CN106377651A - Preparation method for extracting pharmaceutical monomer for preventing and treating hyperuricemia and gout from rhizoma smilacis glabrae - Google Patents
Preparation method for extracting pharmaceutical monomer for preventing and treating hyperuricemia and gout from rhizoma smilacis glabrae Download PDFInfo
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- CN106377651A CN106377651A CN201610996995.0A CN201610996995A CN106377651A CN 106377651 A CN106377651 A CN 106377651A CN 201610996995 A CN201610996995 A CN 201610996995A CN 106377651 A CN106377651 A CN 106377651A
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23F—COFFEE; TEA; THEIR SUBSTITUTES; MANUFACTURE, PREPARATION, OR INFUSION THEREOF
- A23F3/00—Tea; Tea substitutes; Preparations thereof
- A23F3/34—Tea substitutes, e.g. matè; Extracts or infusions thereof
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- 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)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
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- 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)
- A61K36/90—Smilacaceae (Catbrier family), e.g. greenbrier or sarsaparilla
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/55—Liquid-liquid separation; Phase separation
Abstract
The invention relates to a preparation method for extracting a pharmaceutical monomer for preventing and treating hyperuricemia and gout from rhizoma smilacis glabrae. The preparation method comprises: after crushing rhizoma smilacis glabrae raw materials, adding ethanol and heating and reflowing to carry out crude extraction; then adjusting the pH (Potential of Hydrogen) of crude extraction liquid to carry out crude purification; purifying by adopting a polyamide resin column and a macroporous resin column; identifying elution liquid through a thin-layer chromatography; collecting the elution liquid containing a target compound with a high ratio and combining; finally, preparing the elution liquid into a product. By adopting 70% ethanol to decoct and extract and utilizing polyamide resin and macroporous resin to purify, a target monomer compound group is enriched purposefully, the cost is low and the yield is high; industrialization and scale production are easy to realize. Preparations including capsules, tablets, health-care tea and the like, which are prepared by the preparation method, have the characteristics of convenience for oral administration and diversification.
Description
Technical field
The present invention relates to a kind of preparation method preventing and treating hyperuricemia and the medicinal monomer of gout is and in particular to one kind is from soil
Extract in Poria and prevent and treat hyperuricemia and the preparation method of the medicinal monomer of gout.
Background technology
The report of Chinese medicine hyperuricemia and primary gout is more.In clinical practice and daily life, people
Find that some can treat the effective single medicinal material of hyperuricemia, the active component of wherein a lot of medicines and pharmacology are made
With being elucidated with.As Bi, Cortex Fraxini, Bai Ai, Carlina acauliss, Radix Clematidis, Semen Plantaginiss, Cortex Phellodendri, Herba Lysimachiae, Radix Gentianae Macrophyllae etc. have certain
Uric acid resisting acts on[1,2].Research display, Herba Epimedii, Semen Coiciss, Rhizoma Alismatis, Semen Plantaginiss, Radix Gentianae Macrophyllae can increase urate excretion, and Radix Gentianae Macrophyllae also may be used
Increase the dissolving of uric acid；Herba Lycopi, Radix Angelicae Sinensis can suppress uric acid to synthesize.Separately there is research display, Cortex Fraxini, Herba Plantaginiss, Radix Et Rhizoma Rhei, Rhizoma Atractylodis can promote
Uric acid is excluded from kidney, and Radix Et Rhizoma Rhei energy uricosuric excretes from stool；Bulbus Lilii, Pseudobulbus Cremastrae Seu Pleioness etc. have the effect of colchicinoid sample, can
Suppression leucocyte chemotaxises, thus mitigate the inflammatory reaction of gouty arthritises；Exocarpium Benincasae, Pericarpium Arecae, Cortex Mori, Pericarpium Citri Reticulatae, wood
The promoting the circulation of QI to induce diuresis medicine such as perfume, Cortex Sclerotii Poriae can improve endogenous creatinine clearance rate, increases urine volume, discharges uric acid, reduces blood uric acid[3,4].
