CN104398472A - Dithranol oiling agent and preparation process thereof - Google Patents
Dithranol oiling agent and preparation process thereof Download PDFInfo
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- CN104398472A CN104398472A CN201410734577.5A CN201410734577A CN104398472A CN 104398472 A CN104398472 A CN 104398472A CN 201410734577 A CN201410734577 A CN 201410734577A CN 104398472 A CN104398472 A CN 104398472A
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Abstract
The invention provides a dithranol oiling agent which comprises the following medicines and auxiliary components in parts by weight: 1 part of dithranol and 100 parts of an oily matrix, wherein the oily matrix is a mixture of albolene and liquid paraffin. The invention also provides a preparation process for the dithranol oiling agent. The dithranol oiling agent provided by the invention is suitable for treating head psoriasis and has the advantages of good dspersity, simple in preparation, stable in quality, appropriate in consistency, good in ductility and the like; the dithranol oiling agent cannot be putrid, is hard to breed bacteria and has simple prescription, simple process flow and low cost. The novel drug, namely the dithranol oiling agent with the advantages of definite treatment effect, small side effect and low cost is provided by the invention to treat the head psoriasis.
Description
Technical field
The present invention relates to a kind of external preparation of dithranol, particularly relate to a kind of dithranol oil preparation and preparation technology thereof, belong to pharmaceutical preparations technology field.
Background technology
Psoriasis be a kind of involve skin, mucosa and joint have a strong impact on the able-bodied autoimmune disease of patient, because the factors such as environmental change and operating pressure increase cause onset of psoriasis rate in rising trend over nearly 20 years.Because this disease is the autoimmunity hereditary excited by inside and outside triggering factors on the basis of genetic background, can not effect a radical cure.Wherein head is the position that psoriasis is the most easily invaded, and the psoriatic up to 80% can involve head, and the lesions of patients of 1/4 only betides head and do not involve other positions.Head psoriasis is due to pruritus, desquamation and be positioned at exposure portion, causes great mental pressure to patient.
Dithranol has another name called anthraline, dithranol, is the anthracyclinone derivatives of synthetic, is used for the treatment of the history that psoriasis has had 95 years.Galewsky in 1916 etc. have synthesized dithranol for psoriatic treatment.Dithranol is strong reductant, suppressing epidermal cell proliferation, the differentiation of induction epithelial cell, making the mechanism such as enzyme relevant in skin lesion recovers normal, inflammation that is that alleviate skin lesion district reach the psoriatic effect for the treatment of by reducing DNA synthesis.
Dithranol with its curative effect certainly, cheap, prolonged application is without system untoward reaction and have and keep longer paracmastic feature more afterwards, is one of psoriatic first-selected external used medicine for the treatment of always.But the dithranol preparation of external clinically is at present Anthra-Derm, and it does not dissolve in water, medicine eccysis inconvenience, easy pollution clothes, especially can not be used for head curing psoriasis, if because ointment is outer for head, hair is bonded together, cleans very difficult.Therefore, in order to dithranol can be made to be used for the treatment of head psoriasis, in the urgent need to developing the dosage form of applicable head feature.
Summary of the invention
The object of the invention is for the deficiencies in the prior art, by carrying out large quantity research to the prescription of preparation and technique, providing one to can be used for treatment head psoriasis, and good effect, the better tolerance of patient, cheap dithranol oil preparation and preparation technology thereof.
Although dithranol is used for the treatment of the history that psoriasis has had nineties years, but be not all made into oil preparation, for the psoriatic treatment of scalp sites, one of them reason may be always, in vitro tests finds, dithranol discharges slowly in cream base, poor permeability.And the dithranol oil preparation of the present inventor's research and development selects suitable cream base and preparation technology, overcome the deficiencies in the prior art completely, reach the object that head psoriasis is cured.
