CN104548008A - Pharmaceutical composition for preventing and/or treating allergic skin diseases and preparation method for pharmaceutical composition - Google Patents
Pharmaceutical composition for preventing and/or treating allergic skin diseases and preparation method for pharmaceutical composition Download PDFInfo
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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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
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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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/238—Saposhnikovia
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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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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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)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
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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)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
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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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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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)
- A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
- A61K36/725—Ziziphus, e.g. jujube
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- 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)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
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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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9068—Zingiber, e.g. garden ginger
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- 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
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- 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
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- 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
Abstract
The invention discloses a pharmaceutical composition for preventing and/or treating allergic skin diseases and a preparation method for the pharmaceutical composition. The pharmaceutical composition is prepared from the following raw materials in parts by mass: 6-24 parts of astragalus, 4-20 parts of white paeony root, 4-16 parts of cassia twig, 4-16 parts of fresh ginger, 4-16 parts of almond, 2-10 parts of divaricate saposhnikovia root, 1.2-4.8 parts of periostracum cicadae, 2.4-9.6 parts of tangerine, 5-23 parts of jujube (without kernels) and 4-16 parts of radix glycyrrhizae. The preparation method for the pharmaceutical composition comprises the following steps: weighing the astragalus, the white paeony root, the cassia twig, the fresh ginger, the almond, the divaricate saposhnikovia root, the periostracum cicadae, the tangerine, the jujube (without kernels) and the radix glycyrrhiza in proportion, extracting with water, filtering, collecting filtrate, concentrating the filtrate into extract with relative density of 1.05-1.25, thereby obtaining the pharmaceutical composition. The pharmaceutical composition is used for treating the allergic skin diseases such as allergic urticaria, allergic eczema and pollen hypersensitivity, and has the advantages of being remarkable in curative effect, convenient to use, quick in effect-taking, safe and painless, and the like.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition preventing and/or treating allergic skin diseases and preparation method thereof.
Background technology
Anaphylactic disease, is allergic disease again, is a modal class chronic disease at present.It shows as human body and produced strong immunoreation to one or more materials in environment, and causes the damage of tissue and organ, thus affects normal physiological function.Anaphylactic disease has a nature process progressively worsened, and involves more tissue and organ, also can concurrent Other diseases, even threat to life.Type Ⅰ hypersensitivity reaction is a kind of common anaphylaxis, is mainly respiratory tract anaphylaxis reaction, digestive tract anaphylaxis, skin allergy and anaphylactic shock.The disease of performance is mainly allergic rhinitis, allergic asthma, allergic enterogastritis and anaphylaxis dermatosis.
Anaphylaxis dermatosis is the dermatosis caused by anaphylactogen, concrete anaphylactogen can be divided into contact allergy former, suck anaphylactogen, eat anaphylactogen and be injected into anaphylactogen four class.Every class anaphylactogen can cause corresponding anaphylaxis dermatosis.Main manifestations is red swelling of the skin, scratch where it itches, pain, urticaria, eczema, macule, pimple, welt erythra etc.
(1) eczema has and obviously oozes out.The sickness rate of eczema has the trend of rising in recent years, and this is relevant with the factor such as abuse, the environmental pollution of chemicals, the disposal of three wastes is not good at, rhythm of life is accelerated, stress increasing.Characteristics of incidence: any age all can fall ill; Any position of body surface can be betided; Recurrent exerbation; Local or the visible erythema of whole body, pimple, blister, erosion, ooze out, form a scab, desquamation, pigmentation; Violent pruritus.
(2) urticaria (welt, rubella wheal) definition: (expand in the angioneurotic reaction of the one of cutaneous manifestations by hypodermic thin vessels to all kinds of stimulation for body, the permeability of tube wall increases, there is transudation, form local edema).The cause of disease: the (i) stimulation such as hot and cold, daylight of external contact; Mosquito, insect stings; The plant such as Herba Urticae Cannabinae, Toxicodendron verniciflnum (Stokes) F. A. Barkley (Rhus verniciflua Stokes); (ii) the toxin of interior contact fish, shrimp, marine product, mushroom, sulfonamides, salicylic acid, penicillin, serum, parasite generation; (iii) uncomfortable, menoxenia, psychentonia, tired, depressed etc.; (iv) household heredity factors (heredity of allergic constitution).Symptom: (i) skin violent pruritus or burn feeling suddenly.(ii) eruption: edema welt that differ in size, limitation bulk appears rapidly in affected part, little of the grain of rice, greatly to hand size, common be fingernail to coin-size, a little more than surrounding skin.
(3) performance of food anaphylaxis food anaphylaxis can be diversified, and erythra is the most common, face of mostly occurring, the erythema in mouth week, and trunk is also more common, pruritus desquamation, and can have pigmentation.Separately have one, after edible wild herbs, can occur photosensitive dermatitis through sun exposure skin, face neck hand presents chronic edema, malaise, nauseating, diarrhoea, stomachache.Irritated common food is caused to have seafood (especially shellfish), Radix Crotalariae szemoensis, Lentinus Edodes, milk, Fructus Lycopersici esculenti, Fructus Hordei Vulgaris, wild herbs, fruit, kernel, Semen sojae atricolor, Semen arachidis hypogaeae, chocolate etc., but sometimes cause irritated also non-food itself, but disinfectant, antiseptic etc.
(4) cosmetic allergic contact dermatitis cosmetics can cause skin red, swollen, hot, bitterly, the anaphylaxis such as to get blister.From medical angle, if found certain cosmetic allergic contact dermatitis, preferably need not.But but sometimes be unable to do without in life, as middle-aged and elderly people hair dyeing and working woman light make-up.At this moment most scientific method fundamentally improves allergic constitution.
The traditional Chinese medical science is broadly divided into three directions for the treatment of anaphylaxis dermatosis: be first Drug therapy, Therapeutic Principle is the medicine first using heat clearing and blood circulation promoting sensible, after symptom is improved, impose the agent of strengthening spleen, tonifying kidney again, take strengthening the body resistance as target, promote the immunocompetence of patient, make it the object obtaining because immunocompetence improves curing.
Therefore develop a kind of energy rapid relief of symptoms, cure rate is high, relapse rate is low and the medicine of the treatment allergic skin diseases had no adverse reaction, and has actual application value and major and immediate significance.
Summary of the invention
The object of this invention is to provide a kind of pharmaceutical composition preventing and/or treating allergic skin diseases and preparation method thereof.This pharmaceutical composition all has good efficacy to allergic skin diseases such as anaphylaxis urticaria, allergic eczema, pollen hypersensitivitys.
