CN104523853A - Externally applied compound radix arnebiae oil preparation and preparation method thereof - Google Patents
Externally applied compound radix arnebiae oil preparation and preparation method thereof Download PDFInfo
- Publication number
- CN104523853A CN104523853A CN201410839392.0A CN201410839392A CN104523853A CN 104523853 A CN104523853 A CN 104523853A CN 201410839392 A CN201410839392 A CN 201410839392A CN 104523853 A CN104523853 A CN 104523853A
- Authority
- CN
- China
- Prior art keywords
- radix
- preparation
- radix arnebiae
- external preparation
- sophorae flavescentis
- 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.)
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- 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
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Abstract
The invention discloses an externally applied compound radix arnebiae oil preparation and a preparation method thereof. The externally applied compound radix arnebiae oil preparation disclosed by the invention is mainly prepared from radix arnebiae, radix sophorae flavescentis, polygonum cuspidatum and borneolum Luodian. The externally applied compound radix arnebiae oil preparation disclosed by the invention has the effects of clearing heat, removing toxicity, eliminating dampness and eliminating rash, and has the obvious curative effects of treating infant eczema, diaper rash, baby red bottom, infantile eczema, infant skin red due to sweat immersion, skin ulceration due to sweat immersion, red papule, bubble, crusta, infant daily care, adult eczema, burns and scalds due to hot liquid or fire and the like; and furthermore, the externally applied compound radix arnebiae oil preparation disclosed by the invention is free from skin irritation.
Description
Technical field
The present invention relates to a kind of external preparation and preparation method thereof, particularly relate to a kind of Glycyrrhiza Oil Compound external preparation and preparation method thereof.
Background technology
Infantile eczema is a kind of allergic skin disease, is exactly the anaphylaxis dermatosis usually said.Main cause not to tolerate ingestant, inhalation (inhalatio) or contactant or caused by allergy.The child suffering from eczema originally skin rubefaction, occur that erythra, then skin are sent out rough, desquamation, stroke the skin of child as touch is on sand paper.The wet eczema that all can make of heat, chance shows significantly.Newborn diapers eczema causes by the stimulation of wet diaper for a long time mainly due to buttocks and skin of perineum, this is because when defecation mixes, easy generation chemical action and release ammonia, when ammonia acts on skin, then chafe makes it rubescent, time is longer, then stimulate large, severe patient can cause the accompanying infection of candida coccus.The cause of disease of eczema and pathogenesis relate to the inside and outside many factors of body, often betide the individuality with allergic constitution.Specific as follows, 1, Tardive allergy: adult's eczema may be the Tardive allergy caused by the body intrinsic factor of complexity and the basis of extraneous factor.But some eczema then has nothing to do with allergy.The reactive change of patient, often relate to many-sided factor, some is not clear, still needs to be studied from now on.2, body intrinsic factor: this is main relevant with allergic constitution, the classical concept of metabolism, endocrine hormonal system refers to the endocrine gland of the cell composition that a group is becomed privileged.They comprise hypophysis, thyroid, parathyroid gland, adrenal gland, gonad, islets of langerhans, thymus and pinus etc.The dynamical organic chemicals of these glandular secretions (hormone), transmits chemical information to its target cell, target tissue or target organ through blood circulation, play excited or inhibitory action.3, extraneous factor: this is the zest factor that eczema produces, and as foreign preteins, pollen, dust, bacteriological infection, Exposure to Sunlight, colds such as chemicals, cosmetics, spice, dyestuff, cleaning agent, zootoxin, eggs, fish and shrimp and milk, scratches.
At present, the drug main of the treatment eczema that market uses will be divided into interior preparation and external preparation, and interior preparation mainly selects antihistaminic antipruritic, universal eczema can oral or injection glucocorticoid; External preparation mainly selects glucocorticoid cream, burnt oil-like formulations or immunomodulator, as Tacrolimus paste, pimecrolimus ointment, and secondary infection person's added with antibiotic preparation.By above-mentioned, the medicine for the treatment of eczema mostly in the market is hormones and antibiotics, and this kind of medicine irritation is strong, and very large to Health Impact, as life-time service, anaphase effect is not remarkable.Therefore, the medicine inventing a kind of bland treatment eczema evident in efficacy is significant.
Summary of the invention
The object of this invention is to provide a kind of Glycyrrhiza Oil Compound external preparation and preparation method thereof.Glycyrrhiza Oil Compound external preparation of the present invention has heat-clearing and toxic substances removing, and dampness is dispelled effect of rash.To treatment infant eczema, diaper rash, the red hip of baby, infantile eczema, infant skin is wet red, wet rotten, red pimple, blister, crust, infant daily nursing; The eczema of adult, burn due to hot liquid or fire etc. are evident in efficacy.And it is non-stimulated to skin.
