A Multicenter Clinical Trial of Pudilan Anti-inflammatory Oral Liquid of Different Doses in Treatment of Acute Pharyngitis/Tonsillitis Caused by Bacterial Infection in Adults / 中国实验方剂学杂志

ObjectiveThrough a randomized， double-blind， double-simulation， positive-control， multicenter design， this study aimed to analyze the relationship between the dosage， efficacy， and safety of Pudilan anti-inflammatory oral liquid in treating acute pharyngitis/tonsillitis in adults caused by bacterial infection and validate the regulatory effect of Pudilan anti-inflammatory oral liquid on inflammatory markers such as serum amyloid A （SAA）， C-reactive protein （CRP）， white blood cells （WBC）， neutrophil percentage （NE%）， and erythrocyte sedimentation rate （ESR）， thereby exploring the feasibility of using Pudilan anti-inflammatory oral liquid as a substitute for antibiotics in the treatment of infectious diseases and providing a basis for rational clinical medication. MethodUsing a stratified randomized， double-blind， double-simulation， positive-control， multicenter design， 220 participants were enrolled from nine centers. The participants were randomly divided into three groups at 1∶1∶1 — a Pudilan anti-inflammatory oral liquid 20 mL group （73 cases）， a Pudilan anti-inflammatory oral liquid 10 mL group （73 cases）， and a control group （amoxicillin group， 74 cases）. The treatment course was 7 days. The study observed parameters including the total effective rate of sore throat， onset and disappearance time of sore throat， health status score， treatment time， and inflammation markers. Result①Dataset division： The 211 cases were included in the full analysis dataset （FAS）， 208 cases were included in the per-protocol dataset （PPS）， and 218 cases were included in the safety dataset （SS）. ② Efficacy evaluation： There were statistically significant differences （P<0.05） in the comparison of the three groups regarding the total effective rate of sore throat， disappearance time of sore throat， and health status. Both the 20 mL and 10 mL groups were non-inferior to the control group， and there was a statistically significant difference between the 20 mL and 10 mL dosage groups （P<0.05）. There was no statistically significant difference in the comparison of onset time of sore throat among the groups. CRP， WBC， and NE% of patients in all three groups significantly decreased on the 7th day of treatment compared with those before treatment （P<0.01）. ③Safety evaluation： Adverse events mainly occurred in various examination indicators. There were no statistically significant differences in the comparison between groups， and no adverse reactions or serious adverse events occurred. ④Economic evaluation： The increased cost of the 10 mL and 20 mL dosage groups was entirely justified as compared with that in the control group. When comparing the 10 mL and 20 mL dosage groups， the 10 mL dosage group was deemed less advantageous. ConclusionPudilan anti-inflammatory oral liquid can be used alone as an alternative to antibiotics in the treatment of acute pharyngitis/tonsillitis caused by bacterial infection. It demonstrates good safety and can lower inflammation markers such as CRP， WBC， and NE%， suggesting its potential to reduce the body's inflammatory response. Its mechanism of action may be related to its multi-target regulatory mechanism.

The mechanism of action of Pudilan Xiaoyan oral liquid against LPS-induced acute respiratory infection in mice based on biological network analysis and metabolomics / 药学学报

This study integrates metabolomics and network pharmacology techniques to systematically analyze the possible mechanism of Pudilan Xiaoyan oral liquid (PDL) in the treatment of acute respiratory infections. GC-MS metabolomics analysis found 8 endogenous metabolites, 3-phosphoglycerate, α-aminoadipate, D-ribulose-5-phosphate, β-mannosylglyceric acid, D-fructose, urea, D-maltose and ornithine in the serum of mice with acute respiratory infection induced by LPS; these substances can be used as biomarkers for PDL use in the treatment of acute respiratory infections. Biological network studies revealed 10 potential targets for intervention by PDL in the glycolysis and pentose phosphate pathways, including GPI, G6PD, H6PD, PFKM, TALDO1, TKT, GAPDH, HK1, PKLR and TPI1. All animal experiments were carried out with approval of the Animal Ethics Committee of Nanjing University of Chinese Medicine. Our findings indicate that the strategy of combining metabolomics and network analysis can provide information on the possible mechanism of PDL in acute respiratory infections, and reveal that PDL may ameliorate the pathological process of acute respiratory infections by regulating disordered metabolic pathways.

