无载体色甘酸钠粉雾剂的研究 Ⅱ.评价疗效的体外试验方法研究

STUDIES ON DISODIUM CROMOGLYCATECARRIERFREE POWDER INHALATIONII. IN VITRO EVALUATION OF POWDERS FOR INHALATION

采用喷雾干燥技术，经微粉化处理，制备粒径小、流动性好、吸入方便的色甘酸钠（ＳＣＧ）无载体粉雾剂。建立了评价粉雾剂疗效的体外试验方法，包括排空试验、吸入模拟试验和透粘膜试验。试验结果表明：无载体粉雾剂（Ｉ）排空率明显高于市售ＳＣＧ粉雾剂（Ｉ）；吸入模拟试验中，在具治疗意义的部位（第二级）其沉积量为Ｉ的３倍，提示Ｉ的临床疗效优于Ｉ。

The carrierfree powder inhalation (FPI) sodium cromoglycate was obtained by using spray drying technique. The test of evacuation showed that FPI was better than the marketed inhalation powder (MPI). In vitro deposition test by twin impinger, the amount of deposition of FPI in stage II was as 3 times as that of MPI. And in penetrating test through chicken crop membrane the penetrated amount of FPI was also higher than MPI.