| According to preliminary experimental data of Pharmacology,first infusion of Brucea javanica oil emulsion liquid human tolerance studies,selection on the basis of Brucea javanica oil emulsion infusion of oleic acid liquid ingredients to the target human pharmacokinetic testing,observation of Brucea javanica oil emulsion infusion fluid at the body's metabolism,Clinical recommend dosage,Brucea javanica oil emulsion and the effectiveness of fluid infusion study,scientific norms to achieve Brucea javanica oil emulsion infusion fluid of clinical pharmacology research.Cancer patients were selected to have single dose tolerance test:Initial dose of 3g/day/person,maximum dose of 20g/day/person by incremental approach by Fernandez(modified Fibonacci method) increments.Continuous delivery tolerance test:Tolerance test can be tolerated dose selected 10g,20g dose of both according to single-dose.Establish a method to determine the content of oleic acid in human plasma by LC-ESI-MS method,and studied the fat emulsion of Brucea javanica oil oleic acid in the human body pharmacokinetics.We did the research at Symmetry C8(5μm, 2.1mm×50mm) column,methanol:water:acetic acid(90:10:0.1) as mobile phase, with flow rate at 0.15ml/min,column temperature at 30℃,Injection volume of 10μl;Source mass spectrometry using electrospray ionization(ESI-),Selective monitoring of quality of the Netherlands,Belgium,(m/z) to 281,Linear range of:0.0308-2.00 mg·L-1,The limit of detection of 0.2ng(S/N=10),Recovery more than 65%,Days,day coefficient of variation less than 15%.Clinical research using randomized,controlled design,245 cases of non-small cell lung cancer patients were divided into NP programs chemotherapy group 125 eases,NP programs+Brucea javanica oil emulsion infusion liquid 121 cases of United Group.Before and after treatment by evaluating tumor size,physical status, symptoms,quality of life,such as Change,a comprehensive evaluation of Brucea javanica oil emulsion infusion in treating non-small cell lung cancer permit clinical efficacy with the accumulated hotness-toxicity.Tolerance test body which was selected into the group at a total of 30 cases, one of single-dose group 5 dose group,a total of 22 people into the group,continuous administration of two dose group,a total of 8 people into the group.1 was suspended due to adverse reactions,the off rate of 3.33%,Without discounting the number of cases,emerging positive signs and symptoms mainly expressed in seven cases of low-grade fever,2 cases of diarrhea,1 case of laboratory indicators varying significantly decreased WBC,1 case of ALT increasing slightly.We studied with the way of Oleic acid in vivo plasma concentration of the estimated half-life of terminal phase(t1/2) 12.14±6.42h,Peak time(Tmax) at 1.08±0.19h,Peak concentration(Cmax) 95.20±29.10 mg·L-1,AUC0-12 was 370.89±70.71mg·h·L-1,After subjects are administrated.Clinical study results showed that:Attending the first two sets,the difference of the Symptoms,namely cough,shortness of breath,chest pain,bloody sputum was not statistically significant.Living status groups attending the first score,the patients quality of life score,the first patient CT/MRI tumor the size of the group difference was not statistically significant,either.Two groups are comparable.Two points after treatment and the de facto points compared with baseline were highly statistically significant difference.Cancer-wide analysis of efficacy evaluation of two sets,two sets of time to progression of the group difference was not statistically significant.This study of Brucea javanica oil emulsion fluid infusion test clinical tolerance and pharmacokinetics testing,Clinical safety of its use provides a sufficient basis for, recommend the appropriate dose for clinical studies:Per 100ml,1 times/day; Improve the quality of life in patients,the combination chemotherapy was superior to chemotherapy alone group,showed that infusion of Brucea javanica oil emulsion on the improvement of the quality of life of patients may have a role.
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