Meta-analysis on effectiveness and safety of Pudilan Xiaoyan Oral Liquid on child upper respiratory infection / 中国中药杂志

To systematically review the effectiveness and safety of Pudilan Xiaoyan Oral Liquid on child upper respiratory infection and conduct Meta-analysis. We electronically retrieved databases, including PubMed, Web of Science, VIP, WanFang and CNKI, for published articles of randomized controlled trials(RCTs) of Pudilan Xiaoyan Oral Liquid on child upper respiratory infection from inception to April 2019. According to the inclusion and exclusion criteria, two reviewers independently screened out literatures, extracted data and assessed the risk of bias in included studies. Then, Meta-analysis were conducted by Stata 15.0 software. A total of 16 RCTs involving 1 924 patients with upper respiratory infection were included. The results of Meta-analysis showed that the improvement of clinical symptoms, such as fever subsided time(WMD=-3.66, 95%CI[-4.61,-2.72], P<0.001), cough time(WMD=-1.89, 95%CI[-2.51,-1.27], P<0.001), time of runny noses(WMD=-4.60, 95%CI[-5.85,-3.34], P<0.001) and time of sore throat(WMD=-2.62, 95%CI[-3.54,-1.70], P<0.001). Meanwhile, the results of Meta-analysis showed the improvement of laboratory indications, including TNF-α(WMD=-2.68, 95%CI[-2.98,-1.58], P<0.001) and IL-6(WMD=-2.26, 95%CI[-3.36,-2.36], P<0.01). The current evidence shows that Pudilan Xiaoyan Oral Liquid may significantly improve the effectiveness and safety. According to the limited quality of included studies, the above conclusion needs be to verified with more high-quality studies.

Effect of Pudilan Xiaoyan Oral Liquid on Acute Lung Injury Rat Induced by Lipopolysaccharide / 中国实验方剂学杂志

Objective:To explore the effect and mechanism of Pudilan Xiaoyan oral liquid(PDL) on the acute lung injury rat induced by lipopolysaccharide (LPS). Method:The 72 Wistar rats were randomly divided into control group, model group, dexamethasone group, PDL 7, 3.5, 1.75 g·kg-1·d-1 group according to body weight.The acute lung injury model was made through inhalation with lipopolysaccharide in the model group, hexadecadrol group, PDL 7, 3.5, 1.75 g·kg-1·d-1 group.To examining each rat alveolar lavage fluid (BALF) of the total number of white blood cells, enzyme-linked immunosorbent assay (ELISA) was used to detect the levels of nuclear transcription factors-kappa B (NF-κB) and interleukin-10 (IL-10).Hematoxylin-eosin(HE) staining was used to observe morphological changes of lung tissue and explore different doses of PDL effect on acute lung injury in rats. Result:Compared with model group, the account of leukocyte in BALF decreased significantly in PDL 7 g·kg-1·d-1 group and PDL 3.5 g·kg-1·d-1 group (PκB significantly decreased in PDL 7, 3.5, 1.75 g·kg-1·d-1 group (P-1·d-1 group (P-1·d-1 group, the inflammation, edema and congestion in lung tissue reduced (PConclusion:PDL has a significant protective effect on the inflammation of acute lung injury model, and its mechanism is related to the expressions of NF-κB and IL-10. PDL could also repair the injury of lung in acute lung injury model.

