Study on synergistic effect of Qingkailing Injection and Shengmai Injection on organ injury in endotoxemia rats / 中国中药杂志

As a dangerous disease with rapid progression, endotoxemia is easy to induce the damage to multiple organs. However, its specific and efficient treatment methods are still lacking at present. Both Qingkailing Injection(QKLI) and Shengmai Injection(SMI) have been proved effective in anti-inflammation, anti-endotoxin and organ protection. In this study, carrageenan and endotoxin were injected successively into rats to establish an endotoxemia model. Different doses of QKLI and SMI were administered to the endotoxemia rats by intraperitoneal injection separately or in combination. Then the count of white blood cells, the number of platelets, the content of cytokines, biochemical indexes, organ coefficient and pathological changes of main organs in the rats were detected. The results showed that the rats in the model group had obvious symptoms of endotoxemia, i.e., leucopenia, thrombocytopenia, increase in cytokines(IL-6 and TNF-α) and biochemical indexes of liver and kidney function as well as pathological damage to liver, kidney and lung. QKLI alone can alleviate the above symptoms of endotoxemia and the organ injury. SMI alone is less effective in improving disseminated intravascular coagulation(DIC) and cytokine secretion complicated with endotoxemia, but capable of reducing the inflammation degree of the lung, liver and kidney. The combination of QKLI and SMI remarkably increased the number of platelets in the peripheral blood, improved the liver and kidney function and reduced inflammatory factors, with lung, liver, kidney and other organ structures protected well. Moreover, the improvement effect of the combination of QKLI and SMI was stronger than those of the two injections alone at fixed doses, indicative of a synergistic effect.

Research progress on material composition, pre-clinical pharmacokinetic, and pharmacodynamic studies of Shengmai Injection / 中草药

Shengmai Injection (SMI), is a traditional Chinese medicine (TCM) formula injection composed of Panax ginseng, Ophiopogon japonicas and Schisandra chinensis, which is widely used in clinic for the treatment of cardiovascular diseases as well as protecting against pulmonary disease and add-on therapy to cancer chemotherapy. In recent years, the pre-clinical basic research of SMI was widely performed. The studies, including chemical composition, in vivo process, and action mechanism and so on of SMI, helped to provide scientific foundation for revealing the material basis of formula. In this paper, the studies on material composition, pre-clinical pharmacokinetics and pharmacodynamics of this formula were summarized, so as to provide reference for the quality control, second development and rational clinical application of SMI.

Quality control and evaluation of Shengmai injection based on anti-oxidant and anti-inflammatory biological effects / 药学实践杂志

Objective To establish a quality evaluation method for Shengmai injection with antioxidant and anti-inflammatory effects as indicators. Methods Using water-soluble vitamin E (Trolox) and N-nitro-L-arginine methyl ester (L-NAME) as control drugs, using trinitrophenyl-hydrazine (DPPH) method and nitric oxide (NO) detection kit, the anti-oxidation effect and the inhibition ability of lipopolysaccharide (LPS)-induced NO release from mononuclear macrophage RAW264.7 were measured. The sample was converted into the corresponding concentration of the control drug to control and evaluate its methodological and biological effects. Results Each batch of samples had good anti-inflammatory and anti-oxidation effects with high precision and good repeatability. There was no significant difference in the anti-inflammation capacity among batches of. Samples 2 and 8 were significant differences from other samples in anti-inflammatory ability. Conclusion The established method can accurately evaluate the anti-oxidant and anti- inflammatory effects of Shengmai injection.

Chemical Substantial Basis of Shengmai Injection(Ⅰ): Qualitative Analysis of Chemical Components / 中国药学杂志

OBJECTIVE： To conduct a comprehensive and systematic qualitative investigation on chemical components in Shengmai injection. METHODS： Gas chromatography-mass spectroscopy (GC-MS) with pre-column derivatization, rapid resolution liquid chromatography-ion trap-tandem mass spectroscopy (RRLC-IT-MSn) and ion exchange chromatography (IEC) with post-column derivatization were applied in identification of saccharides, saponins, lignins and amino acids in the sample. Furthermore, preliminary investigation on test of macromolecules was performed using size exclusion chromatography-evaporative light scattering detection (SEC-ELSD). RESULTS： Fructose, glucose, sucrose, maltose, 5-hydroxymethyl-2-furaldehyde, 19 saponins, 14 lignins and 16 amino acids were found in Shengmai injection. CONCLUSION： The proposed methods are simple and accurate. The main chemical substantial basis of Shengmai injection is clarified, laying a foundation for further assay of chemical components.

