of the present invention Various customary adjuvants needed for preparing various dosage forms can also be added in component, such as disintegrating agent, lubricant, surfactant, dilution Agent, excipient, absorption carrier, adhesive etc. are prepared into any regular dosage form with conventional method of Chinese medicinal.
The Chinese medicine composition with anti-trioxypurine of the present invention is in preparation prevention and treatment hyperuricemia or gout health care Application in food or drug.
Technical effect of the invention:
1, pharmaceutical composition combination high lithemia gout pathogenesis of the invention and modern pharmacology mechanism are using innovation Prescription theory carries out prescription: Poria cocos in side of the present invention, semen coicis are monarch drug in a prescription, clearing damp and promoting diuresis, strengthening the spleen and stomach, the two compatibility benefit without Wound is mended without stagnant, and pueraria lobata fresh breeze is cold, and net table is evil, expelling pathogenic factors from muscles and skin heat, only polydipsia, and cape jasmine is clearing heat and detoxicating, peach kernel promoting blood circulation, pawpaw Relaxing tendons and activating collaterals dampness elimination together, can play clearing heat and promoting diuresis, the effect removed obstruction in channels to relieve pain, and above four medicine is ministerial drug altogether, lophatherum gracile clearing heat-fire, Reinforce the pharmacological property of the sharp water of monarch drug in a prescription, rhizoma polygonati strengthening spleen and invigorating qi yin-nourishing, ginseng qi-tonifying promotes the production of body fluid, the bias of excessively clear benefit, mulberry in mitigation side Leaf dispelling wind and heat from the body, can reinforce the eliminating impediment and relieving pain effect of pueraria lobata with pueraria lobata compatibility, and Radix Glycyrrhizae, fructus lycii play the work of coordinating the drug actions of a prescription jointly With to make medicine.All medicines share, the benefits of playing clearing damp and promoting diuresis, clearing heat and detoxicating, eliminating impediment and relieving pain altogether.With documents CN106720797A Composition compares the product of the removing blood stasis and promoting blood circulation such as pawpaw, peach kernel of increasing, can in the side of enhancing stasis-dispelling and pain-killing effect, separately have rhizoma polygonati, people The product of the helps such as ginseng can play benefit without hurting with clear sharp water-wet compatibility of drugs treatment gout, mend without stagnant effect, treat high urine Acidaemia and gout better effect.
2, pharmacodynamic experiment shows that the present composition can significantly reduce hyperuricemia model rat serum uric acid level, The effect of middle present composition high dose group anti-trioxypurine is better than (the prescription: pueraria lobata, semen coicis, lophatherum gracile, Poria cocos, sweet of comparison medicine I Grass, fresh Rhizoma Imperatae, mulberry leaf, fructus lycii, Cordyceps militaris) (P < 0.05), and without conspicuousness compared with II group of comparison medicine (Allopurinol Tablets) Difference (P > 0.05), the effect of high dose group anti-trioxypurine are suitable with Allopurinol Tablets.Clinical test proves, 220 hyperuricemias After patient with gout takes present composition tablet 4 weeks, effective percentage 52.7%;After 6 weeks, anti-trioxypurine effective percentage reaches 70.9%, After taking 8 weeks, anti-trioxypurine effective percentage reaches 88.2%.Drug administration process does not observe allergy and other adverse reactions.
3, it is safe dual-purpose of drug and food raw material, edible safety, without any that pharmaceutical composition of the invention is raw materials used Toxic side effect can be eaten for a long time.
4, alcohol extracting or water is respectively adopted for different effective components dissolution feature in pharmaceutical composition preparation process of the invention It mentions, active constituent content and bioavilability greatly improve in the preparation of preparation, puerarin content >=1.2%, 1- deoxidation open country buttocks Mycin content >=0.4%.Have many advantages, such as that simple process, quality are stable, low in cost.
