OBJECTIVE To establish a high-performance liquid chromatographic method for the detection of 10 related substances in 20(S)-protopanaxadiol bulk drug. METHODS Used an ACQUITY UPLC BEH C18 chromatographic column with ultrapure water(A)-acetonitrile(B) as mobile phase. The flow rate was 0.20-0.25 mL·min-1, the detection wavelength was set at 203 nm, the column temperature was maintained at 35℃, and the injection volume was 5 μL. RESULTS 20(S)-protopanaxadiol and various impurities had reached an effective separation with a good linear relationship; the sample recovery(n=9) was ranging from 94.8% to 102.2%. The RSD values were <2.0%; the intra-day and inter-day precision RSD values were<2.0%, with a good precision; the related substances C, F, H, and I were stable in solution with RSD values<2.0% in 48 h at the room temperature; while impurities A, B, D, E, G and J were unstable under the same condition with RSD>2.0%. CONCLUSION The method is simple, sensitive and accurate, which can simultaneously determine 10 related substances in API 20(S)-protopanaxadiol, which can effectively identify the relevant substances in API and provide reference for the improvement of its production process and quality control.

Objective To study of cellular immune function change of elderly patients with non-small car-cinoma after chemotherapy.Methods 62 patients with non-small carcinoma by age was divided into elderly group (≥60 years old)and youth group (<60 years old).The lymphocytes and their subsets CD3,CD4,CD8 levels were detected respectively in 2 weeks after chemotherapy and chemotherapy before compared with 20 cases of healthy vol-unteers.Results The immune condition of CD3[(51.87 ±2.56)%,(58.98 ±3.87)%]and CD4[(35.01 ± 5.12)%,(42.12 ±3.54)%],CD4/CD8[(0.89 ±0.49)%,(1.08 ±0.86)%]levels were significantly lower than those of healthy controls.Two groups of patients compared with healthy group CD3(69.38 ±8.54)%,CD4(48.21 ± 3.45)%,CD4/CD8(1.87 ±0.85)%(t=10.586,5.998,10.087,6.093,5.170,3.236,all P<0.05),and CD8 [(32.68 ±3.64)%,(30.24 ±2.45)%]levels were higher than those of healthy controls (26.10 ±2.89%)(t=6.777,5.531,all P<0.05);The CD3 and CD4,CD4/CD8 of elderly group patients were markedly lower than that of young patients (t=8.472,6.394,3.059,all P<0.05).The CD8 levels of the elderly group was higher than young patients (t=3.114 2,P<0.05);The Elderly group and young patients after 2 cycles of chemotherapy CD3 signifi-cantly was lower than before treatment (t=10.233,16.847,all P<0.05),but the two groups of patients with CD4, CD8 and CD4/CD8 levels before and after treatment (P>0.05);There was no significant difference with CD3 level of the two groups of patients after chemotherapy (P>0.05);The CD3 level of the two groups of patients after chemo-therapy was no significant difference (P>0.05),the elderly group patients after chemotherapy with CD4 levels was lower than young patients (t=7.130,P<0.05).The CD8 and CD4/CD8 level of the two groups after chemotherapy were no significant difference (P>0.05);The CD3 levels of patient withⅠ-Ⅱ stage were significantly better than patients withⅢ-Ⅳstage (t=1.584,1.721,all P<0.05),the CD4,CD8 and CD4/CD8 level of the two groups had no significant difference(P>0.05).Conclusion The senile non-small carcinoma patients need assistance targeted immunotherapy,also need to adjust according to the patient's age and clinical staging in patients with chemotherapy drug doses.