当归微粉化片剂的研制与质量控制  

Preparation and Quality Control of Micronized Angelica Tablets

作　　者：孙强[1] 何应[1] 

机构地区：[1]天津大学药学院,天津300072

出　　处：《食品与药品》2007年第07A期11-13,共3页Food and Drug

摘　　要：目的制备一种新型片剂——当归微粉化片剂,并建立其质量控制方法。方法将当归进行微米级别的超微粉碎,与辅料均匀混合后,用粉末直接压片法制备片剂;用薄层色谱法对处方中主药材进行定性鉴别;用高效液相色谱法测定片剂中阿魏酸的含量。结果阿魏酸在0.512～102.4μg·mL-1浓度范围内与峰面积呈良好的线性关系(r=0.999 6),平均加样回收率为99.17%,RSD=1.47%(n=5)。结论本法简便、准确,可用于此制剂的质量控制;微粉化当归片中阿魏酸的含量高于市售当归片。Objective To prepare the micronized angelica tablets and establish a quality control standards. Methods Micronized angelica tablets were prepared by supercrash and powder direct method. The qualitative identification of the principal agent was performed by TLC and the content of ferulic acid was determined by HPLC. Results The linear range was 0.512 - 102.4 μg · mL^-1 for ferulic acid. The average recovery was 99.17% with RSD 1.47%（n=5）. Conclusion The method is simple and accurate for the quality control of micronized angelica tablets.

关 键 词：当归微粉片 阿魏酸 薄层色谱法 高效液相色谱法 质量控制 

分 类 号：R984[医药卫生—药品]