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Afatinib is an irreversible inhibitor for the ErbB family of tyrosine kinases with oral administration. In two randomized, open-label and multinational phase III trials, the progression-free survival was significantly prolonged by afatinib compared with peme-trexed plus cisplatin (LUX-Lung 3) or gemcitabine plus cisplatin (LUX-Lung 6) in the treatment-naive patients with advanced non-small cell lung cancer ( NSCLC) with activating EGFR mutations. The patient-reported symptoms such as cough and dyspnoea, and certain health-related quality of life after the treatment by afatinib were also better than those treated by control dugs. Afatinib was ap-proved by FDA in July 2013 as the first-line treatment drug for the patients with metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations. The action mechanisms, pharmacokinetics, clinical trials and adverse events were reviewed in this paper.
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Objective: To analyze the uncertainty of quercetin concentration determination in Sicao Tongmai capsules by HPLC. Methods: The source of uncertainty was confirmed by analyzing the HPLC determination process. The uncertainty components were quantified by statistics, and the extended uncertainty and confidence level were finally obtained. Results: The extended uncertainty of the measurement results was 0. 19 μg · g-1 . Quercetin concentration in Sicao Tongmai capsules was (353. 65 ± 0. 19)μg·g-1 . Conclusion: The uncertainty analysis method is suitable for the standard limit formulation for Sicao Tongmai capsules, and it is important to establish uncertainty analysis methods for traditional Chinese medicines.
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OBJECTIVE:To provide reference for the enhancing of the quality of hospital preparations.METHODS:The disqualified reports on Shanghai hospital preparations published in "Shanghai drug and medical equipment quality bulletin" between 2004 and 2007 were collected to investigate the main quality problems.RESULTS:A total of 105 batches(19 dosage forms were covered)of unqualified preparations were reported in spot checks,of which,74(70.5%)were external preparations,17(16.2%)oral preparations,and 14(13.3%)sterility preparations.The common unqualified items include package amount(34.5%),description(15.4%),content(15.4%),pH value(13.6%),and microbial limit(8.2%).The major quality problems were related to package containers and technology.CONCLUSIONS:It is suggested that the concerned department to tighten control on quality of hospital preparations aimed at the above-mentioned problems.
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Objective To establish a RP-HPLC method for simultaneous quantitative determination of 4 anthraquinones in Shugan Quzhi capsules. Methods A RP-HPLC method was used with a Diamonsil C18 column (5 ?m,4.6 mm?150 mm). The mobile phase was composed of methanol and 0.1% H3PO4 water solution (77∶23,v/v). The wavelength of UV detector was 254 nm and column temperature was 30 ℃. Flow rate was 1.0 mL/min and 20 ?L was injected every time. Results The linear ranges of rhein,emodin,chrysophanol and physcion were 0.083 2～2.08,0.100 8～2.52,0.291 2～7.28 and 0.088～2.20 ?g/mL,respectively. Their average recoveries were 97.3%,96.9%,96.5% and 95.9%,respectively. Conclusion This method was sensitive,repeatable and suitable to determine the contents of 4 anthraquinones in Shugan Quzhi capsules.
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OBJECTIVE:To established a method for determining matrine and oxymatrine in human plasma.METHODS:The plasma was extracted with chloroform-n-butyl alcohol(98∶2) after basification and purified with neutral alumina solid-phase extraction.Then it was eluted with a Lichrosorb-NH2 column and CH3CN-CH3CH2OH-H3PO4(80∶10∶8),detected at ? 220nm.RESULTS:The linear range was 1.25mg～40mg/L and the limit of detection was 0.1mg/L(S/N=2).The average recoveries of matrine and oxymatrine were 106.96% and 105.04%,respectively.RSDs of within-day and between-day were lower than 13% and 7% respectively.CONCLUSION:The present study provides a simple and reliable method for determining concentrations of matrine and oxymatrine in human plasma.
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OBJECTIVE:A RP-HPLC method was established to determine the concentration of ambroxol hydrochloride in human plasma.METHODS:Waters HPLC instrument was used with the Hypersil BDS C 18 column(5?m,250mm?4.6mm). Ditiazem hydrochloride was chosen as the internal standard.The mobile phase was composed of acetonitrile-methyl alcohol-0.01mol/L phosphatic buffer(pH7.0)-tetrahydrofuran(35∶35∶27.5∶2.5).Flow rate was1.0ml/min.Detection wavelength was242nm.A single oral dose of90mg imported ambroxol hydrochloride tablet was given to9healthy male volunteers.Ambro xol concentration in plasma was assayed.RESULTS:The standard curve of ambroxol hydrochloride was linear in the range of10～640ng/ml.The minium detection concentration was10ng/ml.The extraction recovery was more than90%.A one-compartment open pharmacokinetic model was adopted in ambroxol plasma concentration-time data analysis.The main pharmac okinetic parameters were as follows:C max =(226.53?34.59)ng/ml,T max =(1.82?0.80)h,T 1/2ke =(6.27?0.66)h,AUC 0～24 =(2363.55?448.86)ng/(h?ml).CONCLUSION:The method is simple.The sensitivity and accuracy are high.It is applicable to study the pharmacokinetics of ambroxol hydrochloride in healthy male volunteers.