External compound tincture for treating dermatitis and preparation method of such external compound tincture

A technology for tinctures and compound prescriptions, which is applied in the field of compound external tinctures and their preparation, can solve the problems of exceeding the standard of related substances, affecting the safety and effectiveness of medication, and achieve the effects of enhancing stability and improving performance.

Inactive Publication Date: 2017-06-27
FRONT PHARM PLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Fluocinonide acetate is a glucocorticoid, and its degradation is mainly caused by the hydrolysis of the 16a, 17-(1-methylethylene) dioxygen bond of fluocinonide acetate. Its stability is affected by high temperature, light, acid and alkali, etc. La...

Method used

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  • External compound tincture for treating dermatitis and preparation method of such external compound tincture
  • External compound tincture for treating dermatitis and preparation method of such external compound tincture

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Embodiment 1

[0018] Embodiment 1: the compound external tincture for the treatment of dermatitis, its composition raw material comprises fluocinolone acetate, salicylic acid, resorcinol, borneol, clathrate, cosolvent, antioxidant, pH regulator and solvent; In parts by weight In total, each 1000g tincture contains the following active ingredients: fluocinolone acetate 0.1-10g, salicylic acid 5-100g, resorcinol 20-200g, borneol 5-50g, clathrate 1-10g, cosolvent 2-40g , 0.30-0.4g of antioxidant, 2-10g of pH regulator and 200-800g of solvent.

[0019] The inclusion compound is cyclodextrin, hydroquinone, urea, deoxycholic acid, methyl cyclodextrin, hydroxypropyl cyclodextrin, hydroxyethyl cyclodextrin, cyclodextrin polymer, ethyl One or more of cyclodextrin and linear cyclodextrin.

[0020] The co-solvents are organic acids and their salts such as benzoic acid, salicylic acid and its sodium salt, glycyrrhizic acid, etc., amides or amine compounds such as nicotinamide, acetamide, diethylamine,...

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Abstract

The invention discloses an external compound tincture for treating dermatitis and a preparation method of such external compound tincture. The external compound tincture for treating the dermatitis comprises fluocinolone acetonide, salicylic acid, resorcinol, borneol, clathrate, a co-solvent, an antioxidant, a pH modifier and a solvent. Every 1000 g of tincture is prepared from, by weight, 0.1-10 g of fluocinolone acetonide, 5-100 g of salicylic acid, 20-200 g of resorcinol, 5-50 g of borneol, 1-10 g of clathrate, 2-40 g of co-solvent, 0.30-0.4 g of antioxidant, 2-10 g of pH modifier and 200-800 g of solvent. The external compound tincture for treating the dermatitis and the preparation method of such external compound tincture have the advantages that a reasonable formula and the preparation method are screened to solve the problems that the content of the fluocinolone acetonide is instable and relative substances exceed standards; with the aid of an inclusion technique and by means of an orthogonal experiment, an optimal inclusion rate, an optimal stirring speed and optimal time are determined with the content of the fluocinolone acetonide and the relative substances as indexes so as to generate an explicit and operable preparation process.

Description

technical field [0001] The invention relates to a compound external tincture for treating dermatitis and a preparation method thereof, belonging to the field of chemical preparations. Background technique [0002] The exact cause of neurodermatitis is still unclear, but it is generally believed to be a neuropsychiatric skin disease and related to cerebral cortex dysfunction. It is difficult to treat and easy to relapse. External use of glucocorticoid preparations is an important treatment. Because neurodermatitis often requires long-term treatment, the curative effect of some topical glucocorticoids such as halcinonide solution often decreases after repeated use, and the recurrence rate is high. Fluocinolone containing a halogen-based structure is a potent glucocorticoid, which has anti-inflammatory and antipruritic effects. External application can shrink dermal capillaries and inhibit the proliferation or regeneration of connective tissue cells; it can stabilize intracellu...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/58A61K31/60A61K31/045A61K47/69A61K47/10A61P17/00A61P25/02
CPCA61K31/58A61K9/0014A61K9/08A61K31/045A61K31/60A61K47/10A61K2300/00
Inventor 戴小华罗传国费成才戴五好戴建
Owner FRONT PHARM PLC
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