CN108403906A - A kind of pharmaceutical composition and preparation method thereof of prevention rheumatoid arthritis - Google Patents
A kind of pharmaceutical composition and preparation method thereof of prevention rheumatoid arthritis Download PDFInfo
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- CN108403906A CN108403906A CN201810571496.6A CN201810571496A CN108403906A CN 108403906 A CN108403906 A CN 108403906A CN 201810571496 A CN201810571496 A CN 201810571496A CN 108403906 A CN108403906 A CN 108403906A
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- pharmaceutical composition
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- morinda officinalis
- rheumatoid arthritis
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- 206010039073 rheumatoid arthritis Diseases 0.000 title claims abstract description 24
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 16
- 230000002265 prevention Effects 0.000 title claims abstract description 9
- 238000002360 preparation method Methods 0.000 title abstract description 10
- 239000003814 drug Substances 0.000 claims abstract description 50
- 229940079593 drug Drugs 0.000 claims abstract description 39
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 32
- 241000096284 Gynochthodes officinalis Species 0.000 claims abstract description 29
- 240000001341 Reynoutria japonica Species 0.000 claims abstract description 16
- 235000018167 Reynoutria japonica Nutrition 0.000 claims abstract description 16
- 239000002994 raw material Substances 0.000 claims abstract description 16
- 241001148782 Davallia Species 0.000 claims abstract description 15
- 239000000463 material Substances 0.000 claims abstract description 15
- 235000002722 Dioscorea batatas Nutrition 0.000 claims abstract description 10
- 235000006536 Dioscorea esculenta Nutrition 0.000 claims abstract description 10
- 240000001811 Dioscorea oppositifolia Species 0.000 claims abstract description 10
- 235000003416 Dioscorea oppositifolia Nutrition 0.000 claims abstract description 10
- 241000405414 Rehmannia Species 0.000 claims abstract description 8
- 241000123589 Dipsacus Species 0.000 claims abstract description 7
- 241000270708 Testudinidae Species 0.000 claims abstract description 7
- 239000000843 powder Substances 0.000 claims description 19
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 15
- 239000000706 filtrate Substances 0.000 claims description 12
- 238000001914 filtration Methods 0.000 claims description 12
- 241000700159 Rattus Species 0.000 claims description 9
- 238000000605 extraction Methods 0.000 claims description 8
- 210000002966 serum Anatomy 0.000 claims description 8
- 108090001005 Interleukin-6 Proteins 0.000 claims description 7
- 238000010992 reflux Methods 0.000 claims description 7
- MZOFCQQQCNRIBI-VMXHOPILSA-N (3s)-4-[[(2s)-1-[[(2s)-1-[[(1s)-1-carboxy-2-hydroxyethyl]amino]-4-methyl-1-oxopentan-2-yl]amino]-5-(diaminomethylideneamino)-1-oxopentan-2-yl]amino]-3-[[2-[[(2s)-2,6-diaminohexanoyl]amino]acetyl]amino]-4-oxobutanoic acid Chemical compound OC[C@@H](C(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCN=C(N)N)NC(=O)[C@H](CC(O)=O)NC(=O)CNC(=O)[C@@H](N)CCCCN MZOFCQQQCNRIBI-VMXHOPILSA-N 0.000 claims description 6
- 108060008682 Tumor Necrosis Factor Proteins 0.000 claims description 6
- 102000000852 Tumor Necrosis Factor-alpha Human genes 0.000 claims description 6
- 239000006071 cream Substances 0.000 claims description 5
- 238000000034 method Methods 0.000 claims description 5
- 238000002156 mixing Methods 0.000 claims description 5
- 238000001694 spray drying Methods 0.000 claims description 5
- 108010002352 Interleukin-1 Proteins 0.000 claims description 4
- 239000008213 purified water Substances 0.000 claims description 4
- 210000005229 liver cell Anatomy 0.000 claims description 3
- 230000009467 reduction Effects 0.000 claims description 3
- 230000004083 survival effect Effects 0.000 claims description 3
- 244000292697 Polygonum aviculare Species 0.000 claims description 2
- 235000006386 Polygonum aviculare Nutrition 0.000 claims description 2
- 206010067125 Liver injury Diseases 0.000 claims 1
- 231100000234 hepatic damage Toxicity 0.000 claims 1
- 230000008818 liver damage Effects 0.000 claims 1
- 206010019851 Hepatotoxicity Diseases 0.000 abstract description 4
- 229940126678 chinese medicines Drugs 0.000 abstract description 4
- 230000007686 hepatotoxicity Effects 0.000 abstract description 4
