补脑安神片质量标准提升的研究

Research to Improve the Quality Standard of Bunaoanshen Tablets

目的：对补脑安神片质量标准进行提升，以更好地控制药品质量。方法：增加当归、制何首乌、黄精的薄层鉴别方法；增加制何首乌中二苯乙烯苷的HPLC含量测定方法，所用色谱柱为DIONEX Acclaim 120 C18（4．6 mm ×250 mm，5μm），流动相为乙腈－水（18∶82），流量为1．0 mL· min－1，检测波长为320 nm；增加朱砂中HgS的含量测定方法。结果：薄层斑点清晰，阴性对照无干扰；二苯乙烯苷进样量在0．03～0．68μg范围内线性关系良好（ r＝0．9999），平均回收率为95．2％，其RSD为0．80％（n＝6）；朱砂的平均回收率为97．4％，其RSD为3．1％（n＝6）。结论：所建方法简便、准确，能更好地控制补脑安神片质量。

Abstrct Objective：To improve the quality standard for Bunaoanshen Tablets .Methods：Angelica sinensis , radix polygoni multiflori praeparata and rhizoma polygonati were identified by TLC .The content of stilbene glycoside in radix polygoni multiflori praeparata was determined by HPLC.DIONEX Acclaim 120 C18 column （4.6 mm ×250 mm,5 μm） was used with the mobile phase of acetonitrile-water （18∶82） at the flow rate 1.0 mL？ min-1 , the detection wavelength was 320 nm.The content of HgS in cinnabar was determined by titration.Results：The TLC sports developed was fairly clear and there were no interferences on the negatives controls .The average recovies were 95.2%with RSD 0.80%（n=6） for stilbene glycoside, and showed a good linear relationship within the range of 0.03-0.68 μg（r=0.999 9）.The average recovies were 97.4%with RSD 3.1%（n=6） for HgS.Conclusion：The method is simple, exclusive and accurate , which can be used for determination and quality control for Bunaoanshen Tablets .