CN102600309B - Traditional Chinese medicine compound preparation for treating acne and seborrheic dermatitis, and preparation method and application of the compound preparation - Google Patents
Traditional Chinese medicine compound preparation for treating acne and seborrheic dermatitis, and preparation method and application of the compound preparation Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine compound preparation for treating acne and seborrheic dermatitis, comprising an active component extract and adjuvants. The active component extract is prepared from the following raw materials by weight: 2-25 parts of cassia twig, 1-15 parts of Herba Asari (Asarum heterotropoides and/or Asarum sieboldii), and at least two components of 3-35 parts of Angelica sinensis, 3-35 parts of Ligusticum chuanxiong, 1-25 parts of orris root, and 3-30 parts of Rhizoma Ligustici (Ligusticum sinense and/or Ligusticum jeholense). The compound preparation is simple and reasonable in prescription, significant in efficacy, and low in toxic and side effects. The extracts of Angelica sinensis, Ligusticum chuanxiong, Rhizoma Ligustici (Ligusticum sinense and/or Ligusticum jeholense), cassia twig, and Herba Asari (Asarum heterotropoides and/or Asarum sieboldii) are not only the effective fractions for treatment of acne and seborrheic dermatitis, but also act as a skin penetration enhancer for the abovementioned extracts and an orris root extract. According to the invention, the effective components of various medicines are extracted and then prepared into a dosage form for an external use with stable property and high convenience, and the obtained preparation can quickly and effectively treat skin diseases, such as acne and seborrheic dermatitis.
Description
Technical field
The present invention relates to compound Chinese medicinal preparation of a kind of Acne treatment, seborrheic dermatitis and preparation method thereof, relate in particular to the medicine of preparing Acne treatment, seborrheic dermatitis with pure Chinese prescription extract.
Background technology
Acne is the chronic inflammatory disease pathological changes of a kind of hair follicle relevant with sebum metabolism, sebaceous gland, because being apt to occur in adolescence, so be commonly called as " comedo ".The morbidity of acne is relevant with the metabolism of sebum, and adolescence is the stage occurred frequently.
Fat seborrheic dermatitis is a kind of inflammatory skin disease that betides seborrhea position.The multiple sebaceous gland more place that distributes of being born in, as scalp, face, chest and gauffer portion.Easily outbreak repeatedly, often with folliculitis, blepharitis, the normal and acne of face, rosacea acarid dermatitis are concurrent.
Acne and seborrheic dermatitis pathogenesis are complicated, with the increasing with gathering, skin microcirculation obstacle, Inheritance and use some cosmetics relevant with medicine of microorganism in secretion rate increase, hair follicle and the sebaceous gland of the excessive keratinization of follicular orifice, smegma sebum, therefore the simple chemicalses such as metronidazole, chloromycetin, erythromycin that use are difficult to produce a desired effect, and drug resistance is the maximum drawback of antibiotic application.
Chinese medicine has multicomponent advantage, can be for the multifactor effect of bringing into play of acne, seborrheic dermatitis morbidity simultaneously, the shortcomings such as but Chinese medicine compound kind is many, and the simple outmoded meeting of preparation process causes utilization rate of active components low, and treatment time is long, therapeutic effect is poor.
Desirable acne, seborrheic dermatitis medicine should have pain relieving fast, promote skin microcirculation, alleviate that skin hyperkeratosis, antibacterial action by force, do not produce Resistant strain, have no side effect, promote skin repair, healing cicatrix is few, non-pigment is calm, the feature such as low price, preservation are easy to use.
Summary of the invention
One of object of the present invention is to provide the compound Chinese medicinal preparation of the dermatosis such as a kind of safe, effective, low toxicity, Acne treatment easy to use, seborrheic dermatitis.
Another object of the present invention is to provide the preparation method of above-mentioned compound Chinese medicinal preparation.
In order to realize foregoing invention object, implementation procedure of the present invention is as follows:
A Chinese medicine compound external preparation for Acne treatment, seborrheic dermatitis, comprises active component extract and adjuvant, and described active component extract is that the raw material by following weight portion makes:
(1) Ramulus Cinnamomi 2-25 part, Herba Asari 1-15 part;
(2) Radix Angelicae Sinensis 3-35 part, Rhizoma Chuanxiong 3-35 part, orrisroot 1-25 part, at least two kinds of components in Rhizoma Ligustici 3-30 part.
