摘要
目的:考察60Co辐照灭菌对地榆槐角丸中5种有效成分含量的影响。方法:采用HPLC法,色谱柱为Waters Sunfire ODS C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.1%磷酸溶液,梯度洗脱;流速:1.0 ml·min^-1;波长:210 nm、278 nm、230 nm、403 nm;柱温:30℃,进样量:10μl,比较有效成分槐角苷、黄芩苷、梓醇、芍药苷、羟基红花黄色素A辐照前后含量的变化,并将所得数据用SPSS 22.0软件分析。结果:地榆槐角丸中的梓醇、芍药苷、羟基红花黄色素A、槐角苷、黄芩苷分别在0.02~0.37μg、0.04~0.59μg、0.11~1.68μg、0.21~3.29μg、0.61~9.74μg范围内线性良好,平均加样回收率分别为101.28%,102.34%,98.42%,99.91%,100.47%,RSD分别为1.15%,1.37%,1.08%,1.63%,1.71%(n=9)。辐照剂量不超过6 kGy时,各组分含量变化无统计学意义(P>0.05),辐照剂量为8 kGy时,芍药苷和羟基红花黄色素A含量在辐照前后变化显著(P<0.05)。结论:所建立的地榆槐角丸活性成分测定方法可作为质控方法。在60Co辐照剂量不超过6 kGy时,5种有效成分含量变化不显著,可为地榆槐角丸辐照灭菌手段提供参考。
Objective:To investigate the effect of 60Co irradiation on the contents of five constituents in Diyu Huaijiao pills.Methods:The HPLC analysis was performed on a Waters Sunfire ODS C18 column(250 mm×4.6 mm,5μm).The mobile phase was methanol-0.1%phosphoric acid with gradient elution at the flow rate of 1.0 ml·min^-1,the wavelengths were 210 nm,278 nm,230nm and 403 nm,the column temperature was 30℃,and the sample size was 10μl.The changes of the active components catalpol,paeoniflorin,hydroxysafflor yellow A,sophoricoside and baicalin before and after the irradiation were compared,and the obtained data were analyzed by SPSS 22.0 software.Results:The linear range of catalpol,paeoniflorin,hydroxysafflor yellow A,sophoricoside and baicalin was 0.02-0.37μg,0.04-0.59μg,0.11-1.68μg,0.21-3.29μg and 0.61-9.74μg,and the average recovery was 1.28%(RSD=1.15%),102.34%(RSD=1.37%),98.42%(RSD=1.08%),99.91%(RSD=1.63%)and 100.47%(RSD=1.71%)(n=9),respectively.When the radiation dose was not more than 6 kGy,the contents of the five components did not change significantly(P>0.05).After 8 kGy radiation,the contents of paeoniflorin and hydroxysafflor yellow A were significantly different(P<0.05).Conclusion:The established method can be used for the quality control of Diyu Huaijiao pills.When the radiation is not more than 6 kGy,the five active ingredients are stable.The proposed methods provide reference for the sterilization of Diyu Huaijiao pills.
作者
唐玉婷
王滨
薛克增
Tang Yuting;Wang Bin;Xue Kezeng(Outpatient Pharmacy,Qingdao Municipal Hospital,Shandong Qingdao 266000,China;Ward Pharmacy,Qingdao Municipal Hospital,Shandong Qingdao 266000,China)
出处
《中国药师》
CAS
2019年第11期2124-2126,2137,共4页
China Pharmacist