Specific embodiment
The present invention is further illustrated below by the mode of embodiment, but does not therefore limit the present invention to the reality It applies among a range.After the present invention has been read, those skilled in the art are equal to the modification of various unsubstantialities of the invention Fall within the application range as defined in the appended claims.
Embodiment 1- medicinal composition tablets of the present invention
1, have effects that the composition of anti-trioxypurine, parts by weight of raw materials array becomes:
It is 50 parts of Poria cocos, 40 parts of semen coicis, 12 parts of cape jasmine, 12 parts of peach kernel, 12 parts of pawpaw, 8 parts of rhizoma polygonati, 10 parts of lophatherum gracile, sweet Careless 10 parts, 3 parts of fructus lycii, 60 parts of pueraria lobata, 40 parts of mulberry leaf, 5 parts of ginseng.
2, preparation step:
(1) 50 parts of Poria cocos, 40 parts of semen coicis, 12 parts of cape jasmine, 12 parts of peach kernel, 12 parts of pawpaw, rhizoma polygonati 8 are weighed in parts by weight Part, 10 parts of lophatherum gracile, 10 parts of Radix Glycyrrhizae, 3 parts of fructus lycii, be added 10 times amount water extract 3 times, 2 hours every time, extracting solution filtration, Specific gravity 1.05 (60 DEG C) are concentrated into, extract I is obtained;
(2) 60 parts of pueraria lobata, 40 parts of mulberry leaf are weighed in parts by weight, and 60% ethyl alcohol that 6 times of amounts are added extracts 3 times, often Secondary 1.5 hours, extracting solution filtration merged, and was concentrated under reduced pressure into specific gravity 1.03 (60 DEG C), and spray drying (140 DEG C of inlet air temperature, stream Fast 45L/h), obtain extract II;
(3) 5 parts of ginseng are weighed in parts by weight, and vacuum drying, crushes at sterilizing, sieves with 100 mesh sieve, obtains ginseng fine powder.
(4) it prepares tablet: extract II is mixed with ginseng fine powder, isomalt, microcrystalline cellulose is added, cross 80 Mesh, until after mixing, spraying into I medicinal extract of extract, granulation is dry to moisture 3.0%-5.0%, crosses 20 mesh in fluidized bed Whole grain is sieved, in the particle after taking magnesium stearate that whole grain is added, mixed pressuring plate, film coating obtains present composition tablet.
3, index components Physico-chemical tests:
According to the Pharmacopoeia of the People's Republic of China 2015 editions and inner controlling standard of enterprise, to 3 be prepared according to the above method It criticizes Puerarin, 2 class index ingredient of 1-DNJ in present composition tablet to be detected, content is above limitation Standard.
1 present composition tablet index component content (%) of table
The pharmaceutical composition pill of the present invention of embodiment 2
1, have effects that the Chinese medicine composition of anti-trioxypurine, parts by weight of raw materials array becomes:
30 parts of Poria cocos, 30 parts of semen coicis, 10 parts of cape jasmine, 10 parts of peach kernel, 10 parts of pawpaw, 6 parts of rhizoma polygonati, 5 parts of lophatherum gracile, Radix Glycyrrhizae 5 parts, 3 parts of fructus lycii, 40 parts of pueraria lobata, 30 parts of mulberry leaf, 3 parts of ginseng.
2, preparation step:
(1) Poria cocos, semen coicis, cape jasmine, peach kernel, pawpaw, rhizoma polygonati, lophatherum gracile, Radix Glycyrrhizae, fructus lycii are weighed in parts by weight, The water that 8 times of amounts are added extracts 2 times, and 2 hours every time, extracting solution filtration was concentrated into specific gravity 1.03 (60 DEG C), obtained extract I;
(2) pueraria lobata, mulberry leaf are weighed in parts by weight, and 80% ethyl alcohol that 5 times of amounts are added extracts 2 times, and 1.5 is small every time When, extracting solution filtration merges, it is concentrated under reduced pressure into specific gravity 1.05 (60 DEG C), spray drying (120 DEG C of inlet air temperature, flow velocity 50L/ H), extract II is obtained;
(3) ginseng is weighed in parts by weight, and vacuum drying, crushes at sterilizing, sieves with 100 mesh sieve, obtains ginseng fine powder.