Anti-fibrotic Effects and Mechanism of Shengmai Injection () on Human Hepatic Stellate Cells LX-2 / 中国结合医学杂志

OBJECTIVE@#To investigate the effects of Shengmai Injection (, SMI) on the proliferation, apoptosis and N-myc downstream-regulated gene 2 (NDRG2, a tumour suppressor gene) expression in varying densities of human hepatic stellate cells LX-2.@*METHODS@#LX-2 cells were cultured in vitro. Then, cells were plated in 96-well plates at an approximate density of 2.5×10 cells/mL and cultured for 48, 72, 96 or 120 h followed by the application of different concentrations of SMI (0.6, 1.2, 2.4, 4.8 or 6 μL/mL). Cell proliferation was measured after an additional 24 or 48 h using the 3(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay. The effects of SMI on different cell growth states (cultured for 48, 72, 96, or 120 h) were observed by light microscopy at 24 h after treatment. When the cells reached 80% conflfluence, apoptosis was detected by flflow cytometry after 24 h. Lastly, LX-2 cells were treated with different concentrations of SMI and extracted with protein lysis buffer. The levels of NDRG2 were measured by Western blot.@*RESULTS@#When the LX-2 cells grew for 48, 72, 96 and 120 h, 4.8 and 6 μL/mL of SMI significantly inhibited cell proliferation at 24 and 48 h after treatment (P<0.05). And 2.4 μL/mL of SMI also inhibited cell proliferation at 24 h after treatment when cell growth for 48 h (P<0.05) and at 48 h after treatment when cell growth for 72, 96 and 120 h (P<0.05). The NDRG2 expression level in the LX-2 cell was significantly increased when treated with SMI at concentrations of 1.2, 2.4, 4.8 or 6 μL/mL (P<0.05).@*CONCLUSION@#The inhibitory effects of SMI on the proliferation of LX-2 cells were related to not only concentration dependent but also cell density. In addition, SMI (2.4, 4.8 and 6 μL/mL) could accelerate apoptosis in LX-2 cells, and the mechanism might be associated with NDRG2 over-expression.

Shengmai Injection combined with conventional treatment for acute myocardial infarction: A systematic review and Meta-analysis / 中草药

This Meta-analysis systematically assessed the efficacy and safety of Shengmai Injection (SMI) combined with conventional treatment for acute myocardial infarction (AMI). Seven online databases were investigated, then randomized clinical trials (RCTs) of treatment effects of AMI patients, for which SMI was used in combination with conventional therapy compared with conventional therapy alone, were included. The literatures selection, data extraction, and quality assessment were in accordance with the Cochrane standards. Data analysis was carried out using RevMan software (V.5.3). RCTs (enrolling 1 258 patients) from 18 literatures published in Chinese journals were included in the systermatic review. The additional SMI could significantly reduce the risk of mortality, arrhythmia, cardiogenic shock, heart failure and improve left ventricular ejection fraction (LVEF), stroke volume (SV), vascular patency rate. The adverse effects of mild bleeding, palpitation, shortness of breath, fatigue could occur both in the control group and the treatment group. Thus, it was difficult to evaluate the safety of SMI due to the limited data and low-guality RCTs. Therefore, high-quality and adequate sample of RCTs with low risk of bias are required to demonstrate its true effects.

Establishment of physical fingerprint of Shengmai Injection and its quality evaluation / 中草药

Objective To establish the physical fingerprint of Shengmai Injection and evaluate its quality. Methods The physical fingerprint was visually showed by the radar map consisting of eight indexes (conductivity, pH, turbidity, refractive index, solid content, relative density, kinematic viscosity, and osmolality). Correlation coefficient method was used to calculate the similarity between the fingerprints and the control fingerprints. Results The products physical fingerprints and parameters of the same species from different manufacturers were quite different. In some companies, the quality of the same product was also unstable among different batches and specifications, mainly reflected in the three indicators of osmolality, conductivity, and turbidity. Conclusion Physical fingerprints can be used to evaluate the quality of Shengmai Injection and provide some ideas for the quality re-evaluation of Chinese medicine injection.