Rhizoma Smilacis Glabrae be liliaceous plant smilacis glabra (Smilax glabra Roxb.) dry rhizome, main product in Guangdong,
Hunan, Anhui, Hubei, Zhejiang, Sichuan etc. save, and summer, the excavation of season in autumn two remove fibrous root, cleaning, drying or take advantage of fresh-cut flakiness, do
Dry.Rhizoma Smilacis Glabrae mainly contains polysaccharide, flavone and flavonoid glycoside, organic acid, Phenylpropanoid Glycosides class, sterols, saponinss and volatile oil
The chemical compositions such as class.Rhizoma Smilacis Glabrae has protection cardiovascular, antitumor, antiinflammatory, immunomodulating, antioxidation, antibacterial, uric acid resisting, guarantor
The aspects such as shield renal function.Confirm through pharmacological testing, Rhizoma Smilacis Glabrae total flavones have the activity of suppression XOD, can suppress purinase, make secondary
Xanthine and xanthine can not be converted into uric acid, thus can reduce rapidly serum Uric Acid Concentration, and suppression tophuses and renal calculuss are formed,
And promote tophuses to eliminate.Thus also can reach wind-induced arthralgia of alleviation pain etc..Rhizoma Smilacis Glabrae mainly has removing toxic substances dehumidifying, leads to
The effects such as effect in sharp joint, clinically it is usually used in the limbs contracture caused by syphilis and mercurialism, bones and muscles pain；Damp and hot stranguria with turbid discharge,
The treatment of leukorrhagia, carbuncle etc..
Treatment by Chinese herbs hyperuricemia and gout evident in efficacy, but Chinese medicine Shortcomings show several in use
Individual aspect：1st, conventional preparation and instructions of taking are inconvenient, such as decocting method, taste weight when taking, taking, and because during personal decoction
Between different with decocting method, curative effect can not be completely secured；2nd, taking dose is big, decocts or directly pulverize the dosage form of preparation, composition
Composition includes active component and invalid component, and taking dose is greatly it is impossible to reach the effect that Special Nursing in Special Disease is controlled, and is possible to produce poison
Side effect；3rd, obtain monomeric compound low yield, high cost with modern separating and purifying technology, be difficult to realize scale and industry
Change；4th, realizing this monomeric compound group by modern synthetic technology still has certain technical difficulty, and high cost.
[1] woods ultramarine, Xie Jian, Wang Haidong. the white Chinese mugwort experimentation [J] to hyperuricemia rat for the extracting solution. Chinese wind
Damp disease magazine, 2005,9 (8):509-510.
[2] Lin Fengping, appoints enlightenment, Song Enfeng etc. the experimentation [J] to urate nephropathy rat for the Radix Clematidis. Chinese patent medicine,
2006,28(6):842-845.
[3] Lee's table, Sun Lin. modern Kidney Disease [M]. Nanchang:In Jiangxi Science technology publishing house, 2000,537-
543.
[4] Shen Qingfa. tcm clinical practice nephrology [M]. Shanghai:Shanghai scientific and technical literature publishing house, 1998,206-
211.
Content of the invention
For the above-mentioned Chinese medicine problem that Shortcomings show in use, a kind of present invention consumption of offer is little, use
Conveniently, untoward reaction is few, low cost, effect are obvious, be easy to the industrialized medicinal singulation preventing and treating hyperuricemia and gout
The preparation method of compound group.
The purpose of the present invention will be achieved through the following technical solutions：A kind of extract from Rhizoma Smilacis Glabrae prevent and treat hyperuricemia and
The preparation method of the medicinal monomer of gout, comprises the following steps：
Step one, thick extraction：After Rhizoma Smilacis Glabrae raw material is smashed, weigh the raw material of certain mass, add 20 times amount 70% second
After alcohol is heated to reflux 2h, extract medicinal residues, in medicinal residues, will add 15 times amount 70% alcohol heating reflux 1.5h, united extraction liquid,
Cold preservation 1d, high speed centrifugation, discard insoluble matter, vacuum distillation ethanol, to relative density 1.2, obtains crude extract；
Step 2, thick purification：To 5, cold preservation 1d, high speed centrifugation concentrates crude extract pH value in hydrochloric acid regulating step one
Liquid, takes insoluble matter, hot water dissolving, and sodium hydroxide adjusts pH to neutral, as extracting solution；
Step 3, chromatographic column purifies：By polyamide resin column on the extracting solution in step 2, static adsorption 2 hours, use
20BV water elution, collects water elution part, concentrating under reduced pressure, upper AB-8 type macroporous resin column, static adsorption 2 hours, uses 10BV
Water elution, discards eluent, then with different concentration ethanol eluting successively from low to high, differentiated with thin layer chromatography in eluent be
A certain monomer and its relative amount in the no group containing monomeric compound, collect and have the eluent of high accounting target compound and close
And, gained eluent is prepared into product.