Expert consensus statement on Pudilan Xiaoyan Oral Liquid in clinical practice / 中国中药杂志

Pudilan Xiaoyan Oral Liquid has effects in clearing away heat and detoxifying,and is used to treat pharynx and throat swelling caused by the syndrome of excessive heat and toxin accumulation. Its efficacy is to relieve swelling and pain( redness,swelling and hot pain). It is included in the Chinese Pharmacopoeia of 2015 Edition,and has been listed in provincial health insurance directories of Shaanxi,Jiangsu,Liaoning,Hunan,Tianjin,Xinjiang and Hebei. It has been recommended by health departments of Beijing,Chongqing and other provinces as a preferred drug for the prevention and treatment of H1 N1 and HFMD,and listed in the diagnosis and Treatment Guide of HFMD by the Ministry of Health,the Clinical Application Guide of Chinese Patent Medicine edited by the Lung Department Disease Branch of China Association of Chinese Medicine,and the Clinical Practice Guide of Single Administration/Combined Administration of Antibiotics in Treatment of Common Infectious Diseases by China Association of Chinese Medicine. To further improve the clinician's understanding of drugs and better guide the rational clinical application,we invited front-line clinical experts from respiratory department,infectious department and dermatology of traditional Chinese and Western medicine to develop and compile the expert consensus. The consensus fully considered the clinical evidence and the expert clinical experience to give recommendations for clinical problems with evidence support and consensus suggestions for clinical problems without evidence support by the nominal group method.This consensus is based on clinical research evidence and expert experience in a simple and clear format,which provides a preliminary reference for the clinical use of the drug.

Pharmacokinetics of active ingredients of Pudilan Xiaoyan Oral Liquid in rats and effect on liver drug-metabolizing enzymes / 中国中药杂志

This study is aimed to establish a method for the determination of baicalin,baicalin and purpurin in the plasma of rats after oral administration of Pudilan Xiaoyan Oral Liquid( PDL) by using liquid chromatography-mass spectrometry( LC-MS),analyze the pharmacokinetics of three components in rats,and investigate the effects of PDL on drug-metabolizing enzymes in rat liver. C18 column was used for liquid chromatography separation,with acetonitrile-water( containing 0. 2% formic acid) as the mobile phase for gradient elution. The mass spectrometry was detected by electrospray ion source( ESI) under multi-reaction monitoring mode( MRM),as well as positive and negative ion alternating mode. Plasma sample collection was performed by using an automatic blood collection meter for small animals. The pharmacokinetic parameters were calculated by Win Nonlin software. The total protein concentration of rat liver microsomes and the total enzyme content of CYP450 were determined by BCA method and spectrophotometry respectively. The methodological study in terms of linear range,recovery rate,precision and sample stability,was used to confirm that the LC-MS analysis method established in this experiment was simple,exclusive,accurate and reliable,and can meet the requirement of determining the content of baicalin,oroxindin and corynoline in plasma after PDL administration in rats. The drug-time curve showed that baicalin and oroxindin had a bimodal phenomenon,and the pharmacokinetic parameters indicated that baicalin,oroxindin and corynoline in PDL had certain drug-like properties. After 7 consecutive days of PDL administration,the rat liver coefficient,total liver microparticle protein and CYP450 enzyme content were increased,but there was no significant difference,indicating that PDL was less likely to develop drug-drug interaction based on CYP enzyme. The results of this experiment can provide reference for the research on in vivo efficacy and drug interaction of PDL as well as on its clinical application.

Identification and attribution of chemical compounds of Pudilan Antiphlogistic Oral Liquid / 中国中药杂志

