Mometasone furoate cream as well as preparation method and application thereof

Abstract

The invention provides mometasone furoate cream as well as a preparation method and application thereof, and belongs to the technical field of external pharmaceutical preparations. The mometasone furoate emulsifiable paste comprises mometasone furoate as an active component and an emulsification system formed by combining an emulsifier hydrogenated soybean phosphatidylcholine, a co-emulsifier and a compound emulsifier. By adjusting an emulsification system, the mometasone furoate emulsifiable paste prepared by the invention can overcome the problem of poor stability of a reference preparation Elocon, and the prepared emulsifiable paste is higher in stability, smaller in droplet particle size, more regular in form and better in in-vitro release.

Description

Technical Field

[0001] The invention belongs to the technical field of external medicine preparations, and particularly relates to a mometasone furoate cream and a preparation method and application thereof. Background Art

[0002] Mometasone Furoate (MF) is a new type of fluorine-free glucocorticoid derivative, with the chemical name 9,21-dichloro-11b,17-dihydroxy-16a-methylpregnane-1,4-diene-3,20-dione 17-(2-furoate). Mometasone furoate is a soft hormone. Soft hormones refer to hormones that are rarely absorbed by the whole body or can be quickly metabolized into inactive degradation products after being absorbed in the skin, but retain a high degree of activity locally. Therefore, the inhibition of the HPA (hypothalamus-pituitary-adrenal cortex) axis and other systemic adverse reactions are greatly reduced, and the therapeutic index is greatly improved. It is suitable for the elderly, infants and large areas. Mometasone furoate is the only corticosteroid hormone approved by the US Food and Drug Administration (FDA) for children, with fewer side effects and safe and reliable.

[0003] The trade name of mometasone furoate cream is Elocon. It is a new type of topical, non-fluorinated, but halogen-containing "potent" glucocorticoid hormone preparation developed and produced by Schering-Plough (now Merck, USA). It was first launched in the United States in 1987 with a specification of 0.1%. It is used to relieve the inflammation and itching symptoms of corticosteroid-responsive skin diseases in patients over 2 years old. The original Russian drug instructions disclose the following prescription: 1g of cream contains: active substance mometasone furoate 1mg, excipients: hexylene glycol 120mg, hydrogenated phosphatidylcholine (hydrogenated soybean phosphatidylcholine) 15mg, octenyl succinate aluminum starch 100mg, titanium dioxide 10mg, white beeswax 50mg, vaseline 674mg, phosphoric acid (to adjust pH value), purified water 30mg. The prescription uses a single emulsifier, hydrogenated soybean phosphatidylcholine, which has the functions of improving skin feel, enhancing penetration, and rebuilding the skin's natural moisturizing barrier.

[0004] When the applicant studied the original reference preparation, it was found that it was easy to stratify during storage, unstable at high temperature, and had poor centrifugal stability, which was not conducive to the stable performance of the drug effect. In response to this problem, the present invention adjusted the emulsification system, retained the natural emulsifier hydrogenated soybean phosphatidylcholine used in the original reference preparation, and used hydrogenated soybean phosphatidylcholine, co-emulsifier and compound emulsifier to jointly construct the emulsification system, aiming to improve the stability of the cream. Summary of the invention

[0005] In view of the defects of the prior art, the present invention provides a mometasone furoate cream and a preparation method and application thereof, which overcomes the problem of poor stability of the reference preparation Elocon and obtains a mometasone furoate cream with improved stability, smaller droplet size, more regular morphology and better in vitro release.

[0006] The invention provides a mometasone furoate cream. The mometasone furoate cream comprises mometasone furoate as an active ingredient, hydrogenated soybean phosphatidylcholine as an emulsifier, an auxiliary emulsifier and a compound emulsifier.

[0007] The auxiliary emulsifier is selected from one or a combination of cetyl alcohol, stearyl alcohol, and cetostearyl alcohol.

[0008] The compound emulsifier is selected from one of mono- and distearic acid glyceryl, a combination of glyceryl stearate and PEG-100 stearate, and a combination of methyl glucoside sesquistearate and PEG-20 methyl glucoside sesquistearate.

[0009] Preferably, in the combination of glyceryl stearate and PEG-100 stearate, the ratio between the two is 1:1.

[0010] Preferably, in the combination of the methyl glucoside sesquistearate and the PEG-20 methyl glucoside sesquistearate, the ratio between the two is 1:1.