Specifically, the present invention is achieved through the following technical solutions: a kind of dithranol oil preparation, comprises medicine and the adjunct ingredient of following weight proportion: dithranol 1 part, oleaginous base 100 parts; Described oleaginous base is: the mixture of white vaseline and liquid paraffin.The ratio of described white vaseline and liquid paraffin is 2:8-7:3, is preferably 4:6.
Now there are some researches show, dithranol is in water or containing all unstable in the larger functional group reagent of polarity or adjuvant, easy degraded, therefore, the oil-soluble substrate that the present invention adopts polarity less is as adjuvant, inventor has carried out large quantity research to the composition of adjuvant and ratio, finally determines that adjuvant adopts vaseline and liquid paraffin.Because dithranol is almost insoluble in vaseline, liquid paraffin matrix, be dispersed in substrate mainly with particle state greatly, form suspension type oil preparation.Inventor has also carried out white vaseline-liquid paraffin different proportion (2:8,3:7,4:6,5:5,7:3) the preparation of bare substrate, to its viscosity, coating condition is investigated, result of the test shows, the ratio of white vaseline and liquid paraffin is between 2:8-7:3, and wherein the optimal proportion of white vaseline-liquid paraffin is 4:6, and now substrate viscosity is the most suitable, be convenient to coating, be best suited for head psoriasis.
The present invention is oil preparation, adopts conventional specification 1%.Dithranol is principal agent, and white vaseline, liquid paraffin are oil adjuvant, is applied on skin and can forms closure oil film, promotes skin hydration effect, has softening and protective effect to epidermis.
The present invention also provides a kind of preparation technology of dithranol oil preparation, and step is as follows:
(1) get principal agent dithranol, after pulverizing, cross 180 mesh sieves, for subsequent use;
(2) get white vaseline-liquid paraffin matrix and be heated to about 80 DEG C, filter while hot with fine cloth or No. seven copper wire sieves after melting, removing impurity; And then be heated to 150 DEG C, and be incubated and within 1 hour, carry out sterilizing and removing moisture, for subsequent use;
(3) treat that white vaseline-liquid paraffin matrix temperature is down to about 50 DEG C, the substrate that takes a morsel and principal agent mixed grinding, then join in remaining substrate, homogenizing stirs 15 ~ 30 minutes, and principal agent is mixed homogeneously with substrate;
(4) semi-finished product content checks;
(5) fill, packaging, Quan Jian, warehouse-in.
For studying most suitable preparation temperature condition, inventor has carried out microscopy test respectively to sample prepared by 40 DEG C of-70 DEG C of different temperatures, and result shows that less than the 60 DEG C oil preparation sample particle prepared are all random, is all less than 80 μm, and nodeless mesh phenomenon; Although the oil preparation sample particle of 70 DEG C of preparations is all less than 80 μm, there is bar-shaped crystallization, had crystalline polamer.Prepare oil preparation when illustrating that temperature is higher and can cause crystallize, should prepare oil preparation below 60 DEG C, optimum selection is 50 DEG C and prepares oil preparation sample.
Because crude drug granularity may make a significant impact bioavailability and clinical efficacy, also may affect the content uniformity of preparation simultaneously.Crude drug particle diameter is excessive, and the drug molecule directly having contacted drug action with patient skin will reduce, and curative effect reduces; Crude drug granularity is less, possible bioavailability and clinical efficacy better, the content uniformity of preparation is better, but crude drug particle diameter is too little, the drug molecule directly having contacted drug action on the one hand with patient skin will increase greatly, because this medicine has certain zest, toxic and side effects may also can increase, and on the other hand, the processing cost of raw material also can increase.The present inventor is through repeatedly studying discovery, and dithranol is by 180 mesh sieves, and the oil preparation particle of preparation is below 10 μm, and prepared oil preparation effect is best.