Pharmaceutical composition provided by the present invention is made up of the raw material of following mass parts: the Radix Astragali 6-24 parts, the Radix Paeoniae Alba 4-20 parts, Ramulus Cinnamomi 4-16 parts, 4-16 parts, Rhizoma Zingiberis Recens, 4-16 parts, Semen Armeniacae Amarum, Radix Saposhnikoviae 2-10 parts, Periostracum Cicadae 1.2-4.8 parts, Exocarpium Citri Rubrum 2.4-9.6 parts, 5-23 parts, Fructus Jujubae (enucleation) and 4-16 parts, Radix Glycyrrhizae.
The mass parts of the described Radix Astragali specifically can be 6-24 parts, 9-21 parts, 12-18 parts, 13-17 parts; The mass parts of the described Radix Paeoniae Alba specifically can be 4-20 parts, 5-19 parts, 9-15 parts, 10-14 parts; The mass parts of described Ramulus Cinnamomi specifically can be 4-16 parts, 6-14 parts, 8-12 parts, 9-11 parts; The mass parts of described Rhizoma Zingiberis Recens specifically can be 4-16 parts, 6-14 parts, 8-12 parts, 9-11 parts; The mass parts of described Semen Armeniacae Amarum specifically can be 4-16 parts, 6-14 parts, 8-12 parts, 9-11 parts; The mass parts of described Radix Saposhnikoviae specifically can be 2-10 parts, 3-9 parts, 4-8 parts, 5-7 parts; The mass parts of described Periostracum Cicadae specifically can be 1.2-4.8 parts, 1.8-4.2 parts, 2.4-3.6 parts, 2.6-3.4 parts; The mass parts of described Exocarpium Citri Rubrum specifically can be 2.4-9.6 parts, 3.6-8.4 parts, 4.8-7.2 parts, 5.2-6.8 parts; The mass parts of described Fructus Jujubae (enucleation) specifically can be 5-23 parts, 8-20 parts, 11-17 parts, 12-16 parts; The mass parts of described Radix Glycyrrhizae specifically can be 4-16 parts, 6-14 parts, 8-12 parts, 9-11 parts.
Described pharmaceutical composition can be made up of following raw material further: the Radix Astragali 9-21 parts, the Radix Paeoniae Alba 5-19 parts, Ramulus Cinnamomi 6-14 parts, 6-14 parts, Rhizoma Zingiberis Recens, 6-14 parts, Semen Armeniacae Amarum, Radix Saposhnikoviae 3-9 parts, Periostracum Cicadae 1.8-4.2 parts, Exocarpium Citri Rubrum 3.6-8.4 parts, 8-20 parts, Fructus Jujubae (enucleation) and 6-14 parts, Radix Glycyrrhizae.
Described pharmaceutical composition is further made up of following raw material: the Radix Astragali 12-18 parts, the Radix Paeoniae Alba 9-15 parts, Ramulus Cinnamomi 8-12 parts, 8-12 parts, Rhizoma Zingiberis Recens, 8-12 parts, Semen Armeniacae Amarum, Radix Saposhnikoviae 4-8 parts, Periostracum Cicadae 2.4-3.6 parts, Exocarpium Citri Rubrum 4.8-7.2 parts, 11-17 parts, Fructus Jujubae (enucleation) and 8-12 parts, Radix Glycyrrhizae.
Described pharmaceutical composition is also made up of following raw material further: the Radix Astragali 13-17 parts, the Radix Paeoniae Alba 10-14 parts, Ramulus Cinnamomi 9-11 parts, 9-11 parts, Rhizoma Zingiberis Recens, 9-11 parts, Semen Armeniacae Amarum, Radix Saposhnikoviae 5-7 parts, Periostracum Cicadae 2.6-3.4 parts, Exocarpium Citri Rubrum 5.2-6.8 parts, 12-16 parts, Fructus Jujubae (enucleation) and 9-11 parts, Radix Glycyrrhizae.
Described pharmaceutical composition is most preferably made up of following raw material: the Radix Astragali 15 parts, the Radix Paeoniae Alba 12 parts, Ramulus Cinnamomi 10 parts, 10 parts, Rhizoma Zingiberis Recens, 10 parts, Semen Armeniacae Amarum, Radix Saposhnikoviae 6 parts, Periostracum Cicadae 3 parts, Exocarpium Citri Rubrum 6 parts, 14 parts, Fructus Jujubae (enucleation) and 10 parts, Radix Glycyrrhizae.
The each crude drug making pharmaceutical composition of the present invention is as proportioning according to mass parts, can increase according to corresponding ratio when producing or reduce, as large-scale production can by kilogram or in units of ton, small-scale production also can be in grams, weight can increase or reduce, but crude drug quality ratio between each composition is constant.
The method preparing aforementioned pharmaceutical compositions comprises following three kinds of methods:
Method one, comprises the steps:
1) take the Radix Astragali, the Radix Paeoniae Alba, Ramulus Cinnamomi, Rhizoma Zingiberis Recens, Semen Armeniacae Amarum, Radix Saposhnikoviae, Periostracum Cicadae, Exocarpium Citri Rubrum, Fructus Jujubae and Radix Glycyrrhizae ten taste medical material by described ratio of quality and the number of copies, decoct with water extraction, collect extracting solution;
2) described extracting solution is condensed into clear paste, lets cool, then in described clear paste, add ethanol or ethanol water makes alcohol volume content reach 30-70%, stir evenly, leave standstill; Leave standstill collection supernatant after terminating and reclaim ethanol, namely obtaining described pharmaceutical composition.
This pharmaceutical composition medicinal liquid directly can be taken or add appropriate correctives and/or pure water makes oral liquid.
Wherein, step 1) in the water yield that adds be 5-10 times of described medical material gross mass; Described decoction extraction can be carried out 1-3 times, and each time decocting extraction can be 1-3 hours.Step 1) in the medical material that adopts be the medical material after clean system.The preferred Radix Glycyrrhizae (processed with honey) of described Radix Glycyrrhizae; The preferred Semen Armeniacae Amarum of Semen Armeniacae Amarum; Periostracum Cicadae also claims Periostracum Cicadae.
Step 2) in clear paste be 70 DEG C measure relative densities be the clear paste of 1.05-1.25; In described ethanol water, the volumn concentration of ethanol specifically can be 60-95%; The described standing time can be 12-96 hours.
