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OBJECTIVE To investigate the effect of Compound danshen tablet s o n improving the blood lipid levels and the mechanism of protecting renal functions in hyperlipidemia model rats. METHODS Sixty male SD rats were divided into normal group，model group ，simvastatin combined with （2S）-N-[N-（3，5-difluorophenylacetyl）-L-alanyl]-2-phenylglycine tert butyl （DAPT）group and low-dose ，medium-dose and high-dose groups of Compound danshen tablets ，with 10 rats in each group. Rats in the normal group received routine diet. The other 5 groups were intraperitoneally injected with 75％ yolk emulsion 10 mL/kg， fasting and drinking freely. After 16 h，they were fed high-fat diet for 4 weeks. Simvastatin combined with DAPT group was given simvastatin 0.002 g/kg and DAPT 0.012 g/kg at the same time of modeling. The low-dose ，medium-dose and high-dose groups of Compound danshen tablets were given Compound danshen tablets 0.25，0.5 and 1 g/kg respectively at the same time of modeling ， the normal group and model group were given equal volume of distilled water ，once a day ，for 4 weeks. The serum levels of total cholesterol（TC），triglyceride（TG），creatinine（Cr）and urea nitrogen （BUN）in serum were detected by biochemical method ； kidney coefficient of rats was calculated ；histopathological changes of rat kidney were observed by HE staining ，and the renal injury was scored according to the degree of renal tubular injury and glomerular sclerosis in renal cortex ；expression levels of Notch signal receptor 1（Notch 1），Notch signal ligand 1（Jagged1）and hairy division associated enhancer 1（Hes1）in kidney were detected by immunohistochemistry ；mRNA expressions of Notch 1，Jagged1 and Hes 1 in renal tissue were detected by real-time fluorescence quantitative polymerase chain reaction. RESULTS Compared with normal group ，the serum levels of TG ， TC，Cr and BUN were increased significantly in model group （P＜0.05）；renal coefficient increased significantly （P＜0.05）； pathological changes occurred in renal tissue ，and the scores of renal tubular injury and glomerular sclerosis increased significantly （P＜0.05）；protein and mRNA expressions of Notch1， Jagged1， Hes1 in renal tissue were increased significantly（P＜0.05）. Compared with model group ，serum levels of TG ，TC，Cr and BUN ，renal coefficient ，the scores of renal tubular injury and glomerular sclerosis ，protein and mRNA expression of Notch 1，Jagged1 and Hes 1 in renal tissue were all decreased in low-dose ，medium-dose and high-dose groups of Compound danshen tablets （P＜0.05），and most indexes showed a dose-dependent trend ；the degree of renal lesions was reduced. CONCLUSIONS Compound danshen tablets possess obvious hypolipidemic effect ，and can protect the renal function of hyperlipidemia model rats by down-regulating Notch 1/Jagged1 signal pathway.
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Objective: Using ultrafine hydroxypropyl cellulose (HPC) powders as coating material to prepare moisture barrier coating film for Compound Danshen Tablets by an innovative electrostatic powder coating technology. The effects of coating prescription and process parameters on coating efficiency and coating film properties were investigated, so as to provide new ideas for moistureproof coating of moisture sensitive traditional Chinese medicine such as Compound Danshen Tablets. Methods: Free films were prepared by applying an electrostatic deposition process, and the effects of liquid plasticizer on the mechanical properties and the water vapor permeability were investigated. And the Compound Danshen Tablets were dry coated with ultrafine powders by the electrostatic coating technology. The effects of coating formulations and processing conditions on the moisture sorption behavior of the barrier film coated tablets were studied. Results: The coating efficiency could be manipulated by adjusting the charging voltage of the electrostatic spray gun and the amount of the liquid plasticizer. Compared with static curing process, dynamic curing process was capable to produce a satisfactory film with an enhanced moisture barrier function for the herbal medicines. The best coating process parameters were plasticizer spraying time 3 min and titanium dioxide addition ratio 1%. The minimum hygroscopicity was achieved when the coating level was increased to 6.7%. Conclusion: The moisture-protective effect by using a novel electrostatic coating technology with ultrafine powders was efficiently achieved, suggesting that it was a promising alternative for the protection for the moisture sensitive drugs.
