CN105963661A - Medicine composition for curing skin itch and preparation method and application thereof - Google Patents
Medicine composition for curing skin itch and preparation method and application thereof Download PDFInfo
- Publication number
- CN105963661A CN105963661A CN201610442511.8A CN201610442511A CN105963661A CN 105963661 A CN105963661 A CN 105963661A CN 201610442511 A CN201610442511 A CN 201610442511A CN 105963661 A CN105963661 A CN 105963661A
- Authority
- CN
- China
- Prior art keywords
- weight portion
- weight
- pharmaceutical composition
- raw material
- fructus amomi
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9068—Zingiber, e.g. garden ginger
-
- 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
- A61K36/236—Ligusticum (licorice-root)
-
- 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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
-
- 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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/489—Sophora, e.g. necklacepod or mamani
-
- 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)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
-
- 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)
- A61K36/75—Rutaceae (Rue family)
- A61K36/756—Phellodendron, e.g. corktree
-
- 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)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9064—Amomum, e.g. round cardamom
-
- 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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
-
- 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
-
- 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
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
-
- 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
- A61K2236/331—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, decoction
-
- 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
Abstract
The invention belongs to the technical field of traditional Chinese medicines and particularly relates to medicine composition for curing skin itch, wherein crude drugs comprise zingiberis, prepared radix licorice, cortex phellodendri, fructus amomi, cinnamon, radix sophorae flavescentis and ligusticum wallichii in weight ratio ranges as follows: 10-50 parts of rhizoma zingiberis, 5-40 parts of prepared radix licorice, 5-40 parts of cortex phellodendri, 3-20 parts of fructus amomi, 3-20 parts of cinnamon, 3-20 parts of radix sophorae flavescentis and 1-10 parts of ligusticum wallichii (by weight). The invention further provides a preparation method and an application of the medicine composition. The pharmacological experiment proves that the medicine composition effectively improves the itch symptoms caused by different causes and has a relatively good therapeutic effect for a patient with skit itch.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, especially relate to a kind for the treatment of and alleviate pharmaceutical composition and the system thereof of skin pruritus
Preparation Method and purposes, belong to technical field of Chinese medicines.
Background technology
Skin pruritus refers to damage without primary cutaneous, and the paresthesia of skin dermatoses with pruritus as cardinal symptom, often
Because scratching the insecondary skin lesions such as scratch, blood crusts, pigmentation and lichenification occur.Limitation can be divided into clinically
With general property.Limitation person, in the majority with pudendum, perianal pruritus；General property person, much the most general whole body.It is usually skin
Being dried the skin pruritus that causes is outstanding behaviours, whole body can without other malaise symptoms, patient's Chang Yin skin pruritus and cause uneasy sleeping at night
Or insomnia, daytime, lassitude, even affected appetite, caused quality of life to decline.Primary disease prevalence 10-50%.Age is more
Greatly, frequency and the degree of skin pruritus are the highest, obstinate because of its symptom again, and course of disease delay difficulty heals, recurrent exerbation, has a strong impact on trouble
The Health and Living quality of person.
Skin pruritus is referred to as " pruritus caused by wind pathogen " by the traditional Chinese medical science, also has " pruritus due to wind pathogen ", " pruritus ", " itching eruption due to wind-heat in blood ", " anal itching ", " the moon
Itch " etc. name of disease.It is indefinite that clinic often shows as pruritus migration, time when sending out only, itching all over the body, night is more so, pachylosis, dry
Dry, plump, desquamation, often scratches hemorrhage, but with broken with receipts, will not erosionization corruption, light red tongue, thin fur, the disease such as thready and weak pulse.In
Medical science is thought, old people's many Liver and kidney asthenia of essence and blood, deficiency of qi and blood, blood deficiency then failure of skin and muscle to be nourished, the raw wind of dryness-transformation；The deficiency of vital energy is then defended the most not
Gu, ailment said due to cold or exposure is easily attacked；Blood deficiency skin loses in moistening foster, and skin is the most flourish, the raw wind of dryness-transformation, causes pruritus, such as " General Treatise on the Cause and Symptoms of Diseases " cloud:
" pruritus caused by wind pathogen person, is body void wind-engaging, and wind people's space between skin and muscles is fought mutually with QI and blood, and is all to and between skin.Pathogen is micro-, it is impossible to punching
Hit for pain, therefore but pruritus also." cover because of patient Nian Gao, function fails, deficiency of both the liver and kidney, or because of Chronic consumptions,
Not healing, QI and blood day loses, asthenia of essence and blood, it is impossible to skin of supplementing nutrition, and life is the driest and causes pruritus；Or because of the old deficiency of vital energy, transport blood
Unable, blood stasis due to qi deficiency, or prolonged illness becomes the stasis of blood, and passages through which vital energy circulates blocks, and battalion must not defend fluent, and skin loses and makes moist and cause pruritus；Or because feelings will presses down
Strongly fragrant, the liver failing to maintain the normal flow of QI, mechanism of qi block, five excessive emotions converting into internal fire, accumulate in heat in blood, heat-transformation wind symptom and cause pruritus.In a word, deficiency of YIN blood is dry, flesh
Skin loses and supports is the basic of its morbidity, and from the point of view of Point of View of Clinical, the hepatic and renal YIN deficiency, blood-deficiency and wind-dry, failure of skin and muscle to be nourished is its different TCM syndrome types.
Treating about it, ancient medicine has discussion more, as " surgery card controls pandect " points out: " pruritus, pruritus all over there is no scabies
Skin ulcer, scratches more than, liver man blood deficiency, dry hot air wind producing, can not absurd throwing wind medicine "." surgery great achievement " is thought: " wind is contained and then itched, lid
For wind person, the mark of fire is also.All wind heat visitor foxtail millet person in skin pruritus, controls suitable dispelling wind, if excessive in wind heat, the blood deficiency person of having an itch, again
When removing heat from blood is moisturized ".Therefore, nourshing Yin and drynsessmoistening prescription, nourishing blood to expel wind is its basic principle for the treatment of.
Summary of the invention
It is an object of the invention to solve the deficiencies in the prior art, it is provided that a kind of with low cost, evident in efficacy, medicine that safety is good
Compositions.This pharmaceutical composition is made up of Rhizoma Zingiberis, Radix Glycyrrhizae Preparata, Cortex Phellodendri, Fructus Amomi, Cortex Cinnamomi, Radix Sophorae Flavescentis and Rhizoma Chuanxiong, has taste
The moon is moisturized, the effect of nourishing blood to expel wind.
