尿毒清胶囊的质量控制方法研究

Specification for Niaoduqing Capsules

目的建立尿毒清胶囊的质量控制方法。方法采用显微鉴别法鉴别大黄、土茯苓;采用薄层色谱法鉴别积雪草、槐米;采用高效液相色谱法同时测定橙皮苷和丹酚酸B的含量。结果大黄的草酸钙簇晶及土茯苓的草酸钙针晶束显微特征清晰,专属性好;薄层色谱法斑点清晰、分离度好,且阴性对照无干扰;橙皮苷及丹酚酸B的线性范围分别为0.072mg^1.812mg(r=0.9998)、0.120mg^3.012mg(r=0.9997),平均加样回收率分别为98.16%、98.58%,RSD分别为1.32%、1.50%。结论该方法专属性强、灵敏度高、重复性好,可用于尿毒清胶囊的质量控制。

OBJECTIVE To establish the specification for Niaoduqing Capsules. METHODS Rhei radix et Rhizoma and Smilacis glabrae Rhizoma were identified under microscope. Thin layer chromatography( TLC) was used to identify Centellae Herba and Sophorae Flos in Niaoduqing Capsules; The contents of hesperidin and salvianolic acid B were determined by high performance liquid chromatography( HPLC). RESULTS The cluster crystal of Rhei radix et Rhizoma and the acicular crystal of Smilacis glabrae Rhizoma were clear and typical. The TLC spots were clear with good resolution and free of interference of negative samples. The hesperidin and salvianolic acid B showed good linear relationship in the range of 0. 072 mg ~ 1. 812mg( r = 0. 9998) and 0. 120 mg ~ 3. 012mg( r =0. 9997). The average recoveries were 98. 16% and 98. 58%. The RSD were 1. 32% and 1. 50%. CONCLUSION The method is simple,specific and durable.