Preferred technical scheme is, above-mentioned active component extract is preferably made by the raw material of following weight portion:
(1) Ramulus Cinnamomi 2-20 part, Herba Asari 1-10 part;
(2) Radix Angelicae Sinensis 5-25 part, Rhizoma Chuanxiong 5-25 part, orrisroot 3-20 part, at least two kinds of components in Rhizoma Ligustici 5-30 part.
Preferred technical scheme is, above-mentioned active component extract is preferably made by the raw material of following weight portion:
(1) Ramulus Cinnamomi 2-15 part, Herba Asari 1-8 part;
(2) Radix Angelicae Sinensis 5-20 part, Rhizoma Chuanxiong 5-20 part, orrisroot 3-20 part, at least two kinds of components in Rhizoma Ligustici 5-25 part.
Most preferred technical scheme is, above-mentioned active component extract is preferably made by the raw material of following weight portion:
(1) 12 parts of Ramulus Cinnamomi, 6 parts of Herba Asaris;
(2) Radix Angelicae Sinensis is 15 parts, 15 parts of Rhizoma Chuanxiongs, 6 parts of orrisroots, at least two kinds of components in 15 parts of Rhizoma Ligusticis.
Above-mentioned compound external-use preparation is O/W type ointment, O/W type microemulsion, O/W type microemulsion spray, O/W type microemulsion medical dressing, alcoholic solution spray, solution medical dressing or lipidosome gel, and in compound external-use preparation, the quality percentage composition of active component extract is 0.5%-10%.
Preparation O/W ointment raw material has: the mixture that Chinese medicine compound is extracted, and substrate auxiliary material liquid paraffin body, hexadecanol or octadecanol, triethanolamine, sodium lauryl sulphate (K12), paregal O, glycerol, polyoxyethylene nonylphenol ether and distilled water etc.
The raw material of preparation O/W type microemulsion has: the mixture that Chinese medicine compound is extracted, and emulsifying agent is that HLB value is that the non-ionic surface active agent of 8-21 is as one or more of polyoxyethylene 20 sorbitan monooleate (Tween-80), polyoxyethylene castor oil, polyoxyethylene hydrogenated Oleum Ricini 40 (Cremophor RH40), Brij92, Emulphor FM, polyoxyethylene oxypropylene oleate, PPG-5 Pilus Caprae seu Ovis alcohol ether etc.; Co-emulsifier is one or more mixture of ethanol, propylene glycol, glycerol, polyglycerin ester, hexadecanol, octadecanol etc.; Oil phase is the multiple long-chain fatty acid wet goods such as the grease self of Chinese medicine extraction or isopropyl myristate, Masine 35-1, ethyl n-butyrate., ethyl oleate, Oleum Glycines, Oleum Arachidis hypogaeae semen or Semen Maydis oil, oleic acid, Palmic acid.The O/W type microemulsion of preparation is filled into the O/W type microemulsion spray that obtains treatment skin injury in dark color (brown, black etc.) spray bottle; The O/W type microemulsion of preparation is adsorbed on medical dressing and is sealed in the O/W type micro-emulsion type medical dressing that obtains treatment skin injury in dark packing.
The raw material of preparing lipidosome gel has: Chinese medicinal compound extract, and adjuvant lecithin, cholesterol, vitamin E, glycerol, Tween-80, Acritamer 940 and distilled water etc.
The preparation method of the Chinese medicine compound external preparation of above-mentioned Acne treatment, seborrheic dermatitis, the preparation method of wherein said active component extract comprises the steps:
(1) extraction of orrisroot active component
Orris root is broken into 10-60 order powder, with 5-25 times of weight 60%-95% ethanol, divides 2-5 lixiviate, filters, and reclaims etoh solvent;
(2) in Rhizoma Ligustici, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Cinnamomi, Herba Asari, the extraction of active component adopts following any means
Rhizoma Ligustici, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Cinnamomi, Herba Asari are ground into respectively or jointly 10-60 order powder, adopt respectively or jointly CO
2supercritical extraction;
Rhizoma Ligustici, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Cinnamomi, Herba Asari are ground into respectively or jointly 10-60 order powder, add respectively or jointly 3-10 times of water gaging and soak 1-4 hour, and 100-120 ℃ of extraction by steam distillation 3-12 hour isolates distillation from distillate;
Rhizoma Ligustici, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Cinnamomi, Herba Asari are broken into respectively or jointly 10-60 order powder, with 3-15 times of weight ethanol, normal hexane or petroleum ether, divide 3-5 lixiviate, filter, and reclaim etoh solvent, normal hexane or petroleum ether;
(3) the extract that merging above-mentioned steps (1) and (2) obtains obtains active component extract.