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- 230000006838 adverse reaction Effects 0.000 abstract description 2
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- 239000002775 capsule Substances 0.000 description 11
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- 210000004027 cell Anatomy 0.000 description 4
- 210000003734 kidney Anatomy 0.000 description 4
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 description 3
- 210000000988 bone and bone Anatomy 0.000 description 3
- 230000000052 comparative effect Effects 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
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- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 206010070863 Toxicity to various agents Diseases 0.000 description 2
- 206010003246 arthritis Diseases 0.000 description 2
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- 239000000341 volatile oil Substances 0.000 description 2
- 102100036475 Alanine aminotransferase 1 Human genes 0.000 description 1
- 108010082126 Alanine transaminase Proteins 0.000 description 1
- 208000023275 Autoimmune disease Diseases 0.000 description 1
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- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- 206010061998 Hepatic lesion Diseases 0.000 description 1
- 206010023230 Joint stiffness Diseases 0.000 description 1
- 206010027336 Menstruation delayed Diseases 0.000 description 1
- 241000157491 Morinda Species 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 235000003143 Panax notoginseng Nutrition 0.000 description 1
- 241000180649 Panax notoginseng Species 0.000 description 1
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Classifications
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- 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)
- A61K36/74—Rubiaceae (Madder family)
- A61K36/746—Morinda
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/58—Reptiles
- A61K35/586—Turtles; Tortoises, e.g. terrapins
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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
- A61K36/11—Pteridophyta or Filicophyta (ferns)
- A61K36/12—Filicopsida or Pteridopsida
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
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- A—HUMAN NECESSITIES
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- 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)
- A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
- A61K36/296—Epimedium
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- A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber tree
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/704—Polygonum, e.g. knotweed
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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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/80—Scrophulariaceae (Figwort family)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- Health & Medical Sciences (AREA)
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- Alternative & Traditional Medicine (AREA)
- Rheumatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract
The invention belongs to the field of Chinese medicines, and in particular to a kind of pharmaceutical composition and preparation method thereof of prevention rheumatoid arthritis, including following raw material:Morinda officinalis, prepared fleece flower root, Herba Epimedii, prepared rehmannia root, tortoise plastron, Morinda officinalis, Cortex Eucommiae, teasel root, the rhizome of davallia, Radix Angelicae Sinensis and Chinese yam, wherein the total weight of the Morinda officinalis is (0.1~0.3) with the total weight ratio of remaining raw material:1, the weight ratio between remaining feed components is 1:1.The present invention provides the drug of prevention rheumatoid arthritis, significant in efficacy, and the new application is reduced compared with conventional medicament dosage.Meanwhile by the way that creatively by part medicinal material alcohol extracting pharmacy again, the hepatotoxicity wind agitation for the drug being prepared substantially reduces, reduces the adverse reaction of clinical application, improve drug safety.
Description
Technical field
The invention belongs to the field of Chinese medicines, and in particular to it is a kind of prevention rheumatoid arthritis pharmaceutical composition and its preparation
Method.
