CN106474059A - A kind of more stable desonide lotion of quality - Google Patents
A kind of more stable desonide lotion of quality Download PDFInfo
- Publication number
- CN106474059A CN106474059A CN201510534825.6A CN201510534825A CN106474059A CN 106474059 A CN106474059 A CN 106474059A CN 201510534825 A CN201510534825 A CN 201510534825A CN 106474059 A CN106474059 A CN 106474059A
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- CN
- China
- Prior art keywords
- desonide
- lotion
- stable
- stable matrix
- quality
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- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 1
- 239000004300 potassium benzoate Substances 0.000 description 1
- 235000010235 potassium benzoate Nutrition 0.000 description 1
- 229940103091 potassium benzoate Drugs 0.000 description 1
- 239000004302 potassium sorbate Substances 0.000 description 1
- 235000010241 potassium sorbate Nutrition 0.000 description 1
- 229940069338 potassium sorbate Drugs 0.000 description 1
- QGPGUZIKJKOKRF-UHFFFAOYSA-M potassium;acetonitrile;dihydrogen phosphate Chemical compound [K+].CC#N.OP(O)([O-])=O QGPGUZIKJKOKRF-UHFFFAOYSA-M 0.000 description 1
- 239000013558 reference substance Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 208000008742 seborrheic dermatitis Diseases 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 229960001866 silicon dioxide Drugs 0.000 description 1
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 239000004299 sodium benzoate Substances 0.000 description 1
- 235000010234 sodium benzoate Nutrition 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000001488 sodium phosphate Substances 0.000 description 1
- 229910000162 sodium phosphate Inorganic materials 0.000 description 1
- 239000004575 stone Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
- 235000002906 tartaric acid Nutrition 0.000 description 1
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- 229940099259 vaseline Drugs 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Landscapes
- Cosmetics (AREA)
- Medicinal Preparation (AREA)
Abstract
A kind of a kind of the invention belongs to field of pharmaceutical preparations, is related to desonide preparation, it particularly relates to the more stable desonide lotion of quality.The more stable desonide lotion of the quality is the lotion containing stable matrix, and the stable matrix is one or more in natural polymer and its derivative, cellulose ethers compound and synthetic macromolecular compound.The desonide lotion of the present invention, with good physical stability and chemical stability, physical stability shows that active component is suspended and is present in lotion no obvious Subsidence trend, product has good uniformity of dosage units, without the need for shaking during use, the occupation mode of patient especially gerontal patient is greatly facilitated.Stable chemical nature shows that relevant material meets control limit of the chemicals about material guideline in lotion, and each component does not have any interference to relevant substance detection system in prescription, better than presently commercially available product.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, is related to a kind of desonide preparation, it particularly relates to a germplasm
The more stable desonide lotion of amount.
Background technology
Desonide belongs to glucocorticoid medicine, with anti-inflammatory, antiallergy, antipruritic and reduce the effect of oozing out etc.；
Can mitigate, reaction of the tissue to inflammation is prevented, heating that local non-infectious inflammation causes can be eliminated, sent out
Red and swelling, so as to the performance for reducing inflammation；With immunosuppressive action：Prevent or suppress cellular immunity anti-
, primary immune response should be suppressed.The external preparation of desonide can be used for that multiple hormone-sensitives are dermopathic to be controlled
Treat such as contact dermatitis, neurodermatitis, seborrhea, eczema, psoriasis, lichen planus, simple
Property liver moss, pompholyx disease and pruritus etc..
Presently commercially available desonide lotion is the exploitation of high dolantin (Galderma) companyIts
In FDA specification show, in prescription in addition to active component desonide, other non-active ingredients include purified water,
Glycerine, propane diols, edta disodium dihydrate, methyl p-hydroxybenzoate, para hydroxybenzene first
Propyl propionate, NaOH, citric acid, lauryl sodium sulfate, sorbester p18, liquid paraffin,light, list are hard
Glycerol, hexadecanol and octadecyl alcolol.The kind is only listed in the U.S. at present, domestic not yet list marketing.