Radix Angelicae Sinensis, nature and flavor Gan Xinwen, energy benefiting blood and regulating blood circulation, can control " wind cutting, all blood are mended all labor, and broken stagnant blood, supports fresh blood "; The pungent temperature of Rhizoma Chuanxiong is the gas medicine in blood; The orrisroot wind pain relieving of faling apart, softening the hard mass detumescent, except pus wound healing, except speckle blazes; Rhizoma Ligustici Xin Wenxin is loose, can dispersing wind and cold damp, and " controlling women's head-ornaments and skin rheumatism all over ", " disease of curing the disease, and skin defect Shao-, wine Zha, acne "; Ramulus Cinnamomi, Herba Asari, activating YANG with pungent and warm drugs, expelling pathogenic factors from muscles expelling pathogenic factors from the exterior.Modern pharmacological research shows: orrisroot mainly contains flavone compound and volatile oil, containing tectoridin, Saponin and tannin, be mainly used in treating acute pharyngitis, eczema, acute icteric infectious hepatitis, urinary obstruction, carbuncle furuncle, external can be removed freckle, vitiligo, cicatrix etc.; The effects such as the fat-soluble and volatile ingredient in the medicines such as Rhizoma Ligustici, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Cinnamomi, Herba Asari has and has putrefaction-removing granulation-promoting, analgesia, antibacterial, anticoagulant and immunomodulating, for the party's pharmacotoxicological effect provides evidence.
Advantage of the present invention and good effect:
(1) reasonable recipe of the present invention, drug effect is remarkable, and toxic action is little; (2) theoretical according to Modern Pharmaceutics and pharmacology, in prescription, the liposoluble constituent of Rhizoma Ligustici, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Ramulus Cinnamomi, Herba Asari or volatile oil are active component, are also each other and the Percutaneous absorption enhancer of orrisroot effective site; (3) the present invention adopts effective site in modern crafts high efficiency extraction compound recipe, and is prepared into the dosage form of the application such as the dermatosis that is suitable for acne, seborrheic dermatitis, production process environmental friendliness, and product stability is guaranteed.
Accompanying drawing explanation
Fig. 1 is the ointment of the prescription 1 preparation therapeutical effect to animal Acne Model.
The specific embodiment
Specifically, the present invention can form 6 concrete prescriptions, for example:
Prescription 1: Radix Angelicae Sinensis 3-35g, Rhizoma Chuanxiong 3-35g, Ramulus Cinnamomi 3-15g, Herba Asari 3-10g;
Prescription 2: orrisroot 3-15g, Radix Angelicae Sinensis 3-30g, Ramulus Cinnamomi 2-12g, Herba Asari 1-8g;
Prescription 3: Rhizoma Ligustici 3-30g, Rhizoma Chuanxiong 3-25g, Ramulus Cinnamomi 3-15g, Herba Asari 2-8g;
Prescription 4: orrisroot 3-20g, Rhizoma Ligustici 3-35g, Ramulus Cinnamomi 4-12g, Herba Asari 1-10g;
Prescription 5: Radix Angelicae Sinensis 3-35g, Rhizoma Ligustici 3-30g, Ramulus Cinnamomi 3-18g, Herba Asari 1-10g;
Prescription 6: orrisroot 3-25g, Rhizoma Chuanxiong 5-30g, Ramulus Cinnamomi 4-12g, Herba Asari 3-8g.