Background technology
Protecting capsule prescription is:Prepared fleece flower root 347.5g, Herba Epimedii 277.5g, prepared rehmannia root 347.5g, tortoise plastron 208.5g, bar
Halberd day 277.5g, Cortex Eucommiae 277.5g, teasel root 277.5g, rhizome of davallia 277.5g, Radix Angelicae Sinensis 208.5g and Chinese yam 277.5g.Preparation method:With
Upper 10 taste takes 1/3 Chinese yam of recipe quantity, is ground into fine powder.Nine taste such as remaining Chinese yam and Herba Epimedii add water to cook it is secondary, every time decoct
1h is boiled, volatile oil is collected simultaneously, merges decoction liquor, is filtered, is concentrated, spray drying will collect obtained volatile oil and spray into Chinese yam
Powder, it is encapsulated with dried cream powder mixing after drying, 1000 are made to get (national drug standards YBZ12742004-2009Z).
Clinic display shield capsule has the function of relatively preventing primary osteoporosis well, but does not have document to disclose or report it
Effect in treating rheumatic arthritis, shield capsule can be applied to treatment rheumatoid arthritis by also not implied.
Rheumatoid arthritis is a kind of with arthralgia, swelling, chronic systemic that is stiff, being deformed into main clinical manifestation
Property autoimmune disease, show as the migrans pain in joint and dysfunction in early days, late period then shows as joint stiffness or useless
And do not have to.Currently, have now been developed such as CN102885961A, CN104367911A, CN102670624A some by simple
The compound system of such as tripterygium hypoglaucum hutcs, Cortex Eucommiae and Radix Angelicae Sinensis, centipede, Radix Notoginseng, Rhizoma Chuanxiong and Herba Epimedii up to 16 kinds or more medicinal materials composition
Agent, above-mentioned preparation achieves preferable curative effect in the prevention of rheumatoid arthritis disease, but clinic generally reflects above-mentioned system
Agent dosage is slightly larger, and side effect is more, and most apparent side effect is exactly the damage to liver, keeps glutamic-pyruvic transaminase in blood dense
Degree increases, and inhibits marrow hemopoiesis, makes blood platelet, Neuroleptic Leukocytopenia etc., is used for a long time larger to human body burden.
As a result, for the above-mentioned prior art present in technical problem, it is necessary to provide a hepatic lesion small treatment class wind
Wet arthritis drug.
Invention content
The present invention is intended to provide a kind of pharmaceutical composition of prevention rheumatoid arthritis of shield, which, which has, significantly controls
The effect of rheumatoid arthritis is treated, meanwhile, by carrying out alcohol extracting to part medicinal material, damage of the drug to liver can be significantly reduced
Evil, reduces the toxic side effect of drug.
In order to achieve the above object, the present invention uses following technical scheme:
Shield capsule is made of 10 taste Chinese medicines, and " monarch " according to traditional Chinese medicine prepares theoretical connected applications modern times system
Medicine technology is made, and using filling liver kidney, the rules for the treatment of of benefiting essence-blood, coordinating yin and yang, is aided with nourshing blood and promoting blood circulation, dispelling wind and eliminating dampness, strengthens muscles and bones, only
The method of pain calmness.Wherein, " prepared fleece flower root ", " Herba Epimedii " are " monarch drug in a prescription " in prescription, play filling liver kidney, benefiting essence-blood and wind-damp dispelling
Effect;And " prepared rehmannia root ", " tortoise plastron " are used as " ministerial drug " in prescription, play the role of nourishing kidney-yin, yin-nourishing of enriching blood;Help again with
Filling liver kidney, strengthening the bones and muscles, dispelling wind and eliminating dampness reinforcement monarch drug in a prescription are played the role of in " Morinda officinalis, Cortex Eucommiae, teasel root, the rhizome of davallia " conduct " adjutant ",
Also add analgesic effect;" Radix Angelicae Sinensis " and " Chinese yam " is used as " making medicine " in prescription, the effect of playing enriching blood and replenishing vital essence.The monarch and his subjects help
The effect of making mutual cooperation, prove effective jointly, obtaining prevention primary osteoporosis well.
