Abstract
A sensitive high-performance liquid chromatography (HPLC-UV) method for determination of omeprazole in beagle dog plasma was developed and to investigate the effect of Sijunzi pills (SJZPs) on the pharmacokinetics of omeprazole in beagle dogs. The beagle dog plasma was extracted with ethyl acetate and n-hexane under alkaline conditions. Omeprazole and internal standard (IS, fluconazole) were separated on an XDB-C18 column, and acetonitrile and 0.1% trifluoroacetic acid were used as the mobile phase. Omeprazole and IS were detected by using a diode array detector. This experiment adopts the experimental design of double-cycle self-control. In the first cycle (group A), six beagle dogs were given omeprazole 0.67 mg/kg orally in a single dose. In the second period (group B), the same six beagle dogs were orally given SJZPs 0.2 g/kg twice a day for 7 consecutive days, and then, omeprazole was orally given. At the different time points after omeprazole was given in the two periods, the blood samples were collected. The concentration of omeprazole was detected by the developed HPLC method. DAS 2.0 was used to calculate the pharmacokinetic parameters of omeprazole. Under the current experimental conditions, this UPLC method showed good linearity in the detection of omeprazole. Interday and intraday precision did not exceed 10%, and the range of accuracy values were from −1.43% to 2.76%. The results of extraction recovery and stability met the requirements of FDA approval guidelines of bioanalytical method validation. The Cmax of omeprazole in group B was 61.55% higher than that in group A, and the AUC(0−t) and AUC(0−∞) of omeprazole in group B were 63.96% and 63.65% higher those that in group A, respectively. At the same time, the clearance (CL) and apparent volume of distribution (Vd) decreased in group B. In this study, an HPLC method for the determination of plasma omeprazole concentration was established. SJZPs could inhibit the metabolism of omeprazole and increase the concentration of omeprazole in beagle dogs. It is suggested that when SJZPs are combined with omeprazole, attention should be paid to the herb-drug interactions and possible adverse reactions.
Highlights
Sijunzi Decoction (SJZD), derived from the prescription of Taiping Huimin Heji Bureau, is a classic representative prescription of Traditional Chinese Medicine (TCM) for supplementing qi
SJZD is composed of Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, and roasted licorice
E preparation method is as follows: 200 g Codonopsis pilosula, 200 g Atractylodes macrocephala, 200 g Poria cocos, and 100 g roasted licorice were crushed into fine powder, sifted, and mixed evenly. e pills were panned with the decoction (50 g ginger and 100 g jujube, decocted and filtered with water several times) and dried
Summary
Sijunzi Decoction (SJZD), derived from the prescription of Taiping Huimin Heji Bureau, is a classic representative prescription of Traditional Chinese Medicine (TCM) for supplementing qi. Omeprazole can be specially distributed in the secretory tubules of gastric mucosal parietal cells and irreversibly combined with the sulfhydryl group of H+ and K+-ATPase ( known as proton pump) in the secretory membrane of parietal cells, so as to inhibit the enzyme activity and block the final step of gastric acid secretion, erefore, this product has a strong and lasting inhibitory effect on gastric acid secretion caused by various reasons. It was suitable for the treatment of gastric ulcer, duodenal ulcer, stress ulcer, reflux esophagitis, and gastrinoma. A method for determination of omeprazole in beagle dog plasma by HPLC-UV was developed and performed using fluconazole as the internal standard (IS), and the effect of SJZP on the changes of pharmacokinetics of omeprazole in beagle dogs was observed
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