CN105816494A - Medicine preparation for treating subacute eczema and chronic eczema and preparing method of medicine preparation - Google Patents
Medicine preparation for treating subacute eczema and chronic eczema and preparing method of medicine preparation Download PDFInfo
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- CN105816494A CN105816494A CN201610321206.3A CN201610321206A CN105816494A CN 105816494 A CN105816494 A CN 105816494A CN 201610321206 A CN201610321206 A CN 201610321206A CN 105816494 A CN105816494 A CN 105816494A
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- oenotherae erythrosepalae
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/237—Notopterygium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K31/355—Tocopherols, e.g. vitamin E
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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)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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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
- A61K2236/331—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
Abstract
The invention belongs to the field of medicine and particularly relates to a medicine preparation for treating subacute eczema and chronic eczema and a preparing method of the medicine preparation. The medicine preparation for treating subacute eczema and chronic eczema is prepared from, by weight, 60-80 parts of evening primrose seed oil, 10-30 parts of notopterygium root extract and 0.5-3 parts of vitamin E, and then auxiliaries commonly used in medical treatment are added to prepare the preparation. Preferably, the preparation is ointment or gel. The medicine preparation is capable of taking effect fast, convenient to apply, small in toxic or side effect, definite in treatment effect and capable of effectively treating subacute eczema and chronic eczema.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of pharmaceutical preparation treating subacute eczema, chronic eczema and preparation method thereof.
Background technology
Subacute eczema, chronic eczema disease are a kind of common skin diseases and multiple dermatosis, belong to the relatively common epidermis caused by multiple internal and external factor and the inflammatory dermatoses of high dermis.Its feature is pruritus conscious, violent, and skin lesion pleomorphism is symmetrical, has and oozes out tendency, the chronic course of disease, easy recurrent exerbation, can betide any age, any position, any season, but recur or aggravation the most later.The morbidity of eczema is in rising trend in recent years, and this may be with Climate and Environment Variation, the application in life of a large amount of chemicalss, psychentonia, and rhythm of life is accelerated, and dietary structure changes all relation.Legs eczema, eczema scrotum, breast eczema, hand eczema, anal eczema, children's face eczema etc. can be divided into according to eczema position symptom difference.
Subacute eczema, the morbidity of chronic eczema are caused by many factors interacts.Acute stage, epidermis sponge edema, vesicle in spinous layer and under angleplied laminate, it is seen that lymphocyte and neutrophilic granulocyte.The slight inflammatory cell infiltration based on lymphocyte around the expansion of high dermis thin vessels, blood vessel.Subacute, chronic phase epidermis thickens, and has parakeratosis, hyperkeratosis, slight sponge edema.Chronic phase trochanterellus significantly extends.The slight inflammatory cell infiltration based on lymphocyte around high dermis thin vessels, blood capillary number increases, endotheliocytic swelling and hypertrophy.
The traditional Chinese medical science is thought, subacute eczema, the pathogenesis of chronic eczema are eating and drinking without temperances, and the product of the pungent wind symptom of surfeit injure taste, accumulate in causing damp, and heresy of sense rheumatism is rich again hits and contaminate skin and a primary disease, damp deep sticky touching endlessly.Wind is contained and is then itched, and wet Sheng then edema is oozed out, and the disease such as blister, erosion even occurs.
At present to subacute eczema, chronic eczema medicine mainly based on hormones emulsifiable paste, curative effect is higher, but hormones emulsifiable paste medicine life-time service likely causes the side effect of atrophoderma, and more after the easy shortcoming such as recurrence；Traditional Chinese medical science routine medicine for external use is that Pulvis Indigo Naturalis plant dresses, and darkish complexion is greasy unhygienic；Chinese medicine decocting water smokes washes soak, is sometimes limited because of condition, is not welcome by patient.Therefore develop a kind of drug effect and can substitute Hormonic autacoid emulsifiable paste and side effect medicine that is little or that have no side effect has realistic meaning for treating the diseases such as skin subacute eczema, chronic eczema.
Summary of the invention
It is an object of the invention to overcome defect of the prior art, it is provided that a kind of pharmaceutical preparation treating subacute eczema, chronic eczema and preparation method thereof.This pharmaceutical preparation is the most rapid-action, easy to use, and toxic and side effects is little, determined curative effect.
The present invention is by using following technical scheme to realize.
A kind of pharmaceutical preparation treating subacute eczema, chronic eczema, including each crude drug of following weight portion: the Radix Oenotherae erythrosepalae oil of 60～80 parts, the Rhizoma Seu Radix Notopterygii extract of 10～30 parts, the vitamin E of 0.5～3 part.