But tests prove that the effect of original prescription is to rheumatoid arthritis is little, on this basis, inventor is with more
The experience in year is adjusted original prescription by a large amount of creative work, specifically, no longer with " how is system in new prescription
The tuber of multiflower knotweed and Herba Epimedii " is monarch drug in a prescription, but using script as " ministerial drug " " Morinda officinalis " increasing dose as " monarch drug in a prescription " of new recipe,
The total weight ratio for controlling its weight and remaining raw material is (0.1~0.3):1, more preferably, control its weight and remaining raw material
Total weight ratio be (0.15~0.3):1, more preferably, both control weight ratio 0.20:1, it plays and tonifies the kidney and support yang, wind-dispelling removes
Wet effect.It is 1 to control the weight ratio between remaining feed components:1.It is " minister with " Radix Angelicae Sinensis, Herba Epimedii and prepared fleece flower root "
Medicine " plays the role of activating blood circulation, tying-in;It helps again with " tortoise plastron, Cortex Eucommiae, teasel root, the rhizome of davallia ", plays strengthening the bones and muscles, wind-damp dispelling
Effect, using " prepared rehmannia root, Chinese yam " as " making medicine ", the effect of playing nourishing yin and supplementing blood.Each component mutually cooperates with, to rheumatism joint
Scorching and rheumatoid arthritis achieves fine curative effect, it is often more important that, it has unexpectedly been found that, the prescription Clinical practice amount compared with
Conventional medicament dosage is reduced, and greatly reduces the medication burden of patient.
Secondly, the preparation method described in the national drug standards is to obtain through refining into 10 taste Chinese medicines by water, people's will of the present invention
Other places finds that by part medicinal material, rest part obtains through refining damage of the standby obtained drug to liver using water can be big using gradient alcohol extracting
It is big to reduce, compared with whole water carry, the pharmacy again after alcohol extracting by Morinda officinalis, prepared fleece flower root, Cortex Eucommiae and the rhizome of davallia, drug
Hepatotoxicity wind agitation reduction is most apparent, and after being co-cultured with liver cell, cell survival rate is up to 100%.
Pharmaceutical composition of the present invention is prepared by following methods:
S1, alcohol extracting:It takes Morinda officinalis, prepared fleece flower root, Cortex Eucommiae and the rhizome of davallia to crush, obtains coarse powder, coarse powder total amount 3~10 is added
95% ethanol solution of times amount, refluxing extraction 1~3 time, every time 1~3h;The 75% of 3~6 times of amounts is added into filter residue for filtering
Ethanol solution, refluxing extraction 1~3 time, 1~3h every time, filtering merges filtrate twice, and filtrate is concentrated into 80 DEG C or less relatively
The medicinal extract that density is 1.05~1.21 is spray-dried the powder that gets dry extract;
S2, water carry:Surplus stock is taken, is crushed, the purified water that 2~6 times of amounts of medicinal material total amount are added decocts 1~3 time, and every time 1
~3h merges decoction liquor, and filtering, filtrate is concentrated into the medicinal extract that 70 DEG C or less relative densities are 1.07~1.13, after spray drying
With dried cream powder mixing obtained by step S1 to get.
The present invention has the following advantages:
1) new application the present invention provides shield capsule in treating rheumatoid arthritis, it is significant in efficacy, and this is new
Purposes is reduced compared with conventional medicament dosage.
2) present invention is by the way that creatively by part medicinal material alcohol extracting pharmacy again, the hepatotoxicity wind agitation for the drug being prepared drops significantly
It is low, the adverse reaction of clinical application is reduced, drug safety is improved.
Specific implementation mode
The specific implementation mode of form by the following examples makees further specifically the above of the present invention
It is bright.But the range that this should not be interpreted as to the above-mentioned theme of the present invention is only limitted to following embodiment.
Embodiment 1 prevents medicine for treating rheumatoid arthritis
In the present embodiment, the total weight ratio of Morinda officinalis and remaining raw material is 0.2:1.