Control and Study on the Visible Particles in Shengmai Injection / 中国药师

Objective:To understand the basic situation of visible particles in Shengmai injection,and study the visible particles control and inspection for Shengmai injection. Methods: The samples of Shengmai injection were collected and the visible particles were checked by light inspection and light scattering,and the results were summarized and analyzed. The exogenous factors and endog-enous factors affecting the visible particles in Shengmai injection were investigated. Results:The positive inspection rate of visible par-ticles in Shengmai injection in market was low. Light,temperature and pH value had mild influence on the visible particles in Sheng-mai injection. Conclusion:The control measurement for the visible particles in Shengmai injection in every enterprise is effective,and the quality control is promising.

Proarrhythmic effect and underlying mechanism of combined use of azithromycin and Shengmai injection in guinea pigs / 中国药理学与毒理学杂志

OBJECTIVE To explore potential proarrhythmic effect and underlying mechanism of azithromycin (AZM) and Shengmai injection (SM) used clinically.METHODS ① In vivo guinea pig ECG recordings were made to analyze effects of jugular intravenous(iv) injection of AZM [38.2 mg· kg-1,one time (clinically relevant dose,CRD)],or SM (4.6 mL· kg-1,one time CRD) or their combination.②In vitro ECG recordings were made to analyze effects of AZM,SM or AZM + SM on ECG in isolated hearts of guinea pigs.AZM [one,five and ten times (clinically relevant concentrations,CRC)] was perfused in this order:41.5 →207.5 → 415 mg· L-1 and SM (one,five and ten times CRC) in this order:5 →25 →50 mL· L-1.Also,AZM (41.5 mg· L-1,one time CRC) +SM (5 mL· L-1,one time CRC) was perfused to isolated hearts of guinea pigs.③ Enzymatically isolated cardiomyocytes from guinea pig left ventricles were perfused in this order:AZM 41.5 mg· L-1 →AZM 41.5 mg· L-1+SM 5 mL· L-1 for action potential,L-type Ca2+ and Na+ current recordings,respectively.RESULTS ① Neither AZM 38.2 mg· kg-1,nor SM 4.6 mL· kg-1 significantly changed the in vivo ECG.However,AZM 38.2 mg· kg-1 +SM 4.6 mL · kg-1 significantly reduced heart rate (P＜0.05) and prolonged the P-R (P＜0.05) and QRS (P＜0.05) intervals.②AZM 41.5,207.5 and 415 mg· L-1 reduced heart rate (P＜0.05) and prolonged the P-R (P＜0.05) and QRS (P＜0.05) intervals in a concentration-dependent manner.AZM 415 mg·L-1 also prolonged QTc (P＜0.05) interval.SM 5,25 and 50 mL· L-1 reduced heart rate (P＜0.05) and prolonged the P-R interval (P＜0.05) in a concentration-dependent manner.SM had no effect on QRS or QTc intervals.Washout partially recovered the above changes.Moreover,AZM 41.5 mg· L-1 + SM 5 mg·L-1 significantly reduced heart rate (P＜0.05) and prolonged the P-R (P＜0.05) and QRS intervals.③ AZM 41.5 mg·L-1 did not significantly change the action potential amplitude (APA),action potential durations at 50％ (APD50) and 90％ (APD90) repolarization levels,or L-type Ca2+ and Na+ currents.However,AZM+SM 5 mg· L-1 significantly reduced APA (P＜0.05),shortened APD50 (P＜0.05) and APD90 (P＜0.05) and inhibited the L-type Ca2+ (P＜0.05) and Na+ (P＜0.05) currents.CONCLUSION AZM and SM has potential prorrhythmic risks.The combined use might cause higher risk of arrhythmia.The underlying mechanism for proarrhythmia is mediated by inhibition of the L-type Ca2+ and Na+ currents.

