摘要
目的正交试验优选中药滴丸制剂的制备工艺并建立中药滴丸的质量标准。方法以复方丹参滴丸为代表,采用正交试验,对药物与基质的用量、药料温度、滴距为因素,优选中药滴丸的最佳制备工艺,高效液相色谱法对滴丸中丹参所含有效成分丹参素进行质量标准研究。结果 (1)中药滴丸的最佳制备工艺条件:药物∶基质=1∶2,基质PEG-4000∶PEG6000=1∶1,药液温度70℃,滴距4 cm,根据试验确定的工艺制备3批样品均符合《中国药典》2015年版关于滴丸的规定;(2)复方丹参滴丸中丹参素的回收率为99.56%,RSD值为1.65%,样品中丹参素含量为8.035 mg/g,符合2015年版《中国药典》对滴丸的含量规定。结论优选的中药滴丸制备工艺简单可行,建立的质量标准可以检测及评价滴丸中有效成分的含量,方法准确,精密度高,含量准确。
Objective To study the preparation technology of traditional Chinese medicine dripping pills and establish the quality standard of Chinese medicine dropping pills. Methods The compound danshen dripping pills were as the representative,the orthogonal experiment was taken,the amount of drugs and the substrate,drug temperature,drop were as factors,preferably the best preparation process of traditional Chinese medicine dropping pills,and high performance liquid chromatography was taken for the study of the quality standards of the effective component of Salvia miltiorrhiza in danshen. Results（ 1）The optimum preparation conditions were as follows： drug∶ matrix = 1∶ 2,matrix PEG-4000∶ PEG6000 = 1∶ 1,liquid temperature70 ℃,dropping 4 cm. According to the experiment to determine the preparation of three batches of samples were all in line with the ＂Chinese Pharmacopoeia＂2015 version of the provisions on the dripping pill.（ 2） The recovery rate of compound Danshen dripping pills Danshensu was 99. 56%,RSD value was 1. 65%,the sample Danshensu content was 8. 035 mg/g,in line with the 2015 version of＂Chinese Pharmacopoeia＂on the content of pills. Conclusion The optimal preparation method of traditional Chinese medicine dropping pills is simple and feasible. The established quality standard can detect and evaluate the content of active ingredients in drip pills. The method is accurate,the precision is high and the content is accurate.
出处
《临床合理用药杂志》
2017年第31期27-28,30,共3页
Chinese Journal of Clinical Rational Drug Use
关键词
中药滴丸
正交试验
质量标准
制备工艺
复方丹参滴丸
Traditional Chinese medicine dropping pills
Orthogonal test
Quality standard
Preparation process
Compound Danshen dripping pills