UPLC-ESI-Orbitrap-MS/MS was used to analyze,identify and attribute the chemical constituents in Pudilan Antiphlogistic Oral Liquid. The analysis was performed on an Agilent Eclipse XDB-C18(4.6 mm × 150 mm,3.5 μm) with a gradient mobile phase of methanol-0.1% formic solution system at the flow rate of 0.5 m L·min-1. The sample volume was 2 μL. The column temperature was30 ℃. The high-resolution orbitrap mass spectrometry was used as detector,with electrospray ion source in both positive and negative models,and the MS scanning ranged between m/z 50 and 2 000. Based on the analysis of mass spectrometry and literature reports,79 compounds were confirmed,including 30 alkaloids,28 organic acids,18 flavonoids and 3 coumarins. Finally,39 compounds,such as rutin,esculetin,gallic acid,caffeic acid,cichoric acid,were identified from Taraxacum mongolicum; 11 compounds,such as baicalin,baicalein,apigenin,chrysin,oroxylin A,were identified from Scutellaria baicalensis; 13 compounds,such as arginine,proline,hypoxanthine,epigoitrin,indirubin,were identified from Isatis indigotica; and 18 compounds,such as dehydrocheilanthifoline,oxysanguinarine,corynoline,protopine,spallidamine,were identified from Corydalis bungeana. After the analysis of chemical model and attribution,the contents of some compounds were high in Pudilan Antiphlogistic Oral Liquid,such as baicalin,wogonoside,baicalein,wogonin,apigenin,chrysin,skullcapflavonⅡ,oroxylin A,cichoric acid,chlorogenic acid,caffeic acid,esculetin,dehydrocheilanthifoline,dihydrosanguinarine,protopine,corynoline and indirubin. The established method is simple,accurate,rapid,sensitive and reproducible,and thus suitable for the qualitative identification and quantitative determination of Pudilan Antiphlogistic Oral Liquid,which lays a foundation for the systematic quality control and the establishment of whole-course traceability system of active ingredients.

Simultaneous Determination of 12 Components in Pudilan Xiaoyan Oral Liquid by Ultra-high Performance Liquid Chromatography Coupled with Triple Quadrupole Mass Spectrometry / 中国实验方剂学杂志

Objective: To establish an ultra-high performance liquid chromatography coupled with triple quadrupole mass spectrometry (UHPLC-QqQ MS) method for the simultaneous determination of twelve components (wogonoside,baicalin,wogonin,chrysin,uteolin,caffeic acid,acetylcorynoline,corynoline,protopine,salicylic acid,uracil and adenosine) in Pudilan Xiaoyan oral liquid. Method: The analysis was performed on an Agilent Extend C18 column(3.0 mm×150 mm,3.5 μm),with a gradient elution by using the mobile phase of methanol-water(0.1%formic acid). The flow rate was 0.3 mL·min-1. Triple quadrupole mass spectrometry, electrospray ionization source (ESI),DMRM mode, and positive and negative ions alternate mode were adopted. Result: The 12 reference substances had a good specificity. Wogonoside,baicalin,wogonin,chrysin,uteolin,caffeic acid,acetylcorynoline,corynoline,protopine,salicylic acid,uracil and adenosine showed good linear relationships within the range of 0.062 24-16.24,33.95-530.4,0.013 64-3.558,0.001 157-0.302 4,0.001 199-0.313 0,0.014 64-3.821,0.000 739 5-0.038 59,0.060 83-3.174,0.002 443-0.637 4,0.021 80-1.138,0.022 99-6.000,0.006 046-1.578 μg·L-1,with a good precision,stability and repeatability. And the average recoveries were 98.9%,100.2%,106.9%,100.8%,101.7%,99.3%,94.6%,100.0%,100.5%,103.4%,96.8%,98.1%. Conclusion: This method was simple,sensitive and reliable. It laid a foundation to promote the quality control standard of Pudilan Xiaoyan oral liquid.

Metabolomics on Pudilan Xiaoyan Oral Liquid in treatment of Influenza A/H1N1-induced pneumonia based on GC-MS / 中草药

Objective To screen the pneumonia-related abnormal metabolites in lung tissue of mice infected by Influenza A/H1N1, and to monitor the regulation effect of Pudilan Xiaoyan Oral Liquid and to explore potential anti-pneumonia mechanism. Methods ICR mice were randomly divided into four groups with ten mice in each group: normal group, model group, Pudilan group, and Ribavirin group. The mice were infected with H1N1 virus intranasally and gavage once every-day for six consecutive days. 2 h after the last dose, the mice were sacrificed and lungs were collected. Metabolomics based on GC-MS was applied to analyze the changes of metabolites in the lung tissue of each group. The potential biomarkers of H1N1-induced pneumonia were screened by three conditions: P 1.0, and Fold Change > 1.5. Metabolic pathways related to the treatment mechanism of Pudilan Xiaoyan Oral Liquid were analyzed. Results The infection of H1N1 virus leads to infiltration of inflammatory cells in the lungs of mice and various degrees of pneumonitis and metabolic disorders. Pudilan Xiaoyan Oral Liquid and ribavirin can both ameliorate the symptoms of pneumonia and play role in callback of various metabolites. Conclusion The treatment effect of Pudilan Xiaoyan Oral Liquid on H1N1-induced pneumonia is related to the regulation effects on 14 potential biomarkers and 12 associated metabolic pathways.