(4) it prepares pill: extract I, extract II and ginseng fine powder is mixed, honey is added, water is made by general ball method Honeyed bolus obtains present composition pill.
3, index components Physico-chemical tests:
According to the Pharmacopoeia of the People's Republic of China 2015 editions and inner controlling standard of enterprise, to 3 be prepared according to the above method It criticizes Puerarin, 2 class index ingredient of 1-DNJ in present composition pill to be detected, content is above limitation Standard.
2 present composition pill index component content (%) of table
Embodiment 3- pharmaceutical composition syrup of the present invention
1, have effects that the Chinese medicine composition of anti-trioxypurine, parts by weight of raw materials array becomes:
It is 60 parts of Poria cocos, 50 parts of semen coicis, 15 parts of cape jasmine, 15 parts of peach kernel, 15 parts of pawpaw, 12 parts of rhizoma polygonati, 12 parts of lophatherum gracile, sweet Careless 15 parts, 10 parts of fructus lycii, 80 parts of pueraria lobata, 50 parts of mulberry leaf, 10 parts of ginseng.
2, preparation step:
(1) 60 parts of Poria cocos, 50 parts of semen coicis, 15 parts of cape jasmine, 15 parts of peach kernel, 15 parts of pawpaw, rhizoma polygonati are weighed in parts by weight 12 parts, 12 parts of lophatherum gracile, 15 parts of Radix Glycyrrhizae, 10 parts of fructus lycii, the water that 8 times of amounts are added extract 3 times, and 1 hour every time, extracting solution was filtered It crosses, be concentrated into specific gravity 1.05 (60 DEG C), obtain extract I;
(2) 80 parts of pueraria lobata, 50 parts of mulberry leaf are weighed in parts by weight, and 70% ethyl alcohol that 5 times of amounts are added extracts 3 times, often Secondary 1 hour, extracting solution filtration merged, and was concentrated under reduced pressure into specific gravity 1.06 (80 DEG C), and spray drying (145 DEG C of inlet air temperature, flow velocity 45L/h), extract II is obtained;
(3) 10 parts of ginseng are weighed in parts by weight, and vacuum drying, crushes at sterilizing, crosses 300 meshes, obtains ginseng fine powder.
(4) it prepares oral solution: extract I, extract II and ginseng fine powder is uniformly mixed, glycerol, sucrose and steaming is added Distilled water, stirring and dissolving are heated to 100 DEG C.It is filtered while hot with calico after boiling, distilled water is added to be settled to encapsulating in right amount, sterilized, obtain Present composition syrup.
3. index components Physico-chemical tests:
According to the Pharmacopoeia of the People's Republic of China 2015 editions and inner controlling standard of enterprise, to 3 be prepared according to the above method It criticizes Puerarin, 2 class index ingredient of 1-DNJ in present composition syrup to be detected, content is above limit Amount standard.
