CAJ | 학술논문

目的：益肾丸原标准仅对当归、黄芪和女贞子进行薄层色谱鉴别，无药效成分含量测定等检查项目。为提高益肾丸的质量，现进一步完善其质量控制标准。方法采用高效液相色谱法检测益肾丸中特女贞苷含量，流动相为甲醇-纯化水；色谱柱：Agilent TC-C18（2）柱（4．6×250 mm，5μm）；体积流量：1．0 mL／min；柱温：25℃；检测波长：224 nm。结果特女贞苷在15．375～246．000μg／mL范围内呈良好的线性关系，精密度实验、稳定性试验和重复性实验相对标准偏差分别为0．44％、0．95％和2．65％，平均回收率为99．60％。制订益肾丸中特女贞苷含量≥0．3 mg／g为合格。结论所用方法简便，重现性好，定量方法准确可靠，可用于益肾丸的质量控制。
목적：익신환원표준부대당귀、황기화녀정자진행박층색보감별，무약효성분함량측정등검사항목。위제고익신환적질량，현진일보완선기질량공제표준。방법채용고효액상색보법검측익신환중특녀정감함량，류동상위갑순-순화수；색보주：Agilent TC-C18（2）주（4．6×250 mm，5μm）；체적류량：1．0 mL／min；주온：25℃；검측파장：224 nm。결과특녀정감재15．375～246．000μg／mL범위내정량호적선성관계，정밀도실험、은정성시험화중복성실험상대표준편차분별위0．44％、0．95％화2．65％，평균회수솔위99．60％。제정익신환중특녀정감함량≥0．3 mg／g위합격。결론소용방법간편，중현성호，정량방법준학가고，가용우익신환적질량공제。
Objective Former standards for Yishen Pills only identify angelica root , astragalus root and ligustrum lucidum by thin layer chromatography ( TLC) and there is no test for the content of effective components .The study was to improve the quality of Yishen Pills by perfecting the quality standards . Methods We determined the content of specnuezhenide in Yishen Pills by high-per-formance liquid chromatography(HPLC), with a mobile phase of MeOH-Water, a chromatography column of Agilent TC-C18(2) (4.6 × 250 mm, 5μm), a flow rate of 1.0 mL/min, a column temperature of 25℃, a detection wavelength of 224 nm, and a sample loop volume of 10μL. Results The linear relationship of specnuezhenide content was good in the range of 15.375μg/mL~246.000μg/mL.The relative standard deviation of precision experiment , stablity experiment and repeatablity experiment was 0.44%, 0.95%and 2.65%re-spectively.The average recovery was 99.60%.The qualified standard for specnuezhenide in Yishen Pills was ≥0.3 mg/g. Conclusion The method is simple , accurate and reliable , with good reproducibility , and it is applicable for the quality control of Yishen Pills .