In addition, oil preparation of the present invention, without the need to adding antiseptic, avoids antiseptic likely on the skin stimulation produced and the impact that may produce the stability of principal agent.And without the need to adding antioxidant, can retention properties stable, avoid the increase adding the technology difficulty that antioxidant brings simultaneously.This is because: 1. dithranol oil preparation take hydrocarbons as substrate, and character is extremely stable, does not occur corrupt and becomes sour, not easy bacteria-developing; 2. in present invention process, vaseline and liquid paraffin are heated to 150 DEG C 1 hour, not only sterilizing but also dewater; 3. principal agent is not moisture, and qualified through microbial limit control.
Further, the present invention also adopts that animal experiment carries out dithranol oil preparation rabbit irritation test, Cavia porcellus smears dithranol oil preparation skin anaphylactic test, result shows: it is 1% dithranol oil preparation that Japan large ear rabbit smears concentration, successive administration 7 days, every day 1 time, have slight to moderate stimulation to rabbit skin, drug withdrawal is after 14 days, and skin can return to normally substantially; The animal of dithranol oil preparation treated animal skin allergic reaction result erythema edema total score >=2 is 0 example, belongs to weak sensitization but has certain zest to skin.Sensitization rate is 0, belongs to weak sensitization, predictably anthrol oil preparation cause human body skin to occur anaphylactoid probability is very little.
By dithranol oil preparation of the present invention, be used for the treatment of scalp psoriasis, obtain good clinical effectiveness, be described further below in conjunction with clinical data.
1 data and method
1.1 case-data
Inclusion criteria: 18-65 year, scalp suffers from psoriatic patient, men and women does not limit, and obtains patient to agree to, and signs Informed Consent Form.Exclusion standard: (1) has whole body or localized contact allergy sufferers to dithranol or triamcinolone acetonide; (2) have the clinical manifestation of systemic infection, or erythra local merges antibacterial or fungal infection; (3) anemia of pregnant woman, plan gestation and women breast-feeding their children; (4) there are obvious endocrine system disease, psychosis, hematopathy, hepatorenal disease, cardiovascular and cerebrovascular disease and immunologic hypofunction person, have tumor history or suffer from tumor person; (5) use other medicine that can affect the psoriasis state of an illness (as lithium agent, epinephrine, receptor blocking agent etc.) simultaneously.(6) the systemic immunity therapists such as corticosteroid, immunosuppressant or NSAID (non-steroidal anti-inflammatory drug) are applied in nearly 4 weeks; (7) systemic anti-curing psoriasis person was once accepted in nearly 4 weeks; Once the anti-curing psoriasis person in regular local was accepted in (8) 4 weeks.
1.2 medicine
Compound recipe triamcinolone acetonide liniment and 1% dithranol oil liniment, prepare by Shandong Dermatopathy Cypridopathy Prevention and Cure Institute Drug Manufacturing Room.
1.3 Therapeutic Method
By the method for table of random number, choose test group and matched group, test group patient uses the dithranol oil liniment treated of 1%; matched group uses compound recipe triamcinolone acetonide liniment treated; determine whether give patient haircut according to patients'wT, before coating, cleaning affected part, dips medicine with hairbrush during treatment and is carefully applied in affected part; treatment every day once; totally 4 weeks, during further consultation, patient was as can not resistance to irriate, then suspend treatment; external protective cream, continual cure after recovering.
1.4 observe and index
Within every 2 weeks, follow up a case by regular visits to 1 time, altogether treat 4 weeks, treatment before and after carry out the skin being grievously injured degree evaluation and hematuria routine, hepatic and renal function inspection.The skin being grievously injured degree comprises erythema, infiltration, squama, is divided into 0-4 to divide according to the order of severity, assesses its area of getting involved (1-6) simultaneously, and the order of severity is multiplied with area and is infringement scoring, and weigh 72 points most, concrete standards of grading participate in PASI.In therapeutic process, follow up a case by regular visits to the untoward reaction of patient's generation and note down.
