圣愈胶囊质量标准的研究及急性毒性试验
Studies on the quality standard and acute toxicity of Shengyu capsule
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摘要: 目的 建立圣愈胶囊的质量标准,并进行LD50测定.方法 采用薄层色谱法对黄芪、党参、白芍和紫河车进行色谱鉴别;醇溶性浸出物测定法测定其浸出物含量;改良寇氏法计算小鼠给药的LD50.结果 薄层色谱法鉴别效果良好.检查项目均符合规定;其醇浸出物含量不低于16.3%;LD50为764.8m/kg,其平均可信限为682.5~847.2mg/kg.结论 所建立的质量控制方法准确可行,制剂安全有效.Abstract: Objective To establish the quality standard of Shengyu capsules and to investigate the acute toxicity of the capsules in mice. Methods Thin layer chromatography was used for simultaneously identification of the main components of alcohol extracts of Radix Astragali, Radix Codonopsis, Radix Paeoniae alba and Placenta Hominis in Shengyu capsules. Extractum content of Shengyu capsule was assayed by ethanol extraction method. LD50 of extractum of Shengyu capsule in mice was calculated with modified Karber's method. Results All spots were clear and concentrated on the thin layer. The results have good repeatability. The extractum content of Shengyu capsules was more than 16. 3%. LD50 and its confidence interval of Shengyu capsule in mice were 764.8 mg/kg and 682.5~847.2 mg/kg, respectively. Conclusion The method for determination the quality standard of Shengyu capsule was feasible and precise. The dosage of Shengyu capsule in clinic use was safe.
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Key words:
- Shengyu capsule /
- qualily standard /
- TLC /
- LD50
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