[0011] In some embodiments, the mometasone furoate cream further comprises a solvent, a base, a thickener 1, a thickener 2, and optionally further comprises a colorant.

[0012] Preferably, the solvent is aqueous phosphoric acid solution and hexylene glycol.

[0013] Preferably, the matrix is ​​white vaseline.

[0014] Preferably, the thickener 1 is white beeswax, and the thickener 2 is aluminum starch octenylsuccinate.

[0015] Preferably, the colorant is titanium dioxide.

[0016] In some embodiments, the mometasone furoate cream of the present invention comprises the following components in weight percentage: 0.1% mometasone furoate, 15% solvent, 1.5% emulsifier hydrogenated soybean phosphatidylcholine, 2-4% co-emulsifier, 2-3% compound emulsifier, 64.4-65.4% matrix, 11-14% thickener and 1% colorant.

[0017] Preferably, the mometasone furoate cream comprises the following components in weight percentage: 0.1% mometasone furoate, 3% phosphoric acid aqueous solution, 12% hexylene glycol, 1.5% hydrogenated soybean phosphatidylcholine, 3% hexyl alcohol, 2% glyceryl mono- and distearate, 65.4% white vaseline, 2% white beeswax, 10% aluminum starch octenylsuccinate and 1% titanium dioxide.

[0018] Preferably, the mometasone furoate cream comprises the following components in weight percentage: 0.1% mometasone furoate, 3% phosphoric acid aqueous solution, 12% hexylene glycol, 1.5% hydrogenated soybean phosphatidylcholine, 4% octadecyl alcohol, 1.5% glyceryl stearate, 1.5% PEG-100 stearate, 64.4% white vaseline, 1% white beeswax, 10% aluminum starch octenylsuccinate and 1% titanium dioxide.

[0019] Preferably, the mometasone furoate cream comprises the following components in weight percentage: 0.1% mometasone furoate, 3% phosphoric acid aqueous solution, 12% hexylene glycol, 1.5% hydrogenated soybean phosphatidylcholine, 2% cetostearyl alcohol, 1% methyl glucoside sesquistearate, 1% PEG-20 methyl glucoside sesquistearate, 64.4% white vaseline, 4% white beeswax, 10% aluminum starch octenylsuccinate and 1% titanium dioxide.

[0020] On the other hand, the present invention also provides a method for preparing the above-mentioned mometasone furoate cream, comprising the following steps:

[0021] (1) Preparation of oil phase: weigh the prescribed amount of base, thickener 1, emulsifier hydrogenated soybean phosphatidylcholine, co-emulsifier, and compound emulsifier, heat and melt to obtain oil phase, and keep warm for later use;

[0022] (2) Preparation of the API phase: Weigh the prescribed amount of solvent and preheat it, then weigh the prescribed amount of the API mometasone furoate and add it to dissolve, raise the temperature after complete dissolution to obtain the API phase, and keep it warm for later use;

[0023] (3) Mixing and emulsification: Add the API phase to the oil phase, keep warm and homogenize to obtain a mixed emulsion, then weigh the prescribed amount of thickener 2 and add it to the mixed emulsion to disperse, mix and homogenize, and then optionally add the prescribed amount of colorant, disperse, mix and homogenize;

[0024] (4) cooling: stirring and cooling to room temperature to obtain mometasone furoate cream;

[0025] There is no order of precedence for steps (1) and (2).

[0026] Preferably, step (1) is specifically as follows: weigh the prescribed amount of matrix, thickener 1, emulsifier hydrogenated soybean phosphatidylcholine, co-emulsifier, and compound emulsifier, heat at 75°C±5°C, and keep warm at 70°C±5°C for later use after complete melting to obtain an oil phase.

[0027] Preferably, step (2) is specifically as follows: weigh the prescribed amount of solvent, heat to 70°C±5°C, add the prescribed amount of the raw material drug mometasone furoate, stir to dissolve, and after complete dissolution, keep warm at 70°C±5°C for later use, to obtain the raw material drug phase.

[0028] Preferably, step (3) is specifically as follows: adding the raw material drug phase to the oil phase, homogenizing at 70°C ± 5°C, with a homogenizing speed of 8.0 to 12.0 kr / min and a homogenizing time of 5 to 10 min, then weighing the prescribed amount of thickener 2, adding it to the mixed emulsion, dispersing, mixing and homogenizing for 5 to 10 min, and then adding the prescribed amount of colorant, dispersing, mixing and homogenizing for 5 to 10 min.

