川降养心滴丸质量标准研究

Study on quality standard for Chuanjiang Yangxin pills

目的建立中药复方制剂川降养心滴丸的质量标准。方法采用TLC法鉴别川降养心滴丸中的川芎、降香;用HPLC法对制剂中丁烯基苯酞和橙花叔醇进行定量分析。结果建立的定性鉴别分离度好、专属性强,丁烯基苯酞质量分数测定的线性范围为0.093 12~0.931 2μg（r=0.999 8,n=6）,平均回收率为96.50%（RSD=1.08%,n=6）;橙花叔醇质量分数测定的线性范围为0.15~1.5μg（r=0.999 9,n=6）,平均回收率为96.71%（RSD=1.40%,n=6）。结论本方法准确可靠、灵敏度高、专属性强,可有效控制川降养心滴丸的质量。

Objective To establish the quality standard for Chuanjiang Yangxin pill. Methods Szechwan lovage rhizome and rosewood were identified by TLC. N-butylidenephthalide and nerolidol were determined by HPLC. Results The characteristic identification by TLC was distinct and highly specific. Nbutylidenephthalide showed a good linearity in the range of 0.093 12-0.931 2 μg（ r = 0.999 8,n = 6）,and the average recovery was 96.50%（ RSD = 1.08%,n = 6）. Nerolidol had a good linearity within the range of0.15-1.5 μg（ r = 0.999 9,n = 6）,the average recovery was 96. 71%（ RSD = 1. 40%,n = 6）. Conclusion The method was reliable,accurate and specific. It could be used for quality control of Chuanjiang Yangxin pills.