CN102000023A - Momestasone furoate cream and preparation method thereof - Google Patents
Momestasone furoate cream and preparation method thereof Download PDFInfo
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Abstract
The invention relates to the technical field of an external preparation medicament, in particular to an external preparation medicament containing momestasone furoate. The external preparation medicament is prepared from the following raw materials in part by weight: 15 parts of the momestasone furoate, 45 parts of hexadecyl-octadecyl alcohol, 7.5 parts of glyceryl monostearate, 5 parts of beeswax, 8 parts of triethanolamine, 35 parts of light liquid paraffin, 2 parts of sodium lauryl sulfate, 8 parts of sodium lauryl sulfate, 25 parts of propylene glycol, 1 part of Hydroxy acetate, 2 parts of tween-80, and the balance of purified water which is added to ensure that the total weight is 500 parts. The cream has better moisture retention and stability because the humectant combination of the triethanolamine and the propylene glycol is adopted.
Description
Technical field
The present invention relates to a kind of technical field of external preparation medicine, especially a kind of external preparation medicine that contains momestasone furoate, this emulsifiable paste are the wetting agent combinations of triethanolamine and propylene glycol owing to what adopt, have better moisture retention and stability.
Background technology
Momestasone furoate is the local glucocorticoid medicine of synthetic, has the low characteristics of cortex hormone function inhibition on the curative effect kidney tonifying.The momestasone furoate emulsifiable paste, the effect that reduces inflammation with pruritus is arranged, be applicable to effective dermatosis of glucocorticoid such as dermatitis (contact dermatitis, seborrheic dermatitis, atoipc dermatitis, neurodermatitis), acute, subacute, chronic eczema, discoid lupus erythematosus, lichen planus, skin amyloidosis lichen, granuloma annulare, the small size psoriasis, pretibial myxedema etc.
At present, the momestasone furoate emulsifiable paste of market sale, stability is generally relatively poor, and emulsifiable paste hardens easily behind the use opening, and product quality changes, the result of use poor response.What is more, there is relevant report to point out that some momestasone furoate emulsifiable paste series of products also has certain side effect, as the hypercortisolisms that the inhibition of HAP axle, long-term a large amount of uses are caused, cause thinning of skin as meeting, the skin surface telangiectasis, and can cause cutis laxa, bring out acne, cause hair follicle to infect, the hair undue growth, skin allergy, and might cause physiological period disorder etc.
Therefore research and develop a moisture retention and stability is better, and the momestasone furoate cream products with low side effect has great importance.
The present invention is to provide the external preparation medicine that contains Momestasone furoate lipidosome, this emulsifiable paste is the wetting agent combination of triethanolamine and propylene glycol owing to what adopt, has better moisture retention and stability.The selection of wetting agent is added can better keep not dehydration of mastic, not atrophy, makes mastic keep stable before the deadline.This emulsifiable paste also has good heat-resisting cold tolerance simultaneously.
Summary of the invention
The purpose of this invention is to provide a kind of momestasone furoate emulsifiable paste, especially a kind of external preparation medicine that contains momestasone furoate, this emulsifiable paste are the wetting agent combinations of triethanolamine and propylene glycol owing to what adopt, thereby have better moisture retention and stability.
Momestasone furoate emulsifiable paste provided by the present invention is achieved through the following technical solutions:
The momestasone furoate emulsifiable paste, make by the following weight proportion raw material: 15 parts of momestasone furoates, 45 parts of hexadeca-octadecyl alcohols, 7.5 parts of single stearic acid glyceride, 5 parts in Cera Flava, 35 parts of light liquid petrolatums, 5 parts of sodium lauryl sulphates, 25 parts of propylene glycol, 1 part in hydroxyl second fat, the purified water ad pond om that adds surplus is 500 parts, wherein: the preparation method of momestasone furoate emulsifiable paste is: 1, oil phase: take by weighing 16-18 required mixed alcohols of recipe quantity, glyceryl monostearate, Cera Flava, liquid paraffin,light, the ethyl hydroxybenzoate Hybrid Heating makes fusion, to 80-85 ℃ the insulation half an hour after, cross 150 mesh sieves, standby; 2, water: take by weighing the required purified water of recipe quantity when being heated to 80 ℃ of left and right sides, add sodium lauryl sulphate and stir and make dissolving, cross 150 mesh sieves, to 80-85 ℃ of insulation half an hour, standby; 3, with momestasone furoate and low amounts of water and mixed with propylene glycol, stir, make mixing, cross 150 mesh sieves, standby; 4, when profit phase temperature during, water is slowly poured in the oil phase, when being stirred to 50-55 ℃,, just slowly be added in emulsive emulsion, continue to stir and be cooled to mastic and be shaped momestasone furoate and low amounts of water and mixed with propylene glycol solution all at 75-80 ℃.