3 present composition syrup index component content (%) of table
Example effects 1
The efficacy of medicine observing that the present composition acts on hyperuricemia model rat anti-trioxypurine
Healthy SD rat, is randomly divided into: Normal group, model control group, 1 present composition tablet of embodiment be low, Middle and high three dosage groups (0.1g/kg, 0.2g/kg, 0.6g/kg), I group of comparison medicine (weigh 25 parts of pueraria lobata, it is 22 parts of semen coicis, light It 21 parts of the leaf of bamboo, 20 parts of Poria cocos, 10 parts of Radix Glycyrrhizae, 10 parts of fresh Rhizoma Imperatae, 8 parts of mulberry leaf, 8 parts of fructus lycii, 7 parts of Cordyceps militaris, cleans, low temperature 55 DEG C dry 45min, then high temperature of 120 DEG C dry 1.5h.Material drying crushed 30 meshes, be added 1 part of ferment powder, mixing granulation must compare Medicine I, dosage 0.6kg/kg), II group of comparison medicine (allopurinol tablet, national drug standard H20033683,0.01g/kg), totally 7 groups, every group 70.In addition to Normal group, remaining each group is given once daily high purine feed modeling, and continuous 25 days.Administration/modeling the 25th day, Eye socket takes blood, and 3500 turns/min is centrifuged 10min and separates serum, measures serum uric acid (UA) in accordance with the law referring to kit specification and contain Amount.As a result as follows:
By table 4 as it can be seen that after giving the high purine feed modeling of model group 25 days, model control group compared with blank control group, The horizontal significant raising (P < 0.01) of blood UA.After administration, 1 present composition low, middle and high dose groups of embodiment, I group of comparison medicine, II group of comparison medicine compared with model control group, blood UA level significantly reduces (P < 0.01).Compared with I group of comparison medicine, the present invention Composition high dose group blood UA level significantly reduces (P < 0.05).Compared with II group of comparison medicine, present composition high dose group Blood UA is horizontal, and there was no significant difference (P > 0.05).The above result shows that present composition high dose group is big to hyperuricemia The effect of mouse anti-trioxypurine is better than comparison medicine I, and the effect of high dose group anti-trioxypurine is suitable with Allopurinol Tablets.
Influence (x ± s) of the table 4 to hyperuricemia rat blood serum UA level
Note: # there were significant differences compared with blank control group P < 0.01.* there were significant differences compared with model control group P < 0.01;Compared with control group I
There were significant differences P < 0.05;△ there were significant differences compared with control group II P < 0.05.
Example effects 2
The present composition treats gout clinical observation on the therapeutic effect
Patient 220, wherein male 110, age distribution was at 42-65 years old;Women 110, age distribution is in 49-66 Year.Diagnostic criteria: patient articular's pain, night-time attack, it is difficult to fall asleep;Blood uric acid increases, and male is higher than 416 μm of olL-1, female Property be higher than 357 μm of olL-1, there is tophus.It takes the embodiment of the present invention 1 and prepares tablet, 3 times a day, 3 tablets once, in the morning, afternoon and evening respectively Once, it continuously takes 2 months.Efficacy assessments standard: cure: laboratory checks that blood uric acid value is normal, and symptoms of joint pain disappears, Tophus removal;Improve: laboratory checks that blood uric acid value reduces, and arthroncus is subsided, and pain relief, tophus is obviously reduced; Invalid: laboratory checks that blood uric acid value and symptom are unchanged, and tophus is unchanged.
As shown in Table 5,1 composition of the embodiment of the present invention is taken after 4 weeks, and 64 patient's blood uric acids restore normal, 52 trouble Person's blood uric acid is substantially reduced, and anti-trioxypurine effective percentage reaches 52.7%;After 6 weeks, 112 patient's blood uric acids restore normal, 44 trouble Person's blood uric acid is substantially reduced, and anti-trioxypurine effective percentage reaches 70.9%;1 composition of the embodiment of the present invention is taken after 8 weeks, 156 trouble Person's blood uric acid restores normal, and 38 patient's blood uric acids are substantially reduced, and anti-trioxypurine effective percentage reaches 88.2%.Drug administration process is not observed To allergy and other adverse reactions.
