What Is Halobetasol Propionate?

Clobetasol propionate is a dermatological medication. Topical application is suitable for chronic eczema, neurodermatitis, psoriasis, palmoplantar pustulosis, lichen planus, discoid lupus erythematosus and other glucocorticoids. Topical treatment is effective for pruritic and non-infectious inflammatory skin diseases.

Clobetasol propionate

Clobetasol propionate is a dermatological medication. Topical application is suitable for chronic eczema, neurodermatitis, psoriasis, palmoplantar pustulosis, lichen planus, discoid lupus erythematosus and other glucocorticoids. Topical treatment is effective for pruritic and non-infectious inflammatory skin diseases.

Chinese name

Clobetasol propionate

Foreign name

Clobetasol Propionate

Drug classification

Dermatology-glucocorticoids

Molecular formula

C25H32ClFO5

[English name] Clobetasol Propionate

[Other Names] Clobeflomethasone Propionate Acetate, Clobetasol, Temet Skin, Anthracene Skin, Clobetasol, Clobetasol Propionate, Clobetasol Propionate, Clobetamethasone Dipropionate, Temet Clobexone propionate

[Drug classification] Dermatology-glucocorticoid

Chemical name: 21-Chloro-9-fluoro-11b, 17-dihydroxy-16b-methylpregna-1,4-diene-3,20-dione 17-propionate

English alias: CLOBETASOLE PROPIONATE; (11beta, 16beta) -21-chloro-9-fluoro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-ylpropanoate; (8xi, 11beta, 14xi , 16beta) -21-chloro-9-fluoro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-ylpropanoate

Molecular formula: C25H32ClFO5

Molecular weight: 466.97

Method name: Clobetasol propionate-Clobetasol propionate-High performance liquid chromatography

Scope of application: This method uses high performance liquid chromatography to determine the content of clobetasol propionate in clobetasol propionate.

This method is applicable to clobetasol propionate.

Principle of the method: After the test product is quantitatively diluted in methanol and added with an internal standard, it is subjected to high-performance liquid chromatography for chromatographic separation.

[Pharmacology and Toxicology] This product has a rapid action, and is currently a highly effective topical corticosteroid in clinical applications. It has a strong capillary contraction effect, and its anti-inflammatory effect is 112.5 times that of hydrocortisone, 2.3 times that of betamethasone sodium phosphate, and 18.7 times that of fluocinolone. The systemic adverse reactions are 3 times that of fluocinolone, the effect of anhydrous sodium retention, and certain promotion of sodium and potassium excretion.

[Pharmacokinetics] This product can be absorbed through intact skin after external use. After absorption, the metabolism of corticosteroids in the body is the same as that of systemic administration of corticosteroids. It is mainly metabolized in the liver and excreted by the kidneys.

[Usage and dosage] For external use, apply a thin layer evenly to the affected area, 1 to 2 times a day. Except for hypertrophic skin lesions of palms, plantar and keratinocytes, packet treatment is generally not suitable. Do not exceed 50g per week.

[Preparation and specifications]

1. This product is not suitable for large-scale or long-term topical application. Large-scale use, not more than 2 weeks, to avoid systemic absorption and cause reversible inhibition of the hypothalamic-pituitary-adrenal axis.

2. Can not be applied to the delicate parts of the skin such as the face, underarms and groin. Even short-term application can cause adverse reactions such as skin atrophy.

3. Pregnant women and lactating women should consider the advantages and disadvantages of medication and use it with caution. Pregnant women should not use it for a long time, in large areas or in large quantities.

4. Not suitable for infants and children.

5. This product cannot be used on the eyes.

6. If accompanied by skin infection, anti-infective drugs must be used at the same time. If the symptoms of infection do not improve in time after concurrent use, the drug should be stopped until the infection is controlled.

S26In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

After accidental contact with eyes, rinse immediately with plenty of water and seek medical advice.

S36Wear suitable protective clothing.

Wear appropriate protective clothing.

R36 / 37 / 38Irritating to eyes, respiratory system and skin.

Irritation of eyes, respiratory system and skin.

Clobetasol propionate

Bingsuan Lvbeitasuo

Clobetasol Propionate

Page number: 2005 edition two -80

[Revised]

[Properties] Melting point The melting point (Appendix VI C) of this product is 194 198 , and it will decompose at the same time when melting.

[Content determination] According to high performance liquid chromatography (Appendix VD).

Chromatographic conditions and system suitability test using octadecylsilane bonded silica gel as filler; 0.05 mol / L sodium dihydrogen phosphate solution (adjust pH to 2.5 with 85% phosphoric acid solution)-acetonitrile-methanol (425: 475 : 100) is the mobile phase; the detection wavelength is 240nm. The theoretical number of plates calculated from the peak of clobetasol propionate is not less than 5000.

The appropriate amount of this product is determined by measurement, accurately weighed, dissolved in methanol and quantitatively diluted to make a solution containing about 40 g per 1 ml, and a precise amount of 10 l is injected into the liquid chromatograph, and the chromatogram is recorded. Appropriate amount of reference substance was determined by the same method. Calculate the peak area according to the external standard method.

[Additional] [Inspection] Take 1.0g of this product for heavy metals and measure it according to law (Appendix H second method). The content of heavy metals must not exceed 20 parts per million.