Component | Content |
Morinda officinalis | 405.9g |
Prepared fleece flower root | 225.5g |
Herba Epimedii | 225.5g |
Radix Angelicae Sinensis | 225.5g |
Tortoise plastron | 225.5g |
Cortex Eucommiae | 225.5g |
Teasel root | 225.5g |
The rhizome of davallia | 225.5g |
Prepared rehmannia root | 225.5g |
Chinese yam | 225.5g |
Preparation method:
S1, alcohol extracting:It takes Morinda officinalis, prepared fleece flower root, Cortex Eucommiae and the rhizome of davallia to crush, obtains coarse powder, 6 times of amounts of coarse powder total amount are added
95% ethanol solution, refluxing extraction 2 times, each 1h;75% ethanol solution of 3 times of amounts is added into filter residue for filtering, returns
Stream extraction 1h, filtering merge filtrate twice, and filtrate is concentrated into the medicinal extract that 80 DEG C or less relative densities are 1.05, is spray-dried
Dried cream powder;
S2, water carry:Surplus stock is taken, is crushed, the purified water that 6 times of amounts of medicinal material total amount are added decocts 2 times, each 1h, merges
Decoction liquor, filtering, filtrate are concentrated into the medicinal extract that 70 DEG C or less relative densities are 1.07, are got dry extract with step S1 after spray drying
Powder mixing is packed into capsule, is made 1000.
Embodiment 2 prevents medicine for treating rheumatoid arthritis
In the present embodiment, the total weight ratio of Morinda officinalis and remaining raw material is 0.15:1.
Component | Content |
Morinda officinalis | 304.4g |
Prepared fleece flower root | 225.5g |
Herba Epimedii | 225.5g |
Radix Angelicae Sinensis | 225.5g |
Tortoise plastron | 225.5g |
Cortex Eucommiae | 225.5g |
Teasel root | 225.5g |
The rhizome of davallia | 225.5g |
Prepared rehmannia root | 225.5g |
Chinese yam | 225.5g |
Preparation method reference implementation example 1.
Embodiment 3 prevents medicine for treating rheumatoid arthritis
In the present embodiment, the total weight ratio of Morinda officinalis and remaining raw material is 0.22:1.
Preparation method reference implementation example 1.
Test example one, the effect to adjuvanticity rheumatoid arthritis rat model
1.1 subjects:Drug described in embodiment 1 protects capsule
1.2 test method:
60 rats are randomly divided into 6 groups, every group 10, half male and half female, be randomly divided into normal group, model group, embodiment 1
High, medium and low dosage group, half separately raising, raises sensitization modeling after 2~32d, and toes are subcutaneously injected behind the normal rats right side
0.9% sodium chloride solution 0.1ml, typeⅡ Collagen 0.1ml sensitization is subcutaneously injected in toes after remaining each group Rat Right.15th day
Start to be administered according to following medication:1. normal group, giving isometric distilled water;2. model group gives isometric distilled water;
3. 1 high dose group of embodiment gives 2.5g crude drugs/kg weight;4. 1 middle dose group of embodiment gives 1.25g crude drugs/kg weight;
5. 1 low dose group of embodiment gives 0.625g crude drugs/kg weight;6. protecting capsule group, shield capsule 0.80g crude drugs/kg is given
Weight, equal gastric infusion, administered volume 15ml/kg weight start to be administered on the day of modeling, 1 time a day, successive administration 28 days.
Etherization mouse after experiment, abdominal aorta blood sampling, 3500r/min centrifuge 10min, take serum, and survey serum IL -1,
The content of IL-6, TNF-α.
1.4 statistical procedures
All data use X ± S to indicate, statistics uses variance analysis, and to variance analysis, there were significant differences is further examined with t
It tests and compares group difference.
2. test result
Table 1 influences (X ± S, pg/ml) to the content of rheumatoid arthritis in rats serum IL -1, IL-6, TNF-α
Note:Compared with normal group,##P < 0.01,#P < 0.05;Compared with model group,**P < 0.01,*P < 0.05.