Method two, comprises the steps:
The Radix Astragali, the Radix Paeoniae Alba, Ramulus Cinnamomi, Rhizoma Zingiberis Recens, Semen Armeniacae Amarum, Radix Saposhnikoviae, Periostracum Cicadae, Exocarpium Citri Rubrum, Fructus Jujubae and Radix Glycyrrhizae ten taste medical material is taken by ratio of quality and the number of copies, the ethanol water being 50-95% by above-mentioned medical material volumn concentration extracts, after extraction, filter, collect filtrate, reclaim ethanol, filtrate is condensed into the thick paste (70 DEG C) that relative density is 1.10 ~ 1.40, obtains described pharmaceutical composition.
Wherein, described in step, extraction can be reflux, extract.When adopting reflux, extract, described extraction is at least carried out once, preferably extracts 1-3 time, and each time of extracting can be 1-3 hour; During each extraction, Extraction solvent add quality be the 5-10 of described quality of medicinal material doubly.
Described extraction also can be merceration and extracts or seepage pressure effects.When adopting merceration extraction method or permeating extraction, Extraction solvent preferred volume percentage composition used is the ethanol water of 60-85%.When merceration extracts, Extraction solvent add quality be the 5-10 of described medical material gross mass doubly; The time that merceration extracts specifically can be 7-15 days.During seepage pressure effects, Extraction solvent add quality be the 5-12 of described medical material gross mass doubly.
Method three, comprises the steps:
The Radix Astragali, the Radix Paeoniae Alba, Ramulus Cinnamomi, Rhizoma Zingiberis Recens, Semen Armeniacae Amarum, Radix Saposhnikoviae, Periostracum Cicadae, Exocarpium Citri Rubrum, Fructus Jujubae and Radix Glycyrrhizae ten taste medical material is taken by described ratio of quality and the number of copies, extract with water, filter, collect filtrate, described filtrate is condensed into the extractum that relative density is 1.05-1.25, obtains described pharmaceutical composition.
Wherein, described extraction can be reflux, extract, and described extraction is generally at least carried out once, and each time of extracting is 1-3.5 hour.During described extraction, the mass ratio of medical material and water is 1:5-10.
Above-mentioned three kinds of methods, in order to obtain solid-state medicine further, described method also comprises: described pharmaceutical composition being condensed into 70 DEG C of mensuration relative densities is the thick paste of 1.10-1.35, dry, pulverize, cross 80-120 mesh sieves, obtain the step of pharmaceutical composition powder.Or described pharmaceutical composition is concentrated, add adjuvant and make granule or described pharmaceutical composition powder is added adjuvant and make granule.
Pharmaceutical composition prepared by said method can be prepared into pharmaceutically acceptable dosage form as required further.
Another object of the present invention is to provide the application of described pharmaceutical composition.
The application of pharmaceutical composition provided by the present invention is that it treats the application in allergic skin diseases medicine in preparation.
Described allergic skin diseases comprises anaphylaxis urticaria, allergic eczema, pollen hypersensitivity etc.
Be that the medicine that active component is made also belongs to protection scope of the present invention with aforementioned pharmaceutical compositions.By by aforementioned pharmaceutical compositions, directly prepare or prepare after adding pharmaceutically acceptable adjuvant, can be made into any pharmaceutically acceptable dosage form.Comprise for oral formulations: capsule, tablet, granule, powder, pill, drop pill, sustained-release preparation, oral liquid, mixture and syrup; Comprise for external preparation: ointment, suppository, patch, medicated wine, tincture, gel, liniment, aerosol, spray and liniment.The medicine of above-mentioned various dosage form all can be prepared according to the conventional method of pharmaceutical field.
In clinical practice, the consumption of medicine is generally 5-50g/ days in effective ingredient, and the course for the treatment of is generally 7-14 days.
The present invention is pure Chinese medicinal preparation, and wherein, the Radix Astragali has tonifying Qi and lifting yang, strengthening superficial resistance to stop perspiration, and inducing diuresis to remove edema promotes the production of body fluid and nourishes blood, the stagnant blood stasis dispelling of row, the effect of expelling pus and toxin by strengthening QI; The Radix Paeoniae Alba has nourishing blood for regulating menstruation, astringing YIN to stop sweating, easing the affected liver to relieve pain, the effect of suppressing liver-YANG; Ramulus Cinnamomi has diaphoresis expelling pathogenic factors from muscles, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, the effect of the flat gas that spins; Rhizoma Zingiberis Recens has the cold expelling that induces sweat, the effect of preventing phlegm from forming and stopping coughing; Semen Armeniacae Amarum has the effect of sending down the abnormal ascending QI relieving cough and asthma; Radix Saposhnikoviae has expelling pathogenic wind from the body surface, the effect of removing dampness to relieve pain; Periostracum Cicadae has dispelling wind and heat pathogens, sore-throat relieving, rash, improving acuity of vision and removing nebula, the effect of spasmolytic; Exocarpium Citri Rubrum has regulating the flow of QI to ease the stomach, the effect of drying dampness to eliminate phlegm; Fructus Jujubae has invigorating the spleen and replenishing QI, the effect of nourishing blood to tranquillize the mind; Radix Glycyrrhizae has invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, the effect of coordinating the actions of various ingredients in a prescription.It is that on basic square basis, plus-minus forms that we tie up to guizhi decoction conjunction YUPINGFENG SAN, has effect that harmonizing yingfen and weifen is defended with consolidating superficial resistance.We are used for the allergic skin diseases such as anaphylaxis urticaria, allergic eczema, pollen hypersensitivity, have rapid relief of symptoms, the advantage such as painless evident in efficacy, easy to use, safe.This medicine had both avoided some side effect of Western medicine, overcame again Chinese medicine slow curative effect, defect that relapse rate is high, had important actual application value.
Detailed description of the invention
Below by specific embodiment, the present invention will be described, but the present invention is not limited thereto.
Experimental technique described in following embodiment, if no special instructions, is conventional method; Described solvent and adjuvant, if no special instructions, all can obtain from commercial channels.
The Radix Astragali used in following embodiment, the Radix Paeoniae Alba, Ramulus Cinnamomi, Rhizoma Zingiberis Recens, Semen Armeniacae Amarum, Radix Saposhnikoviae, Periostracum Cicadae, Exocarpium Citri Rubrum, Fructus Jujubae and Radix Glycyrrhizae all meet the pertinent regulations under Chinese Pharmacopoeia (version in 2010) each medical material item of text.Before feeding intake, be tested and appraised, ingredients material object conforms to title, quality conformance with standard.