Preferably, treatment subacute eczema, the pharmaceutical preparation of chronic eczema includes each crude drug of following weight portion: the Radix Oenotherae erythrosepalae oil of 60～80 parts, the Rhizoma Seu Radix Notopterygii extract of 20～35 parts, the vitamin E of 0.5～3 part.
It is furthermore preferred that treatment subacute eczema, the pharmaceutical preparation of chronic eczema include each crude drug of following weight portion: the Radix Oenotherae erythrosepalae oil of 70 parts, the Rhizoma Seu Radix Notopterygii extract of 29 parts, the vitamin E of 1 part.
Provided by the present invention for treating subacute eczema, the pharmaceutical preparation of chronic eczema can make the pharmaceutical dosage form that this area is conventional, including ointment, ointment, liniment, tincture, gel or emplastrum etc. by adding pharmaceutically acceptable any adjuvant.Preferably, the present invention is used for treating subacute eczema, the pharmaceutical preparation of chronic eczema is ointment or gel.
The pharmaceutical preparation of the present invention is made up, wherein of the Radix Oenotherae erythrosepalae oil of specified weight ratio, Rhizoma Seu Radix Notopterygii extract, vitamin E:
Radix Oenotherae erythrosepalae oil, for the oils and fats of the mature seed refinement of onagraceae plant Radix Oenotherae erythrosepalae OenotheraerythrosepalaBorb.The main composition of Radix Oenotherae erythrosepalae oil is to be in harmonious proportion emulsion, cream, improves eczema, psoriasis, helps wound healing, and fingernail is grown, and solves hair problem, and the dosage of usually 10% uses.Make that capsule is for oral administration can treat cardiovascular disease, premenstrual syndrome, climacteric syndrome etc..
Radix Oenotherae erythrosepalae main product is northern and Changbaishan area in Jilin Province of China and Liaoning Province.
Rhizoma Et Radix Notopterygii, for samphire Rhizoma Et Radix Notopterygii NotopterygiumincisumTingexH.T.Chang or the dry rhizome of Radix et Rhizoma Notopterygii NotopterygiumfranchetiiH.deBoiss. and root.There is relieving exterior syndrome and dispelling cold, expelling wind and removing dampness, the effect of pain relieving.Have a headache for anemofrigid cold, stiffness of the nape of having a headache, rheumatic arthralgia, aching pain in shoulder and back.It is also used for treating edema due to wind pathogen edema, sore swollen toxin, impotence and seminal emission, enuresis frequent micturition, chills and pain of the waist and kness, suffering from a deficiency of the kidney and breathe heavily.
It is distributed mainly under the border of ground height above sea level 2000-4200m, the shrubberies such as Shaanxi, Gansu, Qinghai, Sichuan, Tibet, the Inner Mongol, Shanxi, Ningxia, Qinghai, Hubei, in cheuch thick grass.
Radix Oenotherae erythrosepalae oil is treated coronary heart disease, obesity, diabetes and various inflammation and has been carried out numerous studies by recent domestic scholar.Radix Oenotherae erythrosepalae oil treatment scytitis be have also been made numerous studies work.Skin and the damage of mucosa are the most relevant with inflammatory reaction, study and show that inflammatory reaction and some prostaglandin and the surplus of related substances thereof and shortage are relevant.These materials are to be changed into two height-gamma-linoleic acid or arachidonic acid by gamma-linoleic acid, convert in vivo and are formed.Usual 1 is that prostate have antiinflammatory action, but arachidonic acid is under having lipoxygenase effect, also can produce some anti-inflammatory agent, and vitamin E can suppress arachidonic acid by the oxidizing process of lipoxygenase.
Radix Oenotherae erythrosepalae oil in inventive formulation is principal agent, is equipped with Rhizoma Seu Radix Notopterygii extract and vitamin E, has and dispel the wind, dehumidifying, antipruritic, effect of anti-inflammation detumescence.