Preferably, a kind of described extraction from Rhizoma Smilacis Glabrae prevents and treats hyperuricemia and the preparation side of the medicinal monomer of gout
Method, in described step one, Rhizoma Smilacis Glabrae includes Rhizoma Smilacis Glabrae glycosides A, Rhizoma Smilacis Glabrae glycosides B, Rhizoma Smilacis Glabrae glycosides C, Rhizoma Smilacis Glabrae glycosides D, Rhizoma Smilacis Glabrae glycosides E.
Preferably, a kind of described extraction from Rhizoma Smilacis Glabrae prevents and treats hyperuricemia and the preparation side of the medicinal monomer of gout
Method, in described step 3, the product of eluent processing includes capsule, tablet, mixture, food additive and health tea.
Preferably, a kind of described extraction from Rhizoma Smilacis Glabrae prevents and treats hyperuricemia and the preparation side of the medicinal monomer of gout
Method, the preparation method of described capsule is：Concentrated in vacuo, it is vacuum dried or is spray-dried and to obtain fine powder, plus 6 times amount 20% starch
Paste, pelletizes encapsulated.
Preferably, a kind of described extraction from Rhizoma Smilacis Glabrae prevents and treats hyperuricemia and the preparation side of the medicinal monomer of gout
Method, the preparation method of described tablet is：Gained eluent is vacuum dried or is spray-dried to obtain fine powder, adds 6 times amount 20% starch
Paste, 1 times amount 10%PVP (polyvidone) ethanol, pelletize, and dry, tabletting.
Preferably, a kind of described extraction from Rhizoma Smilacis Glabrae prevents and treats hyperuricemia and the preparation side of the medicinal monomer of gout
Method, the preparation method of described mixture is：Gained eluent concentrates or is diluted to the extractum of relative density 1.2, and bottling makes oral
Liquid.
Preferably, a kind of described extraction from Rhizoma Smilacis Glabrae prevents and treats hyperuricemia and the preparation side of the medicinal monomer of gout
Method, the preparation method of described food additive is：Gained eluent is concentrated in vacuo, is vacuum dried or is spray-dried and to obtain fine powder, that is,
Can be used as food additive.
Preferably, a kind of described extraction from Rhizoma Smilacis Glabrae prevents and treats hyperuricemia and the preparation side of the medicinal monomer of gout
Method, the preparation method of described food additive is：Gained eluent is evaporated to no alcohol taste, you can add as health food
Agent.
Preferably, a kind of described extraction from Rhizoma Smilacis Glabrae prevents and treats hyperuricemia and the preparation side of the medicinal monomer of gout
Method, the preparation method of described health tea is：Gained eluent is evaporated to the extractum of relative density 1.2, with Tie Guanyin tea
By 1：20 mass ratio mixing, dries 8 hours under the conditions of being placed in 55 DEG C, then is ground into 20 mesh, sterilization packaging is put in storage, makes 6g mono-
The uric acid resisting health tea of bag.
The invention has the beneficial effects as follows：Monomer of the present invention is connected with Phenylpropanoid Glycosides by sucrose parent nucleus and forms, in medium pole
Property solvent in as the dissolubility such as n-butyl alcohol, ethyl acetate preferably, and there is certain water solublity.The present invention adopts 70% ethanol to decoct
Boil extraction, polyamide, purification by macroporous resin, autotelic enrichment subject monomers compound group, low cost, high income, hold
Easily realize industrialization and scale.The capsule of this invention preparation, tablet, the dosage form such as health care medicinal tea, taking convenience, have many
Firstization feature.