In above-mentioned prescription, the extracting method of effective ingredient is as follows:
(1) extraction of orrisroot effective ingredient
Get orris root and be broken into 10-80 order powder, 85% ethanol divides reflux, extract, 3-5 time, filters, and merge extractive liquid,, reclaims ethanol, obtains effective site standby;
(2) extraction of the Effective Component of Chinese Medicine such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Ligustici, Ramulus Cinnamomi, Herba Asari can adopt following any means
Get Rhizoma Ligustici, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Cinnamomi, Herba Asari, be ground into respectively or jointly 10-80 order powder, adopt respectively or jointly CO
2supercritical extraction, extract room temperature or low-temperature dark are preserved;
Get Rhizoma Ligustici, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Cinnamomi, Herba Asari, be ground into respectively or jointly 10-80 order powder, above-mentioned medicinal powder adds respectively or jointly 5-8 times of water gaging, soak 1-4 hour, 100-120 ℃ of extraction by steam distillation 3-12 hour, from distillate, isolate effective site, low-temperature dark is preserved.
Get Rhizoma Ligustici, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Cinnamomi, Herba Asari, be broken into respectively or jointly 10-80 order powder, with 3-10, doubly measure ethanol, normal hexane or petroleum ether, divide 3-5 lixiviates, filter, reclaim etoh solvent, normal hexane or petroleum ether, the effective site low-temperature dark of extraction is preserved.
(3) according to prescription, require the effective ingredient of united extraction.
The present invention can be prepared into O/W type ointment, O/W type microemulsion, O/W type microemulsion spray or the medical dressing of active component extract quality percentage composition 0.5%-10.0%, the spray of different concentration ethanol solution or medical dressing, lipidosome gel.
Embodiment 1
1, the extraction of Chinese medicine compound effective ingredient (effective site):
(1) get 50 grams of orrisroots, be ground into 20-60 order powder, 1000 mL 75% ethanol divide reflux, extract, 3-5 time, filter, and merge extractive liquid,, reclaims ethanol, obtains effective site standby;
(2) get respectively Rhizoma Ligustici decoction pieces 100g, 200 grams of angelica sinensis, Rhizoma Chuanxiong decoction pieces 120g, 100 grams of Ramulus Cinnamomi decoction pieces, Herba Asari 80g, be broken into 20-60 order powder respectively or according to prescription proportioning mixed powder, add petroleum ether (60 ℃-90 ℃) 1200mL, soak 3 hours, filter, medicinal residues, with method lixiviate 2 times again, merge petroleum ether extract, 40 ℃ of following reclaim under reduced pressure petroleum ether, obtain effective site;
(3) united extraction thing, obtains Chinese medicine compound effective site.
2, the preparation of O/W emulsifiable paste
Take the effective site 3.0g of any extraction, auxiliary material liquid paraffin body 6.0g, hexadecanol 2.0g, methyl-silicone oil 2.0g, paregal O 1.0g, glycerol 3.0g, triethanolamine are appropriate, distilled water adds to 100g.
Oil-phase component (compound effective component, liquid paraffin, hexadecanol, methyl-silicone oil) and water-phase component (paregal O, glycerol, distilled water) are heated to respectively to 80 ℃, oil phase is added in water, limit edged stirs, triethanolamine is adjusted pH to 6.8, be stirred to coldly, obtain the O/W emulsifiable paste containing 3.0% Chinese medicine compound effective ingredient.
3, the preparation of O/W type microemulsion spray, O/W type microemulsion medical dressing
Preparation 1: take 35g emulsifying agent Tween-80 and 10g co-emulsifier ethanol mixes standby; Separately get the effective site that 2.0g extracts arbitrarily, under stirring, be slowly added drop-wise in the mixture of mentioned emulsifier and co-emulsifier, more slowly add distilled water to 100g, by it high pressure homogenizer cocycle 8-15 time, or with refiner high-speed stirred 0.5-1 hour, obtain the O/W type microemulsion containing 2.0%.
Preparation 2: take 38g emulsifier polyoxyethylene castor oil hydrogenated 40 (Cremophor RH40) and 9.5g co-emulsifier 1,2-PD and mix standby; Separately get the effective site of 2.0g oil phase isopropyl myristate, the above-mentioned any extraction of 3.0g, under stirring, be slowly added drop-wise in the mixture of mentioned emulsifier and co-emulsifier, slowly add again distilled water to 100g, it is circulated 8 times under 800 bar pressure on high pressure homogenizer, or with refiner high-speed stirred 30min, obtain the O/W type microemulsion containing 3.0%.
