文献类型：期刊文献

中文题名：双丹颗粒剂制备工艺的研究

英文题名：Study on Preparation Technology of "Shuang Dan" Granules

作者：霍清[1];孔令旭[1]

第一作者：霍清

机构：[1]北京联合大学生物化学工程学院

第一机构：北京联合大学生物化学工程学院

年份：2009

卷号：20

期号：7

起止页码：1784-1785

中文期刊名：时珍国医国药

外文期刊名：Lishizhen Medicine and Materia Medica Research

收录：北大核心:【北大核心2008】；CSCD:【CSCD_E2011_2012】；

语种：中文

中文关键词：丹皮酚;丹参;牡丹皮;双丹颗粒剂

外文关键词：Paeonol ; Danshen Root ; Tree peony Bark ; Granules

摘要：目的研究双丹颗粒剂制备工艺。方法将处方中丹参、牡丹皮两味药进行水提,以丹皮酚的得率作为考察指标,采用正交实验,HPLC法测定丹皮酚含量,对其得率进行综合评价,优选出最佳的提取工艺。并建立质量标准。结果水提工艺的最佳条件为:加药材9倍量的水回流提取3次,1.5h/次,丹皮酚的提取率最高。高效液相色谱(HPLC)法测定丹皮酚的含量,丹皮酚在0.0044～0.022mg/ml的范围内呈良好的线性关系,r=0.99761。精密性实验RSD为1.4%,稳定性实验RSD为1.81%,回收率为102.158%,RSD=1.79%。由此证明用丹皮酚的含量可作为双丹颗粒剂质量部分的控制指标。结论该工艺合理,检测方法简便可靠,精密度高;质量标准符合《中国药典》相关部分的规定;初步稳定性较好。
Objective To study the preparation technology of Shuang Dan granules. Methods Danshen Root and Tree peony Bark of were prescription extracted by purified water. With orthogonal design, the extraction rate of paeonol was used as the index. The content of paeonol was determined by HPLC, and the quality standard was established. Results The best plan of extraction technology by purified water was decocted three times, 1.5h each time, with nine times purified water added. The extraction rate of paeonol was the highest. The content of paeonol was determined by HPLC. The linear correlation was within the range of 0.004 4 -0. 022 mg/ml ,r = O. 997 61. Precision of HPLC was well. RSD of precision test was 1.4% , and sample solution was stable. RSD of stability test was 1.81%. The average recovery was 102. 158% ,RSD = 1.79% . Therefore, it was proofed that the content of paeonol can regulation indexs of Danshen Root and Tree peony Bark granule on quality. Conclusion The technology is reasonable. The method of detection is convenient and reliable. The precision is high. The quality standard is consistent with rule of related part of pharmacopeia. The primary stability is good.