Determination of Residual Citrinin in Zhibituo Tablets by Solid Phase Extraction-UPLC-MS/MS / 中国药房

OBJECTIVE:To determine residual citrinin in Zhibituo tablet by solid phase extraction-UPLC-MS/MS. METH-ODS:The sample was processed preliminary by solid extraction. The determination was performed on Zorbax Eclipse Plus C18 col-umn with mobile phase consisting of water (0.1% formic acid)-acetonitrile (70:30,V/V,gradient elution) at the follow rate of 0.30 mL/min. The column temperature was 40 ℃,and analysis time was 7 min,the sample size was 2 μL. Ionization mode was positive ion mode. The ion source temperature was 150 ℃,drying gas velocity was 15 L/min,sheath gas temperature was 350 ℃, sheath gas flow rate was 12 L/min,capillary voltage was 3500 V,atomization device pressure was 40 psi,atomization voltage was 0 V. The acquisition mode was MRM mode. RESULTS:The linear range of citrinin was 0.1-20 ng/mL(r=0.9994);the limits of quantitation and detection were 0.05 and 0.01 ng/mL. RSDs of precision,stability and repeatability tests were all lower than 2.0%;recoveries were 98.868%-103.160%(RSD=1.5%,n=6). CONCLUSIONS:The method is rapid,sensitive,accurate and suitable for the determination of residual citrinin in Zhibituo tablet.

Inhibition of pancreatic lipase, α-glucosidase, α-amylase, and hypolipidemic effects of the total flavonoids from Nelumbo nucifera leaves.

ETHNOPHARMACOLOGICAL RELEVANCE: Nelumbo nucifera Gaertn. leaves have been used as medicinal herbs in the past 1300 years, specifically utilized to cure hyperlipidemia, hyperglycemia, and obesity. It has been recorded in the most famous medicinal book in China for more than 400 years. The present study aims to identify the potential therapeutic activities of the flavonoids isolated from Nelumbo nucifera leaves. MATERIALS AND METHODS: Nelumbo nucifera leaf flavonoids (NLF) were tested for the inhibition of lipase, α-glucosidase, and α-amylase activities in vitro. A single dose of NLF was administered by oral gavage in mice for acute toxicity. Wistar rats with high-fat diet-induced hyperlipidemia and two other animal models were used to evaluate the hypolipidemic effects of NLF. RESULTS: Our in vitro biochemistry tests revealed that the NLF showed high inhibitory activity against porcine pancreatic lipase, α-amylase, and α-glucosidase with IC50 values of 0.38 ± 0.022, 2.20 ± 0.18, and 1.86 ± 0.018 mg/mL, respectively. Furthermore, the NLF significantly lowered the lipid components, such as the total cholesterol, triglycerides, low-density lipoprotein cholesterol, and malondialdehyde, in various established in vivo systems and raised the high-density lipoprotein cholesterol. Moreover, the NLF alleviated high-fat diet-induced lipid accumulation in the liver. CONCLUSIONS: The results demonstrate that NLFs can effectively ameliorate hyperlipidemia and inhibit the key enzymes related to type 2 diabetes mellitus. Our findings may provide new pharmacological basis for the treatment of hyperlipidemia, hyperglycemia, and obesity using NLFs.

Efficacy of zhibituo combined with atorvastatin on type 2 diabetic patients with hyperlipidemia / 中国综合临床