1.5 efficacy determination
According to state of an illness scoring decline index be divided into base more, effective, progressive, invalid.Concrete evaluation methodology: infringement scoring decline index=[infringement scoring before (damaging scoring after infringement scoring ﹣ treatment before treatment)/treatment] × 100%.Base is healed: infringement scoring decline index >=90%; Effective: 60%≤infringement scoring decline index <90%; Progressive: 20%≤infringement scoring decline index <60%; Invalid: infringement scoring decline index <20%.Base is healed rate=(base heal number of cases/Eligibility number) × 100%, effective percentage=[(base heal number of cases+effective number of cases)/Eligibility number] × 100%.
1.7 follow up a case by regular visits to
Treatment end was followed up a case by regular visits to after 6 months, accepted to follow up a case by regular visits to patient for base at the end for the treatment of to heal patient, with reference to foreign literature, the standard of recurrence is after original skin lesion disappears, there is kainogenesis skin lesion and coincident with severity degree of condition exceedes original 50%, when meeting this condition, namely assert recurrence.
1.6 statistical method
Measurement data t checks, and compares and adopt x between group
2inspection.
2 results
2.1 physical data
Totally 165 routine patients participate in research, age 18-63 year between, wherein matched group 83 example, test group 82 example.35.29 ± 12.79 years old matched group age, 36.70 ± 13.57 years old test group age, there was no significant difference between 2 groups (t=0.6869,
p>0.40).The sex of 2 groups and staging compare in table 1, between there are no significant difference (x
2=0.0663,
p>0.50; x
2=0.1592,
p>0.50), illustrate that 2 groups have comparability.After treating 4 weeks, test group has 6 examples to come off, and wherein experimenter exits 2 examples automatically, 4 examples lost to follow-up; Matched group has 3 examples to come off, and is lost to follow-up.
The sex of table 1 liang group and by stages
2.2 clinical efficacy
Refer to (table 2), the effective percentage (basic healing+effective) of matched group and test group is respectively 44.58% and 67.07% after 2 weeks for the treatment of, and namely two groups of Different therapeutical effects have statistical significance (x
2=10.106,
p<0.05); Be respectively 63.75% and 93.42% after treatment in 4 weeks, have significant difference (x through statistical analysis
2=25.562,
p<0.01).
Table 2 test group and matched group treat Comparison of therapeutic after 2 weeks and 4 weeks
2.3 untoward reaction
2 groups all there is not serious adverse events, and test group has 2 routine patients to occur scratchiness, and zest pain appears in 1 routine patient, and erythematous response appears in 1 routine patient, and 1 routine patient occurs pigmentation more afterwards.Occurring scratchiness after the application of matched group patient 2 example, there is erythematous response in 1 example.Equal energy tolerance, does not affect treatment.
Follow-up results after 2.4 6 months
The routine patient of test group 59, the routine patient of matched group 33 were almost recovered after 4 weeks, and selected follow-up investigation, after June, two groups have 12 example and 16 routine Patients on Recurrences respectively, and relapse rate is 48.48% and 25.42% respectively, and two groups of relapse rates have statistical significance (table 3)
Table 3 matched group and test group relapse survey (after June)
x
2＝10.106,
P<0.05
3 discuss
Head is one of position of the most easily invading of psoriasis, can psoriatic lesion be there is in psoriatic's scalp sites of 50%-80%, its clinical manifestation difference is very large, patient with slight symptoms only shows as slight erythema, trickle squama, patient with severe symptoms then has the speckle infiltrating plumpness, and the hypertrophica crust of surface coverage, throughout whole scalp.Head is also often the position that psoriasis occurs at first, patient's skin lesion of 1/4 only betides head, do not involve other positions and reach the several years, sometimes mistaken diagnosis can become other diseases, psoriatic lesion can not cause coming off of hair, but can cause pruritus, desquamation, owing to being positioned at exposure portion, affect self-image, usually cause psychological pressure to patient.