First purpose of the present invention is to provide a kind of pharmaceutical composition treating skin pruritus；
Second purpose of the present invention is to provide the preparation method of this Chinese medicine composition；
The 3rd purpose of the present invention is the application providing this Chinese medicine composition in preparation treatment senile skin pruritus medicine.
It is an object of the invention to be achieved through the following technical solutions:
This pharmaceutical composition is made up of following raw material and weight ratio: Rhizoma Zingiberis 10-50 weight portion, Radix Glycyrrhizae Preparata 5-40 weight portion,
Cortex Phellodendri 5-40 weight portion, Fructus Amomi 3-20 weight portion, Cortex Cinnamomi 3-20 weight portion, Radix Sophorae Flavescentis 3-20 weight portion, Rhizoma Chuanxiong 1-10 weight
Amount part.Preferably, Rhizoma Zingiberis 15-45 weight portion, Radix Glycyrrhizae Preparata 10-35 weight portion, Cortex Phellodendri 10-35 weight portion, Fructus Amomi 5-18
Weight portion, Cortex Cinnamomi 5-18 weight portion, Radix Sophorae Flavescentis 5-18 weight portion, Rhizoma Chuanxiong 2-8 weight portion.Preferably, Rhizoma Zingiberis 20-40 weight
Part, Radix Glycyrrhizae Preparata 15-30 weight portion, Cortex Phellodendri 15-30 weight portion, Fructus Amomi 8-15 weight portion, Cortex Cinnamomi 8-15 weight portion, Radix Sophorae Flavescentis
8-15 weight portion, Rhizoma Chuanxiong 3-7 weight portion.Preferably, Rhizoma Zingiberis 25-35 weight portion, Radix Glycyrrhizae Preparata 18-25 weight portion, Cortex Phellodendri
18-25 weight portion, Fructus Amomi 9-12 weight portion, Cortex Cinnamomi 9-12 weight portion, Radix Sophorae Flavescentis 9-12 weight portion, Rhizoma Chuanxiong 4-6 weight portion.
Preferably, Rhizoma Zingiberis 18 weight portion, Radix Glycyrrhizae Preparata 12 weight portion, Cortex Phellodendri 10 weight portion, Fructus Amomi 12 weight portion, Cortex Cinnamomi 6 weight
Part, Radix Sophorae Flavescentis 6 weight portion, Rhizoma Chuanxiong 6 weight portion.
The preparation method of described pharmaceutical composition includes: by straight to Rhizoma Zingiberis, Radix Glycyrrhizae Preparata, Cortex Phellodendri, Fructus Amomi, Cortex Cinnamomi, Radix Sophorae Flavescentis, Rhizoma Chuanxiong
Connect pulverizing, make various clinically-acceptable dosage form through common process.
The preparation method of described pharmaceutical composition includes: Rhizoma Zingiberis, Radix Glycyrrhizae Preparata, Cortex Phellodendri, Fructus Amomi, Cortex Cinnamomi, Radix Sophorae Flavescentis, Rhizoma Chuanxiong are used
After alcohol extraction and water carry, make various clinically-acceptable dosage form through common process.
Specifically facilitate step as follows:
S1: weigh raw material by component and weight ratio；
S2: after raw material mix homogeneously, the ethanol solution reflux, extract, of addition 70%-95% 3 times, each 1.5h, filter, close
And filtrate, concentrating under reduced pressure obtains thick extractum, vacuum dried after extract powder A；
S3: remaining for S2 step medicinal residues are added the soak by water 1 of 5～8 times amount～1.5 hours, decocts 2 times altogether, decocted
Merging secondary decocting liquid after one-tenth, concentrating under reduced pressure obtains thick extractum, vacuum dried after extract powder B；
S4: by extract powder A, extract powder B mixing granulation, add the medicine that pharmaceutically acceptable adjuvant is prepared as pharmaceutically commonly using
Thing preparation.
The pharmaceutical composition of the present invention can be prepared as agent described on any pharmaceutics according to the conventional method of pharmaceutical field
Type；Pharmaceutical composition can be applied to patient by modes such as oral, suction or parenteral administrations.
Described pharmaceutically conventional types of drug preparations includes: the tablet of use, effervescent tablet, capsule, ball during oral administration
Agent, powder, granule, syrup, oral liquid etc.；The freeze-dried powder used when parenteral administration and injection etc..
For making above-mentioned dosage form be capable of, pharmaceutically acceptable adjuvant need to be added when preparing these dosage forms, such as: filler,
Disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, preservative, substrate etc..Filler includes: starch,
Pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.；Disintegrating agent includes: starch, pregelatinated form sediment
Powder, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl are fine
Dimension element sodium etc.；Lubricant includes: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.；Suspending agent includes:
Polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl methyl cellulose etc.；Binding agent includes, starch slurry,
Polyvinylpyrrolidone, hydroxypropyl methyl cellulose etc.；Sweeting agent includes: saccharin sodium, Aspartane, sucrose, cyclamate,
Enoxolone etc.；Correctives includes: sweeting agent and various essence；Preservative includes: parabens, benzoic acid, sodium benzoate,
Sorbic acid and its esters, benzalkonium bromide, fixed, the eucalyptus oil of acetic acid chloroethene etc.；Substrate includes: PEG6000, PEG4000, insect wax
Deng.For making above-mentioned dosage form be capable of pharmacy of Chinese materia medica, other adjuvant (model pharmaceutically acceptable need to be added when preparing these dosage forms
Bi Ting " pharmacy of Chinese materia medica ", the adjuvant that in Shanghai Science Press December the 1st edition in 1997, each dosage form is recorded).Institute of the present invention
Stating Rhizoma Zingiberis processed, Radix Glycyrrhizae Preparata, Cortex Phellodendri, Fructus Amomi, Cortex Cinnamomi, Radix Sophorae Flavescentis and Rhizoma Chuanxiong is that 2010 editions " Chinese Pharmacopoeias " first record
Chinese medicine or its processed product.
