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Clobetasol propionate cream pharmaceutical composition and preparation method thereof

A technology of clobetasol propionate and its composition, which is applied in the field of medicine, can solve problems such as large particle size of cream oil globules, affect use and curative effect, and coarse fineness, achieve suitable viscosity, and process factors are easy to control, fine detail effect

Active Publication Date: 2016-06-22
SICHUAN HAISCO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The existing clobetasol propionate cream is due to the problems of preparation method, prescription composition and ingredient ratio, etc., the prepared cream has large particle size, low consistency, and coarse fineness, which affects the use and curative effect

Method used

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  • Clobetasol propionate cream pharmaceutical composition and preparation method thereof
  • Clobetasol propionate cream pharmaceutical composition and preparation method thereof
  • Clobetasol propionate cream pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] The preparation of embodiment 1 clobetasol propionate cream pharmaceutical composition

[0020] prescription:

[0021] Clobetasol Propionate 0.2g

[0022] Polyethylene glycol (400) monostearate 98.5g

[0023] Caprylic triglyceride 123.1g

[0024] Macrogol Glyceride Oleate 37g

[0025] Carbitol 52g

[0026] Butylparaben 1.0g

[0027] 1,2-propanediol 20g

[0028] Tert-butyl p-hydroxyanisole 0.05g

[0029] Add purified water to 1000g

[0030] Make 100 altogether (10g / support, clobetasol propionate content specification is 0.02%)

[0031] The preparation method is prepared according to the following steps:

[0032] (1) Preparation of oil phase: Weigh clobetasol propionate, butylparaben, and tert-butyl p-hydroxyanisole according to the prescription quantity, and dissolve them in the prescription quantity of 1,2-propanediol to prepare 1,2- Propylene glycol solution; then weigh polyethylene glycol (400) monostearate, triglyceride caprylate, macrogol glycerol oleate,...

Embodiment 2

[0035] The preparation of embodiment 2 clobetasol propionate cream pharmaceutical composition

[0036] prescription:

[0037] Clobetasol Propionate 0.5g

[0038] Polyethylene glycol (400) monostearate 98.5g

[0039] Caprylic triglyceride 123.1g

[0040] Macrogol Glyceride Oleate 37g

[0041] Carbitol 52g

[0042] Butylparaben 1.0g

[0043] 1,2-propanediol 20g

[0044] Tert-butyl p-hydroxyanisole 0.05g

[0045] Add purified water to 1000g

[0046] Make 100 altogether (10g / support, clobetasol propionate content specification is 0.05%)

[0047] The preparation method is prepared according to the following steps:

[0048] (1) Preparation of oil phase: Weigh clobetasol propionate, butylparaben, and tert-butyl p-hydroxyanisole according to the prescription quantity, and dissolve them in the prescription quantity of 1,2-propanediol to prepare 1,2- Propylene glycol solution; then weigh polyethylene glycol (400) monostearate, triglyceride caprylate, macrogol glycerol oleate,...

Embodiment 3

[0051] The preparation of embodiment 3 clobetasol propionate cream pharmaceutical composition

[0052] prescription:

[0053] Clobetasol Propionate 0.15g

[0054] Polyethylene glycol (400) monostearate 225g

[0055] Caprylic triglyceride 150g

[0056] Macrogol Glyceride Oleate 75g

[0057] Carbitol 45g

[0058] Butylparaben 4.5g

[0059] 1,2-propanediol 15g

[0060] Tert-butyl p-hydroxyanisole 0.15g

[0061] Add purified water to 1500g

[0062] Make 100 altogether (15g / support, clobetasol propionate content specification is 0.01%)

[0063] The preparation method is prepared according to the following steps:

[0064] (1) Preparation of oil phase: Weigh clobetasol propionate, butylparaben, and tert-butyl p-hydroxyanisole according to the prescription quantity, and dissolve them in the prescription quantity of 1,2-propanediol to prepare 1,2- Propylene glycol solution; then weigh polyethylene glycol (400) monostearate, triglyceride caprylate, macrogol glycerol oleate, a...

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Abstract

The invention relates to a clobetasol propionate cream pharmaceutical composition and its preparation method and belongs to the field of medical technology. The composition comprises the following ingredients (by weight): 0.01-0.1% of clobetasol propionate, 5-15% of polyethylene glycol (400) monostearate, 10-15% of caprylic capric triglyceride, 2-5% of oleoyl macrogolglycerides, 3-10% of carbitol, 0.05-0.3% of butylparaben, 1-5% of 1,2-propylene glycol, 0.001-0.01% of butylated hydroxyanisole and the rest of purified water. The preparation method comprises the following steps: preparation of an oil phase, modulation of a cream, filling of the cream and the like. According to the invention, problems such as large oil ball strength, low viscosity, low fineness and the like of clobetasol propionate cream in the prior art are greatly solved.

Description

technical field [0001] The invention relates to a clobetasol propionate cream pharmaceutical composition and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Skin disease is a common multiple disease with a high incidence rate, which has seriously affected people's daily life and work. There are many kinds of skin diseases, the etiology is complicated, and it is difficult to cure them, which brings different degrees of distress to patients. Clobetasol propionate (Clobetasol propionate, formula 1) is a potent local corticosteroid with strong anti-inflammatory, anti-pruritic and vasoconstrictive effects, and is widely used in chronic eczema, neurodermatitis, psoriasis, Palmoplantar pustulosis, lichen planus, discoid lupus erythematosus and other topical glucocorticoids are effective in the treatment of itching and non-infectious inflammatory skin diseases. [0003] [0004] The clinical dosage form of clobetasol pro...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/573A61K47/34A61K47/14A61P17/00A61P17/04A61K47/08A61K47/10
Inventor 陈九龙樊永庆
Owner SICHUAN HAISCO PHARMA CO LTD
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