CN106474047A - A kind of desonide preparation stable to light - Google Patents
A kind of desonide preparation stable to light Download PDFInfo
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- CN106474047A CN106474047A CN201510534431.0A CN201510534431A CN106474047A CN 106474047 A CN106474047 A CN 106474047A CN 201510534431 A CN201510534431 A CN 201510534431A CN 106474047 A CN106474047 A CN 106474047A
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Abstract
A kind of a kind of the invention belongs to field of pharmaceutical preparations, is related to desonide preparation, it particularly relates to desonide preparation more stable to light.The described desonide preparation more stable to light be using benzyl carbinol and/or phenmethylol and/or 2- phenoxetol and/or sorbic acid as desonide preparation preservative replacing preservative methyl p-hydroxybenzoate and propylparaben.In the desonide formulation products of the present invention there is no any interference to relevant substance detection system in each component, relevant material meets control limit of the chemicals about material guideline, and the light sensitivity of preparation has obtained obvious improvement, in the contrast of illumination effect factor is investigated, all substantially reduce about mass degradation amplitude and content fall in the desonide preparation of the present invention, product stability is significantly improved.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, is related to a kind of desonide preparation, it particularly relates to a kind of right
The more stable desonide preparation of light.
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 preparation has the desonide that Bayer pharmacy (BAYER HLTHCARE) is developed
Gel (DESONIDE Gel)；Desonide lotion (the DESONIDE of high dolantin (Galderma) company exploitation
LOTION), desonide cream (DESONIDE CREAM) and desonide ointment (DESONIDE
OINTMENT) etc..
But by the research discovery to presently commercially available multiple desonide preparations, the desonide system on existing market
Agent generally existing problems with：(1) desonide preparation such as desonide gelDesonide is washed
AgentAll there is obvious light sensitivity, after preparation is exposed under illumination condition, relevant material is present
Obvious degradation, content are greatly lowered, be because desonide be in weak effect glucocorticoid, itself has
Light sensitivity, unstable under illumination condition, degraded is susceptible to, produces new unknown impuritie；And relevant thing
Being greatly lowered for the degraded of matter and content, certainly will affect product curative effect；(2) presently commercially available desonide preparation
Time to market (TTM) is more early, does not have the particle diameter to product and relevant material to be controlled, after testing, presses
Control according to drug standard newest at present requires which is substantially higher about content of material, more than current
The standard requirement of the relevant material control guideline of chemicals, can not meet existing quality criteria requirements
Control limit；(3) using methyl p-hydroxybenzoate and P-hydroxybenzoic acid in existing desonide preparation prescription
Propyl ester as preservative, but in the detecting system about material its to go out peak position Chong Die with active component presence,
The accurate detection having a strong impact on about material；(4) existing desonide preparation mostly is suspension type preparation, activity
Composition is suspended and is distributed in preparation, but different parts in many batches of commercially available desonide gels and lotion product are taken
The assay result of sample shows there is obvious content inhomogeneities, shows which has obvious sedimentation phenomenon,
During this filling and patient's use on product all there is impact in drug effect.
Content of the invention
In view of the preservative methyl p-hydroxybenzoate adopted in existing desonide preparation prescription and para hydroxybenzene
There is significantly interference in propyl formate, which goes out peak position is present with active component to the detecting system about material
Overlap, the detection accuracy having had a strong impact on about material.Present inventor is by desonide formulation products
There is the methyl p-hydroxybenzoate of interference to product quality detection and propylparaben removes, use instead
The more preferable benzyl carbinol of compatibility and/or phenmethylol and/or 2- phenoxetol and/or sorbic acid, benzyl carbinol, benzene
Methyl alcohol, 2- phenoxetol, sorbic acid are no substantially interfered with to the detection of relevant material, and the standard of detection is greatly improved
True property；In experimental study, also pleasantly surprised discovery, using benzyl carbinol and/or phenmethylol and/or 2- phenoxy group
Ethanol and/or sorbic acid not only improve the interference to the detection of relevant material, and the light of preparation as preservative
Quick property has obtained obvious improvement, in the contrast of illumination effect factor is investigated, the desonide preparation of the present invention
In all substantially reduce about mass degradation amplitude and content fall, product stability is significantly improved.
In view of this, an object of the present invention is to provide a kind of raising desonide preparation photostability
How noiseless about the detection of material in agent made in Germany stabilizer, the stabilizer be over the ground, and makes desonide preparation
In all substantially reduce about mass degradation amplitude and content fall.