As the psoriatic conventional medicament for the treatment of, Anthra-Derm has stimulation to skin, has coloration and is not easily washed off, is usually not used in the psoriatic treatment of head, but dithranol has good effect for the plaque psoriasis of stubbornness, and the paracmastic feature having maintenance longer.Therefore we have developed dithranol oil preparation, it has obvious curative effect for head psoriasis, comparatively matched group compound recipe triamcinolone acetonide liniment is more rapid in onset, namely significant difference is had compared with matched group after 2 weeks, especially comparatively plump speckle, disappear very rapid, after 4 weeks, curative effect is more obviously good, the patient of 77.63% is almost recovered, satisfactory effect.And matched group patient, after application compound recipe triamcinolone acetonide liniment, only have the patient of 41.25% to be almost recovered.Its relapse rate comparatively matched group significantly reduces, and the psoriasis shown after the treatment of dithranol oil preparation can keep the catabasis more grown.
Consistent with research previously, after anthraline oil liniment is applied to scalp, there is zest erythema in some patients, burn feeling, the untoward reaction such as pain, but mostly these reactions are of short duration, slight degree with local, and incidence rate reports obvious minimizing than before, infer relevant with use position, scalp is as large in skin of trunk thickness compared with other positions, sensitivity is low, strong to dithranol toleration, therefore the probability occurring to stimulate is little, and betide scalp sites, even if there is the untoward reaction such as pigmentation, due to the covering of hair, also not easily find, as for the coloration of medicated clothing, also do not exist, patient is high to this acceptance.
This result of study shows, dithranol oil liniment treated scalp psoriasis, comparatively matched group compound recipe triamcinolone acetonide liniment, onset is faster, better efficacy, and recurrence rate after healing is low, catabasis is long, although irritative response appears in few patients, is comparatively applied to other positions and obviously reduces, patient acceptance is high, and potential applicability in clinical practice is wide.
The present invention has following beneficial effect:
1, dithranol oil preparation of the present invention is applicable to head curing psoriasis, and has the advantages such as good dispersion degree, preparation is simple, steady quality, denseness are suitable, ductility is good.
2, not corrupt, the not easy bacteria-developing of oil preparation of the present invention, prescription is simple, and technological process is simple, and cost is low.
3, be new drug dosage form---dithranol oil preparation that treatment head psoriasis provides a determined curative effect, side effect little, cheap.
Accompanying drawing explanation
Fig. 1 is dithranol oil preparation production technological process of the present invention.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is further illustrated, but limited the present invention never in any form, and any conversion done based on training centre of the present invention or replacement, all belong to protection scope of the present invention.
Embodiment 1: a kind of dithranol oil preparation, comprises medicine and the adjunct ingredient of following weight proportion:
Step of preparation process is as follows:
(1) get principal agent dithranol, after pulverizing, cross 180 mesh sieves, for subsequent use;
(2) get white vaseline-liquid paraffin matrix and be heated to about 80 DEG C, filter while hot with fine cloth or No. seven copper wire sieves after melting, removing impurity; And then be heated to 150 DEG C, and be incubated and within 1 hour, carry out sterilizing and removing moisture, for subsequent use;
(3) treat that white vaseline-liquid paraffin matrix temperature is down to about 50 DEG C, the substrate that takes a morsel and principal agent mixed grinding, then join in remaining substrate, homogenizing stirs 15 ~ 30 minutes, and principal agent is mixed homogeneously with substrate;
(4) semi-finished product content checks;
(5) fill, packaging, Quan Jian, warehouse-in.
Embodiment 2: a kind of dithranol oil preparation, comprises medicine and the adjunct ingredient of following weight proportion:
Step of preparation process is with embodiment 1.
Embodiment 3: a kind of dithranol oil preparation, comprises medicine and the adjunct ingredient of following weight proportion:
Step of preparation process is with embodiment 1.
Embodiment 4: a kind of dithranol oil preparation, comprises medicine and the adjunct ingredient of following weight proportion:
Step of preparation process is with embodiment 1.