Present invention also offers the preparation method of a kind of pharmaceutical preparation treating subacute eczema, chronic eczema, comprise the steps of
1) content of jeceric acid in Radix Oenotherae erythrosepalae oil is measured, obtains surveying percentage composition；
2) taking the clean medical material of Rhizoma Et Radix Notopterygii, use steam distillation distillation extraction, extraction time is preferably 3～5 hours, collects distillate, adds sodium chloride the most saturated, collects volatile oil, obtains Rhizoma Seu Radix Notopterygii extract, standby；
3) by the vitamin E mix homogeneously of Radix Oenotherae erythrosepalae oil, the Rhizoma Seu Radix Notopterygii extract of 10～30 parts and 0.5～3 part, being subsequently adding pharmaceutically acceptable adjuvant and make regular dosage form, wherein, the parts by weight of Radix Oenotherae erythrosepalae oil are
In order to further speed up the onset time of medicine, and the drug effect of pharmaceutical preparation of the present invention is performed to best, preferably the pharmaceutical preparation of the present invention is made for ointment and liniment by the adjuvant of specific consumption.
In the embodiment that pharmaceutical preparation of the present invention is ointment, consisting of of crude drug: Radix Oenotherae erythrosepalae oilRhizoma Seu Radix Notopterygii extract g part, vitamin e1 g；The substrate of excipient substance composition 900g altogether.The preparation method of ointment is:
1) content of jeceric acid in Radix Oenotherae erythrosepalae oil is measured, obtains surveying percentage composition；
2) take the clean medical material of Rhizoma Et Radix Notopterygii in distillation extraction device, preferably add 6 times of water, use steam distillation distillation extraction, preferably 4 hours, collect distillate, add sodium chloride to the most saturated, collect volatile oil, obtain Rhizoma Seu Radix Notopterygii extract, standby；
3) Radix Oenotherae erythrosepalae oil is takenRhizoma Seu Radix Notopterygii extract 29g, vitamin e1 g, add stearic acid 120g, lanoline 50g, vaseline 200g, and after mix homogeneously, heating in water bath is to 65～70 DEG C, obtains part A, standby；Weighing medicinal glycerin 60g, triethanolamine 20g, distilled water 439g, mixing post-heating, to 65～70 DEG C, obtains part B, standby；Under constant agitation, part B is added in part A, and continues stirring to 35 DEG C, subpackage and get final product.
In the embodiment that pharmaceutical preparation of the present invention is liniment, consisting of of crude drug: Radix Oenotherae erythrosepalae oilRhizoma Seu Radix Notopterygii extract 24g, vitamin e1 g；The substrate of excipient substance composition 900g altogether.The preparation method of liniment is:
1) content of jeceric acid in Radix Oenotherae erythrosepalae oil is measured, obtains surveying percentage composition；
2) take the clean medical material of Rhizoma Et Radix Notopterygii in distillation extraction device, preferably add 6 times of water, use steam distillation distillation extraction, preferably 4 hours, collect distillate, add sodium chloride to the most saturated, collect volatile oil, obtain Rhizoma Seu Radix Notopterygii extract, standby；
3) Radix Oenotherae erythrosepalae oil is takenRhizoma Seu Radix Notopterygii extract 24g, vitamin e1 g, mix homogeneously, add Oleum Terebinthinae 50ml, ethylparaben 3g, 70% ethanol 700ml, be sufficiently mixed uniformly, finally by 70 ethanol adjustment total amounts to 1000ml, subpackage, sealing, packaging, to obtain final product.
On the other hand, the invention provides treatment subacute eczema, the pharmaceutical preparation of chronic eczema prepared by said method.
Further, the pharmaceutical preparation provided by the present invention purposes in the medicine of subacute eczema, chronic eczema is treated in preparation is additionally provided.
Below by embodiment, the present invention is described in more detail, but these embodiments are not considered as limiting the invention.
Detailed description of the invention
Embodiment 1: the preparation of ointment
Crude drug: Radix Oenotherae erythrosepalae oil 70g, Rhizoma Seu Radix Notopterygii extract 29g, vitamin e1 g.
Preparation method: (1), Radix Oenotherae erythrosepalae oil measure content, calculate inventory by containing jeceric acid amount 10%；
(2), take the clean medical material of Rhizoma Et Radix Notopterygii in distillation extraction device, add 6 times of water, with steam distillation distillation extraction 4 hours, collect distillate, add sodium chloride and make saturated in right amount, collect volatile oil, obtain Rhizoma Seu Radix Notopterygii extract, standby；
(3), taking recipe quantity Radix Oenotherae erythrosepalae oil 70g, Rhizoma Seu Radix Notopterygii extract 29g, vitamin e1 g, add stearic acid 120g, lanoline 50g, vaseline 200g, after mix homogeneously, heating in water bath is to 65～70 DEG C, obtains part A, standby；Weighing medicinal glycerin 60g, triethanolamine 20g, distilled water 439g, mixing post-heating, to 65～70 DEG C, obtains part A, standby；Under constant agitation, part B is added in part A, and continues stirring to 35 DEG C, subpackage and get final product.