For achieving the above object, the technical scheme is that：
The stabilizer of desonide preparation photostability is improved, the stabilizer is benzyl carbinol, phenmethylol, 2-
One or more in phenoxetol and sorbic acid.
The second object of the present invention is to provide a kind of method for improving desonide preparation photostability, the party
Method can significantly improve the more serious problem of existing desonide preparation light sensitivity.
For achieving the above object, the technical scheme is that：
The method that stabilizer based on the present invention improves desonide preparation photostability, using the stabilizer
Preservative as desonide preparation is replacing preservative methyl p-hydroxybenzoate, propylparaben；
The stabilizer is one or more in benzyl carbinol, phenmethylol, 2- phenoxetol and sorbic acid.
Further, the stabilizer is 0.1%-2.0% with the percentage by weight of desonide preparation.
Preferably, the stabilizer is 0.3%-1.0% with the percentage by weight of desonide preparation.
The present invention also aims to providing a kind of desonide preparation prepared by above-mentioned method.
The present invention also aims to described stabilizer is applied to prepare the desonide preparation stable to light
In.
The present invention specifically additionally provides a kind of desonide gel preparation stable to light by active component ground how,
Two parts of moral and non-active ingredient constitute, and the non-active ingredient includes gel-type vehicle, metal ion-chelant
Agent, preservative, NMF, pH adjusting agent and water, wherein, the preservative be benzyl carbinol, phenmethylol,
One or more in 2- phenoxetol and sorbic acid.Benzyl carbinol, phenmethylol, 2- phenoxetol, mountain
Pears acid is no substantially interfered with to the detection of relevant material, and the accuracy of detection is greatly improved；In addition, adopting benzyl carbinol
And/or the desonide gel preparation that phenmethylol and/or 2- phenoxetol and/or sorbic acid are obtained as preservative
Light sensitivity obtained obvious improvement, illumination effect factor contrast investigate in, which is about mass degradation
Amplitude and content fall all substantially reduce, and product stability is significantly improved.
Present inventor has found that in drug research it is uniform that content occurs in existing desonide gel preparation
The poor problem of degree, it is critical only that the viscosity of product prescription is not enough, it is impossible to carry the active cost for suspending,
Active component sedimentation causes suspension less stable.It is preferred, therefore, that the described desonide stable to light
Gel preparation, the desonide gel preparation viscosity control in 40000mPa.s-350000mPa.s, obtain
Desonide gel products have good physical stability, after investigating through high temperature, low temperature and Frozen-thawed cycled, no
Obvious sedimentation phenomenon, content are uniform and stable.
Further, the desonide gel preparation viscosity controls in 50000mPa.s-300000mPa.s.
Gel-type vehicle of the present invention refers to viscosity higher and can be used to carry the pharmaceutically acceptable of active component
Auxiliary material.Can adopt any acceptable material of pharmaceutical field, such as common cellulose derivative, Carbomer,
Alginate, tragacanth, gelatin, starch etc..Carbomer is the most frequently used gel-type vehicle in gel products.
Low viscous Carbomer981 is have selected in existing desonide gel preparation prescription as gel-type vehicle, by its system
Gel products, even if its viscosity is still relatively low under the conditions of peak viscosity, and active component be be suspended
State is present in gel, places a period of time, and especially in the higher environment of temperature, gel viscosity enters
In the case that one step reduces, there is obvious sedimentation phenomenon in active component, cause content in gel serious not
All.Therefore, the desonide gel preparation stable to light of the present invention, preferably described gel-type vehicle be Carbomer,
One or more in cellulose derivative, shitosan, polyvinylpyrrolidone or polyvinyl alcohol etc..
It is furthermore preferred that in the preferred Acritamer 940 of the gel-type vehicle, Carbopol, carbomer934 one
Plant or multiple.
The desonide gel preparation stable to light of the present invention, other non-active ingredient metal ion chelation agents,
NMF, pH adjusting agent are conventional relevant auxiliary materials, such as metal ion chelation agent can for ethylenediamine tetra-acetic acid,
Disodium ethylene diamine tetraacetate, aminotriacetic acid, diethylenetriamines are nothing acetic acid and its salt, tartaric acid, lemon
One or more in acid, hydroxyethylethylene diamine tri-acetic acid and bicine N- etc. are used in combination；Protect
Humectant can be used in combination for one or more in glycerine, propane diols etc.；PH adjusting agent can be as hydrogen-oxygen
One or more that changes in sodium, potassium hydroxide, sodium citrate etc. are used in combination.Its consumption is conventional amount used.