Embodiment 1, prepare the granule of Chinese medicine composition
Get the 75g Radix Astragali, the 60g Radix Paeoniae Alba, 50g Ramulus Cinnamomi, 50g Rhizoma Zingiberis Recens, 50g Semen Armeniacae Amarum, 30g Radix Saposhnikoviae, 15g Periostracum Cicadae, 30g Fructus Citri tangerinae is red, 70g Fructus Jujubae (enucleation) and 50g Radix Glycyrrhizae (processed with honey) ten taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 times and 6 times of medical material gross mass, extraction time is respectively 3 hours and 2 hours, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.10 (70 DEG C of surveys), let cool, the ethanol adding 80% (volumn concentration) makes alcohol content reach 50% (volumn concentration), stir evenly, leave standstill 48 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.20 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieves, add appropriate dextrin and correctives, mixing, with alcohol granulation, dry, granulate, obtain granule.
Embodiment 2, prepare the capsule of Chinese medicine composition
Get the 150g Radix Astragali, the 120g Radix Paeoniae Alba, 100g Ramulus Cinnamomi, 100g Rhizoma Zingiberis Recens, 100g Semen Armeniacae Amarum, 60g Radix Saposhnikoviae, 30g Periostracum Cicadae, 60g Fructus Citri tangerinae is red, 140g Fructus Jujubae (enucleation) and 100g Radix Glycyrrhizae (processed with honey) ten taste only make after medical material, the water of medical material gross mass 10 times is added in above-mentioned medical material, decoct extraction 3 hours, after extraction, filter, filtrate is concentrated into the clear paste that relative density is 1.15 (70 DEG C of surveys), let cool, the ethanol adding 90% (volumn concentration) makes alcohol content reach 60% (volumn concentration), stir evenly, leave standstill 24 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.25 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieves, add the starch of gained medicated powder quality 0.08 times and the Pulvis Talci of 0.01 times, mixing, with alcohol granulation, dry, incapsulate, obtain.
Embodiment 3, prepare the capsule of Chinese medicine composition
Get the 120g Radix Astragali, the 20g Radix Paeoniae Alba, 80g Ramulus Cinnamomi, 20g Rhizoma Zingiberis Recens, 80g Semen Armeniacae Amarum, 10g Radix Saposhnikoviae, 24g Periostracum Cicadae, 12g Fructus Citri tangerinae is red, 115g Fructus Jujubae (enucleation) and 20g Radix Glycyrrhizae (processed with honey) ten taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 times and 6 times of quality of medicinal material, extraction time is respectively 3 hours and 2 hours, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.15 (70 DEG C of surveys), let cool, the ethanol adding 70% (volumn concentration) makes alcohol content reach 40% (volumn concentration), stir evenly, leave standstill 12 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.35 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieves, obtain Chinese medicine composition medicated powder.Add the starch of gained medicated powder quality 0.1 times and the Pulvis Talci of 0.05 times, mixing, granulation, incapsulate, obtain capsule.
Embodiment 4, prepare the oral liquid of Chinese medicine composition
Get the 30g Radix Astragali, the 100g Radix Paeoniae Alba, 20g Ramulus Cinnamomi, 80g Rhizoma Zingiberis Recens, 20g Semen Armeniacae Amarum, 50g Radix Saposhnikoviae, 6g Periostracum Cicadae, 48g Fructus Citri tangerinae is red, 25g Fructus Jujubae (enucleation) and 80g Radix Glycyrrhizae (processed with honey) ten taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 times and 7 times of quality of medicinal material, extraction time is respectively 2 hours, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.10 (70 DEG C of surveys), let cool, the alcoholic solution adding 80% (volumn concentration) makes alcohol content reach 50% (volumn concentration), stir evenly, leave standstill 36 hours, get supernatant and reclaim ethanol to most, add correctives, add pure water to 600ml, mixing, leave standstill, filter, be distributed into 60 bottles.
Embodiment 5, prepare the oral liquid of Chinese medicine composition
Get the 120g Radix Astragali, the 100g Radix Paeoniae Alba, 20g Ramulus Cinnamomi, 20g Rhizoma Zingiberis Recens, 20g Semen Armeniacae Amarum, 50g Radix Saposhnikoviae, 24g Periostracum Cicadae, 12g Fructus Citri tangerinae is red, 25g Fructus Jujubae (enucleation) and 80g Radix Glycyrrhizae (processed with honey) ten taste only make after medical material, above-mentioned medical material is decocted with water extraction 3 times, amount of water is respectively 8 times of quality of medicinal material, 6 times and 5 times, extraction time is respectively 2 hours, 2 hours and 1 hour, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.10 (70 DEG C of surveys), let cool, the ethanol adding 60% (volumn concentration) makes alcohol content reach 30% (volumn concentration), stir evenly, leave standstill 96 hours, get supernatant and reclaim ethanol to most, add correctives, add pure water to 900ml, mixing, leave standstill, filter, be distributed into 90 bottles.
Embodiment 6, prepare the tablet of Chinese medicine composition
Get the 45g Radix Astragali, the 25g Radix Paeoniae Alba, 70g Ramulus Cinnamomi, 70g Rhizoma Zingiberis Recens, 30g Semen Armeniacae Amarum, 15g Radix Saposhnikoviae, 21g Periostracum Cicadae, 42g Fructus Citri tangerinae is red, 40g Fructus Jujubae (enucleation) and 70g Radix Glycyrrhizae (processed with honey) ten taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 times and 6 times of quality of medicinal material, extraction time is respectively 3 hours and 2 hours, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.08 (70 DEG C of surveys), let cool, the ethanol adding 90% (volumn concentration) makes alcohol content reach 50% (volumn concentration), stir evenly, leave standstill 60 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.25 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieves, add the starch of gained medicated powder quality 0.2 times, mixing, granulate, be pressed into tablet, obtain.
Embodiment 7, prepare the tablet of Chinese medicine composition
Get the 105g Radix Astragali, the 95g Radix Paeoniae Alba, 30g Ramulus Cinnamomi, 30g Rhizoma Zingiberis Recens, 70g Semen Armeniacae Amarum, 45g Radix Saposhnikoviae, 21g Periostracum Cicadae, 42g Fructus Citri tangerinae is red, 100g Fructus Jujubae (enucleation) and 30g Radix Glycyrrhizae (processed with honey) ten taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 times and 6 times of quality of medicinal material, extraction time is respectively 3 hours and 1 hour, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.25 (70 DEG C of surveys), let cool, the ethanol adding 70% (volumn concentration) makes alcohol content reach 40% (volumn concentration), stir evenly, leave standstill 72 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.15 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieves, add the starch of gained medicated powder quality 0.2 times, mixing, granulate, be pressed into tablet, obtain.