Present inventor is by commercially available desonide lotionQuality research test find,
There is problems with which：(1) desonide lotionFor suspension type lotion, but to branched lotion
And the assay result of different parts sampling shows there is obvious content difference, show which in single lotion
There is obvious sedimentation phenomenon in active component.Low for product viscosity through analyzing its reason, it is impossible to carry and suspend
In active ingredient particle therein, substantially sedimentation after placing a period of time, can be occurred to cause in product, to form content
Height gradient, therefore using before must be shaken, but for different patients especially gerontal patient, shake
Shake the time and granularity has notable difference, it is difficult to content uniformity when ensureing that product is used, and to product
During filling and patient's use all there is impact in drug effect；(2) on the other hand, original product Time To Market is more early, not
The relevant material to product is had to be controlled, after testing, according to drug standard newest at present
Control requires which is substantially higher about material, can not meet the control limit of existing quality criteria requirements；
(3) using methyl p-hydroxybenzoate and propylparaben as preservative in original product prescription, but
In the detecting system about material its to go out peak position Chong Die with active component presence, have a strong impact on relevant material
Accurate detection.
Content of the invention
In view of this, an object of the present invention is to provide a kind of raising desonide lotion quality stability
Stable matrix, described stable matrix can improve active component sedimentation in existing desonide lotion and substantially, contain
The uneven defect of amount.Another object of the present invention is to provide a kind of quality more stable desonide lotion,
The lotion has good physical stability, after investigating through high temperature, low temperature and Frozen-thawed cycled, no substantially settles
Phenomenon, content are uniform and stable.
For achieving the above object, the technical scheme is that：
Improve desonide lotion quality stability stable matrix, the stable matrix be natural polymer and its
One or more in derivative, cellulose ethers compound and synthetic macromolecular compound；The natural height
Molecule is selected from starch, gelatin, sodium alginate, casein, guar gum, chitosan, gum arabic, Huang
Virgin rubber, soybean protein glue, natural rubber, lanolin, agar；The cellulose ether selected from methylcellulose,
Hydroxypropyl methyl cellulose, sodium carboxymethylcellulose, hydroxyethyl cellulose；The synthesis macromolecule is selected from poly-
Acrylamide, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol oxide, modified paraffin resin, Ka Boshu
Fat, polyacrylic acid, Polyacrylate Emulsion, butadiene rubber, butadiene-styrene rubber, polyurethane, modification are poly-
Urea, low-molecular polyethylene wax.Inventors herein have recognized that, why existing desonide lotion occurs living
Property composition sedimentation, the poor problem of uniformity of dosage units, it is critical only that product viscosity is low, it is impossible to carry outstanding
Float on active ingredient particle therein, after placing a period of time, can occur substantially sedimentation to cause formation in product to contain
Amount height gradient, therefore using before must be shaken, but for different patients especially gerontal patient,
There is notable difference in shaking time and granularity, it is difficult to content uniformity when ensureing that product is used.Institute of the present invention
The stable matrix of the desonide lotion that states refers to certain viscosity and can be used to carry the pharmaceutically acceptable of active component
Auxiliary material.Using the present invention stable matrix obtained in product there is good physical stability, through 60 DEG C of high temperature,
After low temperature and Frozen-thawed cycled are investigated, no obvious sedimentation phenomenon, content are uniform and stable.
Preferably, the stable matrix be xanthans, gum arabic, sodium alginate, methylcellulose,
Hydroxypropyl methyl cellulose and one or more of sodium carboxymethylcellulose.
Further, present invention also offers the desonide lotion containing stable matrix of the present invention.
Further, present invention also offers application of the described stable matrix in desonide lotion is prepared.