Embodiment 2: the preparation of liniment
Crude drug: Radix Oenotherae erythrosepalae oil 75g, Rhizoma Seu Radix Notopterygii extract 24g, vitamin e1 g.
Preparation method: (1), Radix Oenotherae erythrosepalae oil measure content, calculate inventory by containing jeceric acid amount 10%；
(2), take the clean medical material of Rhizoma Et Radix Notopterygii in distillation extraction device, add 6 times of water, with steam distillation distillation extraction 4 hours, collect distillate, add sodium chloride and make saturated in right amount, collect volatile oil, obtain Rhizoma Seu Radix Notopterygii extract, standby；
(3), take recipe quantity Radix Oenotherae erythrosepalae oil 75g, Rhizoma Seu Radix Notopterygii extract 24g, vitamin e1 g, mix homogeneously, add Oleum Terebinthinae 50ml, ethylparaben 3g, 70% ethanol 700ml, it is sufficiently mixed uniformly, finally adjusts total amount to 1000ml, subpackage with 70 ethanol, sealing, packaging, to obtain final product.
Test example 1: anti-inflammation test
1, test specimen and reagent
Of the present invention group: the ointment (containing Radix Oenotherae erythrosepalae oil 8%, Rhizoma Seu Radix Notopterygii extract 2.9%) prepared according to the embodiment of the present application 1.
Positive controls 1: Dexamethasone ointment (containing dexamethasone 0.02%), our company produces.
Positive controls 2: add Radix Oenotherae erythrosepalae oil according to substrate used by the embodiment of the present application 1 and prepare (containing Radix Oenotherae erythrosepalae oil 8%).
Positive controls 3: add Rhizoma Seu Radix Notopterygii extract according to substrate used by the embodiment of the present application 1 and prepare (containing Rhizoma Seu Radix Notopterygii extract 2.9%).
Negative control group: prepare according to substrate complete used by the embodiment of the present application 1.
Reagent: histamine phosphate is Switzerland's Fluka product；Carrageenin provides for Liaoning institute of materia medica；DNFB (chemical pure), Tianjin Chemical Reagents Factory No.1.
2, experimental animal
Kun Ming mice, body weight 24～28g, male and female half and half；SD rat, body weight 150～200g, male and female half and half.
3, test method
(1) impact on mice dimethylbenzene dropsy of ear
Taking white mice 50, be randomly divided into five groups, 0.2g medicine is applied in mouse right ear shell two sides respectively, matched group gives the comparison medicine of same dose simultaneously.Once a day, continuous two days, after last coating 1 hour, dimethylbenzene is dripped and causes inflammation, every 0.03ml in mouse right ear shell two sides.After causing scorching two hours, mice dislocation is put to death, lays left and right two auricles of white mice with a diameter of 9mm card punch respectively, weigh, and using this weight difference as swelling index.The results are shown in Table 1.
The impact on mice dimethylbenzene dropsy of ear of table 1 test specimen
| Group | Mus number (only) | Two auricle weight differences (mg) | P |
| Inventive samples group | 10 | 8.10±1.378 | ＜ 0.001 |
| Positive controls 1 | 10 | 7.08±1.171 | ＜ 0.001 |
| Positive controls 2 | 10 | 12.80±1.237 | ＜ 0.05 |
| Positive controls 3 | 10 | 9.22±1.754 | ＜ 0.01 |
| Negative control group | 10 | 17.20±1.373 |
From table 1 result, inventive samples group matched group each from the positive all has different inhibitory action to mice dimethylbenzene dropsy of ear.Wherein positive controls 1 is slightly stronger than invention sample sets, but without significant difference, shows that inventive samples group has obvious inhibitory action to mice dimethylbenzene dropsy of ear, and its action intensity is close to dexamethasone.And it is used alone the effect that any principal agent all can not reach close.
(2) impact on Rat Carrageenan colloidality foot swelling
Taking rat 24, be randomly divided into four groups, three coating group dosage are respectively high, medium and low three grades.Wherein, middle dosage group medicine be inventive samples add equivalent substrate prepare；Low dose group medicine be middle dosage group medicine add again equivalent substrate prepare.Rats by intraperitoneal injection pentobarbital (35mg/kg) first to be allowed to be in narcotism during experiment, then as shown in table 2, respectively organize medicine, respectively medicine is applied in the right metapedes foot back of the body two sides of rat, matched group smears substrate simultaneously, and after 1 hour, the carrageenin with 1% causes inflammation under the multitudinous aponeurosis (aponeuroses) of Rat Right metapedes.After causing inflammation, coating once, then surveyed foot swelling once at interval of 1 hour again, totally seven times.The results are shown in Table 2.