The momestasone furoate emulsifiable paste, make by the following weight proportion raw material: 15 parts of momestasone furoates, 45 parts of hexadeca-octadecyl alcohols, 7.5 parts of single stearic acid glyceride, 5 parts in Cera Flava, 8 parts of triethanolamine, 35 parts of light liquid petrolatums, 2 parts of sodium lauryl sulphates, 8 parts of sodium laurylsulfates, 25 parts of propylene glycol, 1 part in hydroxyl second fat, 2 parts of tween 80s, the purified water ad pond om that adds surplus is 500 parts, wherein: the preparation method of momestasone furoate emulsifiable paste is: 1, oil phase: take by weighing 16-18 required mixed alcohols of recipe quantity, glyceryl monostearate, Cera Flava, liquid paraffin,light, the ethyl hydroxybenzoate Hybrid Heating makes fusion, to 80-85 ℃ the insulation half an hour after, cross 150 mesh sieves, standby; 2, water: take by weighing the required purified water of recipe quantity when being heated to 80 ℃ of left and right sides, add sodium lauryl sulphate, sodium laurylsulfate and stir and make dissolving, cross 150 mesh sieves, be incubated half an hour to 80-85 ℃ with, tween 80, standby; 3, momestasone furoate is mixed with triethanolamine with low amounts of water, propylene glycol, stir, make mixing, cross 150 mesh sieves, standby; 4, when profit phase temperature during all at 75-80 ℃, water is slowly poured in the oil phase, when being stirred to 50-55 ℃, momestasone furoate and low amounts of water, propylene glycol and triethanolamine mixed solution, just slowly be added in emulsive emulsion, continue to stir and be cooled to mastic and be shaped.
The purpose of this invention is to provide a kind of momestasone furoate emulsifiable paste, its adjuvant is selected appropriate, can be so that momestasone furoate emulsifiable paste performance of keeping humidity is more outstanding.The present invention is except selecting wetting agent, also added non-wetting agent sodium laurylsulfate in the raw material, but through the interpolation of sodium lauryl sulphate, sodium laurylsulfate, tween 80 in the evidence momestasone furoate emulsifiable paste raw material and the wetting agent combination of triethanolamine and propylene glycol, make that the performance of keeping humidity of mastic is better, thereby momestasone furoate emulsifiable paste provided by the present invention has better moisture retention and stability.
Advantage of the present invention: the emulsifiable paste matrix made from stearic acid, the smooth in appearance exquisiteness is attractive in appearance, and be easy to be applied in skin, leave one deck stearic acid thin film after the water evaporates and have protectiveness, wherein the situation of stearic addition also needs to do suitably to adjust according to factors such as season, weathers; The interpolation of Cera Flava, light liquid petrolatum can better be regulated the denseness and increase gloss of mastic; Aqueous phase uses sodium lauryl sulphate as emulsifying agent, makes profit under certain condition biphase, can be closely in conjunction with and mastic is shaped; Add triethanolamine and propylene glycol and make up as wetting agent, can well keep not dehydration of mastic, not atrophy makes mastic keep steady statue before the deadline.
The specific embodiment:
Every gram Eloson emulsifiable paste contains 0.1% momestasone furoate, and other non-active ingredient has white vaseline, white beeswax, stearic acid propyleneglycoles, titanium dioxide, water and phosphoric acid solution.
