Pharmaceutical composition for external use adopting glucocorticoid as active component

Abstract

A pharmaceutical composition for external use which adopts glucocorticoid as an active component is disclosed. The pharmaceutical composition comprises the glucocorticoid adopted as the active component, and one or more pharmaceutical excipient. The pharmaceutical excipient comprises edetate disodium or edetate calcium disodium.

Description

technical field [0001] The invention relates to an external pharmaceutical composition with glucocorticoid as the active ingredient. Background technique [0002] Glucocorticoid drugs, external use can shrink dermal capillaries, inhibit the proliferation or regeneration of epidermal cells, inhibit the regeneration of fibroblasts in connective tissue, stabilize intracellular lysosomal membranes, and prevent tissue damage caused by the release of lysosomal enzymes. Has strong anti-inflammatory and anti-allergic effects. For allergic dermatitis, atopic dermatitis, contact dermatitis, seborrheic dermatitis, eczema, pruritus, psoriasis, neurodermatitis, etc. However, long-term or large-scale application can cause skin atrophy and telangiectasia, acne-like dermatitis, folliculitis, perioral dermatitis, and increased susceptibility to infection. Even can cause allergic contact dermatitis. More importantly, long-term use can also cause pigmentation, that is, skin darkening, and t...

AI Technical Summary

Problems solved by technology

In particular, it should be pointed out that patients with lead poisoning who should be treated with edetate calcium and sodium, especially children, may cause serious decrease in blood calcium, convulsions and even death due to misuse of edetate disodium

[0009] Due to the effects and adverse reactions of glucocorticoids themselves, when used for external use on the skin, according to the regulations of the State Food and Drug Administration, it is no longer possible to use plastic tubes as the packaging of drugs that are in direct contact with the ointment. The packaging directly in contact with preparations takes ointment as an example. The only packaging materials approved by the state for direct contact with medicines are aluminum tubes or medicinal polyethylene / aluminum / polyethylene composite ointment tubes (hereinafter referred to as composite aluminum tubes), aluminum hoses, composite Aluminum tubes all contain aluminum. Although the inner and outer walls of the composite hose are made of plastic and the middle is aluminum, the possibility of leakage at the welded joints of different materials of the composite hose, the longitudinal weld of the tube body welding, and the tube body and the tube shoulder are two different. Injection of materials in which aluminum is very likely to come into direct contact with pharmaceuticals

[0010] There are many active groups in the molecular structure of glucocorticoids. Taking fluocinonide acetate as an example, there are groups such as ester bonds, ketals, ketone groups, hydroxyl groups, and double bonds. There is a possibility of degradation in alkaline, resulting in a decrease in content

Especially after using aluminum tubes for direct packaging, trace metal particles such as aluminum particles will become catalysts for the decomposition of fluocinolone and its esters, and storage will result in a decrease in product content

Images