Embodiment 8, prepare the tablet of Chinese medicine composition
Get the 45g Radix Astragali, the 95g Radix Paeoniae Alba, 30g Ramulus Cinnamomi, 70g Rhizoma Zingiberis Recens, 30g Semen Armeniacae Amarum, 45g Radix Saposhnikoviae, 9g Periostracum Cicadae, 42g Fructus Citri tangerinae is red, 40g Fructus Jujubae (enucleation) and 30g Radix Glycyrrhizae (processed with honey) ten taste only make after medical material, above-mentioned medical material is decocted with water extraction 3 times, amount of water is respectively 8 times of quality of medicinal material, 6 times and 5 times, extraction time is respectively 3 hours, 2 hours and 1 hour, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.15 (70 DEG C of surveys), let cool, the ethanol adding 80% (volumn concentration) makes alcohol content reach 30% (volumn concentration), leave standstill 60 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.15 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieves, add the starch of gained medicated powder quality 0.5 times, mixing, granulate, be pressed into tablet, obtain 150.
Embodiment 9, prepare the tablet of Chinese medicine composition
Get the 90g Radix Astragali, the 45g Radix Paeoniae Alba, 60g Ramulus Cinnamomi, 40g Rhizoma Zingiberis Recens, 60g Semen Armeniacae Amarum, 20g Radix Saposhnikoviae, 18g Periostracum Cicadae, 24g Fructus Citri tangerinae is red, 85g Fructus Jujubae (enucleation) and 40g Radix Glycyrrhizae (processed with honey) ten taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 and 6 times of quality of medicinal material, extraction time is respectively 3 and 2 hours, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.05 (70 DEG C of surveys), let cool, the ethanol adding 95% (volumn concentration) makes alcohol content reach 70% (volumn concentration), stir evenly, leave standstill 96 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.35 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieves, add the starch of gained medicated powder quality 0.3 times, mixing, granulate, be pressed into tablet, obtain.
Embodiment 10, prepare the tablet of Chinese medicine composition
Get the 60g Radix Astragali, the 75g Radix Paeoniae Alba, 40g Ramulus Cinnamomi, 48g Rhizoma Zingiberis Recens, 40g Semen Armeniacae Amarum, 40g Radix Saposhnikoviae, 12g Periostracum Cicadae, 36g Fructus Citri tangerinae is red, 55g Fructus Jujubae (enucleation) and 60g Radix Glycyrrhizae (processed with honey) ten taste only make after medical material, above-mentioned medical material is decocted with water extraction 3 times, amount of water is respectively 8 times of quality of medicinal material, 6 times and 5 times, extraction time is respectively 2 hours, 2 hours and 1 hour, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.15 (70 DEG C of surveys), let cool, the ethanol adding 80% (volumn concentration) makes alcohol content reach 50% (volumn concentration), stir evenly, leave standstill 72 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.25 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieves, add the starch of gained medicated powder quality 0.2 times, mixing, granulate, be pressed into tablet, obtain.
Embodiment 11, prepare the granule of Chinese medicine composition
Get the 90g Radix Astragali, the 45g Radix Paeoniae Alba, 32g Ramulus Cinnamomi, 60g Rhizoma Zingiberis Recens, 40g Semen Armeniacae Amarum, 20g Radix Saposhnikoviae, 18g Periostracum Cicadae, 24g Fructus Citri tangerinae is red, 55g Fructus Jujubae (enucleation) and 60g Radix Glycyrrhizae (processed with honey) ten taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 times and 6 times of medical material gross mass, extraction time is respectively 3 hours and 2 hours, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.10 (70 DEG C of surveys), let cool, the ethanol adding 80% (volumn concentration) makes alcohol content reach 50% (volumn concentration), stir evenly, leave standstill 48 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.20 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieves, add appropriate dextrin and correctives, mixing, with alcohol granulation, dry, granulate, obtain granule.
Embodiment 12, prepare the capsule of Chinese medicine composition
Get the 65g Radix Astragali, the 70g Radix Paeoniae Alba, 45g Ramulus Cinnamomi, 55g Rhizoma Zingiberis Recens, 45g Semen Armeniacae Amarum, 35g Radix Saposhnikoviae, 13g Periostracum Cicadae, 34g Fructus Citri tangerinae is red, 60g Fructus Jujubae (enucleation) and 55g Radix Glycyrrhizae (processed with honey) ten taste only make after medical material, the water of medical material gross mass 10 times is added in above-mentioned medical material, decoct extraction 3 hours, after extraction, filter, filtrate is concentrated into the clear paste that relative density is 1.15 (70 DEG C of surveys), let cool, the ethanol adding 90% (volumn concentration) makes alcohol content reach 60% (volumn concentration), stir evenly, leave standstill 24 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.25 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieves, add the starch of gained medicated powder quality 0.08 times and the Pulvis Talci of 0.01 times, mixing, with alcohol granulation, dry, incapsulate, obtain.
Embodiment 13, prepare the tablet of Chinese medicine composition
Get the 85g Radix Astragali, the 50g Radix Paeoniae Alba, 55g Ramulus Cinnamomi, 45g Rhizoma Zingiberis Recens, 55g Semen Armeniacae Amarum, 25g Radix Saposhnikoviae, 17g Periostracum Cicadae, 21g Fructus Citri tangerinae is red, 80g Fructus Jujubae (enucleation) and 45g Radix Glycyrrhizae (processed with honey) ten taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 times and 6 times of quality of medicinal material, extraction time is respectively 3 hours and 2 hours, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.08 (70 DEG C of surveys), let cool, the ethanol adding 90% (volumn concentration) makes alcohol content reach 50% (volumn concentration), stir evenly, leave standstill 60 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.25 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieves, add the starch of gained medicated powder quality 0.2 times, mixing, granulate, be pressed into tablet, obtain.
Embodiment 14, prepare the tablet of Chinese medicine composition
Get the 65g Radix Astragali, the 70g Radix Paeoniae Alba, 55g Ramulus Cinnamomi, 45g Rhizoma Zingiberis Recens, 45g Semen Armeniacae Amarum, 35g Radix Saposhnikoviae, 13g Periostracum Cicadae, 26g Fructus Citri tangerinae is red, 80g Fructus Jujubae (enucleation) and 55g Radix Glycyrrhizae (processed with honey) ten taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 times and 6 times of quality of medicinal material, extraction time is respectively 3 hours and 1 hour, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.25 (70 DEG C of surveys), let cool, the ethanol adding 70% (volumn concentration) makes alcohol content reach 40% (volumn concentration), stir evenly, leave standstill 72 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.15 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieves, add the starch of gained medicated powder quality 0.2 times, mixing, granulate, be pressed into tablet, obtain.
The test of pesticide effectiveness of the Chinese medicinal composition granules treatment allergic dermatitis of embodiment 15, embodiment 1
Rat is divided into 3 groups at random by body weight: matched group, sodium cromoglicate group, embodiment 1 Chinese medicinal granule group, 10/group, male and female half and half.Test adopts preventive administration, successive administration 14 days before antigen is attacked.
