含黄芪中药袋装煎煮液储存条件与质量稳定性研究  

Storage conditions and quality stability of Chinese medicine decoction fluid bags containing radix astragali

作　　者：周敏华 王红刚 吴晓玲 叶超雄 盛亚丽 黄远聪 

机构地区：[1]广东省中西医结合医院,广东佛山528200 [2]广东药科大学,广州510006

出　　处：《中南药学》2017年第11期1550-1554,共5页Central South Pharmacy

基　　金：佛山市医学类科技攻关项目(编号:2015AB000662)

摘　　要：目的以黄芪作为唯一君药的补阳还五汤和补中益气汤为例,研究不同储存温度及时间对2种含黄芪中药袋装煎煮液质量稳定性的影响。方法微生物限度检测方法参照2015年版中国药典四部,毛蕊异黄酮葡萄糖苷(CP)含量测定采用高效液相色谱法,Phenomenex Luna C18色谱柱(4.6 mm×250mm,5μm),乙腈(A)-0.2%甲酸溶液(B)(15∶85)为流动相进行等度洗脱,检测波长260 nm。结果2种含黄芪中药袋装煎煮液在常温(20℃)和低温(2~8℃)下分别储存0、3、7、14 d后,微生物检测结果均符合药典规定;毛蕊异黄酮葡萄糖苷含量与0 d相比差异均无统计学意义。结论 2种含黄芪中药袋装煎煮液常温和低温储存14 d内各项质量指标均比较稳定,可以常温储存。Objective To determine the quality stability of Chinese medicine decoction fluid bags containing radix astragali as the only sovereign drug stored at different temperatures and different time in the case of Buyang Huanwu decoction and Buzhong Yiqi decoction. Methods According to the fourth part of 2015 edition of Chinese Pharmacopoeia, the method of microbial limit test was adopted. The contents of calycosin-7- glucoside were separated on a phenomenex Luna C18 column （4.6 mm × 250 mm, 5 μm） by gradient with using acetonitrile （A）-0.2% formic acid solution （B） （15 ： 85） as the mobile phase. The detection wavelength was 260 nm. Results The microbiological results of the Buyang Huanwu decoction and Buzhong Yiqi decoction extract stored at room temperature （20 ℃ ） and low temperature （2- 8℃ ） for 0, 3, 7, and 14 days were in line with the relevant provisions of Chinese Pharmacopoeia. There was no significant difference in the content of calycosin-7-glucoside compared with that of the samples of 0 day. Conclusion The quality of Chinese medicine decoction fluid bags containing radix astragali is stable at room temperature or low temperature within 14 days. The decoction fluid bags can be stored at room temperature.

关 键 词：补阳还五汤 补中益气汤 袋装煎煮液 储存条件 微生物限度检查 毛蕊异黄酮葡萄糖苷 

分 类 号：R288[医药卫生—中药学]