Pharmaceutical composition of the present invention provides the benefit that through pharmacodynamics checking:
The present composition to dextran cause mouse skin pruritus, to 2 ' 4-toluene-2,4-diisocyanates cause Mice Auricle prurituss,
4-aminopyridine is caused mouse skin pruritus and is respectively provided with remarkable result.It is clinically used for treating skin pruritus, especially to old skin
Skin pruritus is main, it is adaptable to the pruritus that the various causes of disease cause, as physical property stimulates such as temperature, daylight, humidity etc., biological
Stimulate such as pungent irritable food, drinks, external used medicine and contact chemical substance etc..Pharmaceutical composition of the present invention is except to skin scabies
Outside disease of itching has significant therapeutic effect, cause the experiment of Cavia porcellus ear swelling by dimethyl sulfoxide and show, skin turgor and pain are suffered from
Person also has preferable therapeutical effect.
Detailed description of the invention
Below in conjunction with specific embodiment, technical scheme is described in further detail, but protection scope of the present invention is not limited to
The following stated.
Embodiment 1
Weigh raw material Rhizoma Zingiberis 10kg, Radix Glycyrrhizae Preparata 5kg, Cortex Phellodendri 5kg, Fructus Amomi 3kg, Cortex Cinnamomi 3kg, Radix Sophorae Flavescentis 3kg, Rhizoma Chuanxiong 1kg；
After above-mentioned raw materials mix homogeneously, the ethanol solution reflux, extract, of addition 70% 3 times, each 1.5h, filter, medicinal residues are standby,
Merging filtrate, concentrating under reduced pressure obtains thick extractum, vacuum dried after extract powder A；The soak by water 1 that medicinal residues add 5 times amount is little
Time, decoct 2 times altogether, after having decocted, merge twice decocting liquid, concentrating under reduced pressure obtains thick extractum, vacuum dried after obtain extract powder
B；By extract powder A, extract powder B mixing granulation, conventionally add conventional pharmaceutical adjuvants, uniformly prepare granule, pressure
Sheet, obtains tablet.
Embodiment 2
Weigh raw material Rhizoma Zingiberis 15kg, Radix Glycyrrhizae Preparata 10kg, Cortex Phellodendri 10kg, Fructus Amomi 5kg, Cortex Cinnamomi 5kg, Radix Sophorae Flavescentis 5kg, Rhizoma Chuanxiong
2kg；After above-mentioned raw materials mix homogeneously, the ethanol solution reflux, extract, of addition 80% 3 times, each 1.5h, filter, medicinal residues
Standby, merging filtrate, concentrating under reduced pressure obtains thick extractum, vacuum dried after extract powder A；Medicinal residues are added the decocting of 6 times amount
Boiling 1.5 hours, decoct 2 times altogether, merge twice decocting liquid after having decocted, concentrating under reduced pressure obtains thick extractum, vacuum dried after
Obtain extract powder B；By extract powder A, extract powder B mixing granulation, conventionally add conventional pharmaceutical adjuvants, uniformly prepare
Granule, tabletting, obtain tablet.
Embodiment 3
Weigh raw material Rhizoma Zingiberis 20kg, Radix Glycyrrhizae Preparata 15kg, Cortex Phellodendri 15kg, Fructus Amomi 8kg, Cortex Cinnamomi 8kg, Radix Sophorae Flavescentis 8kg, Rhizoma Chuanxiong
2kg；After above-mentioned raw materials mix homogeneously, the ethanol solution reflux, extract, of addition 80% 3 times, each 1.5h, filter, medicinal residues
Standby, merging filtrate, concentrating under reduced pressure obtains thick extractum, vacuum dried after extract powder A；Medicinal residues are added the decocting of 7 times amount
Boiling 1 hour, decoct 2 times altogether, merge twice decocting liquid after having decocted, concentrating under reduced pressure obtains thick extractum, vacuum dried after must
Extract powder B；By extract powder A, extract powder B mixing granulation, conventionally add conventional pharmaceutical adjuvants, the most prepared
Grain, tabletting, obtain tablet.
Embodiment 4
Weigh raw material Rhizoma Zingiberis 25kg, Radix Glycyrrhizae Preparata 18kg, Cortex Phellodendri 18kg, Fructus Amomi 9kg, Cortex Cinnamomi 9kg, Radix Sophorae Flavescentis 9kg, Rhizoma Chuanxiong
4kg；After above-mentioned raw materials mix homogeneously, the ethanol solution reflux, extract, of addition 90% 3 times, each 1.5h, filter, medicinal residues
Standby, merging filtrate, concentrating under reduced pressure obtains thick extractum, vacuum dried after extract powder A；Medicinal residues are added the decocting of 8 times amount
Boiling 1.5 hours, decoct 2 times altogether, merge twice decocting liquid after having decocted, concentrating under reduced pressure obtains thick extractum, vacuum dried after
Obtain extract powder B；By extract powder A, extract powder B mixing granulation, conventionally add conventional pharmaceutical adjuvants, uniformly prepare
Granule, tabletting, obtain tablet.
Embodiment 5
Weigh raw material Rhizoma Zingiberis 18kg, Radix Glycyrrhizae Preparata 12kg, Cortex Phellodendri 10kg, Fructus Amomi 12kg, Cortex Cinnamomi 6kg, Radix Sophorae Flavescentis 6kg, Rhizoma Chuanxiong
6kg；After above-mentioned raw materials mix homogeneously, the ethanol solution reflux, extract, of addition 95% 3 times, each 1.5h, filter, medicinal residues
Standby, merging filtrate, concentrating under reduced pressure obtains thick extractum, vacuum dried after extract powder A；Medicinal residues are added the decocting of 8 times amount
Boiling 1 hour, decoct 2 times altogether, merge twice decocting liquid after having decocted, concentrating under reduced pressure obtains thick extractum, vacuum dried after must
Extract powder B；By extract powder A, extract powder B mixing granulation, conventionally add conventional pharmaceutical adjuvants, the most prepared
Granule.
Embodiment 6
Weigh raw material Rhizoma Zingiberis 35kg, Radix Glycyrrhizae Preparata 25kg, Cortex Phellodendri 25kg, Fructus Amomi 12kg, Cortex Cinnamomi 12kg, Radix Sophorae Flavescentis 12kg, river
Rhizome of chuanxiong 6kg；After above-mentioned raw materials mix homogeneously, the ethanol solution reflux, extract, of addition 70% 3 times, each 1.5h, filter, medicine
Slag is standby, merging filtrate, and concentrating under reduced pressure obtains thick extractum, vacuum dried after extract powder A；Medicinal residues are added the water of 5 times amount
Decocting 1 hour, decoct 2 times altogether, merge twice decocting liquid after having decocted, concentrating under reduced pressure obtains thick extractum, vacuum dried after
Obtain extract powder B；By extract powder A, extract powder B mixing granulation, conventionally add conventional pharmaceutical adjuvants, uniformly prepare
Granule, loads capsule, obtains capsule.