Clinical Observation of Pudilan Xiaoyan Oral Liquid in the Treatment of Children Acute Upper Respiratory Tract Infection / 中国药房

OBJECTIVE: To investigate the time of clinical symptom disappearance, therapeutic efficacy and safety of Pudilan xiaoyan oral liquid and its effects on immune factors in the treatment of pediatric acute upper respiratory tract infection. METHODS: A total of 142 children aged 3-17 with acute upper respiratory tract infection selected from Chongqing Jiulongpo District Second People's Hospital during May 2015-May 2016 were divided into observation group (72 cases) and control group (70 cases) according to random number tablet. Both groups received symptomatic treatment as antivirus, antipyretic. Observation group was additionally given Pudilan xiaoyan oral liquid 10 mL each time, 3 times a day, treated for consecutive 7 d. The defervescence time, the disappearance time of rhinobyon, coughing, diarrhea and pharynx swelling were compared between 2 groups. The levels of TNF-α, IL-6 and immune factors (CD3+, CD4+ and CD4+/CD8+) were determined in 2 groups before and after treatment. Clinical efficacies and the occurrences of ADR were observed in 2 groups. RESULTS: Compared to control group, the defervescence time, the disappearance time of rhinobyon, coughing, diarrhea, pharynx red and swelling were significantly shortened in observation group (P<0. 05). Before treatment, there was no statistical significance in the serum levels of TNF-α, IL-6 or immune factors between 2 groups (P>0. 05). After treatment, the serum levels of TNF-α and IL-6 in 2 groups were significantly lower than before treatment (P<0. 05). The serum levels of CD3+, CD4+ and CD4+/CD8+ were significantly higher than before treatment of each group (P<0. 05), while the improvement of observation group was significantly better than that of control group (P<0. 05). Total response rate of observation group was significantly higher than that of control group (P<0. 05), but there was no statistical significance in the incidence of ADR between 2 groups (P>0. 05). CONCLUSIONS: Pudilan xiaoyan oral liquid can shorten the time of acute upper respiratory tract infection disapperance as defervescence, nasal congestion and cough. It combined with antiviral drug is better than antiviral drug alone, but antiviral drug combined with it or alone have same safety.

Systematic review of effectiveness and safety of pudilan Xiaoyan oral liquid in treating pediatric suppurative tonsilitis / 中国中药杂志

The review aims to assess the effectiveness and safety Pudilan Xiaoyan oral liquid in treating pediatric suppurative tonsillitis systematically through searching relevant electronic database and collecting relevant literature. Meta-analysis was performed with the RevMan 5.3 software. Eighteen RCTs of 1 883 patients of pediatric suppurative tonsillitis were included. Meta-analysis showed that： compared with the application of antibiotics alone, combined with Pudilan can effectively improve the treatment of pediatric suppurative tonsillitis in efficacy rate and shorten the time of recovering normal temperature, the time of tonsil purulent discharge and can also reduce the extinction time of sore throat, antiadoncus or congestion subsided and appetite recovery. There was no severe adverse reaction during the treatment. Compared with the application of antibiotics alone, combined with Pudilan may be more effective and safe in the treatment of pediatric suppurative tonsillitis, which can not be strongly proved at present for lack of studies with high quality.

