乌藤镇痛片质量标准初步研究

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。

Preliminary Study on Quality Standard of Wuteng Analgesic Tablets

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. Results :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/m L,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 established and the method is simple and accurate. It can control the quality of the preparation effectivly.