The present invention is achieved in that a kind of Glycyrrhiza Oil Compound external preparation, calculates, comprise Radix Arnebiae (Radix Lithospermi) 50 ~ 150 parts, Radix Sophorae Flavescentis 50 ~ 100 parts according to composition by weight, Rhizoma Polygoni Cuspidati 50 ~ 100 parts and Blumeae preparatum Tabellae 0.5 ~ 3 part.
More preferably, aforesaid Glycyrrhiza Oil Compound external preparation, calculates according to composition by weight, comprises Radix Arnebiae (Radix Lithospermi) 80 ~ 120 parts, Radix Sophorae Flavescentis 60 ~ 80 parts, Rhizoma Polygoni Cuspidati 60 ~ 80 parts and Blumeae preparatum Tabellae 1 ~ 2 part.
Optimally, aforesaid Glycyrrhiza Oil Compound external preparation, calculates according to composition by weight, comprises Radix Arnebiae (Radix Lithospermi) 100 parts, Radix Sophorae Flavescentis 70 parts, Rhizoma Polygoni Cuspidati 70 parts and Blumeae preparatum Tabellae 1 part.
The preparation method of aforesaid Glycyrrhiza Oil Compound external preparation is, by Radix Arnebiae (Radix Lithospermi), Radix Sophorae Flavescentis, Rhizoma Polygoni Cuspidati and Blumeae preparatum Tabellae mixing, add customary adjuvant, conveniently technique makes external preparation.
In the preparation method of aforesaid Glycyrrhiza Oil Compound external preparation, described external preparation is liniment, patch or ointment.
In the preparation method of aforesaid Glycyrrhiza Oil Compound external preparation, described liniment is prepared like this: get Radix Sophorae Flavescentis, Rhizoma Polygoni Cuspidati and Radix Arnebiae (Radix Lithospermi), and the Oleum sesami adding the heavy 4-5 times amount of total medical material soaks 5 ~ 8d, period stirs 2-5 time, filters, adds Blumeae preparatum Tabellae powder in filtrate, stir evenly, subpackage, obtain liniment.
In the preparation method of aforesaid Glycyrrhiza Oil Compound external preparation, described liniment can also be prepared like this: get Radix Sophorae Flavescentis, Rhizoma Polygoni Cuspidati and Radix Arnebiae (Radix Lithospermi), adds the Oleum sesami of the heavy 4-5 times amount of total medical material, heating, control temperature extracts 1-2 hour at 80 ~ 90 DEG C, period constantly stirs, and is then cooled to room temperature, filters, Blumeae preparatum Tabellae powder is added in filtrate, stir evenly, subpackage, obtain liniment.
In the preparation method of aforementioned Glycyrrhiza Oil Compound external preparation, described patch is prepared like this:
A. Radix Arnebiae (Radix Lithospermi), Radix Sophorae Flavescentis and Rhizoma Polygoni Cuspidati is got, after adding the soak with ethanol 0.5h of the heavy 3-4 times amount 70% of total medical material, reflux, extract, 2h, cooling, filters, and reclaims ethanol, and when being concentrated into 60 DEG C, relative density is the extractum of 1.14 ~ 1.16, adds the mixing of Blumeae preparatum Tabellae powder, obtains A product;
B. separately get A product weigh 35% sodium polyacrylate, 75% carbomer, 55% glycerol, 30% propylene glycol, 2% diethylamine tetraacethyl mixing, make substrate, add A product and stir evenly, make coating, carry out paintings cream, cutting, lid serve as a contrast, be cut into small pieces, obtain patch.
In the preparation method of aforementioned Glycyrrhiza Oil Compound external preparation, described ointment is prepared like this:
A. Radix Arnebiae (Radix Lithospermi), Radix Sophorae Flavescentis and Rhizoma Polygoni Cuspidati is got, after adding the soak with ethanol 0.5h of the heavy 3-4 times amount 70% of total medical material, reflux, extract, 2h, cooling, filters, and reclaims ethanol, and when being concentrated into 60 DEG C, relative density is the extractum of 1.14 ~ 1.16, adds the mixing of Blumeae preparatum Tabellae powder, obtains A product;
B. separately get A product, add A product and weigh the ethylparaben of 0.1%, the lanoline mixing of 18%, then add the vaseline mixing that A product weigh 2 times amount, obtain ointment.