[0029] Further preferably, the homogenization speed is 10.0 kr / min.

[0030] The present invention also provides use of the mometasone furoate cream in preparing a medicine for treating corticosteroid-responsive skin diseases and related symptoms.

[0031] Preferably, the corticosteroid responsive skin disease and related symptoms are the inflammatory and pruritus manifestations of adult corticosteroid responsive skin disease.

[0032] Compared with the prior art, the present invention has the following beneficial effects:

[0033] The invention adopts hydrogenated soybean phosphatidylcholine, an emulsifier and a compound emulsifier to jointly construct an emulsification system. The prepared mometasone furoate cream is subjected to centrifugal stability inspection, and it is found that the stability is improved to a certain extent; the maximum droplet particle size is smaller than that of a reference preparation, the number of droplets under a single microscopic field of view is more than that of the reference preparation, and the morphology is more regular; the in vitro release rate of the prepared mometasone furoate cream is faster than that of the reference preparation, the release behavior is improved, the penetration effect of the drug is strengthened, and the drug efficacy is enhanced.

[0034] The "mono- and distearic acid glycerides" in the present invention are defined in the Pharmacopoeia of the People's Republic of China (2020). This product is a mixed glyceride of mono-, di-, tri-stearic acid and palmitic acid. It is prepared by esterification reaction of stearic acid and excess glycerol, or by alcoholysis reaction of hydrogenated vegetable oil and glycerol in the presence of a catalyst. The content of monoglyceride should be 40.0% to 55.0%, diglyceride should be 30.0% to 45.0%, and triglyceride should be 5.0% to 15.0%. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 This is a state diagram of each tested mometasone furoate cream after centrifugation in Example 4, wherein from left to right are reference preparation Elocon, mometasone furoate cream 1, mometasone furoate cream 2, and mometasone furoate cream 3.

[0036] Figure 2 This is a microscopic view of the reference preparation Elocon in Example 5.

[0037] Figure 3 This is a microscopic view of mometasone furoate cream 1 in Example 5.

[0038] Figure 4 This is a microscopic view of mometasone furoate cream 2 in Example 5.

[0039] Figure 5 This is a microscopic view of mometasone furoate cream 3 in Example 5. DETAILED DESCRIPTION

[0040] The following examples are used to further illustrate the technical solutions of the present invention, but do not limit the scope of the present invention.

[0041] In the following embodiments, unless otherwise specified, the operating methods used are conventional operating methods, the equipment used are conventional equipment, and the raw materials used are commercially available, which do not limit the present application.

[0042] The following raw and auxiliary materials, the raw material mometasone furoate was sourced from Shandong Sirui Pharmaceutical Co., Ltd.; the auxiliary material white vaseline was sourced from Tianjin Hongfa Shuangsheng Vaseline Co., Ltd., white beeswax, cetyl alcohol, octadecanol and cetostearyl alcohol were sourced from Jiangxi Alpha Hi-Tech Pharmaceutical Co., Ltd., hydrogenated soybean phosphatidylcholine was sourced from Lipoid GmbH, mono- and distearic glyceryl was sourced from GATTEFOSSE, glyceryl stearate was sourced from Jiangsu Hai'an Petrochemical Plant, PEG-100 stearate was sourced from CRODA, methyl glucoside sesquistearate and PEG-20 methyl glucoside sesquistearate were sourced from Ningbo Oriental Yongning Chemical Technology Co., Ltd., hexylene glycol was sourced from Finar, aluminum octenylsuccinate starch was sourced from Dongguan Dongyue Glucose Factory Co., Ltd., and titanium dioxide was sourced from Ningbo Yipin Biotechnology Co., Ltd.

[0043] Examples 1-3

[0044] The formulations of Examples 1-3 are shown in the following table:

[0045]

[0046]

[0047] Note: Preparation method of pH 2.5 phosphoric acid aqueous solution: weigh 0.5g of phosphoric acid and place it in a 50mL beaker, add water to 50g to obtain a 1% phosphoric acid aqueous solution; weigh 30g of purified water and place it in a 50mL beaker, add 1% phosphoric acid aqueous solution to adjust the pH of the purified water to 2.5, stir well and set aside.

