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ObjectiveTo explore the pharmacodynamic ingredients of Zhenqi Fuzheng granules （ZFG） for immunomodulatory through spectrum-effect relationship analysis， which provides experimental basis for improving the quality standard of ZFG. MethodEighteen batches of ZFG from six manufacturers were collected for analysis. The fingerprints were established by high performance liquid chromatography （HPLC）. Acetonitrile （A）-0.1% formic acid aqueous solution （B） were adopted as the mobile phase with gradient elution （0-15 min， 5%A； 15-23 min， 5%-8%A； 23-30 min， 8%-11%A； 30-45 min， 11%-18%A； 45-60 min， 18%-21%A； 60-67 min， 21%-23%A； 67-90 min， 23%-37%A）， the detection wavelength was 220 nm. Chemometric analysis such as similarity analysis and hierarchical cluster analysis （HCA） were subsequently used to analyze the similarities and chemical differences among these samples. A cyclophosphamide-induced immunodeficiency mouse model was used to evaluate the immune-enhancing effects of the products from different manufacturers. The spectrum-effect relationship between HPLC fingerprints and the immunomodulatory effects was examined using Spearman bivariate correlation analysis. HPLC coupled with mass spectrometry （HPLC-MSn） was used to identify the spectrum-effect related peaks with electrospray ionization， positive and negative ion modes， and scanning range of m/z 100-1 500. ResultThe HPLC fingerprint of ZFG was established， and twenty peaks with good resolution were selected as common peaks. The results of quality analysis and pharmacodynamic test showed there were significant differences in both ingredients content and immune-enhancing effects of ZFG from different manufacturers. Through spectrum-effect relationship study， twelve peaks were screened as bioactive ingredients peaks. Thereafter， eight peaks among them were subsequently identified by HPLC-MSn. They were salidroside （peak 2）， echinacoside （peak 5）， calycosin-7-glucoside （peak 6）， isomer of specnuezhenide （peak 7）， isonuezhenide （peak 9）， calycosin （peak 11）， nuezhenide G13 or oleonuezhenide （peak 14）， and formononetin （peak 18）， respectively. ConclusionThere are differences in quality and efficacy of ZFG produced by different manufacturers. Through spectrum-effect relationship analysis， the medicinal ingredients of ZFG for immune-enhancing effects are screened， which can provide reference for the improvement of its quality standard.
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Objective: To estimate the overall quality characteristics of Zhenqi Fuzheng granules (ZQFZ),which were composed of Ligustri Lucidi Fructus and Astragali Radix and collected from different manufacturers (their final preparations included two types,contained sugar and sugar free) by established HPLC methods,in order to propose an appropriate quality-control strategy for promoting the quality control specification of ZQFZ.Method: The quantification of the 6 components (rhodioloside,calycosin-7-O-β-D-glucoside,specnuezhenide,ononin,calycosin and astragaloside IV) were performed on a C18 column with two chromatographic systems.Chromatographic system Ⅰ:methanol and water were adopted as mobile phase with gradient elution,the flow rate was 1.0 mL·min-1,and optimum detection waves were at 224,250 and 275 nm respectively.Chromatographic system Ⅱ:methanol and water (80:20) were adopted as mobile phase with gradient elution at the flow rate of 1.0 mL·min-1,and the detector parameters were set as follows:the drift tube temperature was 75℃,and the carrier gas flow rate was 1.5 L·min-1.Both column temperatures were at 30℃.All of the 80 batches of ZQFZ from different manufacturers were determined and analyzed.Result: All of the six markers could be detected in 80 batches of ZQFZ,but their contents were quite different.The results of the one-way ANOVA showed significant differences between manufacturer 4 and other three manufacturers in sugar-containing preparations (P PConclusion: It is of great significance to increase relevant quality control markers of Ligustri Lucidi Fructus in ZQFZ,such as rhodioloside and specnuezhenide,for standardizing production and improving quality level.