The impact on Rat Carrageenan colloidality foot swelling of table 2 test specimen
Table 2 result shows, inventive samples dosage group high, middle has obvious inhibitory action to Rat Carrageenan colloidality foot swelling.Its swelling degree is significantly lower than matched group, P ＜ 0.01 compared with matched group.
(3) impact on rat dextran foot swelling
Take rat 28, be randomly divided into four groups, the scorching method of drug dose, coating method and cause, anaesthesia dosage equivalent (2) impact on Rat Carrageenan colloidality foot swelling.After anesthesia, rat is caused inflammation with 1% dextran, 1 hour thereafter, start to measure foot swelling, totally six times.The results are shown in Table 3.
The impact on rat dextran foot swelling of table 3 test specimen
Table 3 result shows, product of the present invention has certain inhibitory action to foot swelling caused by rat dextran, and preferably high dose group effect, significant difference.
(4) impact on rat skin capillary permeability
Take 20 rats, it is randomly divided into three groups, then by some for back part of animal skin cropping, after coating 1 hour, at rat back cropping, intradermal injection histamine 2 00 μ g/k is only, and tail vein injection 1%EvansBlue0.4ml/100g immediately, sacrificed by decapitation rat after 20 minutes, coloring skin speckle two diameters in length and breadth are measured in peeling, are averaged radius calculation area.Then coloring skin speckle is shredded, puts into acetone---in normal saline (7 3) solution, soak 24 hours, centrifugal 2000 revs/min, after 10 minutes, take the colorimetric determination at 610nm of supernatant spectrophotometer.The results are shown in Table 4.
The impact on rat capillary permeability of table 4 test specimen
| Group | Mus number (only) | Skin speckle area (mm2) | Optical density (OD) |
| Negative control group | 7 | 866.20±106.970 | 0.29±0.054 |
| Positive controls 1 | 7 | 459.62±57.131** | 0.14±0.022* |
| Inventive samples group | 6 | 366.13±66.310** | 0.14±0.035* |
From table 4 result, inventive samples has obvious inhibitory action to being increased by the rat skin capillary permeability caused by histamine, and action effect is suitable with dexamethasone.
(5) impact on mice delayed hypersensitivity
Take mice 49, be randomly divided into five groups, medicine coating shown according to the form below, once a day, with 7%DNCB (2,4-dinitrochlorobenzene) acetone soln to mouse back subcutaneous injection 0.02ml/ only, after the tenth day, mouse right ear only it is applied to again with 1%DNCB acetone soln 0.03ml/, put to death animal after 16 hours, take two auricles with 9mm card punch, weigh with balance, obtain the weight difference of two ears, in this, as the index of delayed allergy inflammation swelling.The results are shown in Table 5.
The impact on mice delayed hypersensitivity of table 5 test specimen
| Group | Mus number (only) | Skin speckle area (mm2) | P |
| Negative control group | 10 | 7.10±0.957 | |
| Positive controls 1 | 11 | 7.64±0.861 | ＞ 0.05 |
| Positive controls 2 | 10 | 8.39±1.169 | ＞ 0.05 |
| Positive controls 3 | 9 | 6.60±0.888 | ＞ 0.05 |
| Inventive samples group | 9 | 5.67±0.866 | ＞ 0.05 |
Table 5 result shows, inventive samples has certain inhibitory action to mice delayed hypersensitivity.Two ear weight differences reduce compared with matched group, but not statistically significant.Effect degree is better than dexamethasone.
4, result
Inventive samples has obvious inhibitory action to mice dimethylbenzene dropsy of ear, Rat Carrageenan colloidality, dextran foot swelling also there is obvious inhibitory action, and increasing of rat capillary permeability caused by allergic mediators histamine can be suppressed significantly, mice delayed hypersensitivity there is is certain antagonism.The inflammatory seep that multiple proinflammatory agent is caused by visible product of the present invention, the inflammation that edema and allergic mediators cause all has obvious inhibitory action, and the allergic inflammation with immunologic mechanism participation is also had certain inhibitory action.Show that product of the present invention has obvious antiinflammatory, anti-allergic effects.
