摘要
目的 :比较两种不同生产工艺的细辛脑片剂生物利用度。方法 :18名健康志愿者单剂量随机交叉口服不同生产工艺的片剂 1和片剂 2 16 0mg ,及静脉注射细辛脑针剂 16mg后 ,用反相高效液相色谱法测定细辛脑血清浓度 ,对AUC0～∞ ,Cmax和Tmax3个参数进行等效性检验。结果 :片剂 1和片剂 2的绝对生物利用度分别为 (5 .4± 1.6 ) %和 (9.7± 2 .5 ) % ,片剂 2对片剂 1的相对生物利用度为 (181.9± 15 .2 ) %。结论 :经生产工艺改造后的片剂 2生物利用度比原生产工艺片剂 1提高81.9% ,但是 ,细辛脑片剂的绝对生物利用度仍很低。
OBJECTIVE To campare the bioavailability of asarone between tablet 1 and tablet 2 produced with different technology.METHODS The drug concentration in serum was assayed by HPLC, after administration of a sigle oral dose of 120 mg asarone tablet 1or tablet 2 or intravenous dose of 16 mg asarone injection to each of 18 healthy male volunteers in a randomized cross-over study.RESULTS The absolute biavailability of asarone tablet 1 and tablet 2 were( 5.4 ± 1.6 )% and ( 9.7 ± 2.5 )%, respectively. The relative bioavailability of asarone tablet 2 to tablet 1 was( 181.9 ± 15.2 )%?CONCLUSIONS The result showed the two asarone tablets were not bioepuivalent. The absolute bioavailability of asarone tablet 2 produced with improved edwith technology was increased 81.9% than the asarone tablet 1, but the bioavailability of asarone tablets was still lower.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2003年第10期597-598,共2页
Chinese Journal of Hospital Pharmacy