Preparation 3: take 28g emulsifying agent Cremophor RH40,10 grams of Brij92s and 9.5g co-emulsifier ethanol and mix standby; Separately get the effective site of the above-mentioned any extraction of 5.0g, under stirring, be slowly added drop-wise in the mixture of mentioned emulsifier and co-emulsifier, slowly add again distilled water to 100g, by it high pressure homogenizer cocycle 8-15 time, or with refiner high-speed stirred 0.5-1 hour, obtain the O/W type microemulsion containing 5.0% quintessence oil.
The O/W type microemulsion of above-mentioned preparation is sub-packed in and in light tight press-type spray bottle, is O/W type microemulsion spray.
The O/W type microemulsion of above-mentioned preparation is adsorbed in medical dressing (hospital gauze, medical absorbent cotton, medical adhesive-bonded fabric etc.) and goes up and be sealed in and in light tight packaging bag, be O/W type microemulsion medical dressing.
4, the preparation of solution
Take the effective site that 3.0g extracts arbitrarily, measure 35mL medical alcohol, mix, distilled water adds to 100g, obtains the solution containing Chinese medicine compound effective site 3.0%.
The solution of preparation is sub-packed in light tight press-type spray bottle and becomes alcoholic solution spray.
The solution of above-mentioned preparation is adsorbed in medical dressing (hospital gauze, medical absorbent cotton, medical adhesive-bonded fabric etc.) and goes up and be sealed in and in light tight packaging bag, be solution medical dressing.
5, the preparation of lipidosome gel
Take the effective site that 3.0g extracts arbitrarily, 0.6g lecithin, 0.2 mg cholesterol, 0.01g vitamin E and 30 mL chloroforms, jolting is even, is placed in 500 mL eggplant-shape bottles, under 30 ℃ and reduced pressure, 100r/min rotary evaporation steams except chloroform, on bottle wall, forms uniform class membrane of lipoprotein.PBS 15 mL (pH 7.4) that add 50 ℃, 50 ℃ of ultrasonic 5min, change solution into translucent, obtain liposome suspension.It,, high pressure homogenizer cocycle 8-15 time, is put to airtight preservation in brown bottle.
Take 1.0 g Acritamer 940s, glycerol 10 mL, add PBS solution 5 mL fully to stir, and swelling is spent the night, and dripping triethanolamine adjustment pH is 6.0 ~ 6.5.Get above-mentioned liposome turbid liquor, be added drop-wise to the gel-type vehicle that swelling is good, add Tween-80 0.1 g, finally add PBS to 100 g, stir evenly, obtain the lipidosome gel containing Chinese medicine compound effective site 3.0%.
According to above-mentioned preparation method, can specifically obtain the different preparations of prescription 1～6.
Skin irritation and the pharmacodynamic experiment of embodiment 2 compound Chinese medicinal preparation of the present invention
One, irritation test
1. the ointment single-dose skin irritation test that prepared by prescription 1
8 of healthy new zealand rabbits, administration before 24 hours with electric clipper by rabbit back spinal column both sides unhairing, both sides are all about 5 cm * 10 cm.Experiment adopts consubstantiality self-contrast, and depilation district, left side is the tested district of intact skin, and left front is administration district administration 1.0 g prescription 1 ointments, left backly gives ointment blank substrate for check plot; Depilation district, right side is the tested district of injured skin, marks " # " shape wound before administration with aseptic No. 7 injection needles on skin, and wound is grown 2 cm, and wound interval 1 cm be take and scratched epidermis, do not hinder corium, has slight oozing of blood as degree.Right front is administration district, and right back is check plot, and medication is the same.After above 4 region administrations, all with 1 layer of preservative film, cover, then use immobilization with adhesive tape.After administration 6h, with antiseptic gauze, dip in normal saline and wash away tested material, the situation that erythema and edema appear in medicine-feeding part after 1,24,48,72 h removed after tested material in record respectively, and the recovery situation of above-mentioned variation, by irritating property of skin reaction standards of grading, marks.
