参蟾消解胶囊质量标准研究

Quality Criteria of Shenchan Xiaojie Capsules

目的:建立参蟾消解胶囊的质量标准。方法:采用薄层色谱(TLC)法对方中蟾酥、人工牛黄、冰片、芦荟、西红花进行定性鉴别;采用高效液相色谱法对制剂中脂蟾毒配基进行含量测定。结果:TLC斑点清晰、分离度好、专属性强、阴性无干扰。脂蟾毒配基进样量在0.28368～1.41840μg范围内与峰面积积分值呈良好线性关系(r=0.9999);平均回收率为97.67%,RSD=1.29%(n=6)。结论:所建标准可用于参蟾消解胶囊的质量控制。

OBJECTIVE： To establish the quality criteria of Shenchan xiaojie capsules. METHODS： TLC was employed to identify Venenum Bufonis,Calculus Boris Artifactus, Borneolum Syntheticum, Aloe, and Crocus sativus, while the content of resibufogenin in Shenchan xiaojie capsules was determined by HPLC. RESULTS： The TLC spots were clear, well- separated and specific yet without interference from negative control. The linear range of resibufogenin was 0.283 68-1.418 40μ（ r = 0. 999 9） with an average recovery rate of 97.67% （RSD = 1.29 %, n = 6）. CONCLUSION： The established criteria is suitable for the quality control of Shenchan xiaojie capsules.