Another object of the present invention also resides in the desonide lotion more stable there is provided a kind of quality, describedly
How moral lotion is made up of two parts of active component desonide and non-active ingredient, the non-active ingredient except
Outside containing stable matrix of the present invention, also include emulsifying agent, solid oil phase, liquid oil phase, metal from
Sub- chelating agent, preservative, NMF, pH adjusting agent and water.
Existing desonide lotion product Time To Market is more early, not the relevant material limit of control product, and warp
Inventor's testing inspection shows that its actual relevant material has exceeded well over the relevant material control of current chemicals and referred to
The standard for leading principle is required.Preferably, described desonide lotion, the stable matrix and desonide lotion
Percentage by weight be 0.01%-5.0%.
It is furthermore preferred that described desonide lotion, the stable matrix is xanthans, gum arabic, sea
One or more in mosanom, methylcellulose, hydroxypropyl methyl cellulose and sodium carboxymethylcellulose,
The stable matrix is 0.05%-3.0% with the percentage by weight of desonide lotion.
Other non-active ingredient emulsifying agents, solid oil phase, liquid oil phase in the desonide lotion of the present invention,
Metal ion chelation agent, preservative, NMF, pH adjusting agent etc. can be subjected to using pharmaceutical field is any
Material, its consumption is conventional amount used.
Present inventor also has found, the preservative para hydroxybenzene first adopted in existing desonide lotion prescription
There is significantly interference in sour methyl esters and propylparaben, which goes out peak position to the detecting system about material
Put Chong Die with active component presence, to have had a strong impact on about material detection accuracy.Therefore, the present invention is excellent
Choosing, the preservative be sorbic acid, sorbate, benzoic acid, benzoate, 2- phenoxetol,
One or more in benzyl carbinol, phenmethylol and three tert-butyl alcohols.Sorbate includes potassium sorbate, sorbic acid
Calcium etc., benzoate include Sodium Benzoate, Potassium Benzoate etc..Sorbic acid, sorbate, benzoic acid, benzene
Formates, 2- phenoxetol, benzyl carbinol, phenmethylol and three tert-butyl alcohols are no substantially dry to the detection of relevant material
Disturb, the accuracy of detection is greatly improved.The interference problem that preservative is detected to relevant material is eliminated, makes to contain
Amount and the measure about material have more accuracy, product quality is obtained and stablizes, comply fully with medicine newest at present
Amount of substance controls standard.
Further, percentage by weight of the preservative in prescription is 0.1%-2.0%, preferably
0.3%-1.0%.
Further, described preservative is preferably in benzyl carbinol, phenmethylol, sorbic acid and 2- phenoxetol
One or more.
Currently preferred, described emulsifying agent can for lauryl sodium sulfate, sorbester p18, sorbester p17,
One or more in Tween 80, T63, G64 and M68 etc. is used in combination, its consumption in prescription hundred
It can be 0.1%-20.0%, preferably 0.5%-10% to divide ratio.
Currently preferred, described solid oil phase is hexadecanol, octadecyl alcolol, cetostearyl alcohol, solid stone
Being used in combination for one or more in wax, beeswax, glycerin monostearate, single bi-tristearin etc.,
Percentage of its consumption in prescription can be 0.5%-20.0%, preferably 1.0%-5.0%.
Currently preferred, described liquid oil phase is liquid paraffin,light, medium chain triglyceride, vaseline,
One or more in silicone, dimethicone etc. is used in combination, and percentage of its consumption in prescription is permissible
For 0.5%-20.0%, preferably 1.0%-7.0%.
Currently preferred, the metal ion chelation agent be ethylenediamine tetra-acetic acid, disodium ethylene diamine tetraacetate,
Aminotriacetic acid, diethylenetriamines are nothing acetic acid and its salt, tartaric acid, citric acid, AEEA three
One or more in acetic acid and bicine N-, percentage of the metal ion chelation agent consumption in prescription
Than being 0.01%-2.0%, preferably 0.05%-0.5%, more preferably 0.05%-0.1%.