As it can be seen from table 1 compared with normal group, model group rats serum IL -1, IL-6, the content of TNF-α are extremely notable
It increases, shows modeling success.Wherein 1 drug of the embodiment of the present invention, three dosage groups have pole significant difference compared with model group
(P < 0.01) shows that 1 drug of the embodiment of the present invention has significant inhibiting effect to rheumatoid arthritis.And protect capsule
Although each index content of group is less than model group, significant difference is not constituted, this explanation, the shield capsule of original prescription is for wind
Wet arthritis is without apparent inhibiting effect.
Influence of the amount ratio of test example two, different Morinda officinalis and remaining raw material to medicine effect
The amount ratio that different Morinda officinalis and remaining raw material are arranged according to the following table 2 on the basis of embodiment 1 is prepared respectively
Group drug, dosage are 1.25g crude drugs/kg weight, it is investigated to rheumatoid joint rat serum according to one method of test example
IL-1, IL-6 in clear, TNF-α content influence, the results are shown in Table 3.
Drug made from amount ratio of the different Morinda officinalis of table 2 with remaining raw material
The amount ratio of the different Morinda officinalis of table 3 and remaining raw material is to IL-1, IL-6, TNF- in rheumatoid joint rat blood serum
The influence of the content of α
Note:Compared with normal group,##P < 0.01,#P < 0.05;Compared with model group,**P < 0.01,*P < 0.05.
By upper table 3 it is found that dosage of the Morinda officinalis in prescription is affected to the whole curative effect of drug, when amount ratio exists
(0.1~0.3):When 1, significant difference (P < 0.05) is all had compared with model group, especially, when amount ratio is 0.20:1
When, have pole significant difference (P < 0.01), tool be significantly reduced IL-1, IL-6 in rheumatoid arthritis in rats serum,
The effect of the content of the TNF-α factor.And the change of Morinda officinalis and the amount ratio of remaining raw material affects this reduction and acts on.
The influence of test example three, alcohol extracting medicinal material type to drug toxicity
By carrying out alcohol extracting to different medicinal materials, the toxicity for the drug being prepared is investigated, test procedure is as follows:
3.1 material
(alcohol extracting medicinal material is bar for Example 1 (alcohol extracting medicinal material is Morinda officinalis+prepared fleece flower root+Cortex Eucommiae+rhizome of davallia), comparative example 1
Halberd day+prepared fleece flower root+Cortex Eucommiae), comparative example 2 (Morinda officinalis+prepared fleece flower root+Cortex Eucommiae+rhizome of davallia+prepared rehmannia root), 3 (Morinda offcinalis How of comparative example
It+prepared fleece flower root+Cortex Eucommiae+Herba Epimedii) prepare each 5g of drug, with 10ml distillation water dissolution obtain each sample solution to be measured, people is just
Normal liver cell HL-7702 (L02), is purchased from Shanghai Jun Rui Bioisystech Co., Ltd.
3.2 test method
Human normal hepatocyte is inoculated into 96 orifice plates with the quantity of 3000~6000 cells in every hole, after cell is adherent,
The above-mentioned each sample of 0.1ml solution to be measured is added, cultivates 48h, the MTT solution of 10 a concentration of 5mg/ml of μ l is added per hole, continues to train
4h is supported, culture solution is discarded, the DMSO of 100 μ l is added per hole, is rocked in being protected from light on constant speed shaking table.After object to be crystallized fully dissolves,
OD values (wavelength 570nm, reference wavelength 630nm) are read in microplate reader, read the light absorption value per hole, calculate each group cell survival
Rate.
3.3 result
Influence of the 4 alcohol extracting type of table to drug toxicity
By upper table 4 it is found that the type difference of alcohol extracting medicinal material to the hepatotoxicity of the drug of acquisition there are large effect,
In, it is minimum to the toxicity of liver that drug made from alcohol extracting is carried out to Morinda officinalis+prepared fleece flower root+Cortex Eucommiae+rhizome of davallia.
The above-described embodiments merely illustrate the principles and effects of the present invention, and is not intended to limit the present invention.It is any ripe
The personage for knowing this technology can all carry out modifications and changes to above-described embodiment without violating the spirit and scope of the present invention.Cause
This, institute is complete without departing from the spirit and technical ideas disclosed in the present invention by those of ordinary skill in the art such as
At all equivalent modifications or change, should by the present invention claim be covered.