Embodiment 5: a kind of dithranol oil preparation, comprises medicine and the adjunct ingredient of following weight proportion:
Step of preparation process is with embodiment 1.
Test example 1, product quality are investigated
Research sample and reference substance source: test sample dithranol oil preparation, provided (producing in the workshop meeting GPP requirement) by Shandong Dermatopathy Cypridopathy Prevention and Cure Institute.Specification: 1.0%; Lot number: 20121003,2021004,20121005.
One, assay
The preparation of need testing solution: get dithranol oil preparation 2.0g, put in 100ml beaker, puts the fusing of 80 DEG C of heating in water bath, adds acetonitrile 20ml, heated and stirred 4 minutes, take out to set to 0 ~ 4 DEG C of conditions under place 15 ~ 20 minutes, supernatant is transferred in 50ml measuring bottle.Residue substrate extracts 2 times again with method, uses acetonitrile 15ml at every turn.Merge supernatant, add acetonitrile to scale, shake up; Precision measures in above-mentioned solution 5.0ml to 25ml volumetric flask, adds dilution in acetonitrile to scale, shakes up, and filters immediately and gets filtrate 20 μ l injection liquid chromatography.
The preparation of reference substance solution: precision takes dithranol 20.0mg, puts in 50ml measuring bottle, adds acetonitrile and makes dissolving, shake up; Precision measures in 5.0ml to 25.0ml volumetric flask, adds dilution in acetonitrile to scale, shakes up, and gets 20 μ l injection liquid chromatographies immediately, record chromatogram.
By external standard method with dithranol (C in calculated by peak area test sample
14h
10o
3) content.Result of the test is in table 4.
Table 4 dithranol oil content measurement result
From above result of the test, the sample size measurement result of this product three specifications, all in 95% ~ 100% scope, all conforms with the regulations.
Two, character inspection
Dithranol oil preparation shape of the present invention inspection is as follows: respectively to the multiple batches of sample of different time configuration, and the sample appearance of fairly large production three specifications checks, the sample property of each batch of same specification is all consistent, and result of the test is in table 5.
Table 5 dithranol oil preparation character checks
Three, limit test of microbe
Get each batch sample respectively, check microbial limit, result of the test is in table 6.
Table 6 dithranol oil preparation limit test of microbe result
As seen from the experiment, the microorganism in three specification piece all conforms with the regulations.
Four, study on the stability
According to " medicine stability test guideline " (Chinese Pharmacopoeia version in 2010 two annex Ⅹ Ⅸ), influence factor's test, accelerated test, long term test are carried out to dithranol oil preparation sample.
1, influence factor's test
According to Chinese Pharmacopoeia 2010 editions medicine stability test guidelines, place 10 days under this product being placed in respectively high temperature (40 DEG C), illumination (4500lx), high humidity (25 DEG C, RH92.5%) condition, in the 5th day and sampling in the 10th day, the situation of change of the character of sample for reference, uniformity, related substance and content, the results are shown in Table 7.
Table 7 dithranol oil preparation influence factor result of the test
Influence factor's test shows, packaging material outward appearance is all complete, and No leakage phenomenon occurs, and internal layer occurs without variable color, corrosion-free phenomenon, all keeps good working condition.Sample is placed 10 days under high temperature (40 DEG C), low temperature (4 DEG C), illumination (4500lx), high humidity (25 DEG C, RH90%) condition, there is not significant change in content, each major impurity peak is basically identical, have no obvious change, between each Conditions Sample under same testing time point, related substance difference is little.Illustrate adopt prescription, packaging can the requirement of anthrol oil preparation stability contentedly.
2, accelerated test
Experimental condition: 30 DEG C ± 2 DEG C, relative humidity 65% ± 10%;
Get each batch sample of this product, place 6 months under these conditions, at duration of test respectively at the 0th, 1,2,3,6 sampling at the end of month once, each high spot reviews project is tested.Result of the test is in table 8.