Antiserum prepare: (Radix Trichosanthis is sensitinogen, and solvent is commercial available quality mark is 4% ~ 5% gel aluminum hydroxide, is dissolved in 1mL gel aluminum hydroxide temporarily dissolves with 5mg Radix Trichosanthis by four the sole injections of Radix Trichosanthis aluminium hydroxide suspension.), every sole injection 0.1ml, 0.4ml altogether.10-15 days ripe, and eyeball blood-letting is about 10ml, with the centrifugal 15min of 3000 turns/min, gets upper serum and namely obtains antiserum.
Passive sensitization of skin: will test each group of rat back depilation, spinal column both sides are apart from center line 1.5cm, and respectively get 2 points, often some interval 2cm, area is 1 × 1cm about
2, totally 4 points.Sero-fast different dilution factor (1:30,1:40) is injected respectively in skin of back.Carry out quantitative corresponding antigens after 48h to attack.Tail vein injection Radix Trichosanthis adds AZO-blue solution 1mg/kg, sacrificed by decapitation after 30min.
Observation index: intradermal injection sero-fast local skin reaction, and the locus coeruleus diameter (cm) measuring that AZO-blue oozes out.Calculate PCA inhibition percentage (%).
PCA suppression ratio (%)=(blank group locus coeruleus diameter-administration group locus coeruleus diameter)/blank group locus coeruleus diameter × 100%
The impact of table 1, embodiment 1 granules of rats PCA reaction
Note: compared with blank group, * P < 0.05
Table 1 result shows, and pharmaceutical composition of the present invention, when antiserum dilution factor 1:30, compares with blank group, significantly suppresses locus coeruleus diameter, and when dilution factor is 1:40, still have inhibitory action but remarkable, inhibition is suitable with sodium cromoglicate.Show, pharmaceutical composition of the present invention has significant inhibitory action, the prevention of pointing out this pharmaceutical composition to can be used for allergic dermatitis or treatment to anaphylaxis-PCA reaction.
The clinical experiment of embodiment 16, traditional Chinese medicine composition for treating anaphylaxis urticaria of the present invention
Clinical data: ordinary circumstance is originally organized 30 examples and is out-patient, man 18 example, female 12 example; 20 ~ 55 years old age, average 35.8 years old; The course of disease is the shortest 2 days, the longest 1 month, average 10.8 days, and wherein <5 day 13 is routine, 5 days ~ 1 month 17 example.
Patient's inclusive criteria:
1, with pruritus and transient welt for main clinic symptoms, development is frequent, and the welt persistent period, more than 24 hours, does not stay any vestige after disappearing, and the course of disease is more than 6 weeks;
2, do not use glucocorticoid in 1 month, in 2 weeks, do not use Claritin;
3, the age is between 18 years old to 65 years old;
4, without medicine contraindication person;
Excluded cases standard:
1, gestation or women breast-feeding their children;
2, be associated with hepatic and renal function exception or have gastritis, gastric ulcer or concurrent infection person;
3, taking or in 2 weeks, having the medicine person taking treatment urticaria;
4, due to urticaria that physical factor or other known reasons cause.
The standard of curative effect evaluation:
1, cure: welt all disappears, without pruritus, dermatograph test feminine gender, clinical efficacy index decreased rate is more than or equal to 90%;
2, effective: welt major part disappears, slight pruritus, dermatograph test feminine gender, clinical efficacy index decreased rate is more than or equal to 20%.
3, invalid: welt is without obviously disappearing, and pruritus is obvious, dermatograph test is negative, clinical efficacy index decreased rate is less than 20%.
Test method: the granule adopting embodiment 1, oral, 3 times on the one, 1 time 1 bag (every bag of 12g, every gram containing crude drug 2.67g).Within 1 week, be 1 course for the treatment of, 1 course for the treatment of of medication.
Therapeutic outcome: in table 2.
Table 2 embodiment 1 Granules in Treating urticaria result observes (n, %)
Then the granule, capsule, tablet etc. that adopt embodiment 2-14 to prepare respectively carry out the test of pesticide effectiveness.
Granule, oral, 3 times on the one, 1 time 1 bag (every bag of 12g, every gram containing crude drug 2.67g), continuous use 7 days.
Capsule, oral, 3 times on the one, each 3, continuous use 7 days.
Tablet, oral, 3 times on the one, each 3, continuous use 7 days.
Oral liquid, 3 times on the one, each 10ml, continuous use 7 days.
Criterion of therapeutical effect is the same.
Therapeutic outcome: in Table 3-15.
The capsule treatment urticaria result of table 3 embodiment 2 observes (n, %)
Table 4 embodiment 3 capsule treatment urticaria result observes (n, %)
Table 5 embodiment 4 oral liquid treatment urticaria result observes (n, %)
Table 6 embodiment 5 oral liquid treatment urticaria result observes (n, %)
Table 7 embodiment 6 tablet in treatment urticaria result observes (n, %)
| Number of cases (n) | Effective | Effectively | Invalid | Total effective rate |
| n | ％ | n | ％ | n | ％ | (％) | |
| 30 | 13 | 43.3 | 12 | 40.0 | 5 | 16.7 | 83.3 |
Table 8 embodiment 7 tablet in treatment urticaria result observes (n, %)
Table 9 embodiment 8 tablet in treatment urticaria result observes (n, %)
Table 10 embodiment 9 tablet in treatment urticaria result observes (n, %)
Table 11 embodiment 10 tablet in treatment urticaria result observes (n, %)
Table 12 embodiment 11 Granules in Treating urticaria result observes (n, %)
Table 13 embodiment 12 capsule treatment urticaria result observes (n, %)
Table 14 embodiment 13 tablet in treatment urticaria result observes (n, %)
Table 15 embodiment 14 tablet in treatment urticaria result observes (n, %)
Good therapeutic effect is all had to urticaria from the product of above-mentioned table 2-15, embodiment 1-14.
The clinical experiment of embodiment 17, traditional Chinese medicine composition for treating allergic eczema of the present invention
1, clinical data: the routine patient of Stochastic choice 100, all patients are eczema.Wherein acute eczema 55 example, subacute eczema 30 example, chronic eczema 15 example.
2, diagnostic criteria:
, can there is any position of body surface in acute eczema, rapidly, erythra is pleomorphism in morbidity.Main manifestations is pimple, papulovesicle, vesicle, erosion on erythema edema basis, ooze out, incrustation etc., infringement indefinite border, can general whole body time serious, acute pruritus.