Currently preferred, the NMF is glycerine and/or propane diols, NMF consumption in prescription hundred
It can be 1%-20%, preferably 3.0%-15.0% to divide ratio.
Currently preferred, the pH adjusting agent be NaOH, potassium hydroxide, citric acid, sodium citrate,
One or more in phosphoric acid or dibastic sodium phosphate etc. are used in combination, the percentage of the consumption of pH adjusting agent in prescription
Than being 0.001%-1.0%, preferably 0.01%-0.5%, more preferably 0.05%-0.15%.
Beneficial effects of the present invention：
(1) stable matrix of raising desonide lotion quality stability according to the present invention, improves existing
In desonide lotion, active component sedimentation is obvious, the uneven defect of content.
(2) the more stable desonide lotion of quality according to the present invention, the lotion have good physics
Stability, after investigating through high temperature, low temperature and Frozen-thawed cycled, no obvious sedimentation phenomenon, content are uniform and stable,
Filling beneficial to production, while curative effect when ensureing patient medication.Desonide lotion according to the present invention has good
Good content uniformity, using easier, using front without the need for shaking, simplify using for patient and operates,
Solve and the inconvenience for bringing is not known due to shaking time and dynamics, especially facilitate old and weak patients
Use.
(3) the more stable desonide lotion of quality according to the present invention, stable chemical nature are excellent,
Relevant material meets control limit of the chemicals about material guideline, and in prescription each component to relevant
There is no any interference in substance detection system, better than presently commercially available product.
Description of the drawings
The relevant material high-efficient liquid phase chromatogram of Fig. 1 desonide lotion.
Specific embodiment
Illustrated embodiment is to preferably illustrate to present disclosure, but is not the interior of the present invention
Hold and be only limitted to illustrated embodiment.So those of ordinary skill in the art are according to foregoing invention content to embodiment party
Case carries out nonessential modifications and adaptations, still falls within protection scope of the present invention.
The preparation of Part I desonide lotion according to the present invention
In following examples, required each material is all obtained from commercially available channel.
Embodiment 1
The desonide lotion of the present embodiment, its composition are as follows：
Preparation method：
1) water is mutually prepared：Weigh the purified water of recipe quantity, xanthans, glycerine, disodium ethylene diamine tetraacetate,
Phenoxetol, citric acid and sodium citrate, 80 DEG C of heating stirring dissolvings completely, are incubated, add desonide,
40R/min dispersed with stirring is uniform；
2) prepared by oil phase：Weigh sorbester p17, atoleine and the cetostearyl alcohol of recipe quantity, 80 DEG C of heating
Melting completely, is incubated；
3) emulsify：Under 80 DEG C of insulations, water is added in oil phase, 40R/min stirring and emulsifying 10min,
40 DEG C are gradually cooled to, obtain final product lotion.
Embodiment 2
The desonide lotion of the present embodiment, its composition are as follows：
Preparation method：
1) water is mutually prepared：(80 DEG C or so) of hot purified water for weighing recipe quantity half adds hydroxyphenylmethyl fine
The plain dispersed with stirring of dimension, adds the purified water stirring and dissolving of recipe quantity half；It is subsequently adding glycerine, ethylenediamine
Tetraacethyl disodium, phenoxetol, citric acid and sodium citrate, 80 DEG C of heating stirring dissolvings completely, are incubated,
Desonide is added, 40R/min dispersed with stirring is uniform；
2) prepared by oil phase：Weigh sorbester p17, atoleine and the cetostearyl alcohol of recipe quantity, 80 DEG C of heating
Melting completely, is incubated；
3) emulsify：Under 80 DEG C of insulations, water is added in oil phase, 40R/min stirring and emulsifying 10min,
