两煎常压煎药机所制加味当归补血汤的质量考察

Investigation on the Quality of Danggui Buxue Decoction Extracted by Two Fried Normal Pressure Decocting Machine

目的:考察两煎常压煎药机所制加味当归补血汤汤剂在贮存期间的质量变化,为确定所制汤剂保质期限及临床安全用药提供理论依据。方法:采用高效液相色谱法,在加味当归补血汤汤剂制备1,3,5,7,14 d后对阿魏酸进行含量测定并对比分析其结果;同时进行微生物限度检查。结果:所制汤剂于制备第14天阿魏酸含量下降4.12%;微生物限度检查结果均符合药品卫生学标准。结论:使用两煎常压煎药机煎煮含有根茎类药材的加味当归补血汤,加热灭菌30 min,所制汤剂于室温20℃下保存14 d质量稳定。

Objective： To investigate the quality change of Danggui Buxue decoction extracted by two fried normal pressure decoc- ting machihe during the storage and to provide scientific information for the shelf-time determination and rational drug use in clinics. Methods： An HPLC method was used to determine the content of ferulic acid in the decoction on the 1st, 3rd, 5th, 7th and 14th day after the storage, and the results were analyzed. Meanwhile, microbial limit test was carried out. Results： The content of ferulic acid in the extracted decoction showed 4.12% decrease on the 14th day. The results of microbial limit test met the sanitary standards for drugs. Conclusion： Danggui Buxue decoction including rhizome and root crude materials can be kept stable under 20℃ for 14 days af- ter extracted by two fried normal pressure decocting machine and sterilized by heating 30 min.