Effects of Shengmai Injection on Physiological Indices, C-reactive Protein and NO Levels in Experimental Beagle Dogs with Myocardial Ischemia / 世界科学技术-中医药现代化

This study was aimed to explore the effects of Shengmai(SM) injection on blood pressure (BP),heart rate (HR),electrocardiogram (ECG),and serum C-reactive protein (CRP) and NO levelin Beagle dogs with myocardial ischemia (MI).A total of 30 Beagle dogs were divided into 5 groups,which were the blank control group,model control group,SM injection low-dose group (0.80 mL· kg-1),SM injection high-dose group (3.20 mL· kg-1) and isosorbidemononitrate group (0.07 mL· kg-1).The MI model was established by the subcutaneous injection of isoprenaline hydrochloride,and the drug treatments were given at the same time.At 1 h,6 h,12 h,24 h after administration,changes of BP,HR and ECG were recorded;serum CRP and NO content were detected.The results showed that compared with the blank control group,the mean arterial pressure (MBP) was significantly decreased (P＜0.01),HR was significantly increased (P＜0.01,or P＜0.05),the ECG△ST value was significantly increased (P＜0.01) in the model group.SM injection could improve symptoms mentioned above,but the effectswereslow.SM injection had a significant antagonistic effect on the decreasing of CRP content and the increasing of NO content,compared with the model group.The difference was statistically significant (P＜0.01,or P＜0.05).It was concluded that SM injection could improve the physiological indices of Beagle dogs with MI,which might be related to the regulation of CRP and the inhibition of NO secretion.

Study on PK-PD Evaluation of Ginsenoside Rb1 in Subjects with Angina Pectoris Following Intravenous Administration of Shengmai Injection / 世界科学技术-中医药现代化

This study was aimed to establish the pharmacokinetics-pharmacodynamics (PK-PD) model of ginsenoside Rb1 following the intravenous administration of Shengmai injection in subjects with stable angina pectoris.A total of stable angina pectoris were selected and received Shengmai injection for 14 days.Plasma samples were collected at different time points.Plasma concentrations of ginsenoside Rb1 were determined by liquid chromatography-mass spectrometry (LC/MS).The concentration-time curves (AUC) were drawn,and then the PK parameters were calculated.The systolic pressure and diastolic pressure were monitored,and the combined PK-PD model was established based on the theory of effect compartment.The results showed that PK of ginsenoside Rb1 conformed to a mono-compartment model.The effect of Shengmai injection lagged behind the concentrations of ginsenoside Rb1 in plasma.The effect exhibited good correlation with ginsenoside Rb1 in effect compartment.The relationship between effect and plasma concentrations fits the Inhibitory Effect Imax model.It was concluded that the study successfully established the combined PK-PD model of ginsenoside Rb1 in subjects with angina pectoris.The model can efficiently evaluate the effective substance of Shengmai injection.

Effect of psychological intervention on quality of life of chemotherapy patients with advanced non-small cell lung cancer / 中国生化药物杂志

Objective To explore the effect of psychological intervention on the quality of life in patients with advanced non-small cell lung cancer chemotherapy. Methods A total of 60 patients with advanced non-small cell carcinoma chemotherapy in our hospital from January 2015 to January 2017 were enrolled and divided into two groups according to different intervention methods. The control group was treated with Shengmai injection alone. The observation group was treated with psychological intervention + compound Kushen injection.The changes of scores of depression (SDS), anxiety (SAS) and pain (VAS), quality of life (QLQ-CCC) score and adverse reactions were recorded and analyzed before and after intervention in two groups. Results The clinical intervention effect of the observation group was better than that of the control group, the stability of the tumor focus, the degree of pain, the quality of life and other aspects were better than the control group, the difference between the two groups was statistically significant (P<0.05). Conclusion Patients with advanced non-smal cel lung cancer chemotherapy choose psychological intervention +compound sophora injection combined treatment effect is remarkable, which can effectively improve the patient's clinical symptoms and quality of life, is worth widely used clinically.

Simultaneous quantitation of eight ginsenosides in Notoginseng Radix et Rhizoma, Ginseng Radix et Rhizoma, and their related products by online multi heart-cutting two dimensional liquid chromatography / 中草药