Subacute eczema, after acute inflammation alleviates, erythra, based on little pimple, squama and incrustation, only has a small amount of papulovesicle, vesicle and erosion; Skin lesion comparatively limits to, and pruritus is still more violent.
Chronic eczema, is changed by acute eczema, subacute eczema recurrent exerbation.Show as pachylosis, scratch, incrustation, immersion plumpness, part lichenification, pigmentation, periphery has been diffused in papulovesicle.
3, Outcome measure: clinical cure is that skin lesion disappears completely or only stays pigmentation, subjective symptoms disappears; Effectively disappear more than 70% for skin lesion, subjective symptoms obviously alleviates or disappears; Effectively for skin lesion disappears more than 30%, subjective symptoms alleviates; Invalidly to disappear less than 30% for skin lesion.
4, Therapeutic Method: oral medicine of the present invention.
Granule, oral, 3 times on the one, 1 time 1 bag (every bag of 12g, every gram containing crude drug 2.67g), continuous use 14 days.
Capsule, oral, 3 times on the one, each 3, continuous use 14 days.
Tablet, oral, 3 times on the one, each 3, continuous use 14 days.
Oral liquid, 3 times on the one, each 10ml, continuous use 14 days.
Therapeutic outcome: in Table 16-24.
Table 16 embodiment 1 Granules in Treating eczema result observes (n, %)
Table 17 embodiment 3 capsule for treating eczema result observes (n, %)
Table 18 embodiment 4 oral liquid treatment eczema result observes (n, %)
Table 19 embodiment 6 tablet in treatment eczema result observes (n, %)
Table 20 embodiment 7 tablet in treatment eczema result observes (n, %)
Table 21 embodiment 9 tablet in treatment eczema result observes (n, %)
Table 22 embodiment 10 tablet in treatment eczema result observes (n, %)
Table 23 embodiment 12 capsule treatment eczema result observes (n, %)
Table 24 embodiment 13 tablet in treatment eczema result observes (n, %)
Good therapeutic effect is all had to eczema from the product of above-mentioned table 16-24, embodiment 1-14.
The clinical experiment of the Chinese medicinal composition granules treatment pollen hypersensitivity of embodiment 18, embodiment 1
Patient's inclusive criteria: selected 60 examples previously have the patient of pollen hypersensitivity medical history, and fall ill continuous more than 2 years.The equal nutriture of each case is good, and blood glucose, blood fat and hepatic and renal function are all in normal range.Wherein male 40 example, women 20 example, age range 16 ~ 52 years old, 31.01 ± 15.11 years old mean age.
Research method: be divided into treatment group and matched group by randomly assigne, treatment group 30 example, matched group 30 example.The last week from pollen period treatment time starts, matched group is avoided contacting pollen, is specially and occupy indoor as far as possible, close the doors and windows to reduce entering of outdoor pollen, go out by being branded as, mask and wear the medicated clothing of long sleeves, avoid directly contacting with pollen as far as possible; Treatment group adds on matched group basis prevents with the granule of the embodiment of the present invention 1.The granule of embodiment 1, oral, 3 times on the one, 1 time 1 bag (every bag of 12g, every gram containing crude drug 2.67g).
Allergic symptom occurs that situation compares: in matched group 30 example, and have 90% (27 example) to occur the symptom of pollen hypersensitivity, 80% (24 example) must be treated by using antihistamine drug.In treatment group 30 example, have 30% (9 example) to occur the symptom of pollen hypersensitivity, 26.67% (8 example) must be treated by using antihistamine drug.Compare between two groups of groups, difference has extremely significantly statistical significance (P<0.01).
Claims (14)
1. prevent and/or treat a pharmaceutical composition for allergic skin diseases, be made up of the raw material of following mass parts: the Radix Astragali 6-24 parts, the Radix Paeoniae Alba 4-20 parts, Ramulus Cinnamomi 4-16 parts, 4-16 parts, Rhizoma Zingiberis Recens, 4-16 parts, Semen Armeniacae Amarum, Radix Saposhnikoviae 2-10 parts, Periostracum Cicadae 1.2-4.8 parts, Exocarpium Citri Rubrum 2.4-9.6 parts, Fructus Jujubae (pitted) 5-23 parts and 4-16 parts, Radix Glycyrrhizae.
2. pharmaceutical composition according to claim 1, is characterized in that: described pharmaceutical composition is made up of the raw material of following mass parts: the Radix Astragali 9-21 parts, the Radix Paeoniae Alba 5-19 parts, Ramulus Cinnamomi 6-14 parts, 6-14 parts, Rhizoma Zingiberis Recens, 6-14 parts, Semen Armeniacae Amarum, Radix Saposhnikoviae 3-9 parts, Periostracum Cicadae 1.8-4.2 parts, Exocarpium Citri Rubrum 3.6-8.4 parts, Fructus Jujubae (pitted) 8-20 parts and 6-14 parts, Radix Glycyrrhizae.
3. pharmaceutical composition according to claim 2, is characterized in that: described pharmaceutical composition is made up of the raw material of following mass parts: the Radix Astragali 12-18 parts, the Radix Paeoniae Alba 9-15 parts, Ramulus Cinnamomi 8-12 parts, 8-12 parts, Rhizoma Zingiberis Recens, 8-12 parts, Semen Armeniacae Amarum, Radix Saposhnikoviae 4-8 parts, Periostracum Cicadae 2.4-3.6 parts, Exocarpium Citri Rubrum 4.8-7.2 parts, Fructus Jujubae (pitted) 11-17 parts and 8-12 parts, Radix Glycyrrhizae.
4. pharmaceutical composition according to claim 3, is characterized in that: described pharmaceutical composition is made up of the raw material of following mass parts: the Radix Astragali 13-17 parts, the Radix Paeoniae Alba 10-14 parts, Ramulus Cinnamomi 9-11 parts, 9-11 parts, Rhizoma Zingiberis Recens, 9-11 parts, Semen Armeniacae Amarum, Radix Saposhnikoviae 5-7 parts, Periostracum Cicadae 2.6-3.4 parts, Exocarpium Citri Rubrum 5.2-6.8 parts, Fructus Jujubae (pitted) 12-16 parts and 9-11 parts, Radix Glycyrrhizae.