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Objective: To compare the effect and mechanism of Compound Danshen Tablets and its disassembled prescription on learning and memory ability of rats with vascular dementia (VD). Methods: Rats with normal learning and memory ability were screened through the shuttle box, and then divided into seven groups: sham group, model group, contrast group (dihydroergotaminemesylate 0.65 g/kg), Danshen group (ethanol extract of Salvia miltiorrhiza 0.3 g/kg), Senqi group (Panax notoginseng powder 0.3 g/kg), Compound Danshen Tablets group (low dose 0.3 g/kg, high dose 0.6 g/kg), ig administration, once daily one time, after 7 d of continuous administration, the VD rat model was established by bilateral common carotid artery ligation and reperfusion. After 7 d of continuous administration, the shuttle box test and neurological deficit score were performed; TTC staining and Nissl staining were used to detect the area of cerebral ischemia and the pathological changes of rat in the cerebral cortex respectively. The changes of SOD, MDA, Ach, 5-HT in the brain and VEGF, ET, eNOS, IL-6 in the serum were detected by kit. Results: Compared with the model group, the Compound Danshen Tablets group increased the number of conditional stimulation avoidance in VD rats, reduced the neurological function score and cerebral ischemia area, and reduced the MDA in rat brain tissue and ET, eNOS, IL-6 in rat serum, and increased Ach, 5-HT, SOD in the brain and VEGF in the serum. S. miltiorrhiza extract had better performance in reducing MDA in rat brain tissue and ET, eNOS, IL-6 in rat serum, SOD in the brain than in P. notoginseng; P. notoginseng was more advantageous in improving the content of Ach and 5-HT in rat brain tissue. The high-dose group of Compound Danshen Tablets had significant differences in SOD, MDA, ACH, 5-HT, and VEGF compared with Danshen group or Senqi group (P < 0.05, P < 0.01). Conclusion: Compound Danshen Tablets can improve the cognitive learning and memory ability of VD rats. The mechanism maybe enhance the secretion of Ach by the central cholinergic nervous system, improve the content of the monoamine neurotransmitters 5-HT in the hippocampus and hypothalamus, reduce the lipid peroxidation damage of the brain tissue, inhibit the inflammatory injury reaction and promote angiogenesis. In the compound, S. miltiorrhiza extract as the role of “Jun medicine”, plays a major role, while P. notoginseng assists “Jun medicine” in treating VD.
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Objective: Establishing the model of cell bioelectrical sensing effect of Compound Danshen Tablets to study its dissolution kinetics. Methods: By means of real-time cell-based assay, the in vitro dissolution of Compound Danshen Tablets can be investigated, and then the dissolution kinetics model can also be established. In addition, the result was compared and verified by UV-Vis. Results: The cell line with specific dependence on Compound Danshen Tablets was screened by CCK-8 experiment and RTCA experiment. The dissolution kinetics model of Compound Danshen Tablets based on RTCA technology was established, and the best fitting model was obtained: Weibull model ln{ln[1/(1-Q)] =1.071 4 lnt-3.736 7; Establish a dissolution kinetic model of Compound Danshen Tablets based on UV spectrophotometry to obtain the best fitting model, Weibull model ln{ln[1/(1-Q)]}=1.080 4 lnt-3.723 4; Comparing the two Weibull models, the RTCA fitted model worked better. Conclusion: The application of RTCA in the dissolution kinetics of traditional Chinese medicine compound solid preparations is feasible, Which provides new ideas for traditional Chinese medicines and the quality evaluation of traditional Chinese medicine compunds.
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OBJECTIVE:To systematically review the efficacy of Compound danshen dripping pill or Compound danshen tablets for chronic hepatitis B complicated with hepatic fibrosis,and to provide evidence-based reference for clinical treatment.METHODS:Retrieved from PubMed,Cochrane Library,EMBase,Medline,Wanfang database,VIP,CJFD and CBM database,randomized controlled trials (RCTs) about Compound danshen dripping pills or tablets combined with entecavir(trial group) vs.entecavir alone (control group) for chronic hepatitis B complicated with hepatic fibrosis were collected.Meta-analysis was performed by using Rev Man 5.3 statistical software after data extraction and quality evaluation according to Cochrane systematic evaluation manual 5.1.0.RESULTS:A total of 9 RCTs were enrolled,including 714 patients.The results of Meta-analysis showed that ALT [SMD=-0.44,95％CI(-0.86,-0.01),P=0.04],HA [SMD=-1.53,95％CI(-2.28,-0.79),P＜0.001],LN [SMD=-0.93,95％CI(-1.41,-0.46),P＜0.001],CⅣ [SMD=-1.38,95％CI(-2.13,-0.63),P＜0.001] and PCⅢ [SMD=-1.42,95％ CI (-1.60,-1.23),P＜0.001] of trial group were significantly lower than those of control group;HBV-DNA negative rate [OR=3.73,95 ％ CI (2.14,6.49),P ＜ 0.001] was significantly higher than control group,with statistical significance.CONCLUSIONS:Compound danshen dripping pills or tablets can not only improve liver function and liver fibrosis in chronic hepatitis B patients with hepatic fibrosis,but also improve the antiviral effect.