The present invention specifically additionally provides a kind of desonide lotion stable to light, by active component desonide and
Two parts of non-active ingredient constitute, and the non-active ingredient includes lotion stable matrix, emulsifying agent, solid
Oil phase, liquid oil phase, metal ion chelation agent, preservative, NMF, pH adjusting agent and water, wherein,
The preservative is one or more in benzyl carbinol, phenmethylol, 2- phenoxetol and sorbic acid.Benzene second
Alcohol, phenmethylol, 2- phenoxetol, sorbic acid are no substantially interfered with to the detection of relevant material, and inspection is greatly improved
The accuracy of survey；In addition, using benzyl carbinol and/or phenmethylol and/or 2- phenoxetol and/or sorbic acid work
The light sensitivity of the desonide lotion obtained for preservative has obtained obvious improvement, in the right of illumination effect factor
Than, in investigation, which all substantially reduces about mass degradation amplitude and content fall, and product stability is obtained
Significantly improve.
Present inventor has found that in drug research existing desonide lotion uniformity of dosage units occurs relatively
Poor problem, it is critical only that product viscosity is low, it is impossible to carry the active cost for suspending, and active component sinks
Drop causes suspension less stable.It is preferred, therefore, that the described desonide lotion stable to light, described
Lotion stable matrix can be for natural polymer and its derivative (as starch, gelatin, sodium alginate, cheese
Element, guar gum, chitosan, gum arabic, xanthans, soybean protein glue, natural rubber, lanolin,
Agar etc.), cellulose ethers (as methylcellulose, hydroxypropyl methyl cellulose, sodium carboxymethylcellulose,
Hydroxyethyl cellulose etc.), synthesis high score subclass (as polyacrylamide, polyvinyl alcohol, polyvinylpyrrolidone,
Polyethylene glycol oxide, modified paraffin resin, carbomer, polyacrylic acid, Polyacrylate Emulsion, suitable fourth
Rubber, butadiene-styrene rubber, polyurethane, modified polyurea, low-molecular polyethylene wax etc.) in one or more,
Its consumption is 0.01%-5.0% with the percentage by weight of desonide lotion, and it is steady that prepared product has good physics
Qualitative, after investigating through 60 DEG C of high temperature, height low temperature and Frozen-thawed cycled, no obvious sedimentation phenomenon, content are uniform
Stable.
Further, it is preferred that the lotion stable matrix be xanthans, gum arabic, sodium alginate,
One kind in methylcellulose, hydroxypropyl methyl cellulose, sodium carboxymethylcellulose and hydroxyethyl cellulose or
Multiple.
The desonide lotion stable to light of the present invention, other non-active ingredient emulsifying agents, solid oil phase, liquid
Body oil phase, metal ion chelation agent, NMF, pH adjusting agent are conventional relevant auxiliary materials, and such as emulsifying agent can
Think the one kind in lauryl sodium sulfate, sorbester p18, sorbester p17, Tween 80, T63, G64 and M68 etc.
Or multiple be used in combination；Solid oil phase can for hexadecanol, octadecyl alcolol, cetostearyl alcohol, solid paraffin,
Being used in combination for one or more in beeswax, glycerin monostearate or single bi-tristearin；Liquid oil
Can mutually be in liquid paraffin,light, medium chain triglyceride, vaseline, silicone, dimethicone etc.
Kind or multiple be used in combination；Metal ion chelation agent can for 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- etc. are used in combination；NMF can for glycerine, third
One or more in glycol etc. are used in combination；PH adjusting agent can be as NaOH, potassium hydroxide, Chinese holly
One or more in rafter acid sodium etc. are used in combination.The consumption of other non-active ingredients is conventional amount used.
Beneficial effects of the present invention：
(1) how the stabilizer of the raising desonide preparation photostability of the present invention is over the ground about thing in agent made in Germany
The detection of matter is noiseless, and makes all bright about mass degradation amplitude and content fall in desonide preparation
Aobvious reduction.