Specific embodiment
For more fully understanding the present invention, below by following examples, the present invention is made specifically to illustrate further, but not
Can be regarded as limitation of the invention, some made according to foregoing invention content for those skilled in the art are nonessential
Improve and adjustment, be also considered as being within the scope of the present invention.
Embodiment 1, acute toxicity test of the present invention
Laboratory animal：KM mice, SPF level, male, body weight 18-22g, carried by Traditional Chinese Medicine University Of Guangzhou's Experimental Animal Center
For.Normal raising supplied examination after 3 days.
Medicine and reagent：Rhizoma Smilacis Glabrae (Guangzhou Medicinal Material Co., Ltd. Traditional Chinese Medicinal Tablet Factory).
A kind of extraction from Rhizoma Smilacis Glabrae of the present invention prevents and treats hyperuricemia and the preparation method of the medicinal monomer of gout,
Its step is as follows：
Raw medicinal material Rhizoma Smilacis Glabrae adds 20 times amount 70% alcohol heating reflux and extracts 2h, and medicinal residues add the heating of 15 times amount 70% ethanol
Backflow 1.5h, united extraction liquid, cold preservation 1d, high speed centrifugation, discard insoluble matter, decompression recycling ethanol is to relative density 1.2, hydrochloric acid
Adjust pH value to 5, cold preservation 1d, high speed centrifugation concentrated solution, take insoluble matter, hot water dissolving, sodium hydroxide adjusts pH to neutral, upper polyamide
Resin column, static adsorption 2 hours, use 20BV water elution, collect water elution part, concentrating under reduced pressure, upper AB-8 type macroporous resin
Post, static adsorption 2 hours, use 10BV water elution, discard eluent, then with different concentration ethanol eluting successively from low to high, use
Thin layer chromatography differentiates whether to contain a certain monomer and its relative amount in monomeric compound group in eluent, and collection has height and accounts for
Than the eluent of target compound and merge, it is vacuum dried or is spray-dried and to obtain fine powder, be configured to distilled water required before use
Concentration.
Take KM mice 80, be equally divided into four groups, fasting 10h before gavage, prohibits water 6h.Daily gavage twice, every time
0.6ml, continuous 7 days.Medicine small dose group of the present invention：Dosage is 0.12g/kg/d, is equivalent to 30 times of people's consumption；Medicine of the present invention
Middle dose group：Dosage is 1.20g/kg/d, is equivalent to 300 times of people's consumption；Drug bolus group of the present invention：Dosage is 12.0g/
Kg/d, is equivalent to 3000 times of people's consumption；Matched group：Give equivalent distilled water.
Result of the test：7 days mices of experiment all survive, and in rarely seen animal administration 5h, appetite reduces, and activity weakens, medicine color
Loose stool etc., recovers normal after drug withdrawal.4 groups of animals drinking-water, hair color, body weight, feces and the heart, liver, spleen, lung, kidney, thymus, brain,
The aspects such as the form of main organs, size, smoothness such as tongue, stomach, intestinal, bladder, gonad (uterus, ovary or testis and epididymis) are equal
No significant difference.Described above, toxic and side effects of the present invention are little, and because by drug level and volumetric constraint, can not find cause little
The dead dosage of Mus, therefore the LD50 of the present invention cannot be measured.Mice maximum dosage-feeding is 6.00/kg/d, is equivalent to people's consumption
3000 times.
Experiment conclusion：The acute toxicity test of the present invention shows safety non-toxic of the present invention.
Embodiment 2, subchronic toxicity test of the present invention
Laboratory animal：KM mice, SPF level, male, body weight 18-22g, carried by Traditional Chinese Medicine University Of Guangzhou's Experimental Animal Center
For.Normal raising supplied examination after 3 days.
Medicine and reagent：Rhizoma Smilacis Glabrae (Guangzhou Medicinal Material Co., Ltd. Traditional Chinese Medicinal Tablet Factory).
