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目的:提高穿琥宁冻干粉针质量。方法:采用“高纯度穿琥宁生产工艺”专利技术生产穿琥宁冻干粉针并做动物急性毒性试验与其他厂家同类产品进行比较。结果:用专利技术生产的注射用穿琥宁小鼠静脉注射LD_(50)明显高于其他厂家生产的同规格产品,单次静脉给药的LD_(50)达到910 mg/kg,而国家标准说明书中的LD_(50)为675 mg/kg,文献报道穿琥宁注射剂的单次静脉给药的LD_(50)为580~620 mg/kg。结论:采用专利技术可以大大降低注射用穿琥宁产品的毒性,提高临床安全性。
Objective: To improve the quality of freeze-dried powder injection of Chuanhuning. Methods: The patented technology of “high-purity Chuanhuning production process” was used to produce Chuanhuning freeze-dried powder and acute toxicity test of animal was conducted to compare with similar products of other manufacturers. RESULTS: LD_(50) was injected intravenously into chloramphenicol injections using patented technology and was significantly higher than that produced by other manufacturers. The LD_(50) for single intravenous administration reached 910 mg/kg, and the national standard specification The LD_(50) was 675 mg/kg. It was reported that the LD_(50) of chuanhuanning injection was 580~620 mg/kg in a single intravenous administration. Conclusion: The use of patented technology can greatly reduce the toxicity of Chuanhuning injection and improve clinical safety.