After single-dose, blank substrate does not all cause erythema and edema to complete and damaged skin; 3.0% ointment of prescription 1 does not cause rabbit intact skin erythema and edema, and 6% ointment of prescription 1 causes the of short duration erythema of part rabbit intact skin, but has no edema; Rabbit damaged skin finds that after removing tested material slight erythema all appears in 3.0% and 6% ointment group of prescription 1, but have no edema, occurs, erythema disappears after 2 h.The results are shown in Table 1.
Single-dose skin irritation test result and the prescription 1 of other preparations that prescription 2～6 is prepared are basic identical, show preparation single-dose nonirritant of the present invention.
2. the ointment multiple dosing skin irritation test that prepared by prescription 1
Selecting body weight is 8 of the adult healthy man new zealand rabbits of 2. 0 ~ 2. 5 kg, and grouping, model production method, dosage and standards of grading are the same.Multiple dosing group administration every day 3 times, continuous 7 d, after last administration, 24 h wash away residual medicine and blank substrate with warm water, and after tested material is removed in observation, 0,24,48,72 h medicine-feeding parts have or not erythema and edema phenomenon, and the recovery situation of above-mentioned variation and recovery time.
After multiple dosing, rabbit intact skin has no erythema and edema, and damaged skin 0h has 6 animals to occur slight erythema, and 2h all disappears, and none only occurs edema.The results are shown in Table 2.
Multiple dosing skin irritation test result and the prescription 1 of other preparations that prescription 2～6 is prepared are basic identical, show that the skin irritation of preparation multiple dosing of the present invention is very little.
Two, the acute toxicity testing of the ointment of prescription 1 preparation to SD rat skin
32 of healthy SD rats, before administration, 24h loses hair or feathers spinal column both sides with 8 % sodium sulfide solutions, and 0 cm of area approximately 3. 0 cm * 4., is divided into 3 groups at random, and 8 every group, male and female half and half.I.e. the ointment test group of 3.0%, 6.0% prescription 1 and blank substrate matched group, every day, percutaneous drug delivery was 3 times, each 1.0g, successive administration 2 weeks.Raise according to a conventional method, observe rat body performance and the situation of being poisoned to death, comprise the variation of body weight, depilation district red swelling of the skin degree, hair, eyes and the mucosa of animal, the variation of breathing, circulation, central nervous system, extremity activity etc.
Separately get 32 rats, after the same method depilation grouping, with fine sandpaper (400 #), at depilation position, cause scratch, make skin occur intensive petechia, in scratch position administration, observation index is the same immediately.
3.0%, the ointment of 6.0% prescription 1 when application on the behavioral activity of normal skin rat, fur glossiness, diet, body weight etc. all without affecting; In 2 weeks, observe without any acute toxic reaction, without rats death.When 6.0% Chinese medicine compound ointment first day is applied to the rat of injured skin, in contact skin medicine moment, show twinge behavior in short-term, from second day, without any abnormal phenomena.3.0%, 6.0% ointment that shows prescription 1 does not all produce any acute toxic reaction to rat intact skin and damaged skin.
The skin the acute toxicity tests of other preparations that prescription 2～6 is prepared is identical with prescription 1, shows that preparation of the present invention does not all produce any acute toxic reaction to rat intact skin and damaged skin.
Three, the ointment skin allergy test of prescription 1 preparation
40 of healthy guinea pigs, are divided into 4 groups at random by body weight, and 10 every group, male and female half and half.Be respectively 2 experimental grouies of 3.0%, 6.0% ointment and 1 % 2,4-dinitrochlorobenzene positive controls of the blank substrate matched group of Chinese medicinal compound spray, prescription 1 preparation.Before administration, 24h takes off guinea pig back spinal column diamond wool, and the unhairing district every side of scope is about 3cm * 3cm, by warm water wiped clean gently.
Get respectively 3.0%, 6.0% ointment 0. 5 g, blank substrate 0. 5 g, 1 % 2,4-dinitrochlorobenzene 0. 2 mL and be applied to each depilation district, treated animal left side, with gauze, fix, continue, after 6 h, with warm water, to wash away residue.The 7th d and the 14th d, in kind retry once, amounts to 3 times.14d after last is to tested material sensitization, get respectively 3.0%, 6.0% ointment 0.5g, blank substrate 0. 5g of ointment, 1 % 2,4-dinitrochlorobenzene 0. 2 mL give each depilation district, treated animal right side, after 6h, remove tested material, at once observe, then in 24,48,72 h, again observe skin allergy situation.