Glycyrrhiza Oil Compound external preparation of the present invention is made primarily of Radix Arnebiae (Radix Lithospermi), Radix Sophorae Flavescentis, Rhizoma Polygoni Cuspidati and Blumeae preparatum Tabellae.Wherein, Radix Arnebiae (Radix Lithospermi) another name mountain Radix Arnebiae (Radix Lithospermi), Zi Dan, purple cottonrose hibiscus, small, blood, crow rank grass, Radix Arnebiae (Radix Lithospermi), be Boraginaceae Lithospermum, herbaceos perennial.Its nature and flavor are bitter, cold, and function cures mainly removing heat from blood, invigorates blood circulation, heat clearing away, removing toxic substances.Control warm macule, jaundice due to damp-heat, purpura, tell, be defeated in battle, hematuria, stranguria with turbid discharge, constipation with heat retention, burn, eczema, erysipelas, carbuncle and ulcer.In pharmacological action, Radix Arnebiae (Radix Lithospermi) mainly contains following several respects: 1) contraceptive efficacy, is tested show by mice cause for gossip, normal mouse continuous oral Radix Arnebiae (Radix Lithospermi) two months, ovary obviously alleviates, and uterus and hypophysis then slightly alleviate, but to other endocrine gland as thyroid, adrenal weight have no significant effect.2) antibacterial, antiinflammation, Radix Arnebiae (Radix Lithospermi) in vitro has inhibitory action to capital section 68-1 virus, also can suppress staphylococcus aureus, Bacterium prodigiosum.3) antitumor action: it is reported, Radix Arnebiae (Radix Lithospermi) has certain curative effect to chorionic epithelioma and malignant mole.With methylene blue test tube method primary dcreening operation, Radix Arnebiae (Radix Lithospermi) has extremely slight inhibitory action to acute lymphoblastic leukemia.Radix Arnebiae (Radix Lithospermi) can reduce the sickness rate of (Mus) spontaneous mammary carcinoma.
Radix Sophorae Flavescentis, be the dry root of leguminous plant Radix Sophorae Flavescentis, spring, Qiu Erji excavate, removing root head and little supporting root, cleaning, drying, or take advantage of fresh slices, dry.Its nature and flavor are bitter, cold.There is heat clearing and damp drying, parasite killing, the merit of diuresis.For hematodiarrhoea, have blood in stool, jaundice urine retention, leucorrhea with red and white discharge, swelling of the vulva pudendal pruritus, eczema, eczema, skin pruritus, scabies leprosy, external treatment trichomonal vaginitis.
Rhizoma Polygoni Cuspidati is dry rhizome and the root of polygonaceae plant Rhizoma Polygoni Cuspidati Polygonum CU3pidatum Sieb. etZucc..Spring, Qiu Erji excavate, and removing fibrous root, cleans, take advantage of short section of fresh-cut or sheet, dry.Its mildly bitter flavor, cold nature, primary treatment jaundice due to damp-heat, stranguria with turbid discharge, leukorrhagia, rheumatic arthralgia, carbuncle sore tumefacting virus, burn due to hot liquid or fire, amenorrhea, lump in the abdomen, instep plays damage, cough due to lung-heat.Its using method is external, is made into decocting liquid or ointment coating.
Blumeae preparatum Tabellae, be white translucent lamellar, bulk or crystalline particulate, matter is slightly hard and crisp, and hands is twisted with the fingers non-friable.Tool faint scent, acrid in the mouth, cool, tool volatility, has black smoke when lighting, and flame, in yellow, is left over without vestiges.Record according to interrelated data, Blumeae preparatum Tabellae can remove bad odor, wards off pestilence, and parasite killing treats tinea, and control middle damp cholera, open hole powder fire, key is closed in nebula of dispelling improving eyesight, wind-phlegm.In addition, Blumeae preparatum Tabellae also can outward for order disease external oculopathy, the diseases such as aphtha, and can make the application compress preparing traumatic injury.