Objective: To establish a rapid method for the simultaneous quantification of eight ginsenosides in Notoginseng Radix et Rhizoma (NRR), Ginseng Radix et Rhizoma (GRR), and their related products by multi hearting-cutting two dimensional liquid chromatography based a "monomethod-heterotrait matrix" (MHM) strategy. Methods: Corresponding sample preparations were applied to samples, which were different in either product forms or preparation processes. Pressured liquid extraction (PLE) was developed for the raw herbs and related solid-state Chinese patent medicine using two-steps solvent extraction with chloroform and water-saturated n-butanol. One and two dimensional separation conditions including columns selection and gradient elution were optimized systematically. Phenyl-X and C18 were confirmed as 1D and 2D columns, respectively. Eight targeting ingredients were cut alternately into six loops by starting-to-ending time of peaks in 1D column. 2D rapid separation for eight cycles was achieved on core-shell column with 2.6 μm particle to complete eight compounds quantitation. Results: The eight targeting analytes were well separated and quantified in 50 min in different sample matrix (raw herbs, extract, and Chinese patent medicine). Method validation was performed in terms of linearity (r ≥ 0.999), precision (0.52%-1.53%), and recovery (ranged from 94.57% to 103.47%), and the LODs (S/N=3:1) of the eight analytes varied from 0.041 to 0.18 μg/mL respectively. Conclusion: Eight ginsenosides could be quantified accurately for different sample matrix. Combined with its relative proportions of eight ginsenosides, quality evaluation for NRR, GRR, and their related products could be performed scientifically.

Effects of Shengmai injection on platelet parameters and CD4+CD25+T cells in patients with chronic lymphocytic leukemia / 中国生化药物杂志

Objective To study the effect of Shengmai injection on the platelet parameters and CD4+CD25+cells in peripheral blood of patients with chronic lymphocytic leukemia,and to explore the optimal regimen for patients with chronic lymphocytic leukemia.Methods One hundred and twenty patients with chronic lymphocytic leukemia were enrolled in this study from January 2012 to December 2014.(D1),vincristine 4mg(d1),prednisone 60 mg/d(d1-5)were given to the CHOP regimen in the control group: cyclophosphamide 600 mg/m2(d1),doxorubicin 25 mg/m2(d12)28d a course of treatment,a total of 4 courses,the observation group of patients in the control group of patients treated on the basis of Shengmai injection,compared the two groups of patients with chemotherapy,platelet parameters and serum CD4+CD25+T cells and Th17 cells.Results After treatment,the PLT,MPV and PDW of the observation group were(215.4± 31.7),(9.5±2.5)and(16.9±2.4),respectively,which were significantly higher than those of the control group.The CD4+CD25+T cells in the observation group were(1.5±0.8)The total effective rate of the control group was 35.0％,the total effective rate was 35.0％,and the total effective rate of the control group was 35.0％.There were significant difference between the control group and the control group(P<0.05),The difference was statistically significant.Conclusion Shengmai injection combined with CHOP regimen in chronic lymphocytic leukemia patients can improve immune function,promote platelet growth,improve platelet clinical parameters,and help improve the efficiency of chemotherapy,compared with CHOP alone Program treatment is better,worthy of clinical application.

Pharmacokinetics of Shengmai Injection and Shenmai Injection in Angina Pectoris Patients / 世界科学技术-中医药现代化

This study was aimed to compare the pharmacokinetics (PK) of Shengmai injection and Shenmai injection with a single injection administration using a constant speed in subjects with stable angina pectoris.A total of 20 subjects with stable angina pectoris were divided into two groups.Each group was administered with Shengmai and Shenmai injection.The liquid chromatography-mass spectrometry (LC/MS) was adopted to determine concentrations of ginsenosides in plasma at different time points.PK parameters were calculated for comparison.The results showed that after a single intravenous infusion of Shengmai and Shenmai injection,the Cm.of ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1 and ginsenoside Rc in Shenmai group were higher than those of the Shengmai group with statistical significance (P ≤0.05).There were differences on the T1/2 of ginsenoside Rg1,AUC0-144h and CL of ginsenoside Rc,as well as Tmax of ginsenoside Rd (P ≤ 0.05).However,there was no significant difference shown on other PK parameters.It was concluded that after a single Shengmai or Shenmai injection,there were PK differences of ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1 and ginsenoside Rc in the human body.The clinical medication selection should be based on syndrome differentiation and treatment of patients.