Evaluation criterion and result of the test are marked and hypersensitive evaluation by the standards of grading of document skin allergy degree and hypersensitive evaluation criterion, observe animal simultaneously and whether have asthma, the systemic anaphylaxis that astasia or shock etc. are serious, after having tested, takes weight.
Drug test group, negative treated animal are in the observation period after exciting administration, and dermoreaction is normal, without erythema, edema, sensitization rate is 0, pressing standard determination is that animal is also without phenomenons such as asthma, astasia and shocks without allergenic substance, and each animal body mass penalty is obvious; Positive treated animal is at each stipulated time point, and all performance has the anaphylaxiss such as obvious erythema, edema, and response rate is 100%, and indivedual Cavia porcelluss have asthma phenomenon.The results are shown in Table 3.
The skin allergy test result of other preparations that prescription 2～6 is prepared is identical with prescription 1, shows that preparation prepared by the present invention is not to causing skin allergy.
The therapeutical effect of the ointment of embodiment 3 prescription 1 preparations to animal Acne Model
Animal model preparation: 18 large ear rabbits, male and female half and half, body weight 2.5 scholar 0.5kg.With coal tar, smear the rabbit ear 14 days, set up rabbit ear coal tar Acne Model.After modeling, be divided at random 3 groups, i.e. model group, treatment group and matched group.
Treatment: model group is smeared normal saline 3 times every day; Treatment group is smeared 3.0% ointment 3 times every day, each 1.0g, recovery from illness afterwards in 5 days; Matched group is smeared Chloramphenicol Tincture, every day 3 times, each 1.0mL.
Therapeutic outcome shows, as shown in Figure 1, compares with Chloramphenicol Tincture, 3.0% ointment of prescription 1 preparation can obviously improve skin lesion after 5 days, and the rabbit ear is soft, and veins beneath the skin is obvious, with normal rabbit ear color similarity pinkiness, several without secretions, it is normal that sebaceous gland and pore start to recover; Matched group skin surface still has a large amount of secretions for 5 days afterwards, and the rabbit ear is dry to harden, and color is turned white, veins beneath the skin almost illegible.
Prepared other preparations of prescription 2～6 are identical with prescription 1 to the therapeutic outcome of animal Acne Model.
The treatment of the ointment seborrheic dermatitis of embodiment 4 prescription 1 preparations is observed
According to clinical criteria, follow patient and volunteer to screen 117 routine facial patients with seborrheic dermatitis, be divided at random Chinese medicine compound emulsifiable paste group treatment group 59 examples, 1% pimecrolimus emulsifiable paste matched group 58 examples.Treatment group medicine for external application every day compound cream 4 times, matched group outer painting every day 1% pimecrolimus emulsifiable paste 2 times, respectively at observed and recorded clinical symptoms and sign after treatment beginning day and the 1st, 2 weeks.
Result: treatment group is removed 50 examples (87.44%), removes 7 examples (11.86%), total effective rate 96.6% substantially; Matched group is removed 31 examples (53.45%), substantially removes 11 examples (18.96%), total effective rate 72.41%, and both compare, and P<0.05, has significant difference.Treatment group is not observed any untoward reaction, and matched group has 7 examples to occur side effect in various degree.
Conclusion: Chinese medicine compound emulsifiable paste is that a kind of side effect is little, effect is treated facial seborrheic dermatitis active drug significantly.
Other preparations that prescription 2～6 is prepared similar to prescription 1 to the therapeutic outcome of seborrheic dermatitis.
Claims (8)
1. a Chinese medicine compound external preparation for Acne treatment, seborrheic dermatitis, comprises active component extract and adjuvant, it is characterized in that described active component extract is that raw material by following weight portion makes:
(1) Ramulus Cinnamomi 2-25 part, Herba Asari 1-15 part;
(2) Radix Angelicae Sinensis 3-35 part, Rhizoma Chuanxiong 3-35 part, orrisroot 1-25 part, at least two kinds of components in Rhizoma Ligustici 3-30 part.