(2) the desonide quality of the pharmaceutical preparations of the present invention is more stable, and especially illumination condition stability is improved.Test
Detection confirms, after each formulation samples of the present invention are investigated through illumination effect factor, about mass degradation and content
Reduction amplitude is all much smaller than presently commercially available desonide preparation；In addition, compared with existing preparation, relevant material is more
Stable, meet requirement of the current chemicals about material guideline control limit；Each component pair in prescription
Content and relevant material detection noiseless, measurement result is more accurate.
Description of the drawings
The relevant material high-efficient liquid phase chromatogram of Fig. 1 desonide gel.
The relevant material high-efficient liquid phase chromatogram of Fig. 2 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 preparation according to the present invention
In following examples, required each material is all obtained from commercially available channel.
Embodiment 1
The desonide gel of the present embodiment, its composition are as follows：
Preparation method：
1) purified water, Carbomer, glycerine, disodium ethylene diamine tetraacetate and the phenoxetol of recipe quantity are weighed,
Stirring and dissolving is complete；
2) recipe quantity desonide is added step 1) in resulting solution, homogeneous dispersed with stirring；
3) sodium hydroxide solution is added, is uniformly mixed and obtains final product gel.
Embodiment 2
The desonide gel of the present embodiment, its composition are as follows：
Preparation method：With embodiment 1.
Embodiment 3
The desonide gel of the present embodiment, its composition are as follows：
Preparation method：With embodiment 1.
Embodiment 4
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 5
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 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, 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.
Part II experimental example
The physical stability contrast of 1 desonide preparation of experimental example
Subjects：
Desonide gel and commercially available desonide gel prepared by embodiment 1-3(lot number：
LOT87030) contrast；Desonide lotion and commercially available desonide lotion prepared by embodiment 4-6
(lot number：G 54Q) contrast.
Testing program：
1. 60 DEG C of high temperature is investigated 10 days；
2. -20 DEG C -40 DEG C of Frozen-thawed cycled, investigate 12 days (per 2 days inversion temperatures, circulation in 4 days)；
3. 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 formulation samples 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：
Tables 1 and 2 is referred to, desonide preparation obtained in the present invention accelerates to investigate 6 months, high temperature through 40 DEG C
60 DEG C investigate 10 days and Frozen-thawed cycled after result of the test show that physical behavior is stable, active component is suspended in solidifying
In glue, no obvious sedimentation phenomenon, before and after investigation, uniformity of dosage units meets the requirements, better than presently commercially available product.
It follows that the desonide preparation physical stability of the present invention is more preferable.
The desonide gel preparation of 1 present invention of table with commercially availablePhysical stability is contrasted
Note is 1.：Upper, middle and lower from gel preparation 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 desonide lotion of 2 present invention of table with commercially availablePhysical stability is contrasted
Note is 2.：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 preparation of test example
Subjects：
Desonide gel preparation and commercially available desonide gel prepared by embodiment 1-3(lot number：
LOT87030) contrast；Desonide lotion and commercially available desonide lotion prepared by embodiment 4-6
(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. illumination, total illumination are not less than 1.2 × 106Lux·hr.
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 gel frequently, taking-up lets cool, plus sodium chloride 5g, shakes up, and standing takes upper strata clear
Liquid is filtered, and takes filtrate as need testing solution.Take need testing solution and inject liquid chromatograph in right amount, record color
Spectrogram, calculates each impurity content according to peak area normalization.
Experimental Comparison result：
Table 3 and table 4 is referred to, desonide preparation obtained in the present invention is investigated 10 days, accelerated for 60 DEG C through high temperature
40 DEG C are investigated steady quality after 6 months and exposure experiments to light：About the range of decrease under the degraded of material and content after illumination
Degree is far below commercially available prod；Relevant material meets quality standard bound requirements, and in prescription each component to relevant
Material system detection is noiseless, sees accompanying drawing 1 and accompanying drawing 2.Contrast is commercially availableWith
Its relevant material is changed significantly, especially in 60 DEG C of influence factors and the investigation for accelerating 40 DEG C, relevant material drop
Solution trend substantially, all exceedes quality standard control limit.
It follows that the desonide formulation chemist stability of the present invention is more preferably, the desonide preparation light of the present invention
Commercially available prod is far below according to the rear degraded about material and content fall.
The desonide gel preparation of 3 present invention of table with commercially availableChemical stability is contrasted
Note：Wherein 0 day for implementing the testing result before contrast test.
The desonide lotion of 4 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 stabilizer of desonide preparation photostability is improved, it is characterised in that：The stabilizer is benzene second
One or more in alcohol, phenmethylol, 2- phenoxetol and sorbic acid.
