CAJ | 학술논문

目的康复灵颗粒可用于治疗辐射损伤,但其质量标准并未建立,文中旨在建立康复灵颗粒的质量标准,以控制其质量. 方法采用薄层色谱法,对方中黄芪、当归进行定性鉴别;采用高效液相色谱法测定方中黄芪甲苷的含量:色谱柱为Agilent Zorbax Extend-C18 (4.6 mm ×250 mm, 5μm),以乙腈-水(32:68) 为流动相,流速为1.0 mL/min,蒸发光散射检测器检测;采用高效液相色谱法测定方中阿魏酸的含量:色谱柱为Agilent Zorbax SB-C18柱 (250 mm ×4.6 mm, 5μm);流动相:乙腈-0.085%磷酸水(17:83),检测波长:320 nm;流速:1.0 mL/min;柱温:35℃. 结果采用薄层色谱法鉴别黄芪、当归时,供试品的色谱图中,与对照品色谱对应的位置上,显相同颜色的斑点,阴性对照无干扰. 黄芪甲苷的线性范围为0 .030 6~0.612 0 mg/mL,R2 =0.999;稳定性试验RSD为2.17%;精密度试验RSD为1.89%;重复性试验RSD为1.58%;平均加样回收率为101.26%. 阿魏酸的线性范围为0.24~4.80μg/mL,R2 =0.999;稳定性试验RSD为1.37%;精密度试验RSD为0.83%;重复性试验RSD为1.14%;平均加样回收率为98.39%. 暂定本品按干燥品计算,每克含黄芪甲苷(C41H68O14)不得少于0.19 mg,阿魏酸( C10 H10 O4 )不得少于0.08 mg. 结论文中建立的方法操作简便、灵敏度高、准确可靠、重现性好,可作为康复灵颗粒的质量控制方法.
목적 강복령과립가용우치료복사손상,단기질량표준병미건립,문중지재건립강복령과립적질량표준,이공제기질량. 방법 채용박층색보법,대방중황기、당귀진행정성감별;채용고효액상색보법측정방중황기갑감적함량:색보주위Agilent Zorbax Extend-C18 (4.6 mm ×250 mm, 5μm),이을정-수(32:68) 위류동상,류속위1.0 mL/min,증발광산사검측기검측;채용고효액상색보법측정방중아위산적함량:색보주위Agilent Zorbax SB-C18주 (250 mm ×4.6 mm, 5μm);류동상:을정-0.085%린산수(17:83),검측파장:320 nm;류속:1.0 mL/min;주온:35℃. 결과 채용박층색보법감별황기、당귀시,공시품적색보도중,여대조품색보대응적위치상,현상동안색적반점,음성대조무간우. 황기갑감적선성범위위0 .030 6~0.612 0 mg/mL,R2 =0.999;은정성시험RSD위2.17%;정밀도시험RSD위1.89%;중복성시험RSD위1.58%;평균가양회수솔위101.26%. 아위산적선성범위위0.24~4.80μg/mL,R2 =0.999;은정성시험RSD위1.37%;정밀도시험RSD위0.83%;중복성시험RSD위1.14%;평균가양회수솔위98.39%. 잠정본품안간조품계산,매극함황기갑감(C41H68O14)불득소우0.19 mg,아위산( C10 H10 O4 )불득소우0.08 mg. 결론 문중건립적방법조작간편、령민도고、준학가고、중현성호,가작위강복령과립적질량공제방법.
Objective Kangfuling granules can be used for the treatment of radiation damage , but its quality criteria has not been established .This paper aimed to establish the quality criteria of Kangfuling granules to control its quality . Methods Radix as-tragali and Radix angelicae sinensis in the formula both were identified qualitatively by TLC .The content of astragaloside IV was exam-ined by HPLC:Agilent Zorbax Extend-C18 (4.6 mm ×250 mm, 5μm) was used as the chromatographic column .The mobile phase was consisted of acetonitrile-water (32:68) with a flow rate at 1.0 mL/min.The evaporative light scattering detector was used to detect the compound.The content of astragaloside IV and ferulaic acid was examined by HPLC: Agilent Zorbax SB-C18 (4.6 mm ×250 mm, 5 μm) was used as the chromatographic column .The mobile phase was consisted of acetonitrile-0.085% phosphoric acid water (17:83) with a flow rate at 1.0 mL/min.The wave length was 320 nm and column temperature was set at 35℃. Results The same color spot was shown in the chromatogram of the test sample and the control sample in the corresponding position with no interference of negative control.The linear range for Astragaloside IV 0.030 6 mg/mL~0.612 0 mg/mL with R2 =0.999.The RSD of stability test was 2.17%.The RSD of precision test was 1.89%.The RSD of re-peatability test was 1.58%.The average recovery was 101.26%. The linear range for ferulaic acid 0.24-4.80 μg/mL with R2 =0.999.The RSD of stability test was 1.37%.The RSD of precision test was 0.83%.The RSD of repeatability test was 1.14%.The average recovery was 98.39%.This product was tentatively calculat-ed according to the dry matter , the amount of Astragaloside IV and ferulaic acid should not be less than 0.19 mg/g and 0.08 mg/g, re-spectively. Conclusion In this study, the established TLC was used for the qualitative identification of Kangfuling granules , and the content of Astragaloside IV and ferulaic acid was not less than 0.19 mg and 0.08 mg in per gram of Kangfuling granules , respectively. The established standard is suitable for the quality control of Kangfuling granules .