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Objective To observe the role of Zhenqi Fuzheng granules in the treatment of patients with severe pneumonia respiratory failure. Methods A retrospective research was conducted, 96 patients with severe pneumonia admitted to the Department of Critical Care Medicine of the First People Hospital of Baiyin were enrolled, and they were divided into a western medical conventional treatment group (47 cases) and a combined traditional Chinese and western medicine treatment group (49 cases) according to the different treatment methods. A variety of conventional rescue treatments were carried out in the western medicine routine treatment group (conventional group); while in the combined traditional Chinese and western medicine conventional treatment group (combined group), based on the western medical therapies in the conventional group, at the same time, additionally Zhenqi Fuzheng granules 5 g dissolved in 20 mL warm boiled water were given by nasal feeding to the patients, 2 times daily, 7-10 days constituting a therapeutic course, and after 3 courses, the clinical therapeutic effects were evaluated. The mortality and changes of pre- and post-treatment levels of immunoglobulin, procalcitonin (PCT), C-reactive protein (CRP), course of disease, times of using antibacterial drug and ventilator, and changes in lung exudation before and after treatment, and incidence of pulmonary fibrosis were observed in the two groups. Results The mortality of combined group was significantly lower than that of the conventional group [14.29% (7/49) vs. 36.17% (17/47), P < 0.05]. After treatment, the levels of immunoglobulins were significantly higher than those before treatment, while the levels of PCT and CRP were significantly lower than those before treatment in both groups, and the changes after treatment in the combined group were more obvious than those in conventional group [IgG (g/L): 12.48±2.36 vs. 10.35±3.01, IgA (g/L): 4.16±1.08 vs. 3.18±1.13, IgM (g/L): 5.01±1.15 vs. 3.62±1.02, PCT (mg/L): 1.48±1.36 vs. 2.35±1.01, CRP (mg/L): 8.48±2.36 vs. 10.35±2.01, all P <0.05]. Compared with those in conventional group, the patient's disease course, times of using antibacterial drug and ventilator were significantly shorter in combined group [the course of disease (days): 10.86±2.64 vs. 14.38±3.02, time of using antibacterial drug (days): 11.29±3.54 vs. 13.96±4.21, time of using ventilator (days): 8.26±2.64 vs. 10.25±3.08, all P <0.05]; Compared with those in the conventional group, the cases with significant reduction of pulmonary exudation and the cases with complete absorption of pulmonary exudation were markedly increased, while the cases of pulmonary fibrosis were obviously decreased in the combined group (cases of reduction of pulmonary exudation:15 cases vs. 10 cases, complete absorption of pulmonary exudation: 16 cases vs. 9 cases; cases of pulmonary fibrosis:8 cases vs. 10 cases, all P < 0.05). Conclusion Zhenqi Fuzheng granules can significantly reduce the mortality and inflammatory factor levels, raise immunoglobulin, shorten the course of disease and times of using antimicrobial drugs and ventilator, reduce pulmonary exudation and incidence of pulmonary fibrosis obviously in patients with severe pneumonia.
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OBJECTIVE:To establish HPLC fingerprint of Zhenqi fuzheng granules. METHODS:HPLC-ELSD method was ad-opted. The determination was performed on Agilent Zorbax Eclipse XDB-C18 column with mobile phase consisted of acetonitrile-wa-ter(gradient elution)at the flow rate of 1.0 mL/min with column temperature of 40 ℃. The detector evaporation temperature was 50℃,and sample size was 10μL. Using specnuezhenide as reference,HPLC chromatograms of 7 batches of Zhenqi fuzheng gran-ules were determined. The identification and similarity evaluation of common peaks were conducted by using the TCM Chromato-graphic Fingerprint Similarity Evaluation System(2004 A edition). RESULTS:There were 13 common peaks in HPLC chromato-grams of 7 batches of samples. After validated,the similarity of 3 batches of samples in HPLC chromatograms of 7 batches of sam-ples were higher than 0.9,which were in good agreement with control fingerprints. The similarity of 4 batches of samples were <0.9,which were poorly same to control fingerprint. CONCLUSIONS:Established fingerprint can provide reference for quality evalu-ation of Zhenqi fuzheng granules.
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OBJECTIVE:To observe therapeutic efficacy and safety of Zhenqi fuzheng granules in the adjunctive treatment of cervical cancer. METHODS:86 patients with cervical cancer were randomly divided into control group(43 cases)and observation group (43 cases). Control group was given intravenous dripping of Diphenhydramine hydrochloride injection 20 mg,Granisetron hydrochloride and glucose injection 5 mg,Cimetidine injection 20 mg at 0.5 h before chemotherapy. After 0.5 h of intravenous drip-ping,the patients received chemotherapy:Docetaxel injection 40 mg/m2,d1,d8,intravenous dripping;Cisplatin for injection 25 mg/m2,d1-3,intravenous dripping;21 d as a cycle,a total of 4-6 cycles. On the basis of control group,observation group was addi-tionally given Zhenqi fuzheng granules 5 g,twice 2 day. Clinical efficacies of 2 groups were observed as well as T cell subsets in-dexes [CD3+,CD4+,CD8+,natural killer cell(NK)],KPS scores,termination,terminal time,the times of chemotherapy and the oc-currence of toxic reaction before and after treatment. RESULTS:The total remission rate of observation group was significantly higher than that of control group;the proportion of termination of chemotherapy in observation group was significantly lower than control group;terminal time of chemotherapy was significantly shorter than control group;the times of chemotherapy was signifi-cantly more than control group;the incidence of gastrointestinal reaction,anemia,thrombocytopenia and leukopenia were signifi-cantly lower than control group,with statistical significance(P0.05). Before treatment,there was no statistical significance in T cell subsets indexes and KPS scores between 2 groups(P>0.05). After treatment,CD3+,CD4+ and NK cells in observation group were significantly higher than before treatment and control group,while CD8+ was significantly lower than before treatment and control group;KPS scores of 2 groups were significantly higher than before,and the observation group was significantly higher than the control group,with statistical significance(P0.05). CONCLUSIONS:On the basis of routine treatment,Zhenqi fuzheng granules can improve therapeutic efficacy,immune function and the quality of life,moreover,reduce toxic reaction in patients with cervical can-cer.