Embodiment 1, momestasone furoate emulsifiable paste, made by the following weight proportion raw material: 15 parts of momestasone furoates, 45 parts of hexadeca-octadecyl alcohols, 7.5 parts of single stearic acid glyceride, 5 parts in Cera Flava, 35 parts of light liquid petrolatums, 5 parts of sodium lauryl sulphates, 25 parts of propylene glycol, 1 part of ethyl hydroxybenzoate, the purified water ad pond om that adds surplus are 500 parts
Wherein: the preparation method of momestasone furoate emulsifiable paste is: 1, oil phase: take by weighing recipe quantity required 16-18 mixed alcohols, glyceryl monostearate, Cera Flava, liquid paraffin,light, ethyl hydroxybenzoate Hybrid Heating and make fusion, to 80-85 ℃ the insulation half an hour after, cross 150 mesh sieves, standby; 2, water: take by weighing the required purified water of recipe quantity when being heated to 80 ℃ of left and right sides, add sodium lauryl sulphate and stir and make dissolving, cross 150 mesh sieves, to 80-85 ℃ of insulation half an hour, standby; 3, with momestasone furoate and low amounts of water and mixed with propylene glycol, stir, make mixing, cross 150 mesh sieves, standby; 4, when profit phase temperature during, water is slowly poured in the oil phase, when being stirred to 50-55 ℃,, just slowly be added in emulsive emulsion, continue to stir and be cooled to mastic and be shaped momestasone furoate and low amounts of water and mixed with propylene glycol solution all at 75-80 ℃.
Embodiment 2, momestasone furoate emulsifiable paste, made by the following weight proportion raw material: 15 parts of momestasone furoates, 45 parts of hexadeca-octadecyl alcohols, 7.5 parts of single stearic acid glyceride, 5 parts in Cera Flava, 35 parts of light liquid petrolatums, 5 parts of sodium lauryl sulphates, 25 parts of propylene glycol, 1 part in hydroxyl second fat, the purified water ad pond om that adds surplus are 500 parts
Wherein: the preparation method of momestasone furoate emulsifiable paste is: 1, oil phase: take by weighing recipe quantity required 16-18 mixed alcohols, glyceryl monostearate, Cera Flava, liquid paraffin,light, ethyl hydroxybenzoate Hybrid Heating and make fusion, to 80-85 ℃ the insulation half an hour after, cross 150 mesh sieves, standby; 2, water: take by weighing the required purified water of recipe quantity when being heated to 80 ℃ of left and right sides, add sodium lauryl sulphate and stir and make dissolving, cross 150 mesh sieves, to 80-85 ℃ of insulation half an hour, standby; 3, with momestasone furoate and low amounts of water and mixed with propylene glycol, stir, make mixing, cross 150 mesh sieves, standby; 4, when profit phase temperature during, water is slowly poured in the oil phase, when being stirred to 50-55 ℃,, just slowly be added in emulsive emulsion, continue to stir and be cooled to mastic and be shaped momestasone furoate and low amounts of water and mixed with propylene glycol solution all at 75-80 ℃.
Embodiment 3, momestasone furoate emulsifiable paste, made by the following weight proportion raw material: 15 parts of momestasone furoates, 45 parts of hexadeca-octadecyl alcohols, 7.5 parts of single stearic acid glyceride, 5 parts in Cera Flava, 8 parts of triethanolamine, 35 parts of liquid paraffin,lights, 2 parts of sodium lauryl sulphates, 8 parts of sodium laurylsulfates, 25 parts of propylene glycol, 1 part in hydroxyl second fat, 2 parts of tween 80s, the purified water ad pond om that adds surplus are 500 parts.
Wherein: the preparation method of momestasone furoate emulsifiable paste is: 1, oil phase: take by weighing recipe quantity required 16-18 mixed alcohols, glyceryl monostearate, Cera Flava, liquid paraffin,light, ethyl hydroxybenzoate Hybrid Heating and make fusion, to 80-85 ℃ the insulation half an hour after, cross 150 mesh sieves, standby; 2, water: take by weighing the required purified water of recipe quantity when being heated to 80 ℃ of left and right sides, add sodium lauryl sulphate, sodium laurylsulfate and stir and make dissolving, cross 150 mesh sieves, be incubated half an hour to 80-85 ℃ with, tween 80, standby; 3, momestasone furoate is mixed with triethanolamine with low amounts of water, propylene glycol, stir, make mixing, cross 150 mesh sieves, standby; 4, when profit phase temperature during all at 75-80 ℃, water is slowly poured in the oil phase, when being stirred to 50-55 ℃, momestasone furoate and low amounts of water, propylene glycol and triethanolamine mixed solution, just slowly be added in emulsive emulsion, continue to stir and be cooled to mastic and be shaped.
