中国药师
中國藥師
중국약사
CHINA PHARMACIST
2014年
12期
2013-2015
,共3页
中药安慰剂%四草通脉胶囊%制备方法%中药临床试验%评价
中藥安慰劑%四草通脈膠囊%製備方法%中藥臨床試驗%評價
중약안위제%사초통맥효낭%제비방법%중약림상시험%평개
TCM placebo%Sicao Tongmai capsules%Preparation methods%Clinical trials on TCM%Evaluation
目的：：建立制备中药制剂四草通脉胶囊安慰剂的方法，为中药临床试验中安慰剂的制备提供参考。方法：以四草通脉胶囊安慰剂的研制为例，对安慰剂的气味和外观分别通过评价打分及电子鼻进行考察。结果：四草通脉胶囊安慰剂与原药粉末的外观、颜色基本达到一致，口味也基本一致。但气味仍稍有差异。模拟临床试验表明安慰剂不易破盲。结论：该安慰剂已能够满足中药临床试验的需要，但在制备技术上仍有提高的空间。
目的：：建立製備中藥製劑四草通脈膠囊安慰劑的方法，為中藥臨床試驗中安慰劑的製備提供參攷。方法：以四草通脈膠囊安慰劑的研製為例，對安慰劑的氣味和外觀分彆通過評價打分及電子鼻進行攷察。結果：四草通脈膠囊安慰劑與原藥粉末的外觀、顏色基本達到一緻，口味也基本一緻。但氣味仍稍有差異。模擬臨床試驗錶明安慰劑不易破盲。結論：該安慰劑已能夠滿足中藥臨床試驗的需要，但在製備技術上仍有提高的空間。
목적：：건립제비중약제제사초통맥효낭안위제적방법，위중약림상시험중안위제적제비제공삼고。방법：이사초통맥효낭안위제적연제위례，대안위제적기미화외관분별통과평개타분급전자비진행고찰。결과：사초통맥효낭안위제여원약분말적외관、안색기본체도일치，구미야기본일치。단기미잉초유차이。모의림상시험표명안위제불역파맹。결론：해안위제이능구만족중약림상시험적수요，단재제비기술상잉유제고적공간。
Objective:To prepare the placebos of Sicao Tongmai capsules to provide the reference for the placebo preparation in clinical trials of traditional Chinese medicines. Methods: Taking the placebo preparation of Sicao Tongmai capsules as the example, the appearance, color and smell of the placebo were assessed by the scoring method and an electronic nose. Results:The appearance, color and taste of the placebo were in line with those of the drug powder, while there was difference in smell. The simulated clinical ex-periments showed that the placebo was difficult to be unblinded. Conclusion:The placebo can be used in TCM clinical trials, howev-er, the production technology should be further improved and modified.
