Pharmaceutical compositions for the treatment of skin disorders

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex

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514783, 514858, 514859, 514860, 514861, 514862, 514863, 514864, 514865, A61K 3578

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054664527

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BRIEF SUMMARY
The present invention relates to extracts of herbal compositions for use in the treatment of skin disorders such as, for example eczema and psoriasis and to processes for their preparation.
The etiology of eczema and psoriasis is not completely understood. However the symptomotology which characterizes the conditions is well described. The most important features are: irritation, inflammation and itching.
Eczema and psoriasis are expressions of an inappropriate immunological response whereby the body reacts to some of its tissue components as though they were foreign. Treatment is directed towards diminishing the severity of the immune response and alleviating symptoms. In conventional Western medicine topical corticosteroids are used to reduce inflammation and to suppress the immune response. Emollients are used to physically protect and smooth the skin and, where the skin is infected, antiobiotics are used.
Practitioners in traditional Chinese medicine however use decoctions of herbs for oral and topical treatment of dermatological conditions including eczema and psoriasis. A wide variety of agents have been used and in traditional Chinese medicine it is conventional to use a compound prescription which is designed by the practitioner after careful examination of the individual patient. It has been found by clinical experimentation that mixtures of certain herbs can be used to provide a composition which is effective in a large proportion of patients suffering from eczema and psoriasis, without recourse to individualisation of treatment. Different formulae have been devised for dry, weeping, infected and lichenified eczema although the mode of action of traditional Chinese medicines is not fully understood.
Table I shows a number of Chinese herbs which are traditionally used for the treatment of skin disorders together with the principle constituents and their pharmacological actions (Chang and But; Pharmacology and Applications of Chinese Materia Media. World Scientific Publishing 1986, Volumes I and II). The table shows that many of the agents traditionally used have pharmacological properties which are appropriate for the treatment of symptoms of eczema and psoriasis, namely anti-inflammatory, analgesic, anti-pyretic, anti-pruritic, anti-bacterial and immune suppressent activity. Some of the agents listed may stimulate the adrenal cortex to produce endogenous corticosteroids and others may inhibit the breakdown of cortisol in certain tissues such as the skin and lung. The combination of herbs to provide a combined attack on the symptoms of eczema and psoriasis are therefore rational even though at present it is not known exactly which of the constituents are responsible for the beneficial therapeutic effects of the mixtures.
It is possible that some of the herbs in the mixtures are necessary in order to increase the solubility of some of the active constituents in water since the traditional method of preparing extracts is by decoction i.e. boiling in water. In traditional Chinese medicine some herbs are included in prescriptions because they act as demulcents i.e. agents which have a soothing effect on the gastrointestinal tract and facilitate patient acceptance. It is firmly believed by traditional Chinese practitioners that the toxicity of mixtures of herbs is less than that of the herbs given in isolation. Although this has yet to be rigorously proved in controlled clinical trials, conventional wisdom indicates that some of the herbal components have biological activities which summate, and others antagonise the toxic effect of active components. Until the active components have been identified with certainty it has proved prudent to use a decoction, extract or fractionated extract of a plurality of herbs. To be useful in practice it is necessary to have one or more fixed composition mixtures. Surprisingly, it has been found that fixed combinations of specific herbs can be used to treat different types of eczema and psoriasis.
For example a particularly useful formulation of 10 herbs which has bee

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