Embodiment 7
Weigh raw material Rhizoma Zingiberis 40kg, Radix Glycyrrhizae Preparata 30kg, Cortex Phellodendri 30kg, Fructus Amomi 15kg, Cortex Cinnamomi 15kg, Radix Sophorae Flavescentis 15kg, river
Rhizome of chuanxiong 7kg；After above-mentioned raw materials mix homogeneously, the ethanol solution reflux, extract, of addition 85% 3 times, each 1.5h, filter, medicine
Slag is standby, merging filtrate, and concentrating under reduced pressure obtains thick extractum, vacuum dried after extract powder A；Medicinal residues are added the water of 8 times amount
Decocting 1.5 hours, decoct 2 times altogether, merge twice decocting liquid after having decocted, concentrating under reduced pressure obtains thick extractum, vacuum dried
After extract powder B；By extract powder A, extract powder B mixing granulation, conventionally add conventional pharmaceutical adjuvants, uniformly make
Obtain granule, load capsule, obtain capsule.
Embodiment 8
Weigh raw material Rhizoma Zingiberis 45kg, Radix Glycyrrhizae Preparata 35kg, Cortex Phellodendri 35kg, Fructus Amomi 35kg, Cortex Cinnamomi 18kg, Radix Sophorae Flavescentis 18kg, river
Rhizome of chuanxiong 8kg；After above-mentioned raw materials mix homogeneously, the ethanol solution reflux, extract, of addition 90% 3 times, each 1.5h, filter, medicine
Slag is standby, merging filtrate, and concentrating under reduced pressure obtains thick extractum, vacuum dried after extract powder A；Medicinal residues are added the water of 8 times amount
Decocting 1.5 hours, decoct 2 times altogether, merge twice decocting liquid after having decocted, concentrating under reduced pressure obtains thick extractum, vacuum dried
After extract powder B；By extract powder A, extract powder B mixing granulation, conventionally add conventional pharmaceutical adjuvants, uniformly make
Obtain granule, load capsule, obtain capsule.
Embodiment 9
Weigh raw material Rhizoma Zingiberis 50kg, Radix Glycyrrhizae Preparata 40kg, Cortex Phellodendri 40kg, Fructus Amomi 20kg, Cortex Cinnamomi 20kg, Radix Sophorae Flavescentis 20kg, river
Rhizome of chuanxiong 10kg；After above-mentioned raw materials mix homogeneously, the ethanol solution reflux, extract, of addition 80% 3 times, each 1.5h, filter,
Medicinal residues are standby, merging filtrate, and concentrating under reduced pressure obtains thick extractum, vacuum dried after extract powder A；Medicinal residues are added 8 times amount
Soak by water 1.5 hours, decocts 2 times altogether, merges twice decocting liquid after having decocted, and concentrating under reduced pressure obtains thick extractum, does through vacuum
Extract powder B is obtained after dry；By extract powder A, extract powder B mixing granulation, conventionally add conventional pharmaceutical adjuvants, uniformly make
Obtain granule, load capsule, obtain capsule.
Embodiment 10
Weigh raw material Rhizoma Zingiberis 10kg, Radix Glycyrrhizae Preparata 5kg, Cortex Phellodendri 5kg, Fructus Amomi 3kg, Cortex Cinnamomi 3kg, Radix Sophorae Flavescentis 3kg, Rhizoma Chuanxiong 1kg；
After above-mentioned raw materials mix homogeneously, directly pulverize, conventionally add conventional pharmaceutical adjuvants and be prepared as powder.
Embodiment 11
Weigh raw material Rhizoma Zingiberis 15kg, Radix Glycyrrhizae Preparata 10kg, Cortex Phellodendri 10kg, Fructus Amomi 5kg, Cortex Cinnamomi 5kg, Radix Sophorae Flavescentis 5kg, Rhizoma Chuanxiong
2kg；After above-mentioned raw materials mix homogeneously, directly pulverize, conventionally add conventional pharmaceutical adjuvants and be prepared as powder.
Embodiment 12
Weigh raw material Rhizoma Zingiberis 20kg, Radix Glycyrrhizae Preparata 15kg, Cortex Phellodendri 15kg, Fructus Amomi 8kg, Cortex Cinnamomi 8kg, Radix Sophorae Flavescentis 8kg, Rhizoma Chuanxiong
2kg；After above-mentioned raw materials mix homogeneously, directly pulverize, conventionally add conventional pharmaceutical adjuvants and be prepared as oral liquid.
Embodiment 13
Weigh raw material Rhizoma Zingiberis 25kg, Radix Glycyrrhizae Preparata 18kg, Cortex Phellodendri 18kg, Fructus Amomi 9kg, Cortex Cinnamomi 9kg, Radix Sophorae Flavescentis 9kg, Rhizoma Chuanxiong
4kg；After above-mentioned raw materials mix homogeneously, directly pulverize, conventionally add conventional pharmaceutical adjuvants and be prepared as oral liquid.
Embodiment 14
Weigh raw material Rhizoma Zingiberis 18kg, Radix Glycyrrhizae Preparata 12kg, Cortex Phellodendri 10kg, Fructus Amomi 12kg, Cortex Cinnamomi 6kg, Radix Sophorae Flavescentis 6kg, Rhizoma Chuanxiong
6kg；After above-mentioned raw materials mix homogeneously, directly pulverize, conventionally add conventional pharmaceutical adjuvants and be prepared as drop pill.
Embodiment 15
Weigh raw material Rhizoma Zingiberis 35kg, Radix Glycyrrhizae Preparata 25kg, Cortex Phellodendri 25kg, Fructus Amomi 12kg, Cortex Cinnamomi 12kg, Radix Sophorae Flavescentis 12kg, river
Rhizome of chuanxiong 6kg；After above-mentioned raw materials mix homogeneously, directly pulverize, conventionally add conventional pharmaceutical adjuvants and be prepared as drop pill.
