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Alclomethasone dipropionate cream and preparation method thereof

A technology of aclomethasone dipropionate cream and aclomethasone dipropionate, applied in ointment delivery, pharmaceutical formula, emulsion delivery, etc., can solve the problems of poor chemical stability and no prompt function, and achieve good buffering effect of ability

Active Publication Date: 2019-10-25
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The second difficulty is poor chemical stability. Alclomethasone dipropionate is easily hydrolyzed. Because the compound has a typical pregnane main structure, it contains 7α chlorine, 11β hydroxyl, and 16α methyl in its structure, and contains two easily occurring hydrolyzed ester bond
The patent uses 20% propylene glycol and 30% isopropanol to enhance the transdermal effect of the main drug. The propylene glycol and its dosage are selected from the perspective of effectiveness, and there is no indication of the impact of propylene glycol on product quality and chemical stability.
In addition, in this invention, the pH value control may be considered from the stability of aclomethasone dipropionate, and it is controlled in the acidic range, but different dosage forms (the invention is a lotion, which is qualitatively different from the cream), and different types of excipients Different prescriptions have different adaptation ranges for the pH value of the product, so the pH value range of the invention is only effective for the prescription lotion of the invention, and does not have any prompting effect on the pH value required for the preparation of aclomethasone dipropionate cream

Method used

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  • Alclomethasone dipropionate cream and preparation method thereof
  • Alclomethasone dipropionate cream and preparation method thereof
  • Alclomethasone dipropionate cream and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 2

[0175] Embodiment 1 Alclomethasone dipropionate cream formula 1 and preparation method

[0176] (1) Preparation prescription: (made 1000g in total)

[0177]

[0178]

[0179] (2) Preparation method:

[0180] 1) pulverizing the raw material of betamethasone dipropionate through a jet mill to obtain a powder with a particle size of 7 μm;

[0181] 2) Weigh the pulverized alclomethasone dipropionate powder and chlorocresol in the above prescription, dissolve in propylene glycol, dissolve at 50°C for 1 hour under stirring conditions, and dissolve to obtain solution I;

[0182] 3) cetostearyl alcohol, white petrolatum, macrogol-100-stearate, glyceryl monostearate, ceteth-20 are placed in a 1500ml beaker and heated to 70°C, after melting, the oil phase II is obtained;

[0183] 4) Weigh the prescribed amount of sodium dihydrogen phosphate, phosphoric acid, and purified water, put them in a 1000ml beaker and heat to 70°C, and after dissolving, the aqueous phase III is obtained...

Embodiment 2 2

[0187] Embodiment 2 Alclomethasone dipropionate cream formula 2 and preparation method

[0188] (1) Preparation prescription: (made 1000ml in total)

[0189]

[0190]

[0191] (2) Preparation method:

[0192] 1) Pulverizing the raw material of betamethasone dipropionate through a jet mill to obtain a powder with a particle size of 13 μm;

[0193] 2) Weigh the pulverized alclomethasone dipropionate powder and chlorocresol in the above prescription, dissolve in propylene glycol, dissolve at 60°C for 1 hour under stirring conditions, and dissolve to obtain solution I;

[0194] 3) cetostearyl alcohol, white petrolatum, macrogol-100-stearate, glyceryl monostearate, ceteth-20 are placed in a 1500ml beaker and heated to 80°C, after melting, the oil phase II is obtained;

[0195] 4) Weigh the prescribed amount of sodium dihydrogen phosphate, phosphoric acid, and purified water, put them in a 1000ml beaker and heat to 80°C, and after dissolving, the aqueous phase III is obtain...

Embodiment 3 2

[0199] Embodiment 3 Alclomethasone dipropionate cream formula 3 and preparation method

[0200] (1) Preparation prescription: (made 1000ml in total)

[0201]

[0202]

[0203] (2) Preparation method:

[0204] 1) Pulverizing the raw material of betamethasone dipropionate through a jet mill to obtain a powder with a particle size of 10 μm;

[0205] 2) Weigh the pulverized alclomethasone dipropionate powder and chlorocresol in the above prescription, dissolve in propylene glycol, dissolve at 55°C for 1 hour under stirring conditions, and dissolve to obtain solution I;

[0206] 3) cetostearyl alcohol, white petrolatum, macrogol-100-stearate, glyceryl monostearate, ceteth-20 are placed in a 1500ml beaker and heated to After melting at 75°C, the oil phase II is obtained;

[0207] 4) Weigh the prescribed amount of sodium dihydrogen phosphate, phosphoric acid, and purified water, put them in a 1000ml beaker and heat to 75°C, after dissolving, the aqueous phase III is obtained...

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Abstract

The invention provides alclometasone dipropionate emulsifiable paste and a preparation method thereof. Propylene glycol is adopted as a solvent of an active ingredient alclometasone dipropionate, chlorocresol is adopted as a stabilizer, and the problems that alclometasone dipropionate is hard to dissolve and is prone to crystallization and hydrolysis are solved. According to the emulsifiable paste prepared through the formula and method, alclometasone dipropionate exists in a solution state, the medicine effect is good, good physical and chemical stability is achieved, and alclometasone dipropionate is free of crystallization. In the formula, each ingredient and each preparation process are selected through experimental comparison, the optimal formula and preparation method are obtained, pilot scale tests and pilot production enlargement show that the process is simple and feasible, and has reproducibility, and the alclometasone dipropionate emulsifiable paste with the quality meeting the requirement can be produced consistently.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to aclomethasone dipropionate cream and a preparation method thereof. Background technique: [0002] Alclomethasone dipropionate (7α-chloro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate) It is a low-to-medium-efficiency glucocorticoid with anti-inflammatory, anti-allergic, and anti-proliferative effects. It can effectively treat some chronic inflammatory skin diseases when used externally. [0003] The raw material of aclomethasone dipropionate is white crystal or crystalline powder, with a melting point of 194-198°C and a specific rotation of +21°-+25°. Alclomethasone dipropionate has two difficulties in making preparations: [0004] One is poor solubility, because the compound has poor solubility in commonly used pharmaceutical solvents, and is not easily soluble in polar and non-polar solvents. For example, it is only slig...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K31/573A61K47/10A61K47/06A61K47/14A61K47/02A61K47/04A61P29/00A61P37/08A61P43/00A61P17/00
CPCA61K9/06A61K31/573A61K47/02A61K47/06A61K47/10A61K47/14
Inventor 徐飞程霞林子祺
Owner CHONGQING HUAPONT PHARMA