盐酸氟安定(Flurazepam Hydrochlo-ride)是一种较好的镇静催眠药。由于该药对光、热、湿的稳定性较差,目前市售仅有胶囊剂型,尚未见片剂。为提高其稳定性,便于片剂生产,选择了最佳片剂处方及制备工艺;测定了主药含量均匀度、药物溶出速率;预测了稳定性,并测定了室温放置二年的含量变化。 Flurazepam Hydrochlo-ride is a good sedative and hypnotic drug. As the drug on the light, heat, wet stability is poor, the current market only capsule dosage form, no tablet. In order to improve its stability and facilitate tablet production, the best tablet prescription and preparation process were selected. The uniformity of main drug content and drug dissolution rate were determined. The stability was predicted and the content change after two years of storage at room temperature was measured.