Hydroxychloroquine sulfate crystal form A and preparation method thereof

A technology of hydroxychloroquine sulfate crystal and hydroxychloroquine sulfate, which is applied in the field of hydroxychloroquine sulfate crystal form A and its preparation, can solve the problems of poor stability of hydroxychloroquine sulfate, and achieve the effects of easy industrial production, good stability, and stable and reliable quality
CN108727263AInactive Publication Date: 2018-11-02SHANGHAI ZHONGXI SUNVE PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
SHANGHAI ZHONGXI SUNVE PHARMA
Publication Date
2018-11-02
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention discloses a hydroxychloroquine sulfate crystal form A and a preparation method thereof and uses means of XRPD, DSC and IR for representation. The hydroxychloroquine sulfate crystal formA provided by the invention improves the chemical stability of hydroxychloroquine sulfate, is simple in preparation method and easy in industrialized production and can provide a study foundation to development of more hydroxychloroquine sulfate dosage forms at the same time. In the preparation method provided by the invention, a sulfuric acid aqueous solution with the mass percentage being 40-60percent is used, the safety and the operability are improved, and the heat release risk generated by using concentrated sulfuric acid is effectively lowered.
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Description

technical field

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

[0002] Hydroxychloroquine Sulfate (Hydroxychloroquine Sulfate), its chemical name is 2-[[4-[(7-chloro-4-quinolyl)amino]pentyl]ethylamino]-ethanol sulfate, CAS number is 747-36- 40. Hydroxychloroquine sulfate was successfully developed by Winthrop Company. It was first listed in the United States in 1956 and has been listed in France, Denmark, Japan, Germany, Finland and other countries and regions. U.S. FDA approved hydroxychloroquine sulfate tablets on May 29, 1998 for the treatment of lupus erythematosus and rheumatoid arthritis. Hydroxychloroquine sulfate is more and more widely used in the rheumatic field because of its unique mechanism of action and better safety. After the 1990s, the clinical treatment of more than 90% of rheumatic diseases all selects hydroxychloroquine sulfate. Its structure is as follows:

[0003] ...

Claims

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