中国药品标准
中國藥品標準
중국약품표준
DRUG STANDARDS OF CHINA
2015年
2期
104-108
,共5页
补脑安神片%高效液相色谱法%滴定%薄层鉴别%质量标准
補腦安神片%高效液相色譜法%滴定%薄層鑒彆%質量標準
보뇌안신편%고효액상색보법%적정%박층감별%질량표준
Bunaoanshen Tablets%HPLC%titration%TLC%quality standard
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。
目的：對補腦安神片質量標準進行提升，以更好地控製藥品質量。方法：增加噹歸、製何首烏、黃精的薄層鑒彆方法；增加製何首烏中二苯乙烯苷的HPLC含量測定方法，所用色譜柱為DIONEX Acclaim 120 C18（4．6 mm ×250 mm，5μm），流動相為乙腈－水（18∶82），流量為1．0 mL? min－1，檢測波長為320 nm；增加硃砂中HgS的含量測定方法。結果：薄層斑點清晰，陰性對照無榦擾；二苯乙烯苷進樣量在0．03～0．68μg範圍內線性關繫良好（ r＝0．9999），平均迴收率為95．2％，其RSD為0．80％（n＝6）；硃砂的平均迴收率為97．4％，其RSD為3．1％（n＝6）。結論：所建方法簡便、準確，能更好地控製補腦安神片質量。
목적：대보뇌안신편질량표준진행제승，이경호지공제약품질량。방법：증가당귀、제하수오、황정적박층감별방법；증가제하수오중이분을희감적HPLC함량측정방법，소용색보주위DIONEX Acclaim 120 C18（4．6 mm ×250 mm，5μm），류동상위을정－수（18∶82），류량위1．0 mL? min－1，검측파장위320 nm；증가주사중HgS적함량측정방법。결과：박층반점청석，음성대조무간우；이분을희감진양량재0．03～0．68μg범위내선성관계량호（ r＝0．9999），평균회수솔위95．2％，기RSD위0．80％（n＝6）；주사적평균회수솔위97．4％，기RSD위3．1％（n＝6）。결론：소건방법간편、준학，능경호지공제보뇌안신편질량。
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 .
