Preparation Method for a New Dosage Form of Pyritinol Hydrochloride
To develop a new dosage form of pyritinol hydrochloride dry suspension and establish production process.Method:including prescription study,the compatibility test of raw materials and excipient,and prescription screening;then small-scale process development,operating steps,parameters of equipment for each step,and in-process control quality standards;finally,establishing production equipment through pilot trials,and production process.Results:sampling and test,the results of the pilot product met the expected quality objectives and requirements,indicating that the preparation method of pyritinol hydrochloride dry suspension is suitable for industrial production.
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