A multi-center clinical trial: Evaluation on effectiveness and safety of different dosages of Pudilan Xiaoyan Oral Liquid in treatment of infantile acute pharyngitis-tonsillitis with lung-stomach excess-heat syndrome / 中草药

Objective: To evaluate the efficacy and safety of different dosages of Pudilan Xiaoyan Oral Liquid (PXOL) in treatment of infantile acute pharyngitis-tonsillitis with lung-stomach excess-heat syndrome. Methods: A randomized controlled, double-blind, positive drug parallel controlled, and multi-center clinical trial was conducted. Totally 324 children from seven research centers were included, 108 cases in experimental high dose group (A Group), 108 cases in experimental low dose group (B Group), 54 cases in positive medicine group (Xiaoer yanbian Granula, C Group), and 54 cases in placebo group (D Group), with the ratios of 2:2:1:1.5 in a course. Results: (1) Totally 317 cases were in full analysis set (FAS), 284 cases in per-protocol set (PPS) and 324 cases in Safety Set (SS). (2) Evaluation on effectiveness: There was significant difference (P<0.001) between each two groups in the total effective rate of pharyngalgia and pharyngeal swelling. A Group and B Group were both superior to D Group, and were non-inferior to C Group. B Group was non-inferior to A Group. There was significant difference (P<0.001) between each two groups in total effective rate of syndrome of traditional Chinese medicine. There was significant difference (P<0.05) between each two groups in the median time of improving pharyngalgia syndrome. There was significant difference (P<0.001) between each two groups in the median time of pharyngalgia syndrome disappearing. There were significant differences (P<0.05) between each two groups in total effective rate of halitosis, cough, thirst, deep-colored urine, and dry stool. The analysis on PPS agrees with that of FAS. (3) Evaluation on safety: No adverse reactions in clinical significant laboratory examination were found during the trial. Conclusion: High and low dosages of PXOL show advantages over placebo and are non-inferior to the positive medicine Xiaoer Yanbian Granula. High dose group does not show advantage comparing with low dose group. No adverse reactions are found during the trial. Low dose therapy is recommended.

Analysis of curative effects of Pudilan Xiaoyan Koufuye on patients with eOLP and ROU / 中国生化药物杂志

Objective To investigate the clinical effect of the treatment of erosive oral lichen planus and recurrent aphthous ulcer by using Pudilan Xiaoyan Koufuye.Methods The clinical data of 138 cases of oral mucosal diseases were retrospectively analyzed from September 2015 to June 2016 in our hospital, eOLP patients 50 cases, 11 cases in the control group one and the control group two, 28 cases in the observation group; ROU patients 88 cases, 21 cases in the control group one and the control group two, 46 cases in the observation group.The control group one was treated with topical western medicine, while the control group two was treated with Pudilan Xiaoyan Koufuye,and the observation group was treated with local topical spray and Pudilan Xiaoyan Koufuye, compared the total effective rate, VAS score and mucosal congestion in different groups of patients with oral diseases, and to observe the adverse reactions of the patients during the treatment.Results After one week of treatment, the total effective rate of treatment was significantly different between eOLP patients and ROU patients (P<0.05),the total effective rate of the observation group was higher than that of the control group one and the control group two ( P <0.05 ) .After two weeks of treatment, the total effective rate of eOLP patients was significantly different, and the total effective rate of observation group was higher than that of control group one (P<0.05),there was no significant difference among the ROU patients.The degree of mucosal hyperemia and the VAS score in the observation group were significantly different from those in the control group one and control group two in the patients with eOLP and ROU ( P <0.05 ) .No significant adverse mucosal staining occurred in all groups of patients, and there was no discontinuation due to obvious adverse reactions.Conclusion Pudilan Xiaoyan Koufuye adjuvant treatment of eOLP and ROU patients with short-term effect is significant, can improve the total effective rate of treatment, and no serious adverse reactions, high safety.