Table 8 dithranol oil preparation accelerated test result
From above result of the test, this product is through accelerating test in 6 months, and this product related substance slightly increases, and content slightly reduces, and other check items are without significant change.Add up the major impurity in the oil preparation of 3 lot numbers, result is known: oil preparation is placed through accelerating 6 months, and related substance and impurity number slightly increase.There is larger tendency in impurity B.Separately check the microbial limit of this product accelerated test 6 months samples, result all conforms with the regulations.
3, long term test
Experimental condition: temperature 25 DEG C ± 2 DEG C, relative humidity 60% ± 10%
Get this product three batch sample, place 18 months under these conditions, at duration of test respectively at the 0th, 3,6,9,12,18 sampling at the end of month once, each high spot reviews project is tested.Result of the test is in table 9.
Table 9 dithranol oil preparation long-term test results
From above result of the test, this product was through test in long-term 6 months, and this product related substance slightly increases, and content slightly reduces, and other check items are without significant change.Add up the major impurity in the oil preparation of 3 lot numbers, result is known: oil preparation was placed through long-term 6 months, and related substance and impurity number slightly increase.There is larger tendency in impurity B.Separately check the microbial limit of this product long term test 6 months samples, result all conforms with the regulations.
The stability result current according to this product, being fixed tentatively this product effect duration is 12 months, and this product answers shading, and sealing, preserves in cool dark place.
Claims (6)
1. a dithranol oil preparation, is characterized in that, comprises medicine and the adjunct ingredient of following weight proportion: dithranol 1 part, oleaginous base 100 parts; Described oleaginous base is: the mixture of white vaseline and liquid paraffin; The ratio of described white vaseline and liquid paraffin is 2:8-7:3.
2. a kind of dithranol oil preparation as claimed in claim 1, is characterized in that, the ratio of described white vaseline and liquid paraffin is 4:6.
3. a kind of dithranol oil preparation as claimed in claim 2, is characterized in that, comprises medicine and the adjunct ingredient of following weight proportion: dithranol 1 part, white vaseline 40 parts, liquid paraffin 60 parts.
4. a kind of dithranol oil preparation as claimed in claim 3, is characterized in that, comprises medicine and the adjunct ingredient of following weight proportion:
5. a preparation technology for dithranol oil preparation according to claim 1, it is characterized in that, step is as follows:
(1) get principal agent dithranol, after pulverizing, cross 180 mesh sieves, for subsequent use;
(2) get white vaseline-liquid paraffin matrix and be heated to about 80 DEG C, filter while hot with fine cloth or No. seven copper wire sieves after melting, removing impurity; And then be heated to 150 DEG C, and be incubated and within 1 hour, carry out sterilizing and removing moisture, for subsequent use;
(3) treat that white vaseline-liquid paraffin matrix temperature is down to about 50 DEG C, the substrate that takes a morsel and principal agent mixed grinding, then join in remaining substrate, homogenizing stirs 15 ~ 30 minutes, and principal agent is mixed homogeneously with substrate;
(4) semi-finished product content checks;
(5) fill, packaging, Quan Jian, warehouse-in.
6. dithranol oil preparation as claimed in claim 1, is characterized in that, be used for the treatment of head psoriasis.
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|---|---|---|---|
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ID=52636184
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1504007A (en) * | 1976-06-28 | 1978-03-15 | Dermal Lab Ltd | Compositions containing dithranol |
| CN102935063A (en) * | 2012-11-08 | 2013-02-20 | 山东省皮肤病性病防治研究所 | Acetyl dithranol paste and preparation method thereof |
-
2014
- 2014-12-04 CN CN201410734577.5A patent/CN104398472A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1504007A (en) * | 1976-06-28 | 1978-03-15 | Dermal Lab Ltd | Compositions containing dithranol |
| CN102935063A (en) * | 2012-11-08 | 2013-02-20 | 山东省皮肤病性病防治研究所 | Acetyl dithranol paste and preparation method thereof |
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Application publication date: 20150311 |