CAJ | 학술논문

目的：评价复合三联抗结核药硫酸钙／聚氨基酸人工缓释材料的体外抗结核性能。方法将制作的载药人工缓释材料及非载药缓释材料浸泡于模拟体液中，分别于第4周、第8周、第12周取得二者的浸提液，采用高效液相色谱法检测浸提液浓度。实验分为3组：实验组（ A组）为复合三联抗结核药人工缓释材料第4、8、12周的浸提液组，分为A4W、A8W、A12W 3个亚组；实验对照组（B组）为未载药人工缓释材料第4、8、12周的浸提液组，分为B4W、B8W、B12W 3个亚组；空白对照组（ C组）为蒸馏水，分为C4W、C8W、C12W 3个亚组，每个亚组均为20个样本。将进行增殖后的标准结核分枝杆菌H37Rv与3组各样本加入BacT／ALERT 3D培养系统中共同培养。观察阳性率并统计分析培养结果。结果复合三联抗结核药硫酸钙／聚氨基酸人工缓释材料浸提液浓度检测结果（μg／mL）：第4、8、12周时异烟肼的浓度分别为：142．65±2．23，47．83±2．91，0．68±0．17；利福平在第4、8周时的浓度分别为：70．69±7．16，39．95±3．98，第12周时其浓度已测不到；吡嗪酰胺在第4、8、12周时的浓度分别为：893．56±7．09；229．87±9．56，6．36±0．57。经BacT／ALERT 3D系统培养后，A、B、C各亚组结核杆菌阳性率分别为：A4W组15％、A8W组25％、A12W组55％；B4W组80％、B8W组85％、B12W组80％；C4W组90％、C8W组95％、C12W组90％。 A组各样本与B组对应样本比较差异有统计学意义（P＜0．05）。 B组各样本与C组之间比较差异无统计学意义（P＞0．05）。结论本研究表明复合三联抗结核药硫酸钙／聚氨基酸人工缓释材料在体外具有抗结核作用，其作用至第84天仍然存在。
목적：평개복합삼련항결핵약류산개／취안기산인공완석재료적체외항결핵성능。방법장제작적재약인공완석재료급비재약완석재료침포우모의체액중，분별우제4주、제8주、제12주취득이자적침제액，채용고효액상색보법검측침제액농도。실험분위3조：실험조（ A조）위복합삼련항결핵약인공완석재료제4、8、12주적침제액조，분위A4W、A8W、A12W 3개아조；실험대조조（B조）위미재약인공완석재료제4、8、12주적침제액조，분위B4W、B8W、B12W 3개아조；공백대조조（ C조）위증류수，분위C4W、C8W、C12W 3개아조，매개아조균위20개양본。장진행증식후적표준결핵분지간균H37Rv여3조각양본가입BacT／ALERT 3D배양계통중공동배양。관찰양성솔병통계분석배양결과。결과복합삼련항결핵약류산개／취안기산인공완석재료침제액농도검측결과（μg／mL）：제4、8、12주시이연정적농도분별위：142．65±2．23，47．83±2．91，0．68±0．17；리복평재제4、8주시적농도분별위：70．69±7．16，39．95±3．98，제12주시기농도이측불도；필진선알재제4、8、12주시적농도분별위：893．56±7．09；229．87±9．56，6．36±0．57。경BacT／ALERT 3D계통배양후，A、B、C각아조결핵간균양성솔분별위：A4W조15％、A8W조25％、A12W조55％；B4W조80％、B8W조85％、B12W조80％；C4W조90％、C8W조95％、C12W조90％。 A조각양본여B조대응양본비교차이유통계학의의（P＜0．05）。 B조각양본여C조지간비교차이무통계학의의（P＞0．05）。결론본연구표명복합삼련항결핵약류산개／취안기산인공완석재료재체외구유항결핵작용，기작용지제84천잉연존재。
Objective To evaluate vitro anti-tuberculosis performance of calcium sulfate/poly amino acids artificial release material compounded triple anti-tuberculosis drugs Methods Soak the calcium sulfate/poly amino acids artificial release ma-terial compounded triple anti-tuberculosis drugs and the calcium sulfate/poly amino acids artificial release material uncom-pounded triple anti-tuberculosis drugs in the simulation of body fluid.Detect the concentration of extracts obtained in 4th week, 8th week, 12th week with high performance liquid chromatography (HPLC).Experimental group(Group A) was the extracts of calcium sulfate/poly amino acids artificial release material compounded triple anti-tuberculosis drugs in 4th week, 8th week and 12th week, divided into A4W, A8W, A12W 3 sub-groups;experimental control group (Group B) was the extracts of calcium sulfate/poly amino acids artificial release material uncompounded triple anti-tuberculosis drugs in 4th week, 8th week and 12th week, divided into B4W, B8W, B12W 3 sub-groups; blank control group(Group C) was distilled water group, divided into C4W , C8W , C12W 3 sub-groups, each sub-group of 20 samples.Three groups of samples and standard tuberculosis H37Rv were added into BacT/ALERT 3D co-culture fast training instrument,then observe the positive rate of culture results and did statistical analysis .Results The result of the extracts concentration of the calcium sulfate /poly amino acids artificial release material compounded triple anti-tuberculosis drugs (μg/mL):the concentration of isonicotinyl hydrazide in 4th week, 8thweekand12thweekwas142.65 ±2.23,47.83 ±2.91,0.68 ±0.17,respectively.Theconcentrationofrifampinin4th week, 8th week was 70.69 ±7.16, 39.95 ±3.98, respectively, the concentration could not be detected in 12th week.The concentration of pyrazinamide in 4 th week , 8 th week and 1 2 th week was 8 9 3 .5 6 ±7 .0 9 , 2 2 9 .8 7 ±9 .5 6 , 6 .3 6 ±0 .5 7 , respectively.After co-cultured in BacT/ALERT 3D system, the positive rates 3 groups in 4th week, 8th week and 12th week:A4W 15%, A8W 25%, A12W 55%;B4W 80%, B8W 85%, B12W 80%;C4W 90%, C8W 95%, C12W 90%.There were significant differencesbetween corresponding samples of group A and group B (P<0.05).There were no significant difference between corresponding samples of group B and group C (P>0.05).Conclusion The calcium sulfate /poly amino acids artificial release material compounded triple anti-tuberculosis drugs has a very nice vitro anti-tuberculosis effect till the 84th day.