5 present composition of table treats gout clinical efficacy result
Time of Administration It cures (example) It improves (example) (example) in vain Total effective rate (%)
2 weeks 0 40 180 18.2
4 weeks 64 52 104 52.7
6 weeks 112 44 64 70.9
8 weeks 156 38 26 88.2
3.5 concrete case
1. Mr. Wang, male, 45 years old, first visit main suit: right foot big toe redness and swelling of joints 10 days.There is right sufficient big toe in five years ago in patient Redness and swelling of joints.It is higher in local hospital difference blood uric acid, it is diagnosed as gout.Once colchicum bases drug therapy was given, the state of an illness obtains Control.In view of Western medicine side effects of pharmaceutical drugs are larger, seek Chinese medicine treatment then.Indagation is shown in: right foot big toe joint and ankle-joint are red It is swollen to have tenderness.Red tongue body, yellow and greasy fur, slippery and rapid pulse.It has a blood test uric acid level: 560 μm of olL-1.Take 1 composition of the embodiment of the present invention Tablet, 3 times a day, 3 tablets once, each primary in the morning, afternoon and evening.Strict control of diet simultaneously, feeds low purine food.Further consultation after 2 weeks, Right foot big toe joint congestion and swelling pain has disappeared.Blood uric acid value: 382 μm of olL is checked after 4 weeks-1.It is advised to continue to take implementation of the present invention 1 composition tablet of example, no relapse after follow-up 1 year.
2. permitted certain, female, 60 years old, first visit main suit: left side foot big toe redness and swelling of joints 8 days.There is bilateral in being interrupted over 6 years in patient Sufficient big toe joint is repeatedly red and swollen.Once higher in local hospital uric acid of having a blood test, it is diagnosed as gout.
Take Diclofenac Sodium In Treating, pain relief.But in view of Western medicine side effects of pharmaceutical drugs are larger, seek Chinese medicine then and control It treats.Symptoms include right side foot big toe redness and swelling of joints, tenderness is obvious, constipation.Tongue is red, thick,yellow and greasy fur, slippery and rapid pulse.It has a blood test uric acid level: 575mol·L-1.1 composition tablet of the embodiment of the present invention is taken, 3 times a day, 3 tablets once, each primary in the morning, afternoon and evening.It is stringent simultaneously It keeps on a diet, feeds low purine food.3 Zhou Houzai are examined, and left foot big toe joint congestion and swelling pain has disappeared.It is advised to continue to take, after 6 weeks Have a blood test 348 μm of olL of uric acid level-1, do not recur again within follow-up 2 years.
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art For member, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also answered It is considered as protection scope of the present invention.

Claims (12)

1. a kind of have effects that the Chinese medicine composition of anti-trioxypurine, which is characterized in that it includes the raw material of following portions by weight: Poria cocos 20~80 parts, 20~60 parts of semen coicis, 5~20 parts of cape jasmine, 5~20 parts of peach kernel, 5~20 parts of pawpaw, 5~15 parts of rhizoma polygonati, henon bamboo 5~15 parts of leaf, 5~15 parts of Radix Glycyrrhizae, 2~20 parts of fructus lycii, 30~90 parts of pueraria lobata, 20~60 parts of mulberry leaf, 2~15 parts of ginseng.
A kind of has effects that the Chinese medicine composition of anti-trioxypurine 2. according to claim 1, which is characterized in that it includes following The raw material of parts by weight: 30~60 parts of Poria cocos, 30~50 parts of semen coicis, 10~15 parts of cape jasmine, 10~15 parts of peach kernel, pawpaw 10~ 15 parts, 6~12 parts of rhizoma polygonati, 5~12 parts of lophatherum gracile, 5~15 parts of Radix Glycyrrhizae, 3~10 parts of fructus lycii, 40~80 parts of pueraria lobata, mulberry leaf 30 ~50 parts, 3~10 parts of ginseng.
3. according to claim 1 have effects that the Chinese medicine composition of anti-trioxypurine, which is characterized in that it is by following weight parts Several raw materials are made: 30 parts of Poria cocos, 30 parts of semen coicis, 10 parts of cape jasmine, 10 parts of peach kernel, 10 parts of pawpaw, 6 parts of rhizoma polygonati, lophatherum gracile 5 Part, 5 parts of Radix Glycyrrhizae, 3 parts of fructus lycii, 40 parts of pueraria lobata, 30 parts of mulberry leaf, 3 parts of ginseng.