Embodiment 16
Weigh raw material Rhizoma Zingiberis 40kg, Radix Glycyrrhizae Preparata 30kg, Cortex Phellodendri 30kg, Fructus Amomi 15kg, Cortex Cinnamomi 15kg, Radix Sophorae Flavescentis 15kg, river
Rhizome of chuanxiong 7kg；After above-mentioned raw materials mix homogeneously, directly pulverize, conventionally add conventional pharmaceutical adjuvants and be prepared as effervescent tablet
Agent.
Embodiment 17
Weigh raw material Rhizoma Zingiberis 45kg, Radix Glycyrrhizae Preparata 35kg, Cortex Phellodendri 35kg, Fructus Amomi 35kg, Cortex Cinnamomi 18kg, Radix Sophorae Flavescentis 18kg, river
Rhizome of chuanxiong 8kg；After above-mentioned raw materials mix homogeneously, directly pulverize, conventionally add conventional pharmaceutical adjuvants and be prepared as effervescent tablet
Agent.
Embodiment 18
Weigh raw material Rhizoma Zingiberis 50kg, Radix Glycyrrhizae Preparata 40kg, Cortex Phellodendri 40kg, Fructus Amomi 20kg, Cortex Cinnamomi 20kg, Radix Sophorae Flavescentis 20kg, river
Rhizome of chuanxiong 10kg；After above-mentioned raw materials mix homogeneously, directly pulverize, conventionally add conventional pharmaceutical adjuvants and be prepared as granule
Agent.
Embodiment 19
Weigh raw material Rhizoma Zingiberis 18kg, Radix Glycyrrhizae Preparata 12kg, Cortex Phellodendri 10kg, Fructus Amomi 12kg, Cortex Cinnamomi 6kg, Radix Sophorae Flavescentis 6kg, Rhizoma Chuanxiong
6kg；After above-mentioned raw materials mix homogeneously, conventionally it is prepared as decoction.
Embodiment 20
Weigh raw material Rhizoma Zingiberis 18kg, Radix Glycyrrhizae Preparata 12kg, Cortex Phellodendri 10kg, Fructus Amomi 12kg, Cortex Cinnamomi 6kg, Radix Sophorae Flavescentis 6kg, Rhizoma Chuanxiong
6kg；After above-mentioned raw materials mix homogeneously, conventionally it is prepared as granule.
Beneficial effects of the present invention is proved below by concrete pharmacy test:
Pharmaceutical composition trade name of the present invention is fixed tentatively and is: peace itches granule, its drug dose ratio and preparation method with reference to embodiment 5
Carry out.
One, the present composition impact on dextran being caused mouse skin pruritus
1. experiment material
Pacify granule of itching: specification: 1g/ml, numbering is respectively 1,2,3, No. 4, by Drug Manufacturing Room teaching and research room of Chengdu University of Traditional Chinese Medicine
Thering is provided, lot number is: 20150814.Chlorate, Huazhong Pharmaceutical Co., Ltd. produces, lot number: 20141125.
Dextran-40, Qidu Pharmaceutical Co., Ltd., Shandong Prov. produces, lot number: 1D11121307.
2. laboratory animal
KM mice, SPF level, full ♂, body weight (18 ± 2) g, Chengdu reach rich fruit and Company of Animals Ltd.'s offer is provided, experiment is dynamic
The thing quality certification number is: SCXK (river) 2008-24.
3. experimental technique
By 60 KM mices, after weighing, be randomly divided into 6 groups, i.e. model control group, Chlorate group (chlorphenamine
Group, 1.8mg/kg), pacify granule 1-4 sample sets (being called for short No. 1, No. 2, No. 3, No. 4) of itching, often group 10.Except mould
Type matched group ig gives outside isopyknic normal saline, and remaining is respectively organized ig and gives corresponding medicine, is administered volume 10ml/kg,
2 times/d, continuous 5 days.After last administration after 30min, each group mouse tail vein injection 0.16% dextran solution 0.lml/10g.
Scratch head with mice fore paw, after grab trunk of scratching, mouth stings each position of whole body as indicator reaction of scratching where it itches.Observed and recorded pruritus is dived
In volt phase (injection dextran the pruritus response time occur to mice), 30min, mice is scratched where it itches number of times (action meter of once scratching
It is 1 pruritus reaction) and pruritus lasting total time (reaction of scratching for the first time is to without the time reacted of scratching).The results are shown in Table 1.
4. experimental result
Table 1 is pacified granule of itching and dextran is caused the impact of mouse skin pruritus
Note: compare * P < 0.05, * * P < 0.01 with model control group
As shown in Table 1, compare with model control group, although respectively group pruritus is not statistically significant (P > 0.05) incubation period, but
Pruritus relatively model control group incubation period has prolongation trend；No. 4 sample relatively model control group pruritus persistent period significantly shorten, and have notable
Statistical significance (P < 0.05)；Pacify four technique group pruritus number of times the most relatively model control group of granule of itching to substantially reduce, have notable
Statistical significance (P < 0.05), each group pruritus number of times significantly reduces, and has significant difference (* P < 0.05).Result shows,
The present composition causes mouse skin pruritus to dextran and has preferable therapeutical effect.
Two, pharmaceutical composition of the present invention causes the impact of Mice Auricle pruritus to 2 ' 4 toluene-2,4-diisocyanates
1. experiment material
Pacify granule of itching: specification: 1g/ml, numbering is respectively 1,2,3, No. 4, teaching and research by Chengdu University of Traditional Chinese Medicine Drug Manufacturing Room
Room provides, and lot number is: 20150814.Chlorate, Huazhong Pharmaceutical Co., Ltd. produces, lot number:
20141125.2 ' 4-toluene-2,4-diisocyanates, by Gracia Cheical Technology Co.Ltd. lot number: I4000.
2. laboratory animal
KM mice, SPF level, full ♂, body weight (18 ± 2) g, Chengdu reach rich fruit and Company of Animals Ltd.'s offer is provided, experiment is dynamic
The thing quality certification number is: SCXK (river) 2013-24.