In the prescription of Glycyrrhiza Oil Compound external preparation of the present invention, monarch drug Radix Arnebiae (Radix Lithospermi) nature and flavor bitter cold in side, has removing heat from blood, invigorates blood circulation, heat clearing away, Detoxication, control warm macule, jaundice due to damp-heat, purpura, tell, be defeated in battle, hematuria, stranguria with turbid discharge, constipation with heat retention, burn, eczema, erysipelas, carbuncle and ulcer.Accessory drugs Radix Sophorae Flavescentis nature and flavor bitter cold, has heat clearing and damp drying effect, and accessory drugs Rhizoma Polygoni Cuspidati mildly bitter flavor, is slightly cold, has and dispel the wind, dampness removing, removing blood stasis with potent drugs, stimulate the menstrual flow, and accessory drugs Blumeae preparatum Tabellae nature and flavor are pungent, bitter, are slightly cold, and have refreshment of having one's ideas straightened out, clearing away heat to alleviate pain.The all medicine compatibilities of we, have heat-clearing and toxic substances removing, and dampness is dispelled effect of rash.To treatment infant eczema, diaper rash, the red hip of baby, infantile eczema, infant skin is wet red, wet rotten, red pimple, blister, crust, infant daily nursing; The eczema of adult, burn due to hot liquid or fire etc. are evident in efficacy.And non-stimulated to skin, reach goal of the invention.
When the present invention makes liniment, also add Oleum sesami, Oleum sesami external can alleviate the pruritis that eczema is brought.After used in combination with said medicine, curative effect of medication is more remarkable.When the present invention makes liniment, routine fashion is that medical material and Oleum sesami are soaked 5-8 days jointly, filters and get final product.But this method is not suitable for large production, wasting manpower and material resources.Inventor, through a large amount of experimentatioies, for the feature of Chinese crude drug of the present invention, draws and medical material and Oleum sesami is carried 1-2 hour 80 ~ 90 DEG C of temperature, can extract the most of effective ingredient in medicine, make the obvious Oleum Radix Arnebiae (Oleum Radix Lithospermi) of curative effect.
Applicant carried out following experiments, provable the present invention has effective effect;
Experimental example 1.Clinical trial.
1.1 infant quantity and medicines
1.1.1 eczema infant 228 example, is divided into of the present invention group 118 example, matched group 110 example.In of the present invention group, man 56 example, female 62 example; Age 2 months ~ 1 years old have 51 example, 1 ~ 3 years old have 33 example, 3 ~ 5 years old have 34 example; In matched group, man 48 example, female 62 example; Age 2 months ~ 1 years old have 47 example, 1 ~ 3 years old have 45 example, 3 ~ 5 years old have 18 example; The infant course of disease is between 3d ~ 1a.
1.1.2 trial drug
Medicine of the present invention: be prepared according to the method for embodiment 1;
Control drug: get Radix Sophorae Flavescentis 70g, Radix Arnebiae (Radix Lithospermi) 100g, adds the Oleum sesami that total medical material weighs 4 times amount, heating, and control temperature carries 1 hour 80 ~ 90 DEG C of temperature, and period constantly stirs, and is then cooled to room temperature, filters, to obtain final product.
1.2 test method
Of the present invention group: give medicine affected part of exterior coating of the present invention, every day 4 ~ 6 times; The person of oozing out is had to add 2% borate soak, every day 4 ~ 6 times.5 ~ 15d is 1 course for the treatment of.
Matched group: give control drug affected part of exterior coating, every day 4 ~ 6 times.The person of oozing out is had to add 2% borate soak, every day 4 ~ 6 times.5 ~ 15d is 1 course for the treatment of.
1.3 pruritus degree evaluation standards
Be: I degree that infant is commonly used hands and grabbed and rub erythra, and head often swings according to clinical manifestation, irritated, sleep is poor, diet reduces, erythra has erythematous papules vesicle, desquamation of chapping, and rotten to the cornly forms a scab; II degree, hands is grabbed and is rubbed erythra, and head often swings, and sleeps, diet is normal, without sepage; III degree, have erythema, pimple, vesicle, infant is grabbed without hands and is rubbed, and diet, sleep are normally.
1.4 efficacy assessment standard
According to erythra and subjective symptom result of determination.Recovery from illness: deflorescence, gargalesthesia disappears, and diet, sleep are normally; Effective: erythra reduces more than 60%, subjective symptom disappears; Take a turn for the better: deflorescence more than 40%, but have new breakout to occur, gargalesthesia alleviates, and grabs without hands; Invalid: before and after treatment, erythra is without change, and gargalesthesia does not alleviate.
1.5 result
In of the present invention group of 118 examples, 48 examples of fully recovering (40.7%), effective 38 examples (32.2%), 27 examples that take a turn for the better (22.9%), invalid 5 examples (4.2%), total effective rate is 95.8%;
In matched group, 110 examples cure 35 examples (31.8%), and effective 22 examples (20.0%), 37 examples that take a turn for the better (33.6.0%), invalid 16 examples (14.5%), total effective rate is 85.4%.To sum up draw: medicine of the present invention and control drug are treated all effective to infant eczema, but Drug therapy infant eczema curative effect of the present invention is more remarkable.