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OBJECTIVE:To systematically review the efficacy of Compound danshen dripping pill or Compound danshen tablets for chronic hepatitis B complicated with hepatic fibrosis,and to provide evidence-based reference for clinical treatment.METHODS:Retrieved from PubMed,Cochrane Library,EMBase,Medline,Wanfang database,VIP,CJFD and CBM database,randomized controlled trials (RCTs) about Compound danshen dripping pills or tablets combined with entecavir(trial group) vs.entecavir alone (control group) for chronic hepatitis B complicated with hepatic fibrosis were collected.Meta-analysis was performed by using Rev Man 5.3 statistical software after data extraction and quality evaluation according to Cochrane systematic evaluation manual 5.1.0.RESULTS:A total of 9 RCTs were enrolled,including 714 patients.The results of Meta-analysis showed that ALT [SMD=-0.44,95％CI(-0.86,-0.01),P=0.04],HA [SMD=-1.53,95％CI(-2.28,-0.79),P＜0.001],LN [SMD=-0.93,95％CI(-1.41,-0.46),P＜0.001],CⅣ [SMD=-1.38,95％CI(-2.13,-0.63),P＜0.001] and PCⅢ [SMD=-1.42,95％ CI (-1.60,-1.23),P＜0.001] of trial group were significantly lower than those of control group;HBV-DNA negative rate [OR=3.73,95 ％ CI (2.14,6.49),P ＜ 0.001] was significantly higher than control group,with statistical significance.CONCLUSIONS:Compound danshen dripping pills or tablets can not only improve liver function and liver fibrosis in chronic hepatitis B patients with hepatic fibrosis,but also improve the antiviral effect.
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Objective To assess whether treatment with compound danshen tablets plus alendronate would be safe and effective in women with postmenopausal osteoporosis. Methods 180 women with postmenopausal osteoporosis were randomized to receive combination therapy and independent therapy with compound danshen tablets and alendronate for 6 months. Scores of VRS were assessed,mean serum alkaline phosphatase, serum osteocalcin, urinary creatinine, urinary hydroxyproline, urinary calcium were detected. Bone mineral density of lumbar vertebra 1 ~5 was determined by dual X - ray absorptiometry. Results Mean serum alkaline phosphatase, serum osteocalcin, and urinary creatinine, urinary hydroxyproline, urinary calcium were statistically different between the combination therapy group and the independent therapy group, and bone mineral densities increased in all therapy groups while there was higher elevated level in the combination therapy group. Conclusions The combination therapy of compound danshen tablets with alendronate has a favorable influence on women with postmenopausal osteoporosis.
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OBJECTIVE: To establish HPLC fingerprint of Compound danshen tablets.METHODS: The separation was performed on Agilent Eclipse XDB-C18(150 mm?4.6 mm,5?m) column with mobile phase consisted of acetonitrile-0.04% phosphate (gradient elution) at flow rate of 1.0 mL?min-1.Detection wavelength was set at 272 nm and column temperature was 30℃.RESULTS: Established HPLC fingerprint was distinct and reproducible.There were 8 characteristic peaks among which No.5 characteristic peaks,No.6,No.7,No.8 came from HPLC fingerprint of Salvia miltiorrhiza and No.1 characteristic peaks,No.2,No.3,No.4 came from HPLC fingerprint of Panax notoginseng.CONCLUSION: The characteristic peaks of effective parts of Compound danshen tablet mainly come from S.miltiorrhiza.The study can be used for tracing and isolation of effective part of Compound danshen tablet and establishes basis for the further development of Chinese patent drugs.
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OBJECTIVE:To compare the inhibition effect of Compound danshen tablets on platelet activation and that of Danshen tablets in patients with coronary atherosclerosis.METHODS:90 patients with coronary atherosclerosis were randomized into compound danshen tablet group,danshen tablet group and control group with treatment course of 2 months.30 cases were included into normal group.Radioimmunoassay and realtime RT-PCR were applied to detect mRNA expression of PTGIS,cAMP,TXA2 and PGI2 in plasma respectively and compared with control group.RESULTS:As compared with normal group,the mRNA expression of cAMP,PGI2,PTGIS were decreased markedly while expression of TXA2 was increased remarkably.In compound danshen tablets group and danshen tablets group the mRNA expression of cAMP,PGI2 and PTGIS were increased while the expression of TXA2 was decreased.The increase and decrease of mRNA expression in compound danshen tablets group was higher than that in danshen tablet group.CONCLUSION:Both of Compound danshen tablets and Danshen tablets could inhibit platelet activation and prevent acute coronary syndrome.The effect of Compound danshen tablets on inhibiting platelet activation is better than that of Danshen tablets.