Above-mentioned experiment is it is also shown that after Radix Oenotherae erythrosepalae oil and Rhizoma Seu Radix Notopterygii extract composition compound recipe, work in coordination with mutually in terms of antiinflammatory, anti-allergic effects, and the effect of being allowed to is obviously enhanced.This experiment is laid a good foundation for Dermatitis conditions such as its treatment eczemas of clinical practice.And prove that the evident in efficacy of compound preparation is better than single medicine effect, and its action intensity is not less than the hormone of quantity, and this will provide a kind of new external used medicine for clinic.
Test example 2: skin permeation test in vitro
1, test specimen
The ointment (containing Radix Oenotherae erythrosepalae oil 8%, Rhizoma Seu Radix Notopterygii extract 2.9%) prepared according to the embodiment of the present application 1.
2, experimental animal and reagent
Animal: rat body weight 150～180g, male.
Reagent: ethylene glycol, potassium hydroxide, dehydrated alcohol, pentobarbital sodium.
3, test method
Take 16 rats and be randomly divided into two groups, lumbar injection pentobarbital sodium 35mg/kg, it is allowed to be in narcotism.Quantitatively weigh inventive samples 0.30g, be applied to back of the body two sides at the bottom of Rat Right metapedes.
Immediately medicine is all taken off after (1) first treated animal coating.Take off skin surface after second treated animal coating 3 hours and remain whole ointment.Then pressing the determination in quality standard, record two groups of gamma-linoleic acid content meansigma methodss reclaimed in ointment, decrement is skin absorption amount.
Comparision contents before and after the absorption of table 6 test specimen
| Group | Mus number (only) | Gamma-linoleic acid average content (%) | Difference before and after absorption |
| Before medicine is absorbed | 8 | 0.617 | |
| After medicine is absorbed | 8 | 0.350 | 0.267 |
It is 0.617% and 0.350% that result records two groups of gamma-linoleic acid content meansigma methodss reclaimed in ointment, and the difference before and after drug absorption, i.e. skin absorption amount are 0.267%.
(2) after ointment takes off, right metapedes 5ml dehydrated alcohol is rinsed 3 times, then by animal sacrificed by decapitation, take off right metapedes and be placed in 5.5ml dehydrated alcohol immersion 24 hours, 2500 revs/min are centrifuged 10 minutes, take supernatant at ultraviolet spectrophotometer 269 ± 1nm, measure optical density, compare with dehydrated alcohol, the results are shown in Table 6.
Comparision contents before and after the absorption of table 7 test specimen
| Group | Mus number (only) | Optical density (OD) | P |
| Before medicine is absorbed | 8 | 0.070±0.007 | |
| After medicine is absorbed | 8 | 0.149±0.0109 | ＜ 0.001 |
4, result of the test
Above-mentioned test shows, inventive samples has preferable Absorption on skin, thus preferably serves due antiinflammatory action.
Test example 3: animal acute toxicity test
1, laboratory animal: Kun Ming mice, body weight 18～22g, male and female half and half.
2, medication: take 20 mices, by every mouse back shaving about 4cm2, and the most single cage is raised.This product (containing Radix Oenotherae erythrosepalae oil 24%, Rhizoma Seu Radix Notopterygii extract 9%) is applied at mouse back shaving skin, smears continuously twice in one day.Observe one week.
3, experimental result: after white mice coating, observes one week, has no untoward reaction.Without dead example.Animal diet followed, activity are the most normal.Coating position hair growth is good.Non-toxic reaction, also cannot record LD50.
Test example 4: long-term toxicity test for animals
(1) toxicity test to animal normal skin
1, test material
(1) experimental animal: Cavia porcellus, body weight 190～220g, male and female half and half.
(2) medicine and dosage: ointment sample of the present invention, point three dosage groups.High dose group (containing Radix Oenotherae erythrosepalae oil 24%, Rhizoma Seu Radix Notopterygii extract 9%), middle dosage group (containing Radix Oenotherae erythrosepalae oil 16%, Rhizoma Seu Radix Notopterygii extract 6%), low dose group (containing Radix Oenotherae erythrosepalae oil 8%, Rhizoma Seu Radix Notopterygii extract 3%).Substrate completely.
2, test method
32 Cavia porcelluss are randomly divided into four groups, i.e. negative control group and high, medium and low three of medicine is coated with pharmaceutical quantities group.Then by every guinea pig back cropping about 49cm respectively2Account for its body surface area 17% (calculating by Mech formula).Blank group smears substrate, and other are respectively organized the most successively by various dose medicine coating respectively.Every day 2 times, continuous 35 days.Weigh weekly once.