[0048] Examples 1-3 were prepared according to the following steps:

[0049] (1) Preparation of oil phase: Weigh the prescribed amount of white vaseline, white beeswax, hydrogenated soybean phosphatidylcholine, co-emulsifier, and compound emulsifier and heat them at 75°C ± 5°C. After they are completely melted, keep them warm at 70°C ± 5°C for later use.

[0050] (2) Preparation of API phase: Weigh the prescribed amount of hexylene glycol and pH 2.5 phosphoric acid aqueous solution, preheat at 70°C±5°C. When the temperature reaches 65°C±5°C, weigh the prescribed amount of the API mometasone furoate, add and dissolve. After complete dissolution, heat to 70°C±5°C and keep warm for later use.

[0051] (3) Mixing and emulsification: Add the API phase to the oil phase, heat and homogenize at 70°C ± 5°C for 5 min to obtain a mixed emulsion. Then weigh the prescribed amount of aluminum starch octenylsuccinate and add it to the mixed emulsion to disperse, mix and homogenize for 5 min. Then add the prescribed amount of titanium dioxide, disperse, mix and homogenize for 5 min.

[0052] (4) Cooling: Manually stirring and cooling to room temperature to obtain mometasone furoate cream. The mometasone furoate creams prepared in Example 1, Example 2, and Example 3 are respectively named mometasone furoate cream 1, mometasone furoate cream 2, and mometasone furoate cream 3.

[0053] Example 4: Centrifugal stability study

[0054] 5 g of cream was placed in a 10 mL centrifuge tube and centrifuged at 10000 rpm, 60 min, and 25 °C. The phenomena of each test preparation after centrifugation are shown in Table 1. Figure 1 As shown (from left to right: reference preparation Elocon, mometasone furoate cream 1, mometasone furoate cream 2, mometasone furoate cream 3).

[0055] Table 1 Centrifugal stability investigation results

[0056] Test preparation Phenomenon Reference preparation Elocon There is obvious oily liquid precipitation Mometasone furoate cream1 Oily liquid precipitates, but the amount of oil is less than that of the reference preparation Mometasone furoate cream2 Almost oil-free, only a thin oil film on the surface Mometasone furoate cream3 Almost oil-free, with a thin oil film on the surface

[0057] The results showed that the centrifugal stability of mometasone furoate cream was improved to a certain extent after constructing different emulsification systems, among which the emulsification system constructed by octadecyl alcohol, glyceryl stearate and PEG-100 stearate (mometasone furoate cream 2) was the best.

[0058] Example 5: Comparison of microscopic fields of preparations with different emulsification systems

[0059] Use a Leica DM6M microscope (microscope with equivalent performance) and refer to the particle size and particle size distribution determination method (Chinese Pharmacopoeia 2020 General Chapter 0982 Method 1), the steps are as follows:

[0060] 1) Prepare specimens: Take an appropriate amount of the sample, place it on a glass slide, cover it with a cover glass, and press lightly to make it evenly distributed;

[0061] 2) Place the specimen on the stage and select 10X eyepiece magnification and 20X objective lens magnification;

[0062] 3) Focus the specimen until the image is clear and take a photo;

[0063] 4) Manually measure the diameter of the largest droplet in the image;

[0064] 5) Merge and save the images, detect the three fields of view separately, and take the maximum value of the three measured values.

[0065] The microscopic fields of the reference preparations Elocon, mometasone furoate cream 1, mometasone furoate cream 2, and mometasone furoate cream 3 are shown in Figure 1. Figure 2-5 Among them, the maximum droplet size of the reference preparation Elocon is 38.31 μm, the maximum droplet size of mometasone furoate cream 1 is 32.68 μm, the maximum droplet size of mometasone furoate cream 2 is 20.38 μm, and the maximum droplet size of mometasone furoate cream 3 is 25.55 μm.

[0066] The results show that the furoate mometasone cream obtained by constructing different emulsification systems in Examples 1-3 of the present application is observed under a microscope, and the maximum droplet size in the field of view is smaller than that of the reference preparation, the number of droplets in a single field of view is more than that of the reference preparation, and the morphology is more regular. The small particle size of the droplets in the preparation can make the semi-solid multiphase unstable system relatively stable to a certain extent, and it is not easy to separate phases; the small particle size and large number of droplets in the semi-solid preparation can make the drug easier to penetrate, so that the release capacity of the preparation is improved, thereby improving the release behavior of the preparation.

