OBJECTIVE:To optimize the formula of the compound ginkgo leaves tablets.METHODS:The formula(dosage of low-substituted hydroxypropyl cellulose;the ratio between crude drug and loading agent and the dosage of micro-crystalline cellulose)was optimized using orthogonal design and multi-index(tablet weight variation and disintegration de-gree)comprehensive score method.RESULTS:The optimized formula was the following:the dosage of low-substituted hy-droxypropyl cellulose was5%;the ratio between crude drug and loading agent was1∶1and the dosage of microcrystalline cellulose was10%.CONCLUSION:The tablets are reasonable in formula and the forming quality of which is also good.

The study aims to develop a rapid, sensitive and specified method of liquid chromatography with heated electrospray ionization tandem mass spectrometry (LC-HESI/MS/MS) for simultaneous determination of amlodipine, benazepril and benazeprilat in human plasma using amlodipine-d4 and ubenimex as internal standards (ISs). Selected reaction monitoring (SRM) with heated electrospray ionization (HESI) was used in the positive mode for mass spectrometric detection. Analytes and ISs were extracted from plasma by simple protein precipitation. The reconstituted samples were chromatographed on a C18 (100 mm x 4.6 mm, 5 microm) column with mixture of methanol-acetonitrile-5 mmol.L- ammonium acetate-formic acid (30 : 30 : 40 : 0.1) as mobile phase at a flow rate of 0.6 mL.min-1. The standard curves were demonstrated to be linear in the range of 0.02 to 6.00 ng.mL-1 for amlodipine, 0.2 to 1,500 ng.mL-1 for benazepril and benazeprilat with r2>0.99 for each analyte. The lower limit of quantitation was identifiable and reproducible at 0.02, 0.2 and 0.2 ng mL-1 for amlodipine, benazepril and benazeprilat, respectively. The intra-day and inter-day precision and accuracy results were within the acceptable limit across all concentrations. The plasma samples were stable after four freeze-thaw cycles and being stored for 93 days at -20 degrees C. The method was applied to a pharmacokinetic study of a fixed-dose combination of amlodipine and benazepril on Chinese healthy volunteers.

OBJECTIVE:To determine the content of Puerarin in Compound Ginkgo biloba tablets by RP-HPLC. METHODS:The determination was performed on Kromasil C18 column. The mobile phase consisted of methanol-water (20∶80) with a flow rate of 1mL?min-1. The detection wavelength was 250 nm and the temperature of the column was 35℃. RESULTS:The linear range of Puerarin was 0.8～2.4?g (r=0.999 3, n=5),with the average recovery at 99.98%,RSD=1.31%(n=5).CONCLUSION:The method is simple,sensitive and reproducible,and it can be used for the quality control of Compound Ginkgo biloba tablets.