The preparation method of embodiment 3-1, momestasone furoate emulsifiable paste is: 1, oil phase: take by weighing recipe quantity required 16-18 mixed alcohols, glyceryl monostearate, Cera Flava, liquid paraffin,light, ethyl hydroxybenzoate Hybrid Heating and make fusion, to 80 ℃ the insulation half an hour after, cross 150 mesh sieves, standby; 2, water: take by weighing the required purified water of recipe quantity when being heated to 80 ℃ of left and right sides, add sodium lauryl sulphate, sodium laurylsulfate and stir and make dissolving, cross 150 mesh sieves, be incubated half an hour to 80 ℃ with, tween 80, standby; 3, momestasone furoate is mixed with triethanolamine with low amounts of water, propylene glycol, stir, make mixing, cross 150 mesh sieves, standby; 4, when profit phase temperature during, water is slowly poured in the oil phase, when being stirred to 50 ℃,, just slowly be added in emulsive emulsion, continue to stir and be cooled to mastic and be shaped momestasone furoate and low amounts of water, propylene glycol and triethanolamine mixed solution all at 75 ℃.All the other are with embodiment 3.
The preparation method of embodiment 3-2, momestasone furoate emulsifiable paste is: 1, oil phase: take by weighing recipe quantity required 16-18 mixed alcohols, glyceryl monostearate, Cera Flava, liquid paraffin,light, ethyl hydroxybenzoate Hybrid Heating and make fusion, to 85 ℃ the insulation half an hour after, cross 150 mesh sieves, standby; 2, water: take by weighing the required purified water of recipe quantity when being heated to 80 ℃ of left and right sides, add sodium lauryl sulphate, sodium laurylsulfate and stir and make dissolving, cross 150 mesh sieves, be incubated half an hour to 85 ℃ with, tween 80, standby; 3, momestasone furoate is mixed with triethanolamine with low amounts of water, propylene glycol, stir, make mixing, cross 150 mesh sieves, standby; 4, when profit phase temperature during, water is slowly poured in the oil phase, when being stirred to 55 ℃,, just slowly be added in emulsive emulsion, continue to stir and be cooled to mastic and be shaped momestasone furoate and low amounts of water, propylene glycol and triethanolamine mixed solution all at 80 ℃.All the other are with embodiment 3.
The preparation method of embodiment 3-3, momestasone furoate emulsifiable paste is: 1, oil phase: take by weighing recipe quantity required 16-18 mixed alcohols, glyceryl monostearate, Cera Flava, liquid paraffin,light, ethyl hydroxybenzoate Hybrid Heating and make fusion, to 82 ℃ the insulation half an hour after, cross 150 mesh sieves, standby; 2, water: take by weighing the required purified water of recipe quantity when being heated to 80 ℃ of left and right sides, add sodium lauryl sulphate, sodium laurylsulfate and stir and make dissolving, cross 150 mesh sieves, be incubated half an hour to 82 ℃ with, tween 80, standby; 3, momestasone furoate is mixed with triethanolamine with low amounts of water, propylene glycol, stir, make mixing, cross 150 mesh sieves, standby; 4, when profit phase temperature during, water is slowly poured in the oil phase, when being stirred to 53 ℃,, just slowly be added in emulsive emulsion, continue to stir and be cooled to mastic and be shaped momestasone furoate and low amounts of water, propylene glycol and triethanolamine mixed solution all at 78 ℃.All the other are with embodiment 3.
Embodiment 4, momestasone furoate emulsifiable paste make the momestasone furoate emulsifiable paste by the momestasone furoate emulsifiable paste effect that makes of embodiment 1-3 with embodiment 3.
The momestasone furoate emulsifiable paste that is made by embodiment 1, embodiment 2, embodiment 3 is carried out moisture retention test, stability test embodiment and stability test.
The moisture retention experimental example
To be divided into three groups of A, B, C by the momestasone furoate emulsifiable paste that embodiment 1, embodiment 2, embodiment 3 make, the 4th group of D (wherein the 4th group of sample that provides is by the common momestasone furoate emulsifiable paste that obtains on the market) is provided for other.