2. the Chinese medicine compound external preparation of Acne treatment according to claim 1, seborrheic dermatitis, is characterized in that described active component extract is that raw material by following weight portion makes:
(1) Ramulus Cinnamomi 2-20 part, Herba Asari 1-10 part;
(2) Radix Angelicae Sinensis 5-25 part, Rhizoma Chuanxiong 5-25 part, orrisroot 3-20 part, at least two kinds of components in Rhizoma Ligustici 5-30 part.
3. the Chinese medicine compound external preparation of Acne treatment according to claim 2, seborrheic dermatitis, is characterized in that described active component extract is that raw material by following weight portion makes:
(1) Ramulus Cinnamomi 2-15 part, Herba Asari 1-8 part;
(2) Radix Angelicae Sinensis 5-20 part, Rhizoma Chuanxiong 5-20 part, orrisroot 3-20 part, at least two kinds of components in Rhizoma Ligustici 5-25 part.
4. the Chinese medicine compound external preparation of Acne treatment according to claim 3, seborrheic dermatitis, is characterized in that described active component extract is that raw material by following weight portion makes:
(1) 12 parts of Ramulus Cinnamomi, 6 parts of Herba Asaris;
(2) Radix Angelicae Sinensis is 15 parts, 15 parts of Rhizoma Chuanxiongs, 6 parts of orrisroots, at least two kinds of components in 15 parts of Rhizoma Ligusticis.
5. according to one of any described Acne treatment of claim 1 to 4, the Chinese medicine compound external preparation of seborrheic dermatitis, it is characterized in that described compound external-use preparation is O/W type ointment, O/W type microemulsion, O/W type microemulsion spray, O/W type microemulsion medical dressing, alcoholic solution spray or lipidosome gel.
6. the Chinese medicine compound external preparation of Acne treatment according to claim 5, seborrheic dermatitis, is characterized in that: in compound external-use preparation, the quality percentage composition of active component extract is 0.5%-10%.
7. the preparation method of the Chinese medicine compound external preparation of one of any described Acne treatment of claim 1 to 4, seborrheic dermatitis, is characterized in that the preparation method of described active component extract comprises the steps:
(1) extraction of orrisroot active component
Orris root is broken into 10-60 order powder, with 5-25 times of weight 60%-95% ethanol, divides 2-5 lixiviate, filters, and reclaims etoh solvent;
(2) in Rhizoma Ligustici, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Cinnamomi, Herba Asari, the extraction of active component adopts following any means
Rhizoma Ligustici, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Cinnamomi, Herba Asari are ground into respectively or jointly 10-60 order powder, adopt respectively or jointly CO
2supercritical extraction;
Rhizoma Ligustici, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Cinnamomi, Herba Asari are ground into respectively or jointly 10-60 order powder, add respectively or jointly 3-10 times of weight water soaking 1-4 hour, and 100-120 ℃ of extraction by steam distillation 3-12 hour isolates distillation from distillate;
Rhizoma Ligustici, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Cinnamomi, Herba Asari are broken into respectively or jointly 10-60 order powder, doubly measure ethanol, normal hexane or petroleum ether divide 3-5 lixiviate with 3-15, filter, and reclaim etoh solvent, normal hexane or petroleum ether;
(3) the extract that merging above-mentioned steps (1) and (2) obtains obtains active component extract.
8. the application of one of any described Chinese medicine compound external preparation of claim 1 to 4 in the medicine of preparing Acne treatment, seborrheic dermatitis.
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| CN201210018748.5A CN102600309B (en) | 2012-01-21 | 2012-01-21 | Traditional Chinese medicine compound preparation for treating acne and seborrheic dermatitis, and preparation method and application of the compound preparation |
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| CN201210018748.5A CN102600309B (en) | 2012-01-21 | 2012-01-21 | Traditional Chinese medicine compound preparation for treating acne and seborrheic dermatitis, and preparation method and application of the compound preparation |
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| CN102600309A CN102600309A (en) | 2012-07-25 |
| CN102600309B true CN102600309B (en) | 2014-03-26 |
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| CN104771428A (en) * | 2015-04-09 | 2015-07-15 | 苏州市天灵中药饮片有限公司 | Traditional Chinese medicine ointment for treating seborrheic dermatitis and preparation method thereof |
| CN110731956A (en) * | 2019-09-11 | 2020-01-31 | 苏州隽德生物科技有限公司 | Medicine for treating acne and seborrheic dermatitis and preparation method thereof |
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