3. experimental technique
By 60 KM mices, after weighing, be randomly divided into 6 groups, i.e. model control group, Chlorate group (chlorphenamine
Group, 1.8mg/kg), pacify granule 1-4 sample sets of itching, often group 10.Except model control group ig gives isopyknic physiology
Outside saline, remaining is respectively organized ig and gives corresponding medicine, is administered volume 10ml/kg, 2 times/d, continuous 5 days, is grouped and is administered
Dosage is shown in Table 2.30min after last administration, Mice Auricle smears 1%2 ' 4 toluene-2,4-diisocyanates (paraffin oil makees solvent)
30 μ l, start timing from having smeared sensitization, start to occur grabbing that to rub auricle be that cause is itched incubation period to mice, and record 10min
Interior mice grabs the number of times rubbed.The results are shown in Table 2.
4. experimental result
Table 2 is pacified granule of itching and 2 ' 4-toluene-2,4-diisocyanates is caused the impact of Mice Auricle prurituss
Note: compare with model control group*P<0.05,**P<0.01
As shown in Table 2, compare with model control group, pruritus zero difference incubation period (P < 0.05) between each group, but 1,3
Substantially reduce with the pruritus number of times relatively model control group of 4 sample sets, be statistically significant (P < 0.01).Result shows,
The present composition causes Mice Auricle pruritus to 2 ' 4-toluene-2,4-diisocyanates and has preferable therapeutical effect.
Three, pharmaceutical composition of the present invention causes the impact of mouse skin pruritus to 4-aminopyridine
1. experiment material
Pacify granule of itching: specification: 1g/ml, numbering is respectively 1,2,3, No. 4, teaching and research by Chengdu University of Traditional Chinese Medicine Drug Manufacturing Room
Room provides, and lot number is: 20150814.Chlorate, Huazhong Pharmaceutical Co., Ltd. produces, lot number:
20141125.4-aminopyridine, by Gracia Chemical Technology Co.Ltd.Chengdu, lot number: 201205120.
2. laboratory animal
KM mice, SPF level, full ♂, body weight (20 ± 2) g, Chengdu reach rich fruit and Company of Animals Ltd.'s offer, experiment are provided
The animal quality certification number is: SCXK (river) 2008-24.
3. test method
By 60 KM mices, after weighing, be randomly divided into 6 groups, i.e. model control group, Chlorate group (chlorphenamine
Group, 1.8mg/kg), pacify granule 1-4 sample of itching, often group 10.Except model control group ig gives isopyknic physiology salt
Outside water, remaining is respectively organized ig and gives corresponding medicine, is administered volume 10ml/kg, 2 times/d, continuous 5 days, is grouped and to medicament
Amount is shown in Table 3.Experiment carries out mouse back shaving process the previous day, and experimental day, after gastric infusion after 30min, at shaving
Subcutaneous injection 4-aminopyridine lmg/kg.Mice licking response number of times and occur (i.e. the time of Licking response in record 10min
Pruritus incubation period).Record each group of data.The results are shown in Table 3.
4. experimental result
Table 3 is pacified granule of itching and 4-aminopyridine is caused the impact of mouse skin pruritus
Note: compare * P < 0.05, * * P < 0.01 with blank group
As shown in Table 3, comparing with model control group, No. 2 sample prurituss significantly extend incubation period, have significantly system
Meaning (P < 0.01) learned by meter, and remaining each group all has certain prolongation trend；The pruritus number of times the most relatively model pair of 4 sample sets pair
Substantially reduce according to group, have significant statistical significance (P < 0.05).Result shows, 4-aminopyridine is caused by the present composition
Mouse skin pruritus has preferable therapeutical effect.
Four, pharmaceutical composition of the present invention causes the impact of Cavia porcellus ear swelling to dimethyl sulfoxide
1. experiment material
Pacify granule of itching: specification: 1g/ml, numbering is respectively 1,2,3, No. 4, teaching and research by Chengdu University of Traditional Chinese Medicine Drug Manufacturing Room
Room provides, and lot number is: 20150814.Chlorate, Huazhong Pharmaceutical Co., Ltd. produces, lot number:
20141125.Dimethyl sulfoxide (DMSO), Chengdu Ke Long chemical reagent factory, lot number: 120323；ZM208-1 type vernier
Slide calliper rule, Chengdu Chengliang Tools Group Co., Ltd, the number of producing: 4909330644.
2. experimental animal
Cavia porcellus, cleaning grade, full ♂, body weight (200 ± 20) g, plant of laboratory animal special commission of Sichuan Province provide, real
Testing the animal quality certification number is: SCXK (river) 2008-14.
3. experimental technique
By 60 Cavia porcelluss, after weighing, be randomly divided into 6 groups, i.e. model control group, Chlorate group (chlorphenamine group,
1.4mg/kg), granule 1-4 sample of itching, often group 10 are pacified.In addition to model control group ig gives isopyknic normal saline,
Remaining is respectively organized ig and gives corresponding medicine, is administered volume 20ml/kg, and 1 time/d, continuous 5 days, packet and dosage were shown in Table
4.First survey the thickness of 3 fixing points of Cavia porcellus auris dextra with slide gauge, obtain meansigma methods as standard, 30min after last is administered
After, respectively with 80% dimethyl sulfoxide uniform application Cavia porcellus auris dextra exterior feature two sides of 100 μ l dehydrated alcohol configurations, after smearing
(measuring point labelling is solid for the thickness of 30min, 45min, 60min, 120min, 180min slide gauge former 3 fixing points of survey
Fixed), obtain meansigma methods, as ear swelling degree.Result is shown in 4.
4. experimental result
Table 4 is pacified granule of itching and dimethyl sulfoxide is caused the impact of Cavia porcellus ear swelling
Note: compare with blank group,*P<0.05；**P<0.01；***P<0.001
As shown in Table 4, comparing with model group, before being administered, the normal ear thickness no significant difference of each group, smears dimethyl sulfoxide
After, sample 160min, 120min, 180min four-stage ear swelling degree all significantly reduces, statistically significant (P < 0.05),
Sample 2 reduces (P < 0.05) at two stage ear swelling degree of 60min, 180min, and sample 3 reduces at 120min ear swelling degree,
And sample 4 ear swelling degree is five time period equal no significant differences (P > 0.05).Result shows, the present composition is to diformazan
Base sulfoxide causes Cavia porcellus ear swelling and has preferable therapeutical effect.
Five, pharmaceutical composition acute toxicological experiment of the present invention
1. experiment material
Pacifying particulate samples 1 of itching, Drug Manufacturing Room teaching and research room of Chengdu University of Traditional Chinese Medicine provide, lot number is 20150928, sepia
Liquid, concentration is 2.5g/ml.
