乌藤镇痛片质量标准初步研究

Preliminary Study on Quality Standard of Wuteng Analgesic Tablets

目的 ：建立乌藤镇痛片的质量标准。方法 ：采用薄层色谱（TLC）法对制剂中的青风藤、独活、红花进行定性鉴别,并对制剂中双酯型生物碱进行限量检查,用高效液相色谱（HPLC）法测定制剂中青藤碱的含量。结果：TLC可以检测出青风藤、独活、红花的特征性斑点,制剂中双酯型生物碱含量在限量范围内。青藤碱在0.0126~0.1255 mg/m L内线性关系良好,Y=1626.58256X-9.20930,r=0.99998（n=6）,平均回收率98.14%,RSD=1.41%。结论：建立了乌藤镇痛片的质量标准,方法简便、准确,能够有效控制制剂的质量。

Objective：To establish the quality standards of Wuteng analgesic tablets. Methods：The caulis sinomenii,radix angelicae pubescentis,safflower in the preparation were qualitatively identified by thin layer chromatography（TLC） method and the limit test of diester-type alkaloids in the preparation was done. The content of sinomenine in the preparation was identified by high performance liquid chromatography（HPLC） method. Resuhs：TLC can detect the characteristic spots of caulis sinomenii,radix angelicae pubescentis and safflower. The diester-type alkaloids in the preparation is in the limited range. The Sinomenine has good lin ea relation in the range of 0.0126-0.1255 mg/mL,Y=1626.58256X-9.20930,r=0.99998（n=6）,the average recovery rate is 98.14% ,RSD is 1.41%. Conclusion：the quality standard of Wuteng analgesic tablets is es- tablished and the method is simple and accurate. It can control the quality of the preparation effectivly.