不同制剂类型胸腺五肽药效成分含量稳定性分析

摘要

采用反相高效液相色谱法分别对胸腺五肽三种制剂类型：水针、粉针、固体制剂的各10个批次制剂成品进行药效成分含量测定，并对其药效成分的含量进行合格评定。经研究发现，水针、粉针剂型药效成分含量较高，而固体制剂部分含量偏低，可能是由于水针、粉针剂型为无菌制剂，胸腺五肽在无菌条件下，且基质成分单一情况下不易分解变质，而固体制剂肠溶片，为非无菌制剂，另外，片剂对应的药用辅料成分较为错综复杂，对胸腺五肽稳定性有不利影响。开发能使胸腺五肽固体制剂药效成分稳定的辅料成分，对提高胸腺五肽固体制剂生物利用度有较高应用价值。%Reversed phase high performance liquid chromatography was used to analyze three types of the 10 batches thymopentin preparation:water injection,powder injection and solid preparation,and their efficacy assessments were processed through composition content determination.The result indicated that the efficacy composition contents of water and powder injection drugs were higher than that of solid prepa-ration.This could be due to water and powder injection preparation forms were sterile products.The thy-mopentin composition was not easy to decompose and metamorphic with single matrix components under aseptic conditions.Several factors are not conducive thymopentin solid preparation to stability:solid preparation as enteric-coated troche are non-sterile products,in addition,the troche of the corresponding supplementary material composition is complex relatively.The ingredient material make the thymopentin solid preparation composition stable,and the efficacy could be developed.The high value for application could be obtained by improve the bioavailability thymopentin solid preparation.