Antiviral effects of pudilan xiaoyan oral liquid on respiratory syncytial virus and adenovirus in vitro / 实用医学杂志

Objective To study the antiviral effects of Pudilan xiaoyan oral liquid on Hep-2 cell models infected with respiratory syncytial virus (RSV), adenoviruses serotype 3 strains (ADV3) in vitro. Methods The cell cytotoxic and inhibition effect of Pudilan xiaoyan oral liquid on RSV or ADV3 were investigated by MTT assay and the inhibitory assay for cytopathic effect (CPE) in Hep-2 cell cultures to detect its antiviral effects. Results The median toxic concentration (TC50) of Pudilan xiaoyan oral liquid on Hep-2 cells was 776.97 mg/L. The median effective concentration (EC50) of inhibiting RSV and ADV3 were 28.08, 28.10 mg/L,whose therapeutic index (TI) were 27.67 and 27.65 respectively. The safety coefficient of Pudilan xiaoyan oral liquid is higher than that of control, ribavirin. Compared with the virus control group, Pudilan xiaoyan oral liquid can obviously produce actions of a dose-dependent relationship to inhibit CPE in Hep-2 cells infected with RSV or ADV3 virus. Conclusions Pudilan xiaoyan oral liquid significantly improves the protection against RSV and ADV3 virus infection in Hep-2 cells. And the inhibition of CPE induced by viruses infection increased with the elevation of higher drug concentration for its antiviral effect augmented in vitro.

Clinical Observation of Pudilan Xiaoyan Oral Liquid Combined with Bronchial Dilatation Drugs in the Treat-ment of Moderate and Severe Stable Chronic Obstructive Pulmonary Disease / 中国药房

OBJECTIVE:To observe the clinical efficacy and safety of Pudilan xiaoyan oral liquid combined with bronchial dil-atation drugs in the treatment of moderate to severe stable chronic obstructive pulmonary disease(COPD). METHODS:According to admission time,102 patients with stable moderate to severe COPD were randomly divided into treatment group(n=53)and con-trol group(n=49). Control group received Budesonide and formoterol fumarate powder for inhalation and Tiotropium bromide pow-der for inhalation;based on control group,treatment group was additionally treated with Pudilan xiaoyan oral liquid,10 ml/time, 3 times a day, for 12 weeks. The lung function index, number of acute COPD attack, modified medical research council (mMRC),CAT and CCQ were performed and comparison in the two groups. RESULTS:After 12 weeks of treatment,the IC of treatment group was improved significantly,compared to before treatment and control group;there was statistical significance(P0.05);there was no statistical significance in the number of acute COPD attack between 2 groups(P>0.05). mMRC,CAT score and CCQ total score of treatment group were improved significantly,compared to before treatment and control group;there was statistical significance (P<0.05). No obvious ADR was found in 2 groups. CONCLUSIONS:Pudilan xiaoyan oral liquid combined with bronchial dilatation drugs for inhalation is better than powder for inhalation in the treatment of moderate to serve stable COPD,can improve pulmonary function significantly,exercise tolerance and quality of life.

The clinical effect of Pudilan combined with ribavirin in treatment of children with HFMD / 中国基层医药

Objective To investigate the effect of Pudilan combined with ribavirin in treatment of the hand-foot-mouth disease(HFMD). Methods 70 patients were randomly divided into treatment group ( Pudilan combined with ribavirin) and control group (ribavirin only). Results Compared with the control group,the cure rate and the effective rate in treatment group had statistically significant difference ( all P ＜ 0.05 ). Compared with the control group,the rash disappeared time and the fever subsiding time in treatment group were shorter obviously ( all P ＜0. 05 ). The both groups had no obvious side effect. Conclusion Pudilan combined with ribavirin in the treatment of HFMD had a good therapeutic effect and were a safe and effective method.

Determination of Baicalin content in Pudilan Xiaoyan Capsule by HPLC / 中药新药与临床药理

Objective To establish the quality standard for Pudilan Xiaoyan Capsule(PXC).Methods The content of baicalin in PXC was determined by HPLC.The AichromBond-ODS-C18 column(4.6 mm? 150 mm,5 ? m) was used with column temperature being at 30 ℃ and injection volume being 10 ? L.The mobile phase was consisted of CH3OH-H20-H3PO4(40 :60 :0.2) with the flow rate being 1.0 mL/min.The detection wavelength was at 280 nm.Results A good linearity was obtained in the range of 0.062～ 0.372 ? g of baicalin with a good correlation coefficient(r=0.9998).Conclusion The method is accurate and good reproducibility.It can be used effectively for the quality control of Pudilan Xiaoyan Capsule.