Experimental example 2.The test of pesticide effectiveness.
1.1 experimental animals and medicine
1.1.1 one-level New Zealand white rabbit 15 (Guiyang Medical College Experimental Animal Center provides), weight 2400 ~ 3000g, male and female are not limit, and single cage is fed 1 week.
1.1.2 trial drug
Medicine of the present invention: be prepared according to the method for embodiment 1;
Control drug: get Radix Sophorae Flavescentis 70g, Radix Arnebiae (Radix Lithospermi) 100g, adds the Oleum sesami that total medical material weighs 4 times amount, heating, and control temperature carries 1 hour 80 ~ 90 DEG C of temperature, and period constantly stirs, and is then cooled to room temperature, filters, to obtain final product.
1.2 test method
1.2.1 animal model: slough white rabbit dorsal body setae with 8% sodium sulfide, after routine disinfection, anesthesia, 3 pieces of pachydermia sheets that spacing is equal are each side got at back, every block size is 1.6 cm × 1.6 cm, make white rabbit skin trauma model, with invention formulation treatment, use former preparation for treating for two pieces, treat with vaseline (blank) for two pieces for two pieces.
1.2.2 Wound treating method: of the present invention group, white rabbit is cut foraminate arnebia root oils gauze and sticks on wound surface after giving conventional transdermal sterilization by several layers, often drip oil preparation to keep moistening, and covered with thick-layer gauze, if exudate seldom can be changed dressings.Treatment of control group method operates identical with of the present invention group.Vaseline group then gives vaseline conventional treatment.
1.2.3 Wound healing rate measures: after wound the 3rd, 7,14,21 day, takes a picture and measures wound surface size in conjunction with transparent graph paper tracing, calculate Wound healing rate with wound surface.The results are shown in Table 1.
Wound healing rate=(original area-existing wound surface area)/original area × 100%
1.2.4 wound tissue is observed: within after wound the 3rd, 7,14,21 day, get wound tissue, and row Hematoxylin-eosin dyeing after a part is fixing with 10% formaldehyde, carries out wound tissue and observe; Another part Electronic Speculum fixative is fixed, and the ultrastructure of electric Microscopic observation specimen, comprises the relation etc. between cell, subcellular structure and cell.
1.3 result
1.3.1 the comparison of wound repair different times Wound healing rate: in table 1.
Note: * P<0.05, * * P<0.01, #P<0.05 compared with matched group compared with vaseline group.
1.3.2 wound repair different times wound tissue observed result: treatment early stage (after wound the 7th day), of the present invention group, matched group wound granulation tissue growth enliven, color is red, and soft, fibroblast, vascular endothelial cell and epithelial cell are more; Vaseline composition fibrocyte, vascular endothelial cell are relative with epithelial cell less, and granulation tissue is slightly pale, swelling.Treatment mid-term (after wound the 14th day), of the present invention group, matched group wound tissue cell proliferation is vigorous, fibroblast, vascular endothelial cell are more, and secrete collagen and fibronectin, and new vessels is formed; Vaseline composition fibrocyte, vascular endothelial cell and new vessels is less.Treatment late period (after wound the 21st day), of the present invention group, matched group wound tissue is tending towards epithelization, proliferation process slows down, and now fibroblast, vascular endothelial cell number and collagen content are relatively less, and epithelial tissue is more.
Electron microscope showed, of the present invention group, matched group comparatively vaseline form covering weave fibroblast number and increase, reticulum dilatation, the organelle showed increased such as ribosome, blood capillary number increases.Wherein the effect of of the present invention group is better than matched group.
2.1 conclusions: this experimental result shows, of the present invention group after wound the 7th day, the reaction of its wound inflammation is more obvious, fibroblast, collagen and blood vessel endothelium hypertrophy; After wound the 14th day, it is vigorous that wound tissue shows as cell proliferation, and fibroblast, vascular endothelial cell are more; After wound the 21st day, wound surface was tending towards epithelization, and proliferation process stops substantially.Medicine of the present invention is that wound repair provides good material conditions.
Experimental example 3.Untoward reaction is tested
1.1 acute skin irritation test
1.1.1 experimental animal
One-level New Zealand white rabbit 5 (Guiyang Medical College Experimental Animal Center provides), weight 2400 ~ 3000g, male and female are not limit, and single cage is fed 1 week.
Cavia porcellus 5 (Guiyang Medical College Experimental Animal Center provides), weight 300 ~ 350g, male and female are not limit, and single cage is fed 1 week.