The moisture retention experimental example
Extracting waste glazed paper is cut into 1cm * 2cm, 2cm * 4cm, 3cm * 6cm size after precision is heavy, evenly is coated with last layer sample (the different size sheets of each sample are respectively done 2 parts), weigh, after putting into calorstat (25 ± 1) ℃ insulation 4h, taking-up is weighed, unit of account area water evaporates amount, 4 groups of prescription water evaporates amounts are respectively (18.0 ± 2.3) as a result, (9.3 ± 1.4), (8.7 ± 1.3), (19.7 ± 1.2) mgcm
-2
Stability test embodiment
1, accelerated test is investigated the result
We are according to " the requirement of accelerated test in Chinese pharmacopoeia two appendix of version in 2005 " medicine stability test guideline ", A, B, each 15g of C, D prescription substrate are contained in the emulsifiable paste box, being positioned over temperature is 30 ± 2 ℃, relative humidity is in 65 ± 5 ℃ the cupboard that keeps sample, in sampling in 1,2,3,4,5,6 month, in " medicine stability test guideline ", the investigation of character, content, uniformity, catabolite, granularity, lamination has been carried out in every requirement of pharmaceutical preparation stability high spot reviews project to this product.
The result: through 30 ± 2 ℃ of temperature, relative humidity was placed 6 months under 65 ± 5 ℃ environment, can find out obviously that the every index of momestasone furoate emulsifiable paste that embodiment 3 makes has no significant change.Conclusion: this product is 30 ± 2 ℃ of temperature, and relative humidity was placed 6 months under 65 ± 5 ℃ environment, and this product is stable.
2, the investigation result that keeps sample for a long time
We are according to " the requirement of Chinese pharmacopoeia two appendix of version in 2005 " medicine stability test guideline " long term test, A, B, each 15g of C, D prescription substrate are contained in the emulsifiable paste box, being positioned over temperature is 25 ± 2 ℃, relative humidity is in 60 ± 5 ℃ the cupboard that keeps sample, in sampling in 3,6 months, this product has been carried out the investigation of character, content, uniformity, catabolite, granularity, lamination with every requirement of " medicine stability test guideline " Chinese medicine preparation stability high spot reviews project.
The result: kept sample for a long time 6 months, every index was compared with 0 month, no significant change.The test that keeps sample for a long time is still underway.
Low temperature and hot constant temperature test embodiment
Get A, B, C, D prescription substrate 15g and contain in the emulsifiable paste box, place the refrigerator and the incubator of steady temperature respectively, under different temperatures, store 24h, take out, after waiting to return back to room temperature, on microscope slide, be coated with skim, observe lamination, the results are shown in down form.
Annotate: "-" no change, "+" chap, " // " layering
Conclusion (of pressure testing): embodiment result learns according to stability test: the momestasone furoate emulsifiable paste that is made by embodiment 3 has better temperature resistance, and cold-resistant and heat resistance the best can maintain a relatively stable state under-10 ℃-40 ℃; The result learns according to the moisture retention experimental example: the percentage of water loss minimum of the momestasone furoate emulsifiable paste that is made by embodiment 3 has better moisture retention.
Comprehensive above conclusion can be known the momestasone furoate emulsifiable paste the best that is made by embodiment 3.
Claims (3)
1. momestasone furoate emulsifiable paste, made by the following weight proportion raw material: 15 parts of momestasone furoates, 45 parts of hexadeca-octadecyl alcohols, 7.5 parts of single stearic acid glyceride, 5 parts in Cera Flava, 35 parts of light liquid petrolatums, 5 parts of sodium lauryl sulphates, 25 parts of propylene glycol, 1 part in hydroxyl second fat, the purified water ad pond om that adds surplus are 500 parts
It is characterized in that: the preparation method of momestasone furoate emulsifiable paste is: 1, oil phase: take by weighing recipe quantity required 16-18 mixed alcohols, glyceryl monostearate, Cera Flava, liquid paraffin,light, ethyl hydroxybenzoate Hybrid Heating and make fusion, to 80-85 ℃ the insulation half an hour after, cross 150 mesh sieves, standby; 2, water: take by weighing the required purified water of recipe quantity when being heated to 80 ℃ of left and right sides, add sodium lauryl sulphate and stir and make dissolving, cross 150 mesh sieves, to 80-85 ℃ of insulation half an hour, standby; 3, with momestasone furoate and low amounts of water and mixed with propylene glycol, stir, make mixing, cross 150 mesh sieves, standby; 4, when profit phase temperature during, water is slowly poured in the oil phase, when being stirred to 50-55 ℃,, just slowly be added in emulsive emulsion, continue to stir and be cooled to mastic and be shaped momestasone furoate and low amounts of water and mixed with propylene glycol solution all at 75-80 ℃.