40 DEG C are gradually cooled to, obtain final product lotion.
Embodiment 3
The desonide lotion of the present embodiment, its composition are as follows：
Preparation method：
1) water is mutually prepared：Weigh recipe quantity purified water, gum arabic, glycerine, disodium ethylene diamine tetraacetate,
Phenoxetol, citric acid and sodium citrate, 80 DEG C of heating stirring dissolvings completely, are incubated, add desonide,
40R/min dispersed with stirring is uniform；
2) prepared by oil phase：Weigh sorbester p17, atoleine and the cetostearyl alcohol of recipe quantity, 80 DEG C of heating
Melting completely, is incubated；
3) emulsify：Under 80 DEG C of insulations, water is added in oil phase, 40R/min stirring and emulsifying 10min,
40 DEG C are gradually cooled to, obtain final product lotion.
Embodiment 4
The desonide lotion of the present embodiment, its composition are as follows：
Preparation method：
1) water is mutually prepared：Weigh recipe quantity purified water, gum arabic, glycerine, disodium ethylene diamine tetraacetate,
Phenoxetol, citric acid and sodium citrate, 80 DEG C of heating stirring dissolvings completely, are incubated, add desonide,
40R/min dispersed with stirring is uniform；
2) prepared by oil phase：T63, M68 and the cetostearyl alcohol of recipe quantity is weighed, 80 DEG C of heating meltings are complete,
Insulation；
3) emulsify：Under 80 DEG C of insulations, water is added in oil phase, 40R/min stirring and emulsifying 10min,
40 DEG C are gradually cooled to, obtain final product lotion.
Embodiment 5
The desonide lotion of the present embodiment, its composition are as follows：
Preparation method：
1) water is mutually prepared：Weigh recipe quantity purified water, Tween 80, sodium carboxymethylcellulose, glycerine, second
Edetate disodium, phenoxetol, citric acid and sodium citrate, 80 DEG C of heating stirring dissolvings are complete,
Insulation, adds desonide, and 40R/min dispersed with stirring is uniform；
2) prepared by oil phase：Sorbester p17 and the cetostearyl alcohol of recipe quantity is weighed, 80 DEG C of heating meltings are complete,
Insulation；
3) emulsify：Under 80 DEG C of insulations, water is added in oil phase, 40R/min stirring and emulsifying 10min,
40 DEG C are gradually cooled to, obtain final product lotion.
Embodiment 6
The desonide lotion of the present embodiment, its composition are as follows：
Preparation method：
1) water is mutually prepared：Weigh recipe quantity purified water and methylcellulose dispersed with stirring is added, add recipe quantity
Glycerine, disodium ethylene diamine tetraacetate, phenoxetol, citric acid and sodium citrate, 80 DEG C of heating stirrings are molten
Completely, insulation, addition desonide, 40R/min dispersed with stirring are uniform for solution；
2) prepared by oil phase：Weigh sorbester p17, atoleine and the cetostearyl alcohol of recipe quantity, 80 DEG C of heating
Melting completely, is incubated；
3) emulsify：Under 80 DEG C of insulations, water is added in oil phase, 40R/min stirring and emulsifying 10min,
40 DEG C are gradually cooled to, obtain final product lotion.
Part II experimental example
The physical stability contrast of 1 desonide lotion of experimental example
Subjects：
Desonide lotion and commercially available desonide lotion prepared by embodiment 1-6(lot number：G 54Q)
Contrast.
Testing program：
1. 60 DEG C of high temperature is investigated 10 days；
2. high/low temperature circulates 4 DEG C -40 DEG C, investigates 12 days；
3. -20 DEG C -40 DEG C of Frozen-thawed cycled, investigate 12 days；
4. 40 DEG C accelerate to investigate 6 months.
Detecting system：
Chromatographic column：18 silane group silicagel columns (250 × 4.6mm, 5 μm)；
Mobile phase：Acetonitrile-water (40：60)；
Detection wavelength：245nm；
Flow velocity：1.0ml/min；
Sample size：20μL.