4. according to claim 1 have effects that the Chinese medicine composition of anti-trioxypurine, which is characterized in that it is by following weight parts Several raw materials are made: 60 parts of Poria cocos, 50 parts of semen coicis, 15 parts of cape jasmine, 15 parts of peach kernel, 15 parts of pawpaw, 12 parts of rhizoma polygonati, lophatherum gracile 12 Part, 15 parts of Radix Glycyrrhizae, 10 parts of fructus lycii, 80 parts of pueraria lobata, 50 parts of mulberry leaf, 10 parts of ginseng.
5. according to claim 1 have effects that the Chinese medicine composition of anti-trioxypurine, which is characterized in that it is by following weight parts Several raw materials are made: 50 parts of Poria cocos, 40 parts of semen coicis, 12 parts of cape jasmine, 12 parts of peach kernel, 12 parts of pawpaw, 8 parts of rhizoma polygonati, lophatherum gracile 10 Part, 10 parts of Radix Glycyrrhizae, 3 parts of fructus lycii, 60 parts of pueraria lobata, 40 parts of mulberry leaf, 5 parts of ginseng.
6. the described in any item preparation methods with the Chinese medicine composition of anti-trioxypurine of Claims 1 to 5, feature exist In, comprising the following steps:
(1) Poria cocos, semen coicis, cape jasmine, peach kernel, pawpaw, rhizoma polygonati, lophatherum gracile, Radix Glycyrrhizae, fructus lycii are weighed in parts by weight, add water It extracts, extract filtration takes filtrate to be concentrated, and obtains extract I;
(2) pueraria lobata, mulberry leaf are weighed in parts by weight, methanol or ethyl alcohol is added to extract, and filtration, filtrate concentration, drying obtain extract Ⅱ;
(3) ginseng is weighed in parts by weight, and dry, sterilizing crushes, and obtains ginseng fine powder;
(4) it prepares preparation: extract I, extract II and ginseng fine powder being mixed, and the common auxiliary material of pharmacy is added, be made each Kind preparation.
7. the described in any item preparation methods with the composition of anti-trioxypurine of Claims 1 to 5, which is characterized in that packet Include following steps:
(1) Poria cocos, semen coicis, cape jasmine, peach kernel, pawpaw, rhizoma polygonati, lophatherum gracile, Radix Glycyrrhizae, fructus lycii are weighed in parts by weight, are added 6 The water of~12 times of amounts extracts 1~3 time, and 1~3 hour every time, extracting solution filtration, filtrate were concentrated into (60 DEG C of specific gravity 1.03~1.10 ~80 DEG C), obtain extract I;
(2) pueraria lobata, mulberry leaf are weighed in parts by weight, and 20%~80% ethyl alcohol of volumetric concentration that 2~6 times of amounts are added extracts 1 ~3 times, 1~3 hour every time, extracting solution filtration merged, and filtrate decompression is concentrated into specific gravity 1.02~1.08 (60 DEG C~80 DEG C), It is spray-dried under the conditions of 120~150 DEG C of inlet air temperature, 30~60L/h of flow velocity, obtains extract II;
(3) ginseng is weighed in parts by weight, and vacuum drying, crushes at sterilizing, crosses 100 mesh~300 meshes, obtains ginseng fine powder;
(4) it prepares preparation: extract I, extract II and ginseng fine powder being mixed, and pharmacy is added and often uses auxiliary material, is made various Preparation.
8. the described in any item preparation methods with the composition of anti-trioxypurine of Claims 1 to 5, which is characterized in that packet Include following steps:
(1) Poria cocos, semen coicis, cape jasmine, peach kernel, pawpaw, rhizoma polygonati, lophatherum gracile, Radix Glycyrrhizae, fructus lycii are weighed in parts by weight, are added The water of 10 times of amounts extracts 3 times, and 2 hours every time, specific gravity was 1.05 when extracting solution filters, is concentrated into 60 DEG C, obtains extract I;
(2) pueraria lobata, mulberry leaf are weighed in parts by weight, 60% ethyl alcohol of volumetric concentration that 6 times of amounts are added extracts 3 times, and every time 1.5 Hour, extracting solution filtration, merging filtrate, specific gravity is 1.03, at 140 DEG C of inlet air temperature, flow velocity 45L/h when being concentrated under reduced pressure into 60 DEG C Under the conditions of be spray-dried, obtain extract II;
(3) ginseng is weighed in parts by weight, and vacuum drying, crushes at sterilizing, sieves with 100 mesh sieve, obtains ginseng fine powder;
(4) it prepares preparation: extract I, extract II and ginseng fine powder being mixed, and pharmacy is added and often uses auxiliary material, is made various Preparation.