(1), after continuous 35 days coatings of Cavia porcellus each dosage group, animal diet followed, outward appearance and growth conditions are without exception.Coating position hair produces good.Its body weight increases.Without significant difference between each group.The results are shown in Table 8.
The table 8 test specimen long term administration impact on Cavia porcellus body weight
(2) test finds no anaphylaxis to occur, to skin also without obvious zest.
(3) skin histology is observed: after above-mentioned animal sacrificed by decapitation, takes the skin at coating position respectively, does pathological section.Histological observation is made under general optical microscope.On epidermis, corium morphosis, do not see obvious difference between administration group and negative control group, i.e. do not see that this trial drug causes obvious morphologic change at local skin.
(4) tissue examination of routine blood test, Liver and kidney function and main organs；After above-mentioned Cavia porcellus sacrificed by decapitation, take blood, win the heart, liver, spleen, lung, kidney make pathological examination.The results are shown in Table 9.
Table 9 test specimen is the conventional and impact of main organs on guinea pig blood
Test example 5: clinical study results
The ointment of application the embodiment of the present application 1 compares with Dexamethasone ointment, uses Multicenter controlled study, observes the Ointment in Treatment subacute eczema of the present invention, the Clinical efficacy and safety of chronic eczema, observes 422 examples altogether, wherein treatment group 317 example, matched group 105 example.
(1) object and method
All patient is and treats at hospital, age 3～65 years old, and sex, occupation do not limit, and minority has previously medication history, and corticosteroid formulations, antifungal agents are crossed in external.Traditional Chinese medical science cardinal symptom is skin pruritus, redness, edema, blister, oozes out, after to have held pathogenic heat person's skin lesion under the arm rubescent, rotten to the corn.
Clinical anti-eczema is divided into three types: damp-heat type (belonging to acute eczema), damp abundance due to splenic asthenia type (belonging to subacute eczema), blood-deficiency and wind-dry type (belonging to chronic eczema).Damp abundance due to splenic asthenia type (belonging to subacute eczema), blood-deficiency and wind-dry type (belonging to chronic eczema) are observed and have been treated by product of the present invention and Dexamethasone ointment clinically, are placed under identical conditions, use double-blind method, and random packet is carried out.
(2) Therapeutic Method
Of the present invention group with the ointment exterior coating treatment of the embodiment of the present application 1,3 times on the one, affected part is coated with and puts on the skin.The Dexamethasone ointment exterior coating treatment that matched group produces with people pharmaceutical Co. Ltd, 3 times on the one.
During observation, except using in addition to experimental drug, without other desensitizations, antiinflammatory, any medicine such as antipruritic.
(3) curative effect judging standard
Recovery from illness: erythra all disappears, gargalesthesia disappears.
Effective: deflorescence more than 60%, gargalesthesia substantially alleviates.
Effective: deflorescence 20%～60%, gargalesthesia alleviates..
Invalid: deflorescence is less than 20%, and gargalesthesia improves relatively slightly or without improving.
(4) result
The clinical efficacy data results of of the present invention group and matched group is shown in Table 10.
Of the present invention group of table 10 and the clinical efficacy data of matched group
(5) conclusion
The result of table 10 shows, all there were significant differences for the symptom and sign integration before and after of the present invention group and treatment of control group, and the total effective rate of of the present invention group is higher than matched group.Of the present invention group, matched group during clinical research, all there is not untoward reaction, do not find toxic and side effects yet.It is evident in efficacy that product the most of the present invention is that one treats subacute eczema, chronic eczema, the medicine that safety is high.
The foregoing is only presently preferred embodiments of the present invention, not in order to limit the present invention, all within the spirit and principles in the present invention, any modification, equivalent substitution and improvement etc. made, should be included within the scope of the present invention.
Claims (10)
1. the pharmaceutical preparation treating subacute eczema, chronic eczema, it is characterised in that include each crude drug of following weight portion: the Radix Oenotherae erythrosepalae oil of 60～80 parts, the Rhizoma Seu Radix Notopterygii extract of 10～30 parts, the vitamin E of 0.5～3 part.
Treatment subacute eczema the most according to claim 1, the pharmaceutical preparation of chronic eczema, including each crude drug of following weight portion: the Radix Oenotherae erythrosepalae oil of 60～80 parts, the Rhizoma Seu Radix Notopterygii extract of 20～35 parts, the vitamin E of 0.5～3 part.