Processing method：
Precision weighs desonide lotion sample to be detected in right amount (being approximately equivalent to desonide 1mg), puts 50ml palm fibre
In colo(u)r specification bottle, plus diluent [0.1mol/l potassium dihydrogen phosphate-acetonitrile (60: 40)] about 25ml, ultrasound
And shaking is completely dispersed gel in 15 minutes frequently, taking-up lets cool, plus the calcium chloride solution 0.5ml of 0.5g/ml,
Scale is diluted to diluent, shakes up, standing, supernatant filtration is taken, precision measures 20 μ l of filtered solution, note
Enter liquid chromatograph, record chromatogram；It is appropriate that desonide reference substance is separately taken, accurately weighed, plus diluent is super
Sound makes dissolving, and quantitatively the solution in every 1ml containing about 20 μ g is made in dilution, is measured in the same method.By external standard method
With calculated by peak area, obtain final product.
Experimental Comparison result：
Comparing result refers to table 1, and the present invention is obtained desonide lotion and accelerates to investigate 6 months, high temperature through 40 DEG C
After 60 DEG C are investigated 10 days, high/low temperature circulation and Frozen-thawed cycled, physical behavior is stable, and active component is suspended in be washed
In agent, no obvious sedimentation phenomenon, there is good content uniformity using front without the need for shaking, better than current
Commercially available prod.It follows that the desonide lotion physical stability of the present invention is more preferable.
The desonide lotion of 1 present invention of table with commercially availablePhysical stability is contrasted
Note is 1.：Upper, middle and lower from lotion samples 6 points (n=6) to uniformity of dosage units respectively, calculates its uniformity of dosage units RSD, and control limit is RSD≤3.0%.
The chemical stability contrast of 2 desonide lotion of test example
Subjects：
Desonide lotion and commercially available desonide lotion prepared by embodiment 1-6(lot number：G 54Q)
Contrast.
Testing program：
1. 60 DEG C of high temperature is investigated 10 days；
2. accelerate 40 DEG C to investigate 6 months；
3. -20 DEG C -40 DEG C of Frozen-thawed cycled, investigate 12 days.
Detection method：
Chromatographic column：ODS post (250mm × 4.6mm, 5 μm)；
Column temperature：25℃；
Detection wavelength：254nm；
Flow velocity：1.0ml/min；
Diluent：0.1% phosphate aqueous solution-acetonitrile (volume ratio 60：40)；
Mobile phase A：0.1% phosphate aqueous solution；Mobile phase B：Acetonitrile, the condition of according to the form below carry out gradient and wash
De-.
Condition of gradient elution
Processing method：
Testing sample 15g is taken, is put in 50ml brown measuring bottle, add and diluent 15ml is stated, ultrasonic 15min
And shaking is completely dispersed desonide lotion sample frequently, taking-up lets cool, plus sodium chloride 5g, shakes up, standing,
Supernatant liquor filtration is taken, and filtrate is taken as need testing solution.Take need testing solution and inject liquid chromatograph in right amount,
Record chromatogram, calculates each impurity content according to peak area normalization.
Experimental Comparison result：
Comparing result refers to table 2, and the present invention is obtained desonide lotion and investigates 10 days, accelerates for 60 DEG C through high temperature
40 DEG C are investigated steady quality after 6 months and Frozen-thawed cycled, and relevant material meets quality standard bound requirements, and
In prescription, each component is noiseless to the detection of relevant material system, sees accompanying drawing 1.Commercially availableWhich is relevant
Material is changed significantly, especially in 60 DEG C of influence factors and the investigation for accelerating 40 DEG C, relevant mass degradation trend
Substantially, all exceed quality standard control limit.It follows that the desonide lotion chemical stability of the present invention
More preferably.