[0067] Example 6: In vitro release experiment

[0068] Refer to USP1724 diffusion cell determination.

[0069] Release conditions: Take 300 mg of this product and apply it on the artificial membrane. Use 40% ethanol as the receiving liquid, 7 mL of the rotor, 32°C ± 1°C, 600 revolutions per minute, and operate according to the law. Take samples at 0 min, 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, and 6 h.

[0070] Test solution: Take out all the solution at each time point as the test solution.

[0071] Reference solution: Accurately weigh an appropriate amount of mometasone furoate reference substance, dissolve it in receiving solution and quantitatively dilute it to make a solution containing approximately 0.1 μg of mometasone furoate per 1 mL.

[0072] Chromatographic conditions: octadecylsilane bonded silica gel as filler; acetonitrile: water (50:50) as mobile phase; detection wavelength at 254 nm; flow rate at 1.5 mL per minute; column temperature at 30°C; injection volume 100 μL.

[0073] Determination method: Accurately measure the test solution and the reference solution, inject them into the liquid chromatograph respectively, and record the chromatogram.

[0074] The concentration of mometasone furoate in the release solution was calculated by the external standard method, and the 90% confidence interval of the ratio of the median in vitro release rate of the test preparation to the median in vitro release rate of the reference preparation was calculated.

[0075] The cumulative drug release per unit area is plotted against the square root of time. The cumulative drug release per unit area is calculated using the following formula:

[0076]

[0077] in,

[0078] Qn: Cumulative drug release per unit area at the nth time point (unit: μg / cm 2 );

[0079] C n : is the drug concentration at the nth time point (unit: μg / mL);

[0080] C i-1 : is the drug concentration at the i-1th time point (unit: μg / mL);

[0081] V: the volume of the receiving pool (unit: mL); V1: the sampling volume or the refilling volume (unit: mL);

[0082] S: effective release area, 1.767 cm in this test 2 ;

[0083] Js: median in vitro release rate (μg / cm 2 / h 1 / 2 ) is the slope of the regression equation of Qn versus the square root of t.

[0084] The comparison results of the in vitro release rates of mometasone furoate cream 1, mometasone furoate cream 2, mometasone furoate cream 3 with different emulsification system preparations and the reference preparation Elocon are summarized in Table 2, and the comparison results of the in vitro release rates of mometasone furoate cream 1, mometasone furoate cream 2, mometasone furoate cream 3 with the reference preparation Elocon are shown in Tables 3-5, respectively.

[0085] Table 2 Summary of the comparison of in vitro release rates of different emulsified preparations and the reference preparation Elocon

[0086]

[0087] Table 3 Comparison of in vitro release rates of mometasone furoate cream 1 and reference preparation Elocon

[0088]

[0089] Table 4 Comparison of in vitro release rates of mometasone furoate cream 2 and reference preparation Elocon

[0090]

[0091] Table 5 Comparison of in vitro release rates of mometasone furoate cream 3 and reference preparation Elocon

[0092]

[0093] The results showed that the in vitro release of mometasone furoate cream 1, mometasone furoate cream 2, and mometasone furoate cream 3 was faster than that of the reference preparation, among which mometasone furoate cream 2 had the fastest release rate, indicating that after using different emulsifier systems, the release capacity of the preparation was improved, the release behavior was improved, the drug permeation effect was enhanced, and the efficacy was enhanced.

[0094] Although the present invention has been fully described through its embodiments, it is noteworthy that various changes and modifications will be apparent to those skilled in the art, and such changes and modifications should be included within the scope of the appended claims of the present invention.

Claims

1. A mometasone furoate cream, characterized in that, The mometasone furoate cream contains mometasone furoate as an active ingredient, hydrogenated soybean phosphatidylcholine as an emulsifier, an auxiliary emulsifier, and a compound emulsifier.

2. mometasone furoate cream according to claim 1, characterized in that, The auxiliary emulsifier is selected from one or a combination of cetyl alcohol, stearyl alcohol, and cetostearyl alcohol.

3. The mometasone furoate cream according to claim 1 or 2, characterized in that The compound emulsifier is selected from one of mono- and distearic acid glyceryl, a combination of glyceryl stearate and PEG-100 stearate, and a combination of methyl glucoside sesquistearate and PEG-20 methyl glucoside sesquistearate.