2. laboratory animal
Reference " Chinese medicine, natural drug acute toxicity test technological guidance's principle " (State Food and Drug Administration, 2005
03 month year), acute toxicity test need to be carried out with Rodents and two kinds of animals of non-Rodents, and this test rodent selects little
Mus, its heredity, Biological background (including the normal range of the various data such as dissection, physiology, clinical pathology) compare the clearest.
Healthy SPF level KM mice, body weight 18～22g, ♀ ♂ half and half, Da Shuo bio tech ltd, Chengdu provide, qualified
Card: SCXK (river) 2013-24.Observe in IVC animal observation ward of Chengdu University of Traditional Chinese Medicine and raise during test.
3. method and result
3.1 experimental technique
(1) route of administration
Select route of administration--the gastric infusion consistent with clinical administration approach.
(2) animal selects
The healthy KM mice 20 of choosing, body weight 18～22g, male and female half and half.Fasting 18h before test, but can't help water.
(3) dosage and number of times
Through preliminary prerun, it is administered by maximum volume and maximum administration concentration, it is impossible to measure its LD50, therefore according to " new drug approval
Way " regulation, measure its maximum dosage-feeding, continuous gastric infusion 2～3 times in i.e. one day, every minor tick 8～12 hours.
The dosage regimen of particulate samples 1 of itching pacified by table 5
(4) observational technique, time and index
Breeding observing 14 days, the body weight of observed and recorded animal, behavioral activity, food ration, defecation, skin routinely after administration
Hair, inhale and the change such as circulation, change within 4h after being especially administered.Survival mice took off after 14 days cervical vertebra put to death, naked eyes
Observe the vitals (heart, liver, spleen, lung, kidney etc.) of mice, to there being obvious exception person, carry out histopathologic examination.
4. result of the test
(1) maximum dosage-feeding of gastric infusion and administration multiple measure
As shown in table 5, mouse stomach is administered peace and itches particulate samples No. 12 times/24h, every minor tick 12h, observes 14 days,
2 death of mice, each 1 of male and female, through dissection and analysis, 2 to be gavage lethal, and its reason may be that dosage is excessive,
Operational error.Being administered in 30min, animal shows as movable minimizing, and rapid breathing, remaining is without exception；It is administered 4h, animal
The activity that shows as gradually recovers normal, breathes gradually steady, and hair is normal, remaining no abnormality seen symptom；Its reason may be for giving
Dose is big, affects normal activity and the breathing of mice after gavage.During observation, within first 2 days, mice stool is the dilutest, and the later stage is just recovering
Often, remaining is without exception, and analyzing reason may be liquid for sample, and dosage is big, causes its early stage stool the dilutest.De-cervical vertebra
Locate after death, perusal mice vitals (heart, liver, spleen, lung, kidney etc.) discovery the most without exception.Calculate by formula and refer to below
Mark:
Maximum dosage-feeding=the drug level of gastric infusion × administration volume × administration number of times/24h
Pacify No. 1 maximum dosage-feeding=2.5g/ml of the particulate samples × 40ml/kg/ time × 2 times/24h that itches
=200g/kg/24h
(2) food ration is affected
No. 1 gastric infusion of the particulate samples impact on mice food ration of itching pacified by table 6
As shown in Table 6, after sample 1 is administered, food ration declines than before being administered, and prompting medicine is likely to reduced mice food ration effect.
(3) body weight is increased impact
No. 1 gastric infusion of the particulate samples impact on Mouse Weight of itching pacified by table 7
As shown in Table 7, it is more unchanged than before being administered that sample 1 is administered latter first day body heavy phase, comes from fasting 18h before administration, and body weight is subject to
Fasting affects, and after 1d, body weight is that normal condition increases, and points out medicine on body weight without impact.
5. brief summary
The maximum dosage-feeding pacifying No. 1 mouse stomach administration of particulate samples of itching is 200g crude drug in whole/kg/24h, and the maximum multiple that is administered is
171 times of 60kg body weight adult's clinical oral administration day dosage, all without obvious adverse reaction.Conclusion: pacify particulate samples 1 of itching
Gastric infusion safety range 0-200g crude drug in whole/kg/24h.
It addition, pharmaceutical composition of the present invention has also been carried out, hot plate method causes the experiment of mice pain in foot, acetic acid causes mouse writhing reaction, experiment
Result shows that pharmaceutical composition of the present invention has stronger analgesic activity.
Claims (8)
1. the pharmaceutical composition treating skin pruritus, it is characterised in that: it is made up of following raw material and weight ratio: Rhizoma Zingiberis 10-50 weight portion, Radix Glycyrrhizae Preparata 5-40 weight portion, Cortex Phellodendri 5-40 weight portion, Fructus Amomi 3-20 weight portion, Cortex Cinnamomi 3-20 weight portion, Radix Sophorae Flavescentis 3-20 weight portion, Rhizoma Chuanxiong 1-10 weight portion.
A kind of pharmaceutical composition treating skin pruritus the most according to claim 1, it is characterised in that: the ratio of weight and number of described each raw material is: Rhizoma Zingiberis 15-45 weight portion, Radix Glycyrrhizae Preparata 10-35 weight portion, Cortex Phellodendri 10-35 weight portion, Fructus Amomi 5-18 weight portion, Cortex Cinnamomi 5-18 weight portion, Radix Sophorae Flavescentis 5-18 weight portion, Rhizoma Chuanxiong 2-8 weight portion.
A kind of pharmaceutical composition treating skin pruritus the most according to claim 1, it is characterised in that: the ratio of weight and number of described each raw material is: Rhizoma Zingiberis 20-40 weight portion, Radix Glycyrrhizae Preparata 15-30 weight portion, Cortex Phellodendri 15-30 weight portion, Fructus Amomi 8-15 weight portion, Cortex Cinnamomi 8-15 weight portion, Radix Sophorae Flavescentis 8-15 weight portion, Rhizoma Chuanxiong 3-7 weight portion.
A kind of pharmaceutical composition treating skin pruritus the most according to claim 1, it is characterised in that: the ratio of weight and number of described each raw material is: Rhizoma Zingiberis 25-35 weight portion, Radix Glycyrrhizae Preparata 18-25 weight portion, Cortex Phellodendri 18-25 weight portion, Fructus Amomi 9-12 weight portion, Cortex Cinnamomi 9-12 weight portion, Radix Sophorae Flavescentis 9-12 weight portion, Rhizoma Chuanxiong 4-6 weight portion.
