实用药物与临床
實用藥物與臨床
실용약물여림상
PRACTICAL PHARMACY AND CLINICAL REMEDIES
2014年
5期
595-597
,共3页
止汗外用凝胶%质量控制%姜黄素%含量测定%薄层色谱法%高效液相色谱法
止汗外用凝膠%質量控製%薑黃素%含量測定%薄層色譜法%高效液相色譜法
지한외용응효%질량공제%강황소%함량측정%박층색보법%고효액상색보법
Zhihan gel%Quality control%Curcumin%Determination%TLC%HPLC
目的:建立止汗外用凝胶中指标性成分姜黄素的定性鉴别与含量测定方法。方法采用TLC法定性鉴别止汗外用凝胶中的姜黄素。采用HPLC法测定制剂中指标性成分姜黄素的含量,色谱柱:Ecosil ODS C18(4.6 mm ×250 mm,5μm);流动相:乙腈-水-冰醋酸(45∶55∶6);检测波长:254 nm。结果制剂薄层色谱与化学对照品(姜黄素)及阳性对照药材(郁金)薄层色谱在相应位置上显相同斑点。姜黄素的线性范围为0.1~0.8 mg/mL,r=0.9994,平均回收率为100.12%,精密度、重现性、稳定性均符合测定要求。制剂样品中姜黄素的平均含量为0.2016%。结论 TLC法定性鉴别和 HPLC法定量测定止汗外用凝胶中姜黄素,方法可行,重现性好,为止汗外用凝胶的质量控制提供了可靠依据。
目的:建立止汗外用凝膠中指標性成分薑黃素的定性鑒彆與含量測定方法。方法採用TLC法定性鑒彆止汗外用凝膠中的薑黃素。採用HPLC法測定製劑中指標性成分薑黃素的含量,色譜柱:Ecosil ODS C18(4.6 mm ×250 mm,5μm);流動相:乙腈-水-冰醋痠(45∶55∶6);檢測波長:254 nm。結果製劑薄層色譜與化學對照品(薑黃素)及暘性對照藥材(鬱金)薄層色譜在相應位置上顯相同斑點。薑黃素的線性範圍為0.1~0.8 mg/mL,r=0.9994,平均迴收率為100.12%,精密度、重現性、穩定性均符閤測定要求。製劑樣品中薑黃素的平均含量為0.2016%。結論 TLC法定性鑒彆和 HPLC法定量測定止汗外用凝膠中薑黃素,方法可行,重現性好,為止汗外用凝膠的質量控製提供瞭可靠依據。
목적:건립지한외용응효중지표성성분강황소적정성감별여함량측정방법。방법채용TLC법정성감별지한외용응효중적강황소。채용HPLC법측정제제중지표성성분강황소적함량,색보주:Ecosil ODS C18(4.6 mm ×250 mm,5μm);류동상:을정-수-빙작산(45∶55∶6);검측파장:254 nm。결과제제박층색보여화학대조품(강황소)급양성대조약재(욱금)박층색보재상응위치상현상동반점。강황소적선성범위위0.1~0.8 mg/mL,r=0.9994,평균회수솔위100.12%,정밀도、중현성、은정성균부합측정요구。제제양품중강황소적평균함량위0.2016%。결론 TLC법정성감별화 HPLC법정량측정지한외용응효중강황소,방법가행,중현성호,위지한외용응효적질량공제제공료가고의거。
Objective To establish the method for qualitative identification and determination of curcumin in Zhihan gel. Methods TLC method was adopted to qualitatively identify curcumin in Zhihan gel. HPLC method was a-dopted to quantitatively identify curcumin in Zhihan gel. Chromatographic conditions were as follows:Ecosil ODS C18 column (4. 6 mm × 250 mm,5 μm) was used with mobile phase consisted of acetonitrile-water-phosphoric acid (45∶55∶6) under a detection wavelength at 254 nm. Results Zhihan gel had the same chromatograms with reference sub-stance of C. wenyujin and standard reference substance of curcumin by TLC. The linear range of curcumin was 0. 1 ~0. 8 mg/mL ( r =0. 999 4 ) with an average recovery rate of 100. 12%, reproducibility, precision and stability were fine. The mean content of curcumin in Zhihan gel was 0. 201 6%. Conclusion The method is simple,reliable and ac-curate,and can be used for the quality control of Zhihan gel.