双丹颗粒剂制备工艺的讨论【摘要】 目的讨论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，采纳正交实验，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， h/次，丹皮酚的提取率最高。高效液相色谱法测定丹皮酚的含量，丹皮酚在 4～ mg/ml 的范围内呈良好的线性关系，r = 0. 997 61。精密性实验 RSD 为%，稳定性实验 RSD 为%，回收率为％，RSD＝%。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。【关键词】 丹皮酚；丹参；牡丹皮；双丹颗粒剂 Abstract：ObjectiveTo study the preparation technology of Shuang Dan 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 The best plan of extraction technology by purified water was decocted three times， 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 4 ～ mg/ml,r= of HPLC was well. RSD of precision test was %，and sample solution was stable. RSD of stability test was %. The average recovery was ％，RSD＝% .Therefore， it was proofed that the content of paeonol can regulation indexs of Danshen Root and Tree peony Bark granule on quality. ConclusionThe technology is method of detection is convenient and reliable. The precision is quality standard is consistent with rule of related part of primary stability is good. Key words： Paeonol； Danshen Root； Tree peony Bark； Granules 双丹颗粒剂的主要成...