1.1.2 test method: slough New Zealand white rabbit dorsal body setae with 8% sodium sulfide, routine disinfection, is divided into three pieces of impartial regions.Within 24 hours, remove tested material after using medicine of the present invention (being prepared according to the method for enforcement 1) and control drug (preparation method is with experimental example 1) to be coated with skin respectively, carry out dermoreaction intensity ratings.With distilled water the same operation as a control group.Cavia porcellus group is as the same.
More than 1.2 Skin Irritation Test
1.2.1 experimental animal
Cavia porcellus 5 (Guiyang Medical College Experimental Animal Center provides), weight 300 ~ 350g, male and female are not limit, and single cage is fed 1 week.
1.2.2 test method: slough Cavia porcellus dorsal body setae with 8% sodium sulfide, routine disinfection, is divided into three pieces of impartial regions.Be coated with skin every day by invention formulation group, former preparation group respectively, continuous 14 days, carry out dermoreaction intensity ratings.Histopathologic examination is done in off-test.With distilled water the same operation as a control group.
1.3 Skin allergy test
1.3.1 experimental animal
Cavia porcellus 30 (Guiyang Medical College Experimental Animal Center provides), weight 300 ~ 350g, male and female are not limit, and single cage is fed 1 week.Be divided into three groups, often organize 10.
1.3.2 test method: Cavia porcellus left abdomen, routine disinfection, do partial closure and be coated with pico farad (BT), the 1st day by patch in guinea pig back on the left of the 2 × 2cm unhairing district of 0.5ml with the tested thing prepared by suitable vehicle, close with adhesive tape fixing, continue 6 hours.7th and respectively repeat once with same method for 14 days.(of the present invention group and matched group all use the method) matched group only uses excipient.Excite: after last sensitization 14 ~ 28 days, by tested for 0.5ml thing patch 2 × 2cm unhairing district on the right side of guinea pig back, continue to close and fix 6 hours, observing response after 24 and 48 hours.
2 results
Note: stimulus intensity is evaluated each group and is nonirritant.
Acute skin irritation test (table 2) only individual animal has and is visiblely reluctantly dispersed in erythema, without edema.Erythema greatly about painting skin after 6 hours occur, remove tested material after 24 hours erythema disappear.Nonirritant is belonged to by dermoreaction intensity evaluation standard.
Repeatedly Skin Irritation Test (table 3) increases with painting skin number of times, and erythema increases gradually, obviously, but degree is not serious.Skin wound repair score value, between 0 ~ 2, has no edema.Pathologic finding main manifestations acanthosis, cuticle thickening and hypergranulosis and other epidermises change.Have no corium to change.Pathological reaction integrated value 0 ~ 2.By evaluation criterion repeatedly Skin Irritation Test belong to without obvious irritation.
Note: * skin average response value=skin average response intensity total mark/total number of animals
Skin allergy test (table 4) performance is dispersed in erythema (sensitization rate 0) without animal, but is confined to excite position, dermoreaction intensity score value 0 ~ 1, without edema, also has no other General Symptomies.Divide generic weak sensitizer by sensitization rate intensity.
3 results: seen by experimental result, acute skin irritation test is nonirritant, illustrates that the present invention and the stimulation of control drug to skin are acceptables; Repeatedly Skin Irritation Test pathologic finding main manifestations is acanthosis, and slight erythema appears in perusal, but incidence rate is lower; Skin allergic reaction performance is similar, and sensitization rate is 0, is evaluated as weak sensitizer.According to evaluation criterion, generally causing strong irritated material with it Cavia porcellus may cause a large amount of allergy on the person, causes weak allergy sufferers with it likely maybe can not cause human body allergy Cavia porcellus.Owing to causing the reason of allergic contact dermatitis complicated in crowd, influence factor is many, and this product animal test results is weak sensitizer, can not get rid of its sensitization to sensitive group.
Conclusion: pharmaceutical through skin of the present invention is non-stimulated.
Detailed description of the invention
Embodiment 1.
Formula: Radix Arnebiae (Radix Lithospermi) 100g, Radix Sophorae Flavescentis 70g, Rhizoma Polygoni Cuspidati 70g, Blumeae preparatum Tabellae 1g.
Technique: get Radix Sophorae Flavescentis, Rhizoma Polygoni Cuspidati and Radix Arnebiae (Radix Lithospermi), add the Oleum sesami of the heavy 4-5 times amount of total medical material, heating, control temperature extracts 1-2 hour at 80 ~ 90 DEG C, and period constantly stirs, and is then cooled to room temperature, filters, adds Blumeae preparatum Tabellae powder, stir evenly, subpackage, obtain liniment in filtrate.