Effects of Shengmai Injection on Myocardial Function of Patients with General Anesthesia of Hysterectomy / 中国药房

OBJECTIVE:To investigate the effect and safety of Shengmai injection on myocardial function of patients with gen-eral anesthesia of hysterectomy. METHODS:40 patients underwent hysterectomy were randomly divided into observation group and control group with 20 cases in each group. Both groups received general anesthesia induction of fentanyl citrate and rocuroni-um,and inhalation anesthesia of propofol. Observation group was given Shengmai injection 1 ml/kg,ivgtt;control group was given same dose of 0.9%Sodium chloride injection,ivgtt,before anesthesia. Mean arterial pressure(MAP),heart rate(HR),central ve-nous pressure(CVP),blood oxygen saturation(SpO2),the levels of MDA,SOD and NOS were compared between 2 groups be-fore operation(T0),before anesthesia induction(T1),reaction during(T2),after operation(T3). The occurrence of ADR was also observed. RESULTS:There was no statistical significance in MAP and HR between 2 groups at T0 and T1 (P>0.05). MAP and HR of observation group was significantly higher than those of control group at T2 and T3,with statistical significance(P0.05). There was no statistical significance in MDA,SOD and NOS levels between 2 groups at T0(P>0.05). MDA and NOS levels of 2 groups increased signifi-cantly at T1,T2 and T3,while SOD level decreased significantly;MDA and NOS level of observation group were lower than the control group while SOD level was higher than control group at T1,T2,with statistical significance (P<0.05). No obvious ADR was found in 2 groups. CONCLUSIONS:Shengmai injection can maintain stable HR and MAP,and reduce the oxide in patients underwent hysterectomy surgery so as to protect myocardial function with good safety.

Effect of Shengmai injection combined with norepinephrine on apoptosis of lym-phocyte and apoptosis protein in MODS rats / 中国免疫学杂志

Objective:To study the effect of the Shengmai injection combined with norepinephrine on cellular immunity in rats with multiple organ dysfunction syndrome .Methods:40 healthy male rats were randomly divided into the control group ,the Shengmai injection group ,the norepinephrine group and the Shengmai injection combined with norepinephrine group of 10 rats in each group after MODS rat model were established by intraperitoneal injection of zymosan .The plasma level of TNF-α, IL-1β, IL-12 and IL-2 were detected by ELISA ,and the protein expression of caspase-3,caspase-9 and caspase-8 in spleen were tested by IHC during 6 h,24 h,48 h.And the lymphocyte number of apoptosis and the ratio of Th 1/Th2 were tested by flow cytometry.Results: ① Compared with the control group, the plasma concentrations of TNF and IL-1βwere not significant increased in the Shengmai injection group , the norepinephrine group and the Shengmai injection combined with norepinephrine group ,as the extension of treatment time ,the plasma concentration of TNF and IL-1βwere significant lower in treatment groups than control group .While the plasma concentration of IL-12 and IL-2 were significantly increased in treatment groups , and the combined treatment group was more obvious .② Compared with control group,the protein expression of caspase-3,caspase-9 and caspase-8 in spleen were decreased in the Shengmai injection group , the norepinephrine group and the Shengmai injection combined with norepinephrine group ,and the combined treatment group was more obvious.③The lymphocyte number of positive apoptosis were significantly decreased , and the Th1/Th2 ratio were increased in the Shengmai injection group ,the norepinephrine group and the Shengmai injection combined with norepinephrine group ,and the combined treatment group was more obvious .Conclusion: The Shengmai injection combined with norepinephrine can reduce the inflammatory reaction and improve the immune function in the rat with multiple organ dysfunction .

Prognosis Effect of Shengmai Injection to the rt-PA Thrombolysis on Broadened Therapeutic Window Pa-tients of Mild-to-moderate Cerebral Infarction / 中国药房

