Hydroxychloroquine sulphate solid preparation and preparation method thereof

Abstract

The invention discloses a hydroxychloroquine sulphate solid preparation, which contains hydroxychloroquine sulphate or pharmaceutically acceptable salts thereof and an auxiliary material, wherein the auxiliary material comprises a buffer pair; the buffer pair is dissolved in water to form a buffer solution with pH of 4-6.5; and the content of the buffer pair is 0.05-2% in terms of mass percentage. The invention further discloses a preparation method of the hydroxychloroquine sulphate solid preparation. The hydroxychloroquine sulphate solid preparation disclosed by the invention has excellent dissolution property and stability, and particularly, is obviously increased in stability compared with the prior art.

Description

technical field

[0001] The invention relates to a hydroxychloroquine sulfate solid preparation and a preparation method thereof. Background technique

[0002] Hydroxychloroquine sulfate is a 4-aminoquinoline antimalarial drug, which has been included in major foreign pharmacopoeias for a long time, and is currently included in BP2007 edition and USP32 edition. Hydroxychloroquine is similar to chloroquine in structure, but has different effects and adverse reactions in some aspects. Since the 1950s, with the application of antimalarial drugs in the treatment of systemic lupus erythematosus and rheumatoid arthritis, the efficacy of hydroxychloroquine sulfate has been affirmed. It is currently the main drug for the treatment of lupus erythematosus, and it can improve the condition as a slow response Drugs are widely used to treat rheumatoid arthritis. Rheumatoid arthritis is a multi-system inflammatory autoimmune disease involving the surrounding joints. The incidence of rheu...

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