The present study was designed to explore the food-drug and pharmacokinetic interaction between C.frutescens, a culinary herb on hypoglycemic activity of glimepiride, a sulfonyl urea derivative used in the treatment of type-2 diabetes) in diabetic rats in combination of each as single doses for one day. Further it is also aimed to study the effect of AQEFCF on antidiabetic effect of glimepiride by repeated dose treatment of AQEFCF for 8 days followed by single dose of Glimepiride in diabetic rats and also with repeated dose treatment of both drugs for 8 days in diabetic rats. Acute toxicity study was conducted as per OECD guidelines 425, as per this study maximum 2000 mg/kg dose was given to albino mice as observed for mortality of the aqueous extract of C.frutescens. Later in order to know the dose dependent action three doses were selected (1/5th,1/10th and 1/20th) for antidiabetic study. Before treatment with either AQEFCF or Glimepiride fasting ‘0’ blood samples were collected and serum glucose levels were analysed by GOD-POD method using semi-auto analyser. AQEFCF (100, 200 and 400 mg/kg p.o) glimepiride 1/2TD, TD and 2TD (0.036, 0.072 and 0.144 mg/200 g p.o) were administered orally alone as well as in combination i.e. AQEFCF as single dose followed by a single dose of glimepiride 30 min later in Phase I. In II Phase repeated doses of AQEFCF for 8 days followed by a single dose of glimepiride (30 min later) on 8th day. In Phase III both the drugs are administered as single doses for 8 days in the same group of diabetic rats. After the treatment serum glucose levels were determined in all the groups of rats at prefixed time intervals i.e.; 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 h. Both AQEFCF and glimepiride when administered as single doses produced a dose dependent antidiabetic activity in diabetic rats. The combination of AQEFCF and glimepiride at the different dose levels has shown an better antidiabetic effect. AQEFCF augmented the effect of glimepiride in streptozotocin induced diabetic rats. It has been concluded that no significant food drug interaction occurred between AQEFCF of C. frutescence and glimepiride either single dose or combination of repeated doses. Empirical evidences clears that there is also no pharmacokinetic interaction also observed.

中文翻译：

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辣椒果实提取物与格列美脲在糖尿病大鼠中的食物-药物相互作用及药代动力学研究。

本研究旨在研究糖尿病大鼠C.frutescens与格列美脲的降血糖活性之间的食物-药物和药代动力学相互作用。格列美脲是一种用于治疗2型糖尿病的磺酰脲衍生物）单剂一天。此外，本发明还旨在研究AQEFCF对格列美脲的抗糖尿病作用的作用，方法是在糖尿病大鼠中重复给药AQEFCF 8天，然后单剂量使用格列美脲，以及在糖尿病大鼠中对这两种药物重复剂量治疗8天。急性毒性研究是根据OECD指南425进行的，根据该研究，对白化病小鼠给予最大2000 mg / kg的剂量，以观察果糖梭菌水提取物的死亡率。后来为了了解剂量依赖性作用，选择了三个剂量（1 / 5、1 / 10和1/20）用于抗糖尿病研究。在用AQEFCF或格列美脲治疗之前，空腹'0'血样被收集，并使用半自动分析仪通过GOD-POD方法分析了血清葡萄糖水平。AQEFCF（100、200和400 mg / kg口服）格列美脲1 / 2TD，TD和2TD（0.036、0.072和0.144 mg / 200 g po）口服给药以及联合给药，即AQEFCF单次给药，然后单次给药在第一阶段30分钟后服用格列美脲。在第二阶段，重复剂量的AQEFCF持续8天，然后在第8天单次服用格列美脲（30分钟后）。在第三阶段中，在同一组糖尿病大鼠中，两种药物均以单剂量给药，持续8天。在治疗后，在预定的时间间隔即在所有大鼠组中测定血清葡萄糖水平。1、2、3、4、6、8、10、12、16和24小时。当以单剂量给药时，AQEFCF和格列美脲在糖尿病大鼠中均产生剂量依赖性的抗糖尿病活性。AQEFCF和格列美脲在不同剂量水平下的组合已显示出更好的抗糖尿病作用。AQEFCF增强了格列美脲在链脲佐菌素诱导的糖尿病大鼠中的作用。已经得出结论，单剂量或重复剂量的C. frutescence的AQEFCF和格列美脲之间没有发生显着的食品药物相互作用。经验证据清楚地表明，也没有观察到药代动力学相互作用。当单剂量给药时，AQEFCF和格列美脲在糖尿病大鼠中均产生剂量依赖性的抗糖尿病活性。AQEFCF和格列美脲在不同剂量水平下的组合已显示出更好的抗糖尿病作用。AQEFCF增强了格列美脲在链脲佐菌素诱导的糖尿病大鼠中的作用。已经得出结论，单剂量或重复剂量的C. frutescence的AQEFCF和格列美脲之间没有发生显着的食品药物相互作用。经验证据清楚地表明，也没有观察到药代动力学相互作用。当以单剂量给药时，AQEFCF和格列美脲在糖尿病大鼠中均产生剂量依赖性的抗糖尿病活性。AQEFCF和格列美脲在不同剂量水平下的组合已显示出更好的抗糖尿病作用。AQEFCF增强了格列美脲在链脲佐菌素诱导的糖尿病大鼠中的作用。已经得出结论，单剂量或重复剂量的C. frutescence的AQEFCF和格列美脲之间没有发生显着的食品药物相互作用。经验证据清楚地表明，也没有观察到药代动力学相互作用。AQEFCF增强了格列美脲在链脲佐菌素诱导的糖尿病大鼠中的作用。已经得出结论，单剂量或重复剂量的C. frutescence的AQEFCF和格列美脲之间没有发生显着的食品药物相互作用。经验证据清楚地表明，也没有观察到药代动力学相互作用。AQEFCF增强了格列美脲在链脲佐菌素诱导的糖尿病大鼠中的作用。已经得出结论，单剂量或重复剂量的C. frutescence的AQEFCF和格列美脲之间没有发生显着的食品药物相互作用。经验证据清楚地表明，也没有观察到药代动力学相互作用。