A kind of pharmaceutical composition treating skin pruritus the most according to claim 1, it is characterised in that: the ratio of weight and number of described each raw material is: Rhizoma Zingiberis 18 weight portion, Radix Glycyrrhizae Preparata 12 weight portion, Cortex Phellodendri 10 weight portion, Fructus Amomi 12 weight portion, Cortex Cinnamomi 6 weight portion, Radix Sophorae Flavescentis 6 weight portion, Rhizoma Chuanxiong 6 weight portion.
6. the method for the pharmaceutical composition of the treatment skin pruritus prepared in claim 1-5 described in any one claim, it is characterised in that: it comprises the following steps:
S1: weigh raw material by component and weight ratio；
S2: after raw material mix homogeneously, adds the ethanol solution reflux, extract, 3 times of 70%-95%, each 1.5h, filters, merging filtrate, and concentrating under reduced pressure obtains thick extractum, vacuum dried after extract powder A；
S3: remaining for S2 step medicinal residues add the soak by water 1 of 5～8 times amount～1.5 hours, decocts 2 times altogether, merges secondary decocting liquid after having decocted, concentrating under reduced pressure obtains thick extractum, vacuum dried after obtain extract powder B；
S4: by extract powder A, extract powder B mixing granulation, add the pharmaceutical preparation that pharmaceutically acceptable adjuvant is prepared as pharmaceutically commonly using.
The preparation method of a kind of pharmaceutical composition treating skin pruritus the most according to claim 5, it is characterised in that: described pharmaceutical preparation is tablet, pill, powder, capsule, granule, oral liquid, injection or injectable powder.
8. the purposes in preparation treatment senile skin pruritus medicine of the pharmaceutical composition as described in any one claim in Claims 1 to 5.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610442511.8A CN105963661A (en) | 2016-06-20 | 2016-06-20 | Medicine composition for curing skin itch and preparation method and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610442511.8A CN105963661A (en) | 2016-06-20 | 2016-06-20 | Medicine composition for curing skin itch and preparation method and application thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105963661A true CN105963661A (en) | 2016-09-28 |
Family
ID=57021406
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610442511.8A Pending CN105963661A (en) | 2016-06-20 | 2016-06-20 | Medicine composition for curing skin itch and preparation method and application thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105963661A (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103394002A (en) * | 2013-07-05 | 2013-11-20 | 李青平 | Medicinal composition for treating cutaneous pruritus as well as preparation method and application thereof |
| CN104474391A (en) * | 2014-11-20 | 2015-04-01 | 张进良 | Medicine for treating skin itch |
-
2016
- 2016-06-20 CN CN201610442511.8A patent/CN105963661A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103394002A (en) * | 2013-07-05 | 2013-11-20 | 李青平 | Medicinal composition for treating cutaneous pruritus as well as preparation method and application thereof |
| CN104474391A (en) * | 2014-11-20 | 2015-04-01 | 张进良 | Medicine for treating skin itch |
Non-Patent Citations (3)
| Title |
|---|
| 徐宜厚著: "《全国著名老中医临床经验从书-徐宜厚皮肤病临床经验辑要》", 31 October 1998, 中国医药科技出版社 * |
| 老姜: "《生姜治疗皮肤病》", 《湖南农机》 * |
| 苗明三: "《对药的化学、药理与临床》", 30 April 2002 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN109674958B (en) | Traditional Chinese medicine composition with effect of reducing uric acid and preparation method and application thereof | |
| CN101632827B (en) | Traditional Chinese medicine composition for treating psoriasis and preparation method thereof | |
| CN102940779B (en) | Medicine composition for treating chronic ulcerative colitis and preparation process of medicine composition | |
| CN103784933B (en) | Recurrent oral ulceration falls apart | |
| WO2022036779A1 (en) | Huashibaidu granule, preparation method therefor and anti-viral drug | |
| CN103405742B (en) | Drug composition for treating infantile diarrhea and preparation method thereof | |
| CN103520293A (en) | Oral traditional Chinese medicine for improving and treating constipation | |
| CN103446525A (en) | Traditional Chinese medicine composition for treating skin diseases as well as preparation method and application of traditional Chinese medicine composition | |
| CN102106965B (en) | Composition for treating acute injury of soft tissue and application thereof | |
| CN102139051B (en) | Application of soft capsule capable of clearing heat and eliminating toxin in preparation of medicament for treating viral pneumonia | |
| CN103394002B (en) | Medicinal composition for treating cutaneous pruritus as well as preparation method and application thereof | |
| CN114712478B (en) | Traditional Chinese medicine composition for treating intestinal diseases, preparation and preparation method thereof | |
| CN104189289B (en) | A kind of Chinese medicine for the treatment of acute icterohepatitis and preparation method thereof | |
| CN105963661A (en) | Medicine composition for curing skin itch and preparation method and application thereof | |
| CN102716221A (en) | Preparation for mahuang decoction and oral preparation of adjusted formula thereof, and clinic application | |
| CN105833055A (en) | Traditional Chinese medicine composition for treating hypertension, hyperlipidemia and hyperglycemia and preparing method and application thereof | |
| CN104800675A (en) | Medicament for treating active ulcerative colitis | |
| CN111329966A (en) | Traditional Chinese medicine composition for treating skin itch and extract and preparation thereof | |
| CN105982906A (en) | Application of 20(R)-ginsenoside Rg3 in preparing medicines or health products capable of alleviating or/and treating rheumatoid diseases and medicines | |
| CN105749199A (en) | Traditional Chinese medicinal composition for warming middle warmer and invigorating spleen, and preparation method thereof | |
| CN104383163A (en) | Pharmaceutical composition for treating atherosclerosis of aorta | |
| CN104224929B (en) | A kind of Chinese medicine composition and its preparation method and application being used for the treatment of flu and upper respiratory tract infection | |
| CN103933154A (en) | Traditional Chinese medicine composition for treating gout disease and preparation method thereof | |
| CN104825624A (en) | Application of traditional Chinese medicine composition in preparation of drug for treating herpetic stommightitis | |
| CN110448622B (en) | Medicine for treating heat type cold and preparation method and application thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20160928 |