5. the method for the pharmaceutical composition of preparation according to any one of claim 1-4, comprises the steps:
1) take the Radix Astragali, the Radix Paeoniae Alba, Ramulus Cinnamomi, Rhizoma Zingiberis Recens, Semen Armeniacae Amarum, Radix Saposhnikoviae, Periostracum Cicadae, Exocarpium Citri Rubrum, Fructus Jujubae (pitted) and Radix Glycyrrhizae ten taste medical material by described ratio of quality and the number of copies, decoct with water extraction, collect extracting solution;
2) described extracting solution is condensed into clear paste, lets cool, then in described clear paste, add ethanol or ethanol water makes alcohol volume content reach 30-70%, stir evenly, leave standstill; Leave standstill after terminating and collect supernatant, namely obtain described pharmaceutical composition.
6. method according to claim 5, is characterized in that: described step 1) in the water yield that adds be 5-10 times of described medical material gross mass; Described decoction extraction is carried out 1-3 times, and each time decocting extraction is 1-3 hours; Step 1) described in medical material be the medical material after clean system;
Step 2) in clear paste be 70 DEG C measure relative densities be the clear paste of 1.05-1.25; In described ethanol water, the volumn concentration of ethanol is 60-95%; The described standing time is 12-96 hours.
7. the method for the pharmaceutical composition of preparation according to any one of claim 1-4, comprises the steps:
The Radix Astragali, the Radix Paeoniae Alba, Ramulus Cinnamomi, Rhizoma Zingiberis Recens, Semen Armeniacae Amarum, Radix Saposhnikoviae, Periostracum Cicadae, Exocarpium Citri Rubrum, Fructus Jujubae (pitted) and Radix Glycyrrhizae ten taste medical material is taken by ratio of quality and the number of copies, the ethanol water being 50-95% by above-mentioned medical material volumn concentration extracts, after extraction, filter, collect filtrate, filtrate being condensed into 70 DEG C of mensuration relative densities is the thick paste of 1.10 ~ 1.40, obtains described pharmaceutical composition.
8. method according to claim 7, is characterized in that: described in be extracted as reflux, extract; Described reflux, extract, is at least carried out once, preferably extracts 1-3 time, and each time of extracting is 1-3 hour; During each extraction, Extraction solvent add quality be the 5-10 of described quality of medicinal material doubly;
The described merceration that is extracted as extracts or seepage pressure effects; Described merceration extract or seepage pressure effects time, the ethanol water of Extraction solvent used to be volumn concentration be 60-85%; When described merceration extracts, Extraction solvent add quality be the 5-10 of described quality of medicinal material doubly; The time that merceration extracts is 7-15 days; During described seepage pressure effects, Extraction solvent add quality be the 5-12 of described quality of medicinal material doubly.
9. the method for the pharmaceutical composition of preparation according to any one of claim 1-4, comprises the steps:
The Radix Astragali, the Radix Paeoniae Alba, Ramulus Cinnamomi, Rhizoma Zingiberis Recens, Semen Armeniacae Amarum, Radix Saposhnikoviae, Periostracum Cicadae, Exocarpium Citri Rubrum, Fructus Jujubae (pitted) and Radix Glycyrrhizae ten taste medical material is taken by described ratio of quality and the number of copies, extract with water, filter, collect filtrate, described filtrate is condensed into the extractum that relative density is 1.05-1.25, obtains described pharmaceutical composition.
10. method according to claim 9, is characterized in that: described in be extracted as reflux, extract, described extraction is at least carried out once, and each time of extracting is 1-3.5 hour; During described extraction, the mass ratio of described medical material gross mass and water is 1:5-10.
Pharmaceutical composition according to any one of 11. claim 1-4 is preparing the application prevented and/or treated in allergic skin diseases medicine.
12. application according to claim 11, is characterized in that: described allergic skin diseases comprises anaphylaxis urticaria, allergic eczema and/or pollen hypersensitivity.
13. 1 kinds of medicines preventing and/or treating allergic skin diseases, its active component is arbitrary described pharmaceutical composition in claim 1-4.
14. medicines according to claim 13, is characterized in that: described allergic skin diseases comprises anaphylaxis urticaria, allergic eczema and/or pollen hypersensitivity.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104352896A (en) * | 2014-12-05 | 2015-02-18 | 济南高达信息技术有限公司 | Traditional Chinese medicine preparation for treating angioneurotic edema |
| CN106267115A (en) * | 2016-10-02 | 2017-01-04 | 成都市飞龙水处理技术研究所 | A kind of Chinese medicine composition treating anaphylaxis dermatosis and preparation method thereof |
| CN113975320A (en) * | 2021-11-17 | 2022-01-28 | 上海运佳黄浦制药有限公司 | Traditional Chinese medicine composition for resisting skin allergy and preparation method and application thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH06279305A (en) * | 1993-03-25 | 1994-10-04 | Kuga Takaaki | Agent for treatment of dermatic disease such as atopic dermatitis |
| CN102294007A (en) * | 2011-08-30 | 2011-12-28 | 杨万明 | Medicament for treating urticaria |
| CN104436145B (en) * | 2014-12-25 | 2017-11-03 | 吉林一正药业集团有限公司 | It is a kind of to prevent and/or treatment allergic rhinitis and the pharmaceutical composition of allergic asthma |
-
2014
- 2014-12-25 CN CN201410824931.3A patent/CN104548008B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH06279305A (en) * | 1993-03-25 | 1994-10-04 | Kuga Takaaki | Agent for treatment of dermatic disease such as atopic dermatitis |
| CN102294007A (en) * | 2011-08-30 | 2011-12-28 | 杨万明 | Medicament for treating urticaria |
| CN104436145B (en) * | 2014-12-25 | 2017-11-03 | 吉林一正药业集团有限公司 | It is a kind of to prevent and/or treatment allergic rhinitis and the pharmaceutical composition of allergic asthma |
Non-Patent Citations (4)
| Title |
|---|
| 《国学典藏书系》丛书编委会: "《偏方秘方》", 28 February 2011, 吉林出版集团有限责任公司 * |
| 苗明三等: "《对药的化学、药理与临床》", 30 April 2002, 军事医学科学出版社 * |
| 陈沛沛等: "《简易健康脐疗》", 31 October 2008, 上海科学技术出版社 * |
| 高学敏等: "《临床中药学》", 31 January 2006, 河北科学技术出版社 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104352896A (en) * | 2014-12-05 | 2015-02-18 | 济南高达信息技术有限公司 | Traditional Chinese medicine preparation for treating angioneurotic edema |
| CN106267115A (en) * | 2016-10-02 | 2017-01-04 | 成都市飞龙水处理技术研究所 | A kind of Chinese medicine composition treating anaphylaxis dermatosis and preparation method thereof |
| CN113975320A (en) * | 2021-11-17 | 2022-01-28 | 上海运佳黄浦制药有限公司 | Traditional Chinese medicine composition for resisting skin allergy and preparation method and application thereof |
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| CN104548008B (en) | 2018-04-06 |
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