Claims (9)
1. a kind of pharmaceutical composition of prevention rheumatoid arthritis, which is characterized in that including following raw material:How are Morinda officinalis, system
The tuber of multiflower knotweed, Herba Epimedii, prepared rehmannia root, tortoise plastron, Morinda officinalis, Cortex Eucommiae, teasel root, the rhizome of davallia, Radix Angelicae Sinensis and Chinese yam, wherein the Morinda officinalis
The total weight ratio of total weight and remaining raw material is (0.1~0.3):1, the weight ratio between remaining feed components is 1:1.
2. pharmaceutical composition as described in claim 1, which is characterized in that the total weight of the Morinda officinalis is total with remaining raw material
Weight ratio is (0.15~0.3):1.
3. pharmaceutical composition as claimed in claim 2, which is characterized in that the total weight of the Morinda officinalis is total with remaining raw material
Weight ratio is 0.20:1.
4. pharmaceutical composition as described in claim 1, which is characterized in that described pharmaceutical composition is prepared by following methods
It arrives:
S1, gradient alcohol extracting:It takes Morinda officinalis, prepared fleece flower root, Cortex Eucommiae and the rhizome of davallia to crush, obtains coarse powder, coarse powder total amount 3~10 is added
95% ethanol solution of times amount, refluxing extraction 1~3 time, every time 1~3h;The 75% of 3~6 times of amounts is added into filter residue for filtering
Ethanol solution, refluxing extraction 1~3 time, 1~3h every time, filtering merges filtrate twice, and filtrate is concentrated into 80 DEG C or less relatively
The medicinal extract that density is 1.05~1.21 is spray-dried the powder that gets dry extract;
S2, water carry:Surplus stock is taken, is crushed, the purified water that 2~6 times of amounts of medicinal material total amount are added decocts 1~3 time, every time 1~3h,
Merge decoction liquor, filtering, filtrate be concentrated into 70 DEG C or less relative densities be 1.07~1.13 medicinal extract, after spray drying with step
Dried cream powder mixing obtained by S1 to get.
5. the pharmaceutical composition as described in Claims 1 to 4 is any is preparing the purposes in treating medicine for treating rheumatoid arthritis.
6. purposes as claimed in claim 5, described pharmaceutical composition reduce IL-1 in rheumatoid arthritis in rats serum,
The content of IL-6, the TNF-α factor.
7. the pharmaceutical composition as described in Claims 1 to 4 is any is preparing the drug-induced liver damage of reduction rheumatoid arthritis
Purposes in evil drug.
8. purposes as claimed in claim 7, described pharmaceutical composition improves the survival rate of human liver cell HL-7702 (L02).
9. a kind of method preparing the pharmaceutical composition as described in Claims 1 to 4 is any, which is characterized in that including following step
Suddenly:
A) gradient alcohol extracting:It takes Morinda officinalis, prepared fleece flower root, Cortex Eucommiae and the rhizome of davallia to crush, obtains coarse powder, coarse powder total amount 3~10 is added
95% ethanol solution of times amount, refluxing extraction 1~3 time, every time 1~3h;The 75% of 3~6 times of amounts is added into filter residue for filtering
Ethanol solution, refluxing extraction 1~3 time, 1~3h every time, filtering merges filtrate twice, and filtrate is concentrated into 80 DEG C or less relatively
The medicinal extract that density is 1.05~1.21 is spray-dried the powder that gets dry extract;
B) water carries:Surplus stock is taken, is crushed, the purified water that 2~6 times of amounts of medicinal material total amount are added decocts 1~3 time, every time 1~3h,
Merge decoction liquor, filtering, filtrate be concentrated into 70 DEG C or less relative densities be 1.07~1.13 medicinal extract, after spray drying with step
Dried cream powder mixing obtained by S1 to get.
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