Usage and consumption: get and be applied to affected part in right amount, every day 4-6 time.
Embodiment 2.
Formula: Radix Arnebiae (Radix Lithospermi) 60g, Radix Sophorae Flavescentis 50g, Rhizoma Polygoni Cuspidati 50g, Blumeae preparatum Tabellae 0.5g.
Technique: dosage form is that the Glycyrrhiza Oil Compound external preparation of liniment is prepared like this; Get Radix Sophorae Flavescentis, Rhizoma Polygoni Cuspidati and Radix Arnebiae (Radix Lithospermi), the Oleum sesami adding the heavy 4-5 times amount of total medical material soaks 5 ~ 8d, and period stirs 2-5 time, filters, adds Blumeae preparatum Tabellae powder, stir evenly, subpackage, obtain liniment in filtrate.
Usage and consumption: get and be applied to affected part in right amount, every day 4-6 time.
Embodiment 3.
Formula: Radix Arnebiae (Radix Lithospermi) 120g, Radix Sophorae Flavescentis 90g, Rhizoma Polygoni Cuspidati 90g, Blumeae preparatum Tabellae 2g.
Technique: dosage form is that the Glycyrrhiza Oil Compound external preparation of patch is prepared like this;
A. Radix Arnebiae (Radix Lithospermi), Radix Sophorae Flavescentis and Rhizoma Polygoni Cuspidati is got, after adding the soak with ethanol 0.5h of the heavy 3-4 times amount 70% of total medical material, reflux, extract, 2h, cooling, filters, and reclaims ethanol, and when being concentrated into 60 DEG C, relative density is the extractum of 1.14 ~ 1.16, adds the mixing of Blumeae preparatum Tabellae powder, obtains A product;
B. separately get A product weigh 35% sodium polyacrylate, 75% carbomer, 55% glycerol, 30% propylene glycol, 2% diethylamine tetraacethyl mixing, make substrate, add A product and stir evenly, make coating, carry out paintings cream, cutting, lid serve as a contrast, be cut into small pieces, obtain patch.
Usage and consumption: get and be applied to affected part in right amount, every day 4-6 time.
Embodiment 4.
Formula: Radix Arnebiae (Radix Lithospermi) 150g, Radix Sophorae Flavescentis 100g, Rhizoma Polygoni Cuspidati 100g, Blumeae preparatum Tabellae 3g.
Technique: dosage form is that the Glycyrrhiza Oil Compound external preparation of ointment is prepared like this;
A. Radix Arnebiae (Radix Lithospermi), Radix Sophorae Flavescentis and Rhizoma Polygoni Cuspidati is got, after adding the soak with ethanol 0.5h of the heavy 3-4 times amount 70% of total medical material, reflux, extract, 2h, cooling, filters, and reclaims ethanol, and when being concentrated into 60 DEG C, relative density is the extractum of 1.14 ~ 1.16, adds the mixing of Blumeae preparatum Tabellae powder, obtains A product;
B. separately get A product, add A product and weigh the ethylparaben of 0.1%, the lanoline mixing of 18%, then add the vaseline mixing that A product weigh 2 times amount, obtain ointment.
Usage and consumption: get and be applied to affected part in right amount, every day 4-6 time.
Claims (9)
1. a Glycyrrhiza Oil Compound external preparation, is characterized in that: calculate according to composition by weight, comprise Radix Arnebiae (Radix Lithospermi) 50 ~ 150 parts, Radix Sophorae Flavescentis 50 ~ 100 parts, Rhizoma Polygoni Cuspidati 50 ~ 100 parts and Blumeae preparatum Tabellae 0.5 ~ 3 part.
2. Glycyrrhiza Oil Compound external preparation as claimed in claim 1, is characterized in that: calculate according to composition by weight, comprise Radix Arnebiae (Radix Lithospermi) 80 ~ 120 parts, Radix Sophorae Flavescentis 60 ~ 80 parts, Rhizoma Polygoni Cuspidati 60 ~ 80 parts and Blumeae preparatum Tabellae 1 ~ 2 part.
3. Glycyrrhiza Oil Compound external preparation as claimed in claim 2, is characterized in that: calculate according to composition by weight, comprise Radix Arnebiae (Radix Lithospermi) 100 parts, Radix Sophorae Flavescentis 70 parts, Rhizoma Polygoni Cuspidati 70 parts and Blumeae preparatum Tabellae 1 part.
4. a preparation method for the Glycyrrhiza Oil Compound external preparation according to any one of claim 1-3, is characterized in that: by Radix Arnebiae (Radix Lithospermi), Radix Sophorae Flavescentis, and Rhizoma Polygoni Cuspidati and Blumeae preparatum Tabellae mixing, add customary adjuvant, conveniently technique makes external preparation.
