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目的从安全、有效、质量可控等方面对中药新药痰热清注射液进行初步评价。方法以中医药理论为指导,对其处方组成与配伍进行分析,并根据安全性试验、毒性试验和Ⅰ期临床试验结果,对其安全性进行初步评价。从其实验药理学与临床试验结果,对其有效性进行初步评价。从中药指纹图谱检测结果对其质量进行评价。结果痰热清注射液处方合理,且有创意,工艺先进,安全性可靠鸦实验药理学研究与临床试验有明显的对应性关系。通过Ⅱ、Ⅲ期临床试验,疗效确切。结论中药新药痰热清注射液具有清热、解毒、化痰的功能,适用于急性支气管炎、急性肺炎,属于痰热阻肺证者,治疗安全、有效,质量可控。
Objective To evaluate the new traditional Chinese medicine Tanreqing injection from the aspects of safety, effectiveness and quality control. Methods According to the theory of Chinese medicine, the composition and compatibility of prescriptions were analyzed. According to the results of safety tests, toxicity tests and phase I clinical trials, the safety of the prescriptions was evaluated. From its experimental pharmacology and clinical trial results, a preliminary evaluation of its effectiveness was made. The quality of Chinese herbal medicine fingerprints was evaluated. Results Qinreqing injection prescription is reasonable, creative, advanced technology, safe and reliable crow experimental pharmacology research and clinical trials have obvious correspondence. Through the phase II and III clinical trials, the curative effect is exact. Conclusion The new Chinese medicine Xinreqing injection has the functions of heat-clearing, detoxification and phlegm-removing. It is suitable for acute bronchitis and acute pneumonia. It belongs to phlegm-heat-resisting lung syndrome. The treatment is safe, effective and the quality is controllable.