Objective: To explore a new method to appraise the quality of medicine. Methods: Achyranthes bidentata BI. from 18 batches were chosen for study. HPLC fingerprints of Achyranthes bidentata BI. were developed, and the proliferation activity of osteoblast of these samples were also analyzed by MTT assay. The correlation analysis between the HPLC fingerprints of samples and proliferation activity of osteoblast were carried out with partial least squares ( PLS) method. The range of medicine quality was defined by normal fitting of YZL. Results: Among 16 common chromato-graphic peaks in HPLC fingerprints of Achyranthes bidentata BI. , peaks 1 ,2,4,5,6,7,11,13,16 were positively relevant to proliferation activity of osteoblast and the other peaks were negatively related to proliferation activity. When YZL value was less than 0. 6112,the quality of sample was inferior, while YZL value was more than 0. 9639, the quality of sample was superior. Conclusion: PLS can be a feasible method to investigate the relationship between HPLC fingerprints of Achyranthes bidentata BI. and proliferation activity of osteoblast. YZL value can be used to appraise the quality of medicine. When YZL value is less than 0. 6112,the quality of sample is inferior, while YZL value is more than 0. 9639, the quality of sample is superior, which is proved to be used as a new method to appraise the quality of medicine.%目的:探索评价药材质量优劣的新方法.方法:以怀牛膝药材为研究对象,采用HPLC法构建18批怀牛膝药材的化学成分群图谱；采用MTT法测定各批怀牛膝药材相应的成骨细胞增殖活性,由此构建活性数据库；利用偏最小二乘法(PLS)对药材指纹图谱与成骨细胞增殖活性的相关性进行分析；对分析得到的YZL值进行正态拟合,并界定判定药材质量优劣的YZL值区间；并以另外10批药材对该判定方法和YZL区间值进行验证.结果:从测定得到的18批怀牛膝药材的指纹图谱中提取得到16个共有峰；以PLS法建立了药材共有峰峰面积与活性间的回归模型,得到相应的标准化回归系数,由此判断出怀牛膝指纹图谱的16个共有峰中1、2、4、5、6、7、11、13、15、16号色谱峰与活性呈正系数相关,其余各峰与活性呈负系数相关；基于回归模型相应标准化回归系数盼正负性,经多重综合分析,提炼出YZL值(正、负系数相关峰峰面积和之比值)；通过对YZL值进行正态拟合并界定,得到当YZL值≥0.9639时,该怀牛膝药材为优品；当YZL值≤0.6112时,该怀牛膝药材为劣品；该判定方法得到了验证.结论:PLS法适用于怀牛膝指纹图谱与成骨细胞增殖活性的相关性分析；YZL值可用于判定和划分怀牛膝药材质量的优劣；当YZL值≥0.9639时怀牛膝药材为优品,当YZL值≤0.6112时怀牛膝药材为劣品；验证性判断结果支持本文所建立的药材质量优劣评价新方法.
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