5. the preparation method of Glycyrrhiza Oil Compound external preparation as claimed in claim 4, is characterized in that: described external preparation is liniment, patch or ointment.
6. the preparation method of Glycyrrhiza Oil Compound external preparation as claimed in claim 5, it is characterized in that: described liniment is prepared like this: get Radix Sophorae Flavescentis, Rhizoma Polygoni Cuspidati and Radix Arnebiae (Radix Lithospermi), the Oleum sesami adding the heavy 4-5 times amount of total medical material soaks 5 ~ 8d, period stirs 2-5 time, filter, add Blumeae preparatum Tabellae powder in filtrate, stir evenly, subpackage, obtains liniment.
7. the preparation method of Glycyrrhiza Oil Compound external preparation as claimed in claim 5, it is characterized in that: described liniment is prepared like this: get Radix Sophorae Flavescentis, Rhizoma Polygoni Cuspidati and Radix Arnebiae (Radix Lithospermi), add the Oleum sesami of the heavy 4-5 times amount of total medical material, heating, control temperature extracts 1-2 hour at 80 ~ 90 DEG C, period constantly stirs, and is then cooled to room temperature, filters, Blumeae preparatum Tabellae powder is added in filtrate, stir evenly, subpackage, obtain liniment.
8. the preparation method of Glycyrrhiza Oil Compound external preparation as claimed in claim 5, is characterized in that: described patch is prepared like this:
A. Radix Arnebiae (Radix Lithospermi), Radix Sophorae Flavescentis and Rhizoma Polygoni Cuspidati is got, after adding the soak with ethanol 0.5h of the heavy 3-4 times amount 70% of total medical material, reflux, extract, 2h, cooling, filters, and reclaims ethanol, and when being concentrated into 60 DEG C, relative density is the extractum of 1.14 ~ 1.16, adds the mixing of Blumeae preparatum Tabellae powder, obtains A product;
B. separately get A product weigh 35% sodium polyacrylate, 75% carbomer, 55% glycerol, 30% propylene glycol, 2% diethylamine tetraacethyl mixing, make substrate, add A product and stir evenly, make coating, carry out paintings cream, cutting, lid serve as a contrast, be cut into small pieces, obtain patch.
9. the preparation method of Glycyrrhiza Oil Compound external preparation as claimed in claim 5, is characterized in that: described ointment is prepared like this:
A. Radix Arnebiae (Radix Lithospermi), Radix Sophorae Flavescentis and Rhizoma Polygoni Cuspidati is got, after adding the soak with ethanol 0.5h of the heavy 3-4 times amount 70% of total medical material, reflux, extract, 2h, cooling, filters, and reclaims ethanol, and when being concentrated into 60 DEG C, relative density is the extractum of 1.14 ~ 1.16, adds the mixing of Blumeae preparatum Tabellae powder, obtains A product;
B. separately get A product, add A product and weigh the ethylparaben of 0.1%, the lanoline mixing of 18%, then add the vaseline mixing that A product weigh 2 times amount, obtain ointment.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105147896A (en) * | 2015-10-27 | 2015-12-16 | 王秀英 | Compound bassia dasyphylla external medicament clearing fire and removing toxicity and preparing method thereof |
| CN108096347A (en) * | 2016-11-25 | 2018-06-01 | 深圳市和步健康科技有限公司 | Diaper rash treats prescription and application process |
| CN109481725A (en) * | 2018-12-12 | 2019-03-19 | 徐子寒 | A kind of instant Glycyrrhiza Oil Compound dressing and preparation method thereof |
| CN110755475A (en) * | 2019-11-27 | 2020-02-07 | 贵州泰尔医药研究所 | External preparation for treating cervicitis and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105147896A (en) * | 2015-10-27 | 2015-12-16 | 王秀英 | Compound bassia dasyphylla external medicament clearing fire and removing toxicity and preparing method thereof |
| CN108096347A (en) * | 2016-11-25 | 2018-06-01 | 深圳市和步健康科技有限公司 | Diaper rash treats prescription and application process |
| CN109481725A (en) * | 2018-12-12 | 2019-03-19 | 徐子寒 | A kind of instant Glycyrrhiza Oil Compound dressing and preparation method thereof |
| CN110755475A (en) * | 2019-11-27 | 2020-02-07 | 贵州泰尔医药研究所 | External preparation for treating cervicitis and preparation method thereof |
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| CN104523853B (en) | 2017-08-15 |
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