Optical stable desonide preparation

Abstract

The invention belongs to the field of the pharmaceutical preparation, relates to a desonide preparation, and in particular to a more optical stable desonide preparation which uses phenylethyl alcohol and / or benzyl alcohol and / or 2-phenoxyl ethanol and / or sorbic acid as antiseptics of the desonide preparation to replace the antiseptics methyl-p-hydroxybenzoate and propyl p-hydroxybenzoate. Each component in the desonide preparation does not disturb a related substance detection system. Related substances meet control limitations of related substance guiding principles of chemical medicaments, and photosensitiveness of the preparation is obviously improved. In a contrast investigation of illumination influence factors, the related substance degraded amplitude and the content decrease amplitude in the desonide preparation are all obviously reduced, and the product stability is improved significantly.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a desonide preparation, in particular to a desonide preparation more stable to light. Background technique [0002] Desonide is a glucocorticoid drug, which has anti-inflammatory, anti-allergic, anti-itching and reducing exudation effects; it can reduce and prevent tissue responses to inflammation, and can eliminate local non-infectious inflammation caused by fever, redness and Swelling, thereby reducing the manifestations of inflammation; has an immunosuppressive effect: prevents or suppresses cellular immune responses, suppresses primary immune responses. The topical preparations of desonide can be used for the treatment of various hormone-sensitive skin diseases such as contact dermatitis, neurodermatitis, seborrheic dermatitis, eczema, psoriasis, lichen planus, lichen simplex, sweat blisters and pruritus Wait. [0003] Currently commercially available desonide prepa...

AI Technical Summary

Problems solved by technology

[0004] However, through the research on various desonide preparations currently on the market, it is found that the following problems generally exist in the desonide preparations on the existing market: (1) desonide preparations such as desonide gel Desonide Lotion All have obvious photosensitivity. After the preparation is exposed to light, the related substances are obviously degraded, and the content is greatly reduced. This is because desonide is a moderately weak glucocorticoid, which itself has photosensitivity and is unstable under light conditions. , easy to degrade, and produce new unknown impurities; and the degradation of related substances and the substantial reduction in content will inevitably affect the efficacy of the product; According to the control requirements of the latest drug quality standards, the content of related substances is obviously high, exceeding the standard requirements of the current guidelines for the control of related substances in chemical drugs, and can no longer meet the existing quality standards The required control limit; (3) Methyl p-hydroxybenzoate and propyl p-hydroxybenzoate are used as preservatives in the existing prescription of desonide preparations, but in the detection system of related substances, their peak positions are different from those of the active ingredients. overlap, seriously affecting the accurate detection of related substances; (4) most of the existing desonide preparations are suspension-type preparations, and the active ingredients are suspended and distributed in the preparations. The results of content determination of samples taken from different parts of the drug product show that there is obvious content inhomogeneity, indicating that there is obvious sedimentation, which will affect the filling of the product and the efficacy of the drug when used by patients.

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