4. Mometasone furoate cream according to claim 3, characterized in that, In the combination of glyceryl stearate and PEG-100 stearate, the ratio between the two is 1:

1.

5. The mometasone furoate cream according to claim 3, wherein In the combination of the methyl glucoside sesquistearate and the PEG-20 methyl glucoside sesquistearate, the ratio between the two is 1:

1.

6. The mometasone furoate cream according to any one of claims 1 to 5, characterized in that The mometasone furoate cream further comprises a solvent, a base, a thickener 1, a thickener 2, and optionally further comprises a colorant.

7. The mometasone furoate cream according to claim 6, characterized in that The solvents are aqueous phosphoric acid solution and hexylene glycol.

8. The mometasone furoate cream according to claim 6, characterized in that The matrix is ​​white vaseline.

9. The mometasone furoate cream according to claim 6, characterized in that The thickener 1 is white beeswax, and the thickener 2 is aluminum starch octenylsuccinate.

10. The mometasone furoate cream according to claim 6, characterized in that The colorant is titanium dioxide.

11. The mometasone furoate cream according to any one of claims 1 to 10, characterized in that The mometasone furoate cream comprises the following components in percentage by weight: 0.1% mometasone furoate, 15% solvent, 1.5% hydrogenated soybean phosphatidylcholine emulsifier, 2-4% auxiliary emulsifier, 2-3% compound emulsifier, 64.4-65.4% matrix, 11-14% thickener and 1% colorant.

12. The mometasone furoate cream according to any one of claims 1 to 11, characterized in that The mometasone furoate cream comprises the following components in percentage by weight: 0.1% mometasone furoate, 3% phosphoric acid aqueous solution, 12% hexylene glycol, 1.5% hydrogenated soybean phosphatidylcholine, 3% hexyl alcohol, 2% glyceryl mono- and distearate, 65.4% white vaseline, 2% white beeswax, 10% aluminum starch octenylsuccinate and 1% titanium dioxide.

13. The mometasone furoate cream according to any one of claims 1 to 11, characterized in that The mometasone furoate cream comprises the following components in percentage by weight: 0.1% mometasone furoate, 3% phosphoric acid aqueous solution, 12% hexylene glycol, 1.5% hydrogenated soybean phosphatidylcholine, 4% octadecyl alcohol, 1.5% glyceryl stearate, 1.5% PEG-100 stearate, 64.4% white vaseline, 1% white beeswax, 10% aluminum starch octenylsuccinate and 1% titanium dioxide.

14. The mometasone furoate cream according to any one of claims 1 to 11, characterized in that The mometasone furoate cream comprises the following components in percentage by weight: 0.1% mometasone furoate, 3% phosphoric acid aqueous solution, 12% hexylene glycol, 1.5% hydrogenated soybean phosphatidylcholine, 2% cetostearyl alcohol, 1% methyl glucoside sesquistearate, 1% PEG-20 methyl glucoside sesquistearate, 64.4% white vaseline, 4% white beeswax, 10% aluminum starch octenylsuccinate and 1% titanium dioxide.

15. A method for preparing the mometasone furoate cream according to any one of claims 1 to 14, characterized in that: The following steps are involved: (1) Preparation of oil phase: weigh the prescribed amount of base, thickener 1, emulsifier hydrogenated soybean phosphatidylcholine, co-emulsifier, and compound emulsifier, heat to melt, and keep warm for later use; (2) Preparation of the API phase: Weigh the prescribed amount of solvent and preheat it, then weigh the prescribed amount of the API mometasone furoate and add it to dissolve, raise the temperature after it is completely dissolved, and keep it warm for later use; (3) Mixing and emulsification: Add the API phase to the oil phase, keep warm and homogenize to obtain a mixed emulsion, then weigh the prescribed amount of thickener 2 and add it to the mixed emulsion to disperse, mix and homogenize, and then optionally add the prescribed amount of colorant, disperse, mix and homogenize; (4) cooling: stirring and cooling to room temperature to obtain mometasone furoate cream; There is no order of precedence for steps (1) and (2).

16. Use of the mometasone furoate cream according to any one of claims 1 to 14 in the preparation of a medicament for treating corticosteroid-responsive skin diseases and related symptoms, wherein the corticosteroid-responsive skin diseases and related symptoms are preferably the inflammation and itching manifestations of corticosteroid-responsive skin diseases in adults.

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