中药附子质量控制研究

目的HPLC法同时测定附子饮片（生品和炮制品）中3种双酯型生物碱含量，达到控制附子质量及指导临床安全用药的目的。方法以附子饮片（生品和炮制品）为研究对象，采用Agilent Extend—C18（4．6mm×150ram，5lxm）色谱柱，以乙腈-40mmol·L^-1乙酸铵（氨水调pH10．0）为流动相，建立乌头碱、新乌头碱和次乌头碱的含量测定方法，采用外标法测定药材中3种生物碱的含量，并比较各样品之间的差异。结果3种生物碱分离度良好，回收率均在95％－105％。黑顺片中乌头碱、新乌头碱及次乌头碱的含量与其余五批生附片及另一批白附片相比，差别较大。白附片与生附片之间差异较小。同一产地的5批生附片中各生物碱的含量亦存在差异。结论通过同时控制乌头碱、新乌头碱和次乌头碱的含量来控制附子饮片（生品和炮制品）的质量较为合理有效，且简单易行。

Quality control of chinese medicine-Radix Aconiti Lateralis

OBJECTIVE To quantitatively determine three alkaloids in the Chinese traditional medicine Radix Aconiti Lateralis by high performance liquid chromatography. METHODS Radix Aconiti Lateralis as the researchobject,an Agilent Extend-C18 （4. 6ram × 150mm,5μm） column was used by a gradient elution using acetonitrile- 40mmol . L^-1 ammonium acetate （ adjusted to pill0. 0 with aqueous ammonia）, a which was established to deter- mine aconitine,hypaconitine, mesaconitine in Radix Aconiti preparata and crude, the external standard method was used to calculate the content of three alkaloids in herbs, and the differences between the samples were com- pared. RESULTS Three alkaloids can be completely separated and determined quantitatively, and the average rate of recovery were between 95% to 105%. Aconitine, mesaconitine, and hypaconitine in Heishunpian were much less than those in Baifupian and Shengfupian. The difference between Baifupian and Shengfupian was small. Contents of Alkaloids in the five batches of Shengfupian from one place was different from each other. CONCLUSION By sim- ultaneously controlling aconitine, mesaconitine and hypaconitine content and to control Radix Aconiti Lateralis （raw products and processed products） quality was more reasonable, effective and simple.