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目的建立莪术挥发油中吉马酮高效液相色谱含量测定方法,并用此方法对莪术油葡萄糖注射液进行稳定性考察。方法含量测定采用HPLC法。选用ODS C18柱(5μm,4.6 mm×200 mm),流动相为甲醇-水(80:20),流速0.8 mL·min-1,测定波长204 nm。稳定性研究采用高温加速试验法。结果吉马酮进样量在0.496～3.968μg内线性关系良好(r=0.999 9),平均回收率101.0%,RSD为1.78%(n=9)。用HPLC法和药典方法考察自制莪术油葡萄糖注射液的降解t1/2分别为21.52h和12.05 h。结论 HPLC法能很好地分离检测莪术油中的吉马酮,可用于莪术油原料及制剂的含量测定;自制莪术油葡萄糖注射液的稳定性较差。
Objective To establish a HPLC method for the determination of germacrone in volatile oil of Curcuma phaeocaulis and study the stability of Curcuma oil and glucose injection by this method. Determination of content by HPLC method. The ODS C18 column (5 μm, 4.6 mm × 200 mm) was used. The mobile phase was methanol-water (80:20) and the flow rate was 0.8 mL · min-1. The wavelength was 204 nm. Stability studies using high temperature accelerated test method. Results The calibration curve of gemcitabine was linear within the range of 0.496 ~ 3.968 μg (r = 0.999 9). The average recovery was 101.0%. The RSD was 1.78% (n = 9). The degradation of homemade Curcuma oil glucose injection by HPLC and pharmacopoeial methods was t1.5 and 21.05 h, respectively. Conclusion HPLC method can be very good for the determination of gemcitabine in zedoary turmeric oil, which can be used for the determination of the raw materials and preparations of zedoary turmeric oil. The stability of homemade zedoary turmeric oil glucose injection is poor.