Objective To observe the efficacy of zhibituo combined with atorvastatin on type 2 diabetic patients with hyperlipidemia and its impact on blood lipids,fibrinogen (Fib) and D-dimer.Methods One hundred and seventy type 2 diabetic patients with hyperlipidemia visited our hospital from January 2010 to December 2012 were randomly divided into observation group and control group(with 85 cases in each group).Control group were given atorvastatin (1 0 mg,1 times / day),and the observation group were treated with zhibituo(1.05 g,3 times/day) on the basis of atorvastatin treatment,both treatment were 8 weeks.The levels of fasting plasma glucose (FPG),glycosylated hemoglobin (HbAlc),lipids,Fib and D-dimer were observed before and after treatment,and the efficacy of the two groups were compared.Results The efficacy in observation group was significantly higher than that in the control group (92.94％ (79/85) vs.81.18％ (69/85),x2 =4.229,P ＜ 0.05).There was significant difference on the levels of total cholesterol (TC) ((7.46 ±1.83) mmol/L vs.(4.28 ± 1.94) mmol/L,triglycerides (TG) (3.57 ± 1.32) mmoL/L vs.(1.47 ± 0.86)mmol/L,low-density lipoprotein cholesterol (LDL-C) (4.68 ± 1.04) mmol/L vs.(2.19 ± 0.72) mmol/L,high density lipoprotein cholesterol (HDL-C) (0.85 ± 0.21) mmol/L,vs.1.47 ± 0.43) mmol/L,fasting plasma glucose (FPG) ((8.65 ± 2.19) mmol/L vs.(6.38 ± 0.83) mmol/L).glvcosvlated hemoglobin (HbAlc) ((7.49 ± 1.67)％ vs.(6.28 ± 1.48)％),fibre(FiB) ((7.42 ± 1.38) mg/L vs.(3.76 ± 1.18)mg/L),and D-dimer ((1.18 ±0.17) g/L vs.(0.51 ±0.18) g/L) in observation group before and after treatment(t =10.993,12.289,18.849,11.945,8.936,4.999,18.584,24.949 respectively,all P ＜ 0.05).And there was also significant difference on the levels ofTC ((7.51 ± 1.27) mmol/L vs.(5.10 ±2.18) mmol/L),TG((3.48 ± 1.29) mmol/L vs.(1.88 ±0.37) mmol/L),LDL-C((4.57 ± 1.18) mmol/L vs.(2.81 ±0.83) mmol/L),HDL-C ((0.83 ± 0.22) mmol/L vs.(1.16 ± 0.28) mmol/L),FPG((8.72 ± 1.92) mmol/L vs.(7.42 ± 1.82) mmol/L),HbAlc((7.53 ± 1.32)％ vs.(6.79 ± 1.23)％),Fib((7.38 ± 1.63) mg/L vs.(4.41 ± 1.02) mg/L) and D-dimer ((1.20 ±0.15) g/L vs.(0.65 ±0.12) g/L) in control group before and after treatment (t =8.807,10.992,11.248,8.544,4.530,3.781,14.240,26.397,respectively,all P ＜0.05).The elevated levels of the observation group were more obvious compared with control group ((t =2.591,4.038,5.202,5.570,4.793,2.443,3.842,5.967 respectively,all P ＜0.01).Conclusion The efficacy of zhibituo combined with atorvastatin is obvious in type 2 diabetic patients with hyperlipidemia,it is helpful to regulate the disorders of fibrinolysis and coagulation.

Cost-effectiveness analysis of zhibituo and simvastatin in treatment of hyperlipemia / 中国基层医药

Objective To explore the cost-effectiveness analysis of zhibituo and simvastatin in treatment of hyperlipemia. Methods 68 cases with hyperlipemia were divided into two groups randomly:group A were treated with imvastatin (n = 33),group B were treated with zhibituo(n = 35). The data was evaluated with eost-effectiveneas analysis. Results The cost of the two groups was 462.56 yuan and 257.60 yuan respectivdy. The effective rate was 74.28 % and 73.9.3 %respectivdy. The cost-effectiveness ratio was 6.23 and 3.48 respectively. The increased cost-effectiveness ratio of group A vs group B was 585.6. No significant differences were found in both effective rate and ADRS between two groups(P＞0.05).Conclusion Zhibituo was an effective and safe drug in treating hyperlipidemia as well as simvastatin. But zhibituo was better than simvastatin based on the oost-effeetiveness analysis.

Comparison of zhibituo and lovastatin in the treatment of hyperlipidemia / 医学研究生学报

Objective:To compare the efficacy, safety and economics of zhibituo and lovastatin in the treatment of hyperlipidemia. Methods:Searching medical references were done, The qualified results of clinical trials were Meta-analysed for evaluating the efficacy of zhibituo comparing with lovastatin. The characters of zhibituo and lovastatin were also compared through scoring by senior physicians. Results:The results of Meta-analysis showed that zhibituo had stronger effects on lowering TG and elevating HDL.It had less severe ADR for old people and cost less than lovastatin. The results of physicians-scoring records showed no significant difference between these two drugs. Conclusion:Zhibituo and lovastatin both are potential lipid-lowering agents. zhibituo is safer and more cost-effective for old people with mild to moderate elevated serum LDL level.

Economic Analysis of Three Antihyperlipoidemics / 中国药房

OBJECTIVE:To study the pharmacoeconomic effectiveness of three antihyperlipoidemics METHODS:According to literature reports,158 patients with hyperlipoidemia were selected These patients were randomly divided into three groups which received zhibituo,pravastatin and simvastatin respectively The results were evaluated with pharmacoeconomic analysis RESULTS & CONCLUSION:The cost of zhibituo is minimal