The desonide lotion of 2 present invention of table with commercially availableChemical stability is contrasted
Note：Wherein 0 day for implementing the testing result before contrast test.
Finally illustrate, above example only in order to technical scheme to be described and unrestricted, although
The present invention is described in detail with reference to preferred embodiment, it will be understood by those within the art that,
Technical scheme can be modified or equivalent, without deviating from technical solution of the present invention
Objective and scope, its all should cover in the middle of scope of the presently claimed invention.
Claims (10)
1. the stable matrix of desonide lotion quality stability is improved, it is characterised in that：The stable matrix is
One kind or many in natural polymer and its derivative, cellulose ethers compound and synthetic macromolecular compound
Kind；The natural polymer selected from starch, gelatin, sodium alginate, casein, guar gum, chitosan,
Gum arabic, xanthans, soybean protein glue, natural rubber, lanolin, agar；The cellulose ether
Selected from methylcellulose, hydroxypropyl methyl cellulose, sodium carboxymethylcellulose, hydroxyethyl cellulose；Described
Synthesis macromolecule is selected from polyacrylamide, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol oxide, modification
Paraffin resin, carbomer, polyacrylic acid, Polyacrylate Emulsion, butadiene rubber, butadiene-styrene rubber,
Polyurethane, modified polyurea, low-molecular polyethylene wax.
2. stable matrix according to claim 1, it is characterised in that：The stable matrix be xanthans,
Gum arabic, sodium alginate, methylcellulose, hydroxypropyl methyl cellulose and sodium carboxymethylcellulose
One or more.
3. the desonide lotion containing the stable matrix described in claim 1 or 2.
4. application of the stable matrix described in claim 1 or 2 in desonide lotion is prepared.
5. the more stable desonide lotion of a kind of quality, the desonide lotion be based on claim 1 or 2
Described stable matrix and prepare, it is characterised in that：The desonide lotion by active component desonide and
Two parts of non-active ingredient constitute, and the non-active ingredient also includes in addition to containing the stable matrix
Emulsifying agent, solid oil phase, liquid oil phase, metal ion chelation agent, preservative, NMF, pH adjusting agent
And water.
6. desonide lotion according to claim 5, it is characterised in that：The stable matrix and desonide
The percentage by weight of lotion is 0.01%-5.0%.
7. desonide lotion according to claim 6, it is characterised in that：The stable matrix and desonide
The percentage by weight of lotion is 0.05%-3.0%.
8. desonide lotion according to claim 5, it is characterised in that：The preservative be sorbic acid,
In sorbate, benzoic acid, benzoate, 2- phenoxetol, benzyl carbinol, phenmethylol and three tert-butyl alcohols
One or more.
9. desonide lotion according to claim 8, it is characterised in that：The preservative be benzyl carbinol,
One or more in phenmethylol, 2- phenoxetol and sorbic acid.
10. desonide lotion according to claim 5, it is characterised in that：The preservative and desonide
The percentage by weight of lotion is 0.1%-2.0%.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106474048A (en) * | 2015-08-27 | 2017-03-08 | 重庆华邦制药有限公司 | A kind of more stable desonide gel preparation of quality |
| CN106474047A (en) * | 2015-08-27 | 2017-03-08 | 重庆华邦制药有限公司 | A kind of desonide preparation stable to light |
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| CN106474047A (en) * | 2015-08-27 | 2017-03-08 | 重庆华邦制药有限公司 | A kind of desonide preparation stable to light |
| CN106474048A (en) * | 2015-08-27 | 2017-03-08 | 重庆华邦制药有限公司 | A kind of more stable desonide gel preparation of quality |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106474048A (en) * | 2015-08-27 | 2017-03-08 | 重庆华邦制药有限公司 | A kind of more stable desonide gel preparation of quality |
| CN106474047A (en) * | 2015-08-27 | 2017-03-08 | 重庆华邦制药有限公司 | A kind of desonide preparation stable to light |
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