Treatment subacute eczema the most according to claim 1, the pharmaceutical preparation of chronic eczema, it is characterised in that include each crude drug of following weight portion: the Radix Oenotherae erythrosepalae oil of 70 parts, the Rhizoma Seu Radix Notopterygii extract of 29 parts, the vitamin E of 1 part.
4. according to claims 1 to 3 arbitrary described treatment subacute eczema, the pharmaceutical preparation of chronic eczema, it is characterised in that also include the pharmaceutically acceptable adjuvant for making ointment, ointment, liniment, tincture, gel or emplastrum.
Treatment subacute eczema the most according to claim 4, the pharmaceutical preparation of chronic eczema, it is characterised in that: described preparation is ointment or gel.
6. the preparation method of the pharmaceutical preparation treating subacute eczema, chronic eczema, it is characterised in that comprise the steps of
1) content of jeceric acid in Radix Oenotherae erythrosepalae oil is measured, obtains surveying percentage composition；
2) take the clean medical material of Rhizoma Et Radix Notopterygii, use steam distillation distillation extraction, collect distillate, add sodium chloride the most saturated, collect volatile oil, obtain Rhizoma Seu Radix Notopterygii extract, standby；
3) by the vitamin E mix homogeneously of Radix Oenotherae erythrosepalae oil, the Rhizoma Seu Radix Notopterygii extract of 10～30 parts and 0.5～3 part, being subsequently adding pharmaceutically acceptable adjuvant and make conventional formulation, wherein, the parts by weight of Radix Oenotherae erythrosepalae oil are
Treatment subacute eczema the most according to claim 6, the preparation method of pharmaceutical preparation of chronic eczema, it is characterised in that described conventional formulation is ointment, and the preparation method of described ointment is:
1) content of jeceric acid in Radix Oenotherae erythrosepalae oil is measured, obtains surveying percentage composition；
2) take the clean medical material of Rhizoma Et Radix Notopterygii, use steam distillation distillation extraction, collect distillate, add sodium chloride the most saturated, collect volatile oil, obtain Rhizoma Seu Radix Notopterygii extract, standby；
3) Radix Oenotherae erythrosepalae oil is takenPart, Rhizoma Seu Radix Notopterygii extract 29 parts, vitamin e1 part, add stearic acid 120 parts, lanoline 50 parts, 200 parts of vaseline, and after mix homogeneously, heating in water bath is to 65～70 DEG C, obtains part A, standby；Weighing medicinal glycerin 60 parts, triethanolamine 20 parts, distilled water 439 parts, mixing post-heating, to 65～70 DEG C, obtains part B, standby；Under constant agitation, part B is added in part A, and continues stirring to 35 DEG C, subpackage and get final product.
Treatment subacute eczema the most according to claim 6, the preparation method of pharmaceutical preparation of chronic eczema, it is characterised in that described preparation is liniment, and the preparation method of described liniment is:
1) content of jeceric acid in Radix Oenotherae erythrosepalae oil is measured, obtains surveying percentage composition；
2) take the clean medical material of Rhizoma Et Radix Notopterygii, use steam distillation distillation extraction, collect distillate, add sodium chloride the most saturated, collect volatile oil, obtain Rhizoma Seu Radix Notopterygii extract, standby；
3) Radix Oenotherae erythrosepalae oil is takenG, Rhizoma Seu Radix Notopterygii extract 24g, vitamin e1 g, mix homogeneously, add Oleum Terebinthinae 50ml, ethylparaben 3g, 70% ethanol 700ml, be sufficiently mixed uniformly, finally by 70 ethanol adjustment total amounts to 1000ml, subpackage, sealing, packaging, to obtain final product.
9. treatment subacute eczema, the pharmaceutical preparation of chronic eczema prepared according to the arbitrary described preparation method of claim 6 to 8.
10. one kind according to the arbitrary described pharmaceutical preparation of claim 1 to 5 or 9 preparation treatment subacute eczema, chronic eczema medicine in purposes.
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| CN110801461A (en) * | 2019-11-15 | 2020-02-18 | 健民药业集团股份有限公司 | Aerosol for treating eczema |
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| CN101091735A (en) * | 2006-06-21 | 2007-12-26 | 杨文龙 | Gel preparation for treating subacute eczema and chronic eczema, and preparation method |
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| CN101091735A (en) * | 2006-06-21 | 2007-12-26 | 杨文龙 | Gel preparation for treating subacute eczema and chronic eczema, and preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110801461A (en) * | 2019-11-15 | 2020-02-18 | 健民药业集团股份有限公司 | Aerosol for treating eczema |
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Application publication date: 20160803 |