复方鸦胆子油软胶囊质量标准及初步药效学研究

Quality standard for compound brucea javanica oil soft capsule and initial pharmacodynamics study

目的:建立复方鸦胆子油软胶囊的质量控制方法,观察复方鸦胆子油软胶囊制剂对S180肿瘤模型小鼠的治疗作用。方法:采用薄层色谱法对复方鸦胆子油软胶囊中的鸦胆子和蟾皮进行定性鉴别,采用气相色谱法对复方鸦胆子油软胶囊中的油酸进行含量测定,采用高效液相色谱法对复方鸦胆子油软胶囊中脂蟾毒配基和华蟾酥毒基总含量进行测定;通过S180腹水型肿瘤细胞建立肿瘤模型,以抑瘤率、胸腺指数和脾脏指数为考察指标,观察复方鸦胆子油软胶囊对肿瘤小鼠的治疗作用。结果:TLC鉴别方法分离度良好、斑点清晰;油酸在0.270 4 mg/mL^1.622 4 mg/mL范围线性关系良好,平均回收率95%~105%;脂蟾毒配基和华蟾酥毒基在0.005 6 mg/mL^0.061 6 mg/mL范围线性关系良好,平均回收率95%~105%;用S180腹水型肿瘤可以成功地制备小鼠肿瘤模型,复方鸦胆子油软胶囊具有治疗作用。结论:本方法专属性强、结果准确、耐用性好,可很好地控制复方鸦胆子油软胶囊的质量,值得进一步开发研究。

Objective：To establish quality standards of compound brucea javanica oil soft capsule and observe its curative effect on S180 tumor mice models. Methods：Brucea and toad skin in brucea javanica oil soft capsule were identified by TLC. GC was used to determine oleicaeid content in compound brucea javanica oil soft capsule. The total contents of the cinobufagiu and recibufogenin in capsule were tested by HPLC. Tumor models were set up by the type Sis0 aseites tumor cells, then the tumor inhibition rate, thymus index and spleen index were observed. Results：Clears pots with good separa- tion were obtained in TLC.Content of oleicacid showed a good linear relationship at a range of 0.270 4 mg/mL-1.622 4 mg/mL,and the recovery rate was 95%-105%. The total contents of cinobufagin and recibufogenin showed a good linear relationship at a range of 0.005 6 mg/mL-0.061 6 mg/mL and the recovery rate was 95%-105%. The capsule had thera- peutic effect on tumor model. Conclusion：The proposed method is accurate with the good reproducibility and can be used for the quality control of compound brueea javanica oil soft capsule and deserves a further study.