A kind of extraction from Rhizoma Smilacis Glabrae of the present invention prevents and treats hyperuricemia and the preparation method of the medicinal monomer of gout,
Its step is as follows：
Raw medicinal material Rhizoma Smilacis Glabrae adds 20 times amount 70% alcohol heating reflux and extracts 2h, and medicinal residues add the heating of 15 times amount 70% ethanol
Backflow 1.5h, united extraction liquid, cold preservation 1d, high speed centrifugation, discard insoluble matter, decompression recycling ethanol is to relative density 1.2, hydrochloric acid
Adjust pH value to 5, cold preservation 1d, high speed centrifugation concentrated solution, take insoluble matter, hot water dissolving, sodium hydroxide adjusts pH to neutral, upper polyamide
Resin column, static adsorption 2 hours, use 20BV water elution, collect water elution part, concentrating under reduced pressure, upper AB-8 type macroporous resin
Post, static adsorption 2 hours, use 10BV water elution, discard eluent, then with different concentration ethanol eluting successively from low to high, use
Thin layer chromatography differentiates whether to contain a certain monomer and its relative amount in monomeric compound group in eluent, and collection has height and accounts for
Than the eluent of target compound and merge, it is vacuum dried or is spray-dried and to obtain fine powder, be configured to distilled water required before use
Concentration.
Take KM mice 80, be equally divided into four groups, fasting 10h before gavage, prohibits water 6h.Daily gavage twice, every time
0.6ml, continuous 14 days, observes after drug withdrawal 14 days again.Medicine small dose group of the present invention：Dosage is 0.06g/kg/d, is equivalent to people
30 times of consumption；Medicine middle dose group of the present invention：Dosage is 0.60g/kg/d, is equivalent to 300 times of people's consumption；Medicine of the present invention is big
Dosage group：Dosage is 6.00g/kg/d, is equivalent to 3000 times of people's consumption；Matched group：Give equivalent distilled water.
Result of the test：In each group mouse species administration 5h, appetite reduces, and activity weakens, and medicine color loose stool etc. is extensive after drug withdrawal
Multiple normal.Average weight when each test group is the 14th day after being administered 14d and being discontinued no significant difference (P compared with matched group>
0.05).The Erythrocytes of test group mice, total white blood cellses, content of hemoglobin, platelet count after drug withdrawal the 1st day and
14th day no significant difference (P compared with matched group after drug withdrawal>0·05).The serum glutamic pyruvic transminase of each test group mice, paddy
Careless transaminase, alkali phosphatase after drug withdrawal the 1st day and be discontinued after the 14th day no significant difference (P compared with matched group>0.05).
The 1st day and the 14th day after drug withdrawal, cut open inspection is shown in that each group heart, liver, spleen, lung, kidney, the form of harmonization of the stomach intestinal, color, quality are normal.Disease
Reason histological examination, the high, medium and low dosage group of the present invention and control group mice are showed no obvious pathological change.
Through experiment, the high, medium and low dosage group of the present invention is above clinical treatment dosage, does not find in the corresponding course for the treatment of
Any subchronic toxicity reaction.In conjunction with acute toxicity test, its consumption is equivalent to 3000 times of people's consumption and also has no that any poison is secondary
Reaction, the therefore present invention can be used as preventing and treating hyperuricemia, the dual-purpose formula of gout medicinal health food and preparation.
Conclusion (of pressure testing)：The subchronic toxicity test of the present invention shows safety non-toxic of the present invention.
The clinical observation of embodiment 3, clinical treatment hyperuricemia of the present invention and gout
1. basic document：All cases derive from outpatient service, totally 60, each 30 of men and women.Application table of random number is divided into be controlled
Treatment group 30, matched group 30, two groups of sexes, age, course of disease comparing differences are not statistically significant.
2. diagnostic criteria
2.1 Western medicine diagnostic criteria
1. write within 2005 according to Chinese Medical Association《Clinic diagnosis guide rheumatism fascicle》Standard:Male's blood
Uric acid level>417mmol/L；Women Level of Serum Uric Acid>357mmol/L；2. acute gouty arthritises Western medicine diagnostic criteria (reference
American Rheumatism Association's standard in 1977) (1), look in synovial bursa liquid and see specificity uric acid crystal；(2), tophuses are through chemical method
Or PLM is it was demonstrated that crystallize containing Monosodium urate；Possess following clinical manifestation, lab testing and x line sign etc.
