摘要
目的应用双定性双定量混批勾兑技术控制玄参-地黄渗漉液质量。方法采用反相高效液相色谱法,以CenturySIL C18BDS(200 mm×4.6 mm,5μm)色谱柱,1%HAC-水和1%HAC-乙腈为流动相,梯度洗脱,流速1.0 mL.min-1,柱温(30.00±0.15)℃,进样量5μL,紫外检测波长280 nm。结果以哈巴俄苷为参照物峰,确定17个共有峰,建立了玄参-地黄渗漉液的HPLC指纹图谱。用孙国祥等研制的"中药色谱指纹图谱超信息特征数字化评价系统"软件计算获得其双定性相似度(SF和S′F)和双定量相似度(C和P)结果。10批玄参-地黄渗漉液的含量除S1与S3完全合格外,S2与S4含量明显偏高,其余6批次含量明显偏低。以双定量相似度的均值为控制指标经混批勾兑后所得15批样品的双定性相似度和双定量相似度都符合要求,混批勾兑后15批样品的双定性相似度的RSD<2.4%,双定量相似度的RSD<4%。结论以双定性双定量相似度理论为基础的混批勾兑技术能够消除药材、制剂或其提取物中间体的批间化学成分数量、分布比例和含量差异,可从宏观角度准确有效地控制中药材、提取物、中间体和制剂质量。
Objective To use double the qualitative and double quantitative blending technology （DQDQBT） to evaluate the quality of percolate of radix scrophulariae （RS） and radix rehmannia （RR）. Methods Chromatography was carried out by injecting 5μL of the sample solution each time in a CenturySIL C18 BIDS column （200 min×4.6 ram, 5 μm） with the low-pressure gradient elution solvent consisting of 1% acetic acid water and 1% acetic acid acetonitrile. The flow rate was 1.0 mL · min^-1. The column temperature was maintained at （30.00±0.15） ℃, and the detection wavelength was 280 nm. Results The chromatographic fingerprints were evaluated by the software of digitalized evaluation system for super-information characteristics of TCM fingerprints 3.0, which was invented by SUN Guoxiang, etc. By analyzing the double qualitative similarities （both SF and S＇F） and the double quantitative similarities （both C and P） of the 10 batches of RS and RR percolates, we found that there were great differences between them in overall contents： except that S1 and S3 were quite qualified, S2 and S4 were extremely high, while other batches were too low. We selected the mean of every batch of double quantitative similarities as the objective function to control the overall contents of 15 batches of samples respectively from double qualitative and double quantitative similarities to meet the requirements, and their RSDs were less than 2.4% and 4% after blending, respectively. Conclusion The tests proved that DQDQBT based theory of the double qualitative and double quantitative similarities could cancel any differences of the quantities of chemical constituents, distributions and contents between the crude drugs, preparations and their extracts or intermediates respectively. DQDQBT can effectively and authentically control the quality of Traditional Chinese Medicine.
出处
《中南药学》
CAS
2008年第4期470-474,共5页
Central South Pharmacy
基金
国家自然科学基金重大研究计划资助课题(No.90612002)
关键词
HPLC指纹图谱
双定性双定量混批勾兑技术
双定性相似度
双定量相似度
渗漉液
chromatographic fingerprint
double qualitative and double quantitative blending technology
the double qualitative similarities
the double quantitative similarities
percolate
作者简介
孙国祥，男，博士，副教授，硕士生导师，主要从事中药指纹图谱学体系及其信息学研究，Tel：（024）23986286，Email：gxswmwys@163．com
