Research of Quality Evaluation Method of Liyan Dan Complex Pharmaceutics by Biological Effect Ratio / 现代生物医学进展

ABSTRACT

Objective: To determine biological effect ratio (BER) on anti-herpes simplex virus-Ⅰ (HSV-Ⅰ)of Liyan Dan (LYD) complex pharmaceutics and its active components alignment (ACA), and to discuss the new identification method of Chinese patent medicine expressed by standard BER. Methods: Protective effect to cells infected by HSV-Ⅰ was evaluated by a 3-(4,5-dimethyl-2 thiazoyl)-2,5-diphenyl-2H-tetrazolium bromide (MTT) assay. The ACA was determined by high performance liquid chromatography (HPLC) and ultraviolet spectrophotometry. By the protective percent (PP) to cells infected by HSV-Ⅰ of LYD and its ACA the BER was calculated. BERS= PPS / PPACA (protective percent to cells infected by HSV-Ⅰ of sample/protective percent to cells infected by HSV-Ⅰ of ACA; the concentration of sample was 2-x mg/mL). Results: LYD can inhibit cytopathogenic effect (CPE) and its BER was 1.16. Conclusion: BER and ACA of Chinese patent medicine can reflect connotation of Chinese patent medicine quality. This index described intrinsic quality of curative effect on Chinese materia medica.The new concepts of BER and ACA were pulled into the study. This research offered a new train of thought and method to study Chinese patent medicine quality as follows. Firstly, establish standard biological effect of ACA as a standard of effect; secondly,measure the biological effect of sample by the method of measuring effective standard of ACA; thirdly, calculate BER according to the formula (BERS=PPS/PPACA). Standard of BER on quality evaluation is as follows. If 1 ≥ BERS ≥ 0.9, the sample is eligible; if BERS＞1, the sample is of high quality; if BERS＜0.9, the sample is disqualification. This quality evaluation method is much more scientific than the method that evaluate quality only by one or two components contents.