6 persons in 12：1), more than 1 time acute arthritises outbreak：Inflammation shows in 1 day and peaks；2), monarthritis are sent out
Make；3), affected skin is in kermesinus；4), Metatarsophalangeal joint pain or swelling；5), Metatarsophalangeal joint is involved in unilateral outbreak；
6), midtarsal joints are involved in unilateral outbreak：7), can there are tophuses；8), hyperuricemia：9), x-ray display joint asymmetry
Swelling；10), x ray photograph shows that under cortical bone, cyst is not with bone erosion；11), joint fluid not companion's microorganism during arthritis outbreak
Culture is negative.Any l item possessing in above-mentioned 2 can be clarified a diagnosis.
2.2 TCM syndrome diagnostic criteria：Clinical manifestation is retention of damp-heat in the interior syndrome person：Joint is red, swollen, hot, bitterly, song is stretched not
Profit；Occur together heat, heaviness of the head as if it were tightly bandaged, limb fiber crops are heavy, fatigue and weakness, mouth stick or bitter taste, loose stool is not well or stool is smooth, it is red to urinate；Body of the tongue
Red or light red, side print with teeth, yellowish fur, soft pulse or rolling pulse or sliding number.
3. Therapeutic Method：Treatment group gives oral capsule of the present invention, every 0.3g, 1 every time, daily 2 times；Matched group
Give allopurinol tablet 0.1g/ time, 2 times/d.Two groups of courses for the treatment of are 4 weeks, follow-up 2 weeks.
4. criterion of therapeutical effect and therapeutic outcome
4.1 clinical total effectses evaluation criteria references《New Chinese medicine guideline of clinical investigations (trying) (Zheng Xiao cornel. Chinese medicine
Clinical Researches of New Drugs guideline (trying) [S]. Beijing:China Medical Science Press, 2002:78-79.) draft.Clinic is fullyed recover from an illness
More：Symptom is wholly absent, and main physico-chemical examination index is normal；Effective：Cardinal symptom disappears, and main physico-chemical examination index is substantially just
Often；Effectively：Cardinal symptom disappears substantially, and main physico-chemical examination index makes moderate progress；Invalid：Compared with pre-treatment, each side are equal
No improve.
Before and after 4.2 liang of group treatments, Level of Serum Uric Acid compares
After two groups of treatments, Level of Serum Uric Acid all declines, and compares P before and after treatment<0.01, treatment group and matched group comparing difference do not have
Statistically significant P<0.05, refer to table 1：
Before and after 1 liang of group treatment of table, Level of Serum Uric Acid compares
Note * P<0.01
4.3 liang of group Clinical efficacy comparisons
Treatment group's clinical recovery 17, effective 6, effective 5, total effective rate 93.33%；Matched group clinical recovery 10
Example, effective 8, effective 6, total effective rate 80%.Two groups of comparitive study, difference significance (P<0.05), refer to table 2：
2 liang of group Clinical efficacy comparisons of table
Note * P<0.05
Conclusion (of pressure testing)：The present invention has significant therapeutic effect to hyperuricemia and gout.
The foregoing is only presently preferred embodiments of the present invention, not in order to limit the present invention, all essences in the present invention
Within god and principle, any modification, equivalent substitution and improvement made etc., should be included within the scope of the present invention.
