Objective To observe and evaluate the tolerance and safety of Muxiangdongli capsule in Chinese volunteers.Methods Twenty four,twelve healthy subjects,seperated to 5 different dose(0.25,0.5 1.0,1.5,2.0 g) and 2 difference dose(1.5,2.0 g) respectively.Single-dose(n=24) and multipl dose(n=12) groups according to different gender randomly gender randomly.The clinical symptoms,signs of life,etc were observed.Results The result of routine blood tests,APTT and Cr beyond the normal range occurred in 6 persons in the single dose group.The result of routine blood tests,FIB and TT beyond the normal range were founded in 7 cases in the multiple dose groups.There was no clinical significance for the changes after combing with other indicators.Conclusion Healthy volunteers can tolerate single oral dose of 0.25-2.00 g·d-1 each day and multiple dose 1.5 or 2.0 g·d-1.
Objective To establish a liquid chromatography-mass spectrometry(LC-MS/MS) method for evaluating the bioequivalence of luofenpuxinnamin dispersible tabletsand compound zinc gluconate and ibuprofen granules in healthy volunteers .Methods According to a random opening, two-period crossover design(cleaning phase is two weeks). Twenty healthy volunteers take a single same oral dose of luofenpuxinnamin dispersible tablets (test)and compound zinc gluconate and ibuprofen granules(reference) (equal to 4 mg chlorpheniramine maleate). Using indapamide as internal standard, the content of chlorpheniramine maleate was determined by SRM model. The pharmacokinetic parameters was calculate by soft were. Results The main pharmacokinetic parameters of luofenpuxinnamin dispersible tablets(test) and ibuprofen granules (reference) of were as follows:Cmax were (12.27±3.04) and (13.47±3.52)ng·mL-1; tmax were (2.43±1.49) and (2.10±1.07) h; AUC0-t were (303.17±91.39) and (315.58±76.78) ng·h·mL-1; AUC0-∞ were (355.19±120.30) and (365.71±100.48) ng·h·mL-1; t1/2 were (24.86±5.83) and (24.71±5.96) h, resperitively. The relative bioavailability of test was (99.80± 41.20)%. Conclusion The chlorpheniramine maleate of test and reference was bioequivalence.
目的:用β-环糊精对利胆排石片中的挥发油进行包合的工艺研究.方法:采用均匀设计,通过饱和水溶液法制备包合物,筛选包合最佳工艺.结果:挥发油与β-环糊精的最佳包合比例为1mL:9g,包合温度50℃,包合时间2h.结论:对多因素多水平实验采用均匀设计得出的包合工艺合理,包合率高,稳定性好.
目的:检测不同厂家生产的人工牛黄的质量.方法:依照中华人民共和国部颁标准,采用试管法、薄层色谱法、紫外分光光度法对人工牛黄进行定性、定量的测定.结论:部颁标准能够很好的控制人工牛黄的质量,为含人工牛黄的中成药质量标准研究提供了确切的依据.