2. momestasone furoate emulsifiable paste, made by the following weight proportion raw material: 15 parts of momestasone furoates, 45 parts of hexadeca-octadecyl alcohols, 7.5 parts of single stearic acid glyceride, 5 parts in Cera Flava, 8 parts of triethanolamine, 35 parts of liquid paraffin,lights, 2 parts of sodium lauryl sulphates, 8 parts of sodium laurylsulfates, 25 parts of propylene glycol, 1 part in hydroxyl second fat, 2 parts of tween 80s, the purified water ad pond om that adds surplus are 500 parts.
It is characterized in that: the preparation method of momestasone furoate emulsifiable paste is: 1, oil phase: take by weighing recipe quantity required 16-18 mixed alcohols, glyceryl monostearate, Cera Flava, liquid paraffin,light, ethyl hydroxybenzoate Hybrid Heating and make fusion, to 80-85 ℃ the insulation half an hour after, cross 150 mesh sieves, standby; 2, water: take by weighing the required purified water of recipe quantity when being heated to 80 ℃ of left and right sides, add sodium lauryl sulphate, sodium laurylsulfate and stir and make dissolving, cross 150 mesh sieves, be incubated half an hour to 80-85 ℃ with, tween 80, standby; 3, momestasone furoate is mixed with triethanolamine with low amounts of water, propylene glycol, stir, make mixing, cross 150 mesh sieves, standby; 4, when profit phase temperature during all at 75-80 ℃, water is slowly poured in the oil phase, when being stirred to 50-55 ℃, momestasone furoate and low amounts of water, propylene glycol and triethanolamine mixed solution, just slowly be added in emulsive emulsion, continue to stir and be cooled to mastic and be shaped.
3. momestasone furoate emulsifiable paste according to claim 2 is characterized in that: the momestasone furoate emulsifiable paste that makes have well preserve moisture and resist cold, heat resistance.
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| CN106138066A (en) * | 2015-04-02 | 2016-11-23 | 广州朗圣药业有限公司 | A kind of Momestasone furoate cream and preparation method thereof |
| CN109512778A (en) * | 2017-09-18 | 2019-03-26 | 江苏吉贝尔药业股份有限公司 | A kind of cream and preparation method of Halometasone |
| CN112754990A (en) * | 2020-11-12 | 2021-05-07 | 广州白云山医药集团股份有限公司白云山何济公制药厂 | Mometasone furoate cream and preparation method thereof |
| CN113230203A (en) * | 2021-05-18 | 2021-08-10 | 广州白云山医药集团股份有限公司白云山何济公制药厂 | Mometasone furoate gel and preparation method thereof |
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| CN106138066A (en) * | 2015-04-02 | 2016-11-23 | 广州朗圣药业有限公司 | A kind of Momestasone furoate cream and preparation method thereof |
| CN106138066B (en) * | 2015-04-02 | 2018-12-28 | 广州朗圣药业有限公司 | A kind of Momestasone furoate cream and preparation method thereof |
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| CN112754990A (en) * | 2020-11-12 | 2021-05-07 | 广州白云山医药集团股份有限公司白云山何济公制药厂 | Mometasone furoate cream and preparation method thereof |
| CN112754990B (en) * | 2020-11-12 | 2023-08-29 | 广州白云山医药集团股份有限公司白云山何济公制药厂 | Mometasone furoate emulsifiable paste and preparation method thereof |
| CN113230203A (en) * | 2021-05-18 | 2021-08-10 | 广州白云山医药集团股份有限公司白云山何济公制药厂 | Mometasone furoate gel and preparation method thereof |
| CN113520993A (en) * | 2021-07-30 | 2021-10-22 | 海南海神同洲制药有限公司 | Preparation method of low-viscosity sertaconazole nitrate cream and product prepared by same |
| CN113520993B (en) * | 2021-07-30 | 2022-07-29 | 海南海神同洲制药有限公司 | Preparation method of low-viscosity sertaconazole nitrate cream and product prepared by same |
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