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OBJECTIVE:To determine and to compare the content of salvianolic acid B and tanshinoneⅡ A in compound danshen tablets and its drop pills.METHODS:The determination was performed on Eclipse XDB-C 18 with column temperature at30℃,the mobile phases were methanol-0.2%phosphoric acid solution(40∶60)and methanol-water(85∶15),respective_ ly with the flow rate at1.0ml/min and the detective wavelength at280nm.RESULTS:Good linear relations were obtained when the sample size of salvianolic acid B and tanshinoneⅡ A were within the range of0.1?g～2.0?g(r=0.9998for salvianol_ ic acid B and r=0.9999for tanshinoneⅡ A );The average recoveries of salvianolic acid B and tanshinoneⅡ A of compound danshen tablets were100.7%(RSD=1.9%)and101.0%(RSD=1.5%),respectively;And those for the compound danshen drop pills were98.6%(RSD=1.2%)and98.8%(RSD=1.4%),respectively.CONCLUSION:The method was accurate,re?liable and reproducible.The contents of salvianolic acid B and tanshinoneⅡ A in compound tanshen tablets are higher,while no fixed quantity were detected in the above2components in compound danshen drop pills.
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AIM: To test the contents of tanshinone Ⅱ_A and salvianolic acid B in 56 batches of samples by HPLC,evaluate the current quality of Compound Danshen Tables. METHODS: HPLC,chromatographic conditions: The detection column was Agela-C_(18)(5 ?m,46 mm?250 mm) for tanshinone Ⅱ_A,mobile phase was methanol-water(73(∶)27),UV detection wavelength was set at 270 nm.The flow rate was 1 mL/min.The detection column of Agela-C_(18)(5 ?m,4.6 mm?250mm) was used for salvianolic acid with mobile phase of acetonitrile-methanol-formic acid-water(10(∶)30(∶)1(∶)59). UV wavelength was set at 286 nm.The flow rate was 1 mL/min.(RESULTS:) The most of samples conform to the requirement of Chinese Pharmacopoeia(2005),but the content of tanshinone Ⅱ_A was widely different and three batches of salvianolic acid B were lower than the requirement of Chinese Pharmacopoeia(2005). CONCLUSION: The quality of Compound Danshen Tables will be improved.
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AIM: To establish the method for determing effective components of notoginsenoside in Compound Danshen Tablets(Radix et Rhizoma Salviae miltiorrhizae,Radix et Rhizoma Notoginseng,Borneolum Syntheticum) by RP-HPLC. METHODS: The contents of notoginsenoside R_1,ginsenoside Rg_1,ginsenoside Re and ginsenoside Rb_1 were simultaneously determined by an HPLC system with Kromasil C_(18)(5 ?m,250 mm?4.60 mm),the mobile phase was CH_3CN-0.05%H_3PO_4(CH_3CN 0-12 min:22%;12-20 min:22%-28%;20-60 min:28%-43%).The flow rate was 1 mL/min.The detection wavelength was set at 203 nm. RESULTS: The linear ranges of notoginsenoside R_1,ginsenoside Rg_1,ginsenoside Re and ginsenoside Rb_1 were 0.326-3.260 ?g(r=(0.999 7),) 0.890-8.900 ?g(r=0.999 8),0.144-1.440 ?g(r=0.999 6),0.940-9.400 ?g(r=0.999 8),respectively.Their average recoveries(n=6) were 99.08%,98.36%,97.54% and 96.07%,corresponding RSD were 4.41%,1.64%,2.77% and 1.12%,respectgively. CONCLUSION: The results indicate that the HPLC method is simple,accurate,highly selective and reproducible,thus it could be used as quality control in the preparation of Compound Danshen Tablets.
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This article reviews the study on Compound Danshen Tablets. Based on collecting and analyzing literatures, about the pharmacological actions, preparation procedure, quality control methods, dosage improvement, etc. of Compound Danshen Tablets, it is considered that Compound Danshen Tablets has been extensively studied mrecent years, but quality control methods should be improved further and basic research should attract attention.
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The dissolution rate of Compound Danshen Tablets made by different factories was determined with rotatory-basket method, The variance analysis showed obvious differential among the relative accumulation releasing amounts from samples of different factories (P