2. the method that the stabilizer based on claim 1 improves desonide preparation photostability, its feature exist
In：Using the stabilizer as desonide preparation preservative come replace preservative methyl p-hydroxybenzoate,
Propylparaben.
3. method according to claim 2, it is characterised in that：The stabilizer and the weight of desonide preparation
Amount percentage is 0.1%-2.0%.
4. method according to claim 3, it is characterised in that：The stabilizer and the weight of desonide preparation
Amount percentage is 0.3%-1.0%.
5. the desonide preparation that prepared by the method described in any one of claim 2-4.
6. application of the stabilizer described in claim 1 in the desonide preparation stable to light is prepared.
7. the stable desonide gel preparation of pair light, by two parts of active component desonide and non-active ingredient
Composition, the non-active ingredient include gel-type vehicle, metal ion chelation agent, preservative, NMF, pH
Conditioning agent and water, it is characterised in that：The preservative is benzyl carbinol, phenmethylol, 2- phenoxetol and mountain
One or more in pears acid.
8. the desonide gel preparation stable to light according to claim 7, it is characterised in that：Describedly
How moral gel preparation viscosity controls in 40000mPa.s-350000mPa.s.
9. the stable desonide lotion of pair light, is made up of two parts of active component desonide and non-active ingredient,
The non-active ingredient includes lotion stable matrix, emulsifying agent, solid oil phase, liquid oil phase, metal ion
Chelating agent, preservative, NMF, pH adjusting agent and water, it is characterised in that：The preservative be benzyl carbinol,
One or more in phenmethylol, 2- phenoxetol and sorbic acid.
10. the desonide lotion stable to light according to claim 9, it is characterised in that：The lotion
Stable matrix be xanthans, gum arabic, sodium alginate, methylcellulose, hydroxypropyl methyl cellulose,
One or more in sodium carboxymethylcellulose and hydroxyethyl cellulose.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN106474059A (en) * | 2015-08-27 | 2017-03-08 | 重庆华邦制药有限公司 | A kind of more stable desonide lotion of quality |
| CN112057418A (en) * | 2020-09-24 | 2020-12-11 | 广州帝奇医药技术有限公司 | Fudosteine oral liquid and preparation method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1460013A (en) * | 2000-08-03 | 2003-12-03 | 陶氏药物科学公司 | Topical gel delivery system |
| CN104095805A (en) * | 2014-01-02 | 2014-10-15 | 江苏知原药业有限公司 | Desonide emulsifiable paste and preparation method thereof |
| CN104473865A (en) * | 2014-11-17 | 2015-04-01 | 重庆华邦制药有限公司 | Desonide gel and preparation method thereof |
| 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 |
| CN106474059A (en) * | 2015-08-27 | 2017-03-08 | 重庆华邦制药有限公司 | A kind of more stable desonide lotion of quality |
-
2015
- 2015-08-27 CN CN201510534431.0A patent/CN106474047A/en not_active Withdrawn
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1460013A (en) * | 2000-08-03 | 2003-12-03 | 陶氏药物科学公司 | Topical gel delivery system |
| CN104095805A (en) * | 2014-01-02 | 2014-10-15 | 江苏知原药业有限公司 | Desonide emulsifiable paste and preparation method thereof |
| CN104473865A (en) * | 2014-11-17 | 2015-04-01 | 重庆华邦制药有限公司 | Desonide gel and preparation method thereof |
| 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 |
| CN106474059A (en) * | 2015-08-27 | 2017-03-08 | 重庆华邦制药有限公司 | A kind of more stable desonide lotion of quality |
Non-Patent Citations (3)
| Title |
|---|
| 姚静编: "《药用辅料应用指南》", 31 August 2011, 中国医药科技出版社 * |
| 潘卫三主编: "《工业药剂学 第2版》", 30 June 2010, 中国医药科技出版社 * |
| 董银卯主编: "《化妆品配方设计与生产工艺》", 30 April 2007, 中国纺织出版社 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN106474059A (en) * | 2015-08-27 | 2017-03-08 | 重庆华邦制药有限公司 | A kind of more stable desonide lotion of quality |
| CN112057418A (en) * | 2020-09-24 | 2020-12-11 | 广州帝奇医药技术有限公司 | Fudosteine oral liquid and preparation method thereof |
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