9. according to the preparation method of the described in any item compositions with auxiliary lipid-lowering function of claim 6~8, feature Be: the dosage form of the preparation is tablet, pill, syrup, any one in capsule.
10. special according to the preparation method of the described in any item compositions with auxiliary lipid-lowering function of claim 6~8 Sign is that the pharmacy is often disintegrating agent, lubricant, surfactant, diluent, cosolvent, excipient, absorption with auxiliary material Any one or a few in carrier or adhesive.
11. special according to the described in any item preparation methods with the Chinese medicine composition of anti-trioxypurine of claim 6~8 Sign is: Puerarin percentage composition >=1.2% in the preparation, 1-DNJ percentage composition >=0.4%.
12. the described in any item Chinese medicine compositions with anti-trioxypurine of Claims 1 to 5 prevent and treat hyperuricemia in preparation Or the application in gout health care food or drug.
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CN110575533A (en) * 2019-09-12 2019-12-17 广东雪芝康生物科技有限公司 Composition for treating gout by regulating gene expression and reducing uric acid and preparation method thereof
CN110604794A (en) * 2019-10-14 2019-12-24 彭祥林 Preparation method of traditional Chinese medicine preparation and functional beverage for reducing uric acid and blood sugar
CN111617202A (en) * 2020-05-09 2020-09-04 广州市比拓人力资源有限公司 Uric acid-reducing tea
CN111713700A (en) * 2020-07-15 2020-09-29 沈阳膳源善食生物科技有限公司 A food composition
CN113209248A (en) * 2021-05-06 2021-08-06 徐荣华 Traditional Chinese medicine composition for treating gouty arthritis and hyperuricemia, medicament, decoction-free granules and application of traditional Chinese medicine composition
CN113876898A (en) * 2021-10-14 2022-01-04 合肥安药会健康产业有限公司 Traditional Chinese medicine gout-dispelling tea capable of reducing uric acid and preparation method thereof
CN116158529A (en) * 2021-11-25 2023-05-26 辽宁医学诊疗科技研发中心有限公司 Functional food composition with auxiliary uric acid reducing and gout relieving effects
CN114747766A (en) * 2022-04-27 2022-07-15 上海诚明圣源生物科技有限公司 Health-care food composition capable of reducing uric acid and preparation method and application thereof
CN114796392A (en) * 2022-05-31 2022-07-29 谷医堂(湖南)健康科技有限公司 Traditional Chinese medicine composition for treating gout and application thereof
CN114796392B (en) * 2022-05-31 2023-09-15 谷医堂(湖南)健康科技有限公司 Traditional Chinese medicine composition for treating gout and application thereof
CN116688068A (en) * 2023-04-18 2023-09-05 武汉华康臣生物科技有限公司 Nutritional intervention preparation suitable for people with hyperuricemia and gout and preparation method thereof
CN116850244A (en) * 2023-08-10 2023-10-10 深圳市一宝通食品技术有限公司 Traditional Chinese medicine composition for preventing and treating gout and lowering uric acid, preparation method thereof and beverage containing same

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Denomination of invention: A traditional Chinese medicine composition with the effect of reducing uric acid, its preparation method and application

Effective date of registration: 20221019

Granted publication date: 20220405

Pledgee: Shanghai Bank Co.,Ltd. Suzhou Branch

Pledgor: LEIYUNSHANG PHARMACEUTICAL GROUP Co.,Ltd.

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