OBJECTIVE:To explore the prognosis effect of Shengmai injection to the rt-PA thrombolysis on broadened thera-peutic window patients of mild-to-moderate cerebral infarction under the guidance of computer tomography(CT). METHODS:168 patients with mild-to-moderate cerebral infarction were randomly divided into control group (84 cases) and observation group (84 cases). Control group received rt-PA(0.9 mg/kg),and 10% of the total rt-PA was mixed and injected into patients within 1 min, the rest 90% adding into 250 ml 0.9% Sodium chloride injection (no less than 1 h),CT was performed after 24 h thrombolytic therapy,and the patients with no intracerebral hemorrhage in re-examination received 300 mg/d aspirin for 10 d,then 100 mg/d for 90 d,and appropriate statins,calcium antagonists,β-blockers and nitrates;observation group additionally received 40 ml Sheng-mai injection,adding into 250 ml 5% Glucose injection,intravenous infusion,once a day,for 28 d. National Institutes of Health Stroke Scale (NIHSS) score,Rankin score,daily living-Barthel Index (Barthel) score,rate of symptomatic intracranial hemor-rhage,rate of secondary hemorrhage,hospitalization time,3-month postoperative mortality and incidence of adverse reactions in 2 groups were observed. RESULTS:Before treatment,there were no significant differences in the NIHSS score,Rankin score and Barthel score(P>0.05). The NIHSS score in 2 groups after 6 h,24 h and 7 d were significantly lower than before,and observa-tion group was lower than control group after 24 h and 7 d;Rankin score after 3 months was significantly lower than before,and observation group was lower than control group;Barthel score after 3 months was significantly higher than before,and observation group was higher than control group,The differences were statistically significant (P<0.05). The hospitalization time in observa-tion group was significantly shorter than in control group,and 3-month postoperative mortality was significantly lower than control group,the differences were statistically significant(P<0.05). There were no obvious adverse reactions during treatment. CONCLU-SIONS:Based on conventional treatment,Shengmai injection has improvement in the rt-PA intravenous thrombolysis on broadened therapeutic window patients of mild-to-moderate cerebral infarction under the guidance of CT,it can reduce NIHSS score and Rankin score,increase Barthel score,shorten hospitalization time and reduce the 3-month postoperative mortality,with good safety.

Analysis of lignans in Shengmai injection by HPLC-MS/MS / 中国药学杂志

OBJECTIVE: To establish a determination method of lignans in Shengmai injection. METHODS: On the basis of the study on the chemical constituents of Schisandrae Chinensis Fructus extracts, the peaks in the chromatograms of Shengmai injections from eight production enterprises were identified by HPLC-MS/MS. Agilent 6320 Ion Trap LC/MS, the separation was carried out by using an Waters symmetry shield TM RP18 column (4.6 cm × 25 cm, 5 μm), with a gradient mobile phase of acetonitrile-ammonium acetate water solution, detector wavelength was 203 nm; MS parameters; nebulizer: 2 kPa; dry gas: 12 mL · min-1; dry temperature 350°C; collision pressure: 1.0 V; positive ion scan. RESULTS: By comparing the Schisandrae Chinensis Fructus extracts and the Shengmai injection, it indicated that the lignans is the primary component in Schisandrae Chinensis Fructus extracts, and the mutual ingredients of the 8 enterprises is schizandrol A, gomisin D, gomisin J and angeloylgomisin Q. CONCLUSION: The established HPLC-MS/MS method can be used as the basis for further study and quality control of lignans in Shengmai injection.

Chemo-sensitivity enhancing effects of Shengmai Injection on various chemotherapeutic drugs / 中草药

Objective: To investigate the chemo-sensitivity enhancing effect and its major active mechanism of Shengmai Injection (SMI). Methods: MTT assay was used to determine the chemo-sensitivity enhancing activity of SMI combined with various current- used chemotherapeutic drugs. Flow cytometry was conducted to determine the effect of Epirubicin combined with SMI on the cell cycle distribution and apoptotic cell death, and the mRNA expression level of MDR-1 gene was determined by RT-PCR. Results: SMI (30 μL/mL) combined with gemcitabine, cisplatin, paclitaxel, and Epirubicin exihibited the potent antiproliferative effects on human lung carcinoma A549, gastric carcinoma SGC-7901, breast carcinoma MCF-7, and hepatocellular carcinoma HepG-2 cell lines, respectively. SMI showed the most significant enhancing effects on HepG-2 cells in combination with Epirubicin, and the sensitivity of HepG-2 to Epirubicin was increased by 16 fold. Whereas SMI (30 μL/mL) alone did not affect the cell cycle distribution and apoptosis of HepG-2 cells, it enhanced the cellular responses when combined with Epirubincin together with a down-regulated mRNA level of MDR-1 gene. Conclusion: SMI combined with the different chemotherapeutic drugs could enhance the sensitivity of cancer cells significantly via down-regulating the mRNA expression level of MDR-1 and the expression of P-glucoprotein with the excretion of drugs.