Claims (9)
1. a kind of extract the preparation method preventing and treating hyperuricemia and the medicinal monomer of gout from Rhizoma Smilacis Glabrae it is characterised in that bag
Include following steps：
Step one, thick extraction：After Rhizoma Smilacis Glabrae raw material is smashed, weigh the raw material of certain mass, add 20 times amount 70% ethanol to add
After hot reflux 2h, extract medicinal residues, 15 times amount 70% alcohol heating reflux 1.5h, united extraction liquid, cold preservation will be added in medicinal residues
1d, high speed centrifugation, discard insoluble matter, vacuum distillation ethanol, to relative density 1.2, obtains crude extract；
Step 2, thick purification：Crude extract pH value in hydrochloric acid regulating step one to 5, cold preservation 1d, high speed centrifugation concentrated solution, take
Insoluble matter, hot water dissolving, sodium hydroxide adjusts pH to neutral, as extracting solution；
Step 3, chromatographic column purifies：By polyamide resin column on the extracting solution in step 2, static adsorption 2 hours, use 20BV water
Eluting, collects water elution part, concentrating under reduced pressure, upper AB-8 type macroporous resin column, static adsorption 2 hours, uses 10BV water elution,
Discard eluent, then with different concentration ethanol eluting successively from low to high, differentiate whether contain in eluent with thin layer chromatography
A certain monomer and its relative amount in monomeric compound group, collect and have the eluent of high accounting target compound and merge, will
Gained eluent is prepared into product.
2. a kind of extraction from Rhizoma Smilacis Glabrae according to claim 1 prevents and treats hyperuricemia and the preparation of the medicinal monomer of gout
Method it is characterised in that：In described step one, Rhizoma Smilacis Glabrae includes Rhizoma Smilacis Glabrae glycosides A, Rhizoma Smilacis Glabrae glycosides B, Rhizoma Smilacis Glabrae glycosides C, Rhizoma Smilacis Glabrae glycosides
One or more of D, Rhizoma Smilacis Glabrae glycosides E.
3. a kind of extraction from Rhizoma Smilacis Glabrae according to claim 1 prevents and treats hyperuricemia and the preparation of the medicinal monomer of gout
Method it is characterised in that：In described step 3, the product of eluent processing includes capsule, tablet, mixture, food additive
And health tea.
4. a kind of extraction from Rhizoma Smilacis Glabrae according to claim 3 prevents and treats hyperuricemia and the preparation of the medicinal monomer of gout
Method is it is characterised in that the preparation method of described capsule is：Concentrated in vacuo, it is vacuum dried or is spray-dried and to obtain fine powder, plus 6
Times amount 20% gelatinized corn starch, pelletizes encapsulated.
5. a kind of extraction from Rhizoma Smilacis Glabrae according to claim 3 prevents and treats hyperuricemia and the preparation of the medicinal monomer of gout
Method is it is characterised in that the preparation method of described tablet is：Gained eluent is vacuum dried or is spray-dried to obtain fine powder, adds 6
Times amount 20% gelatinized corn starch, 1 times amount 10%PVP (polyvidone) ethanol, pelletize, and dry, tabletting.
6. a kind of extraction from Rhizoma Smilacis Glabrae according to claim 3 prevents and treats hyperuricemia and the preparation of the medicinal monomer of gout
Method is it is characterised in that the preparation method of described mixture is：Gained eluent concentrates or is diluted to the extractum of relative density 1.2,
Bottling makes oral liquid.
7. a kind of extraction from Rhizoma Smilacis Glabrae according to claim 3 prevents and treats hyperuricemia and the preparation of the medicinal monomer of gout
Method is it is characterised in that the preparation method of described food additive is：Gained eluent is concentrated in vacuo, is vacuum dried or sprays
Dry fine powder, you can as food additive.
8. a kind of extraction from Rhizoma Smilacis Glabrae according to claim 3 prevents and treats hyperuricemia and the preparation of the medicinal monomer of gout
Method is it is characterised in that the preparation method of described food additive is：Gained eluent is evaporated to no alcohol taste, you can make
For food supplement.
9. a kind of extraction from Rhizoma Smilacis Glabrae according to claim 3 prevents and treats hyperuricemia and the preparation of the medicinal monomer of gout
Method is it is characterised in that the preparation method of described health tea is：Gained eluent is evaporated to the extractum of relative density 1.2,
Press 1 with Tie Guanyin tea：20 mass ratio mixing, dries 8 hours under the conditions of being placed in 55 DEG C, then is ground into 20 mesh, sterilization packaging
Warehouse-in, makes the uric acid resisting health tea of 6g mono- bag.
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