Guizhou Zhengxin Pharmaceutical Co. Ltd.

(1) To evaluate the effect of Shuangyang Houbitong Granules in improving pharyngeal symptoms and signs and shortening the course of the disease in the treatment of acute pharyngitis-tonsillitis (exogenous wind-heat syndrome) in children. Observation indicators: VAS score change of pharyngeal symptom severity, onset time and disappearance time of pharyngeal symptoms, effective rate of pharyngeal signs, clinical cure rate, efficacy of TCM syndrome, and disappearance rate of other single symptoms. (2) To observe the safety of Shuangyang Houbitong Granules in clinical application. Observation indicators: incidence of clinical adverse events/adverse reactions, laboratory tests, vital signs, etc.

The pharmacokinetic parameters were used as the primary endpoint evaluation indicators to compare the pharmacokinetic behavior of norfloxacin capsules (specification: 0.1g/capsule) produced by Guizhou Bailing Enterprise Group Zhengxin Pharmaceutical Co., Ltd. and norfloxacin tablets (BACCIDAL ® , specification: 100mg/tablet) produced by Xinglin Pharmaceutical Co., Ltd. in healthy subjects under fasting state, and to evaluate the bioequivalence of the two preparations. Evaluate the safety of the test preparation and the reference preparation in healthy subjects under fasting conditions.