白芍配方颗粒制备工艺优化及质量控制

Technique Optimization of Preparation and Quality Control of Paeonia Lactiflora Formula Granules

目的:优化白芍配方颗粒的制备工艺,建立其中芍药苷的含量测定方法。方法:以正交试验法对白芍配方颗粒中白芍水提工艺的影响因素进行考察,优选工艺条件;用高效液相色谱法测定芍药苷含量:色谱柱为CrosmosilC18(250mm×4.6mm,5μm),流动相为乙腈-0.1磷酸(14∶86),检测波长为230nm,柱温为25℃。结果:优选提取工艺为:12倍量水、回流提取3次(每次1h)。芍药苷提取率为85.7%,平均得率为34.4%;芍药苷在0.128～0.640μg(r=0.9998)范围内呈良好线性关系,平均回收率为100.76%(RSD=1.26%)。结论:白芍配方颗粒的制备工艺稳定、可行,评价指标可靠、合理。

OBJECTIVE： To optimize the extraction process for the preparation of Paeonia lactiflora formula granules and establish an HPLC method for the determination of Paeoniflorin in the samples. METHODS： The optimum water extraction process was selected by the L9（3^4） orthogonal design and the content of Paeoniflorin in formula granules was analyzed by HPLC.The HPLC assay was performed on a crosmosil C18-MS- Ⅱ（250mm×4.6mm,5μm） column. The mobile phase was employed by using acetonitrile- 0.1% phosphoric acid（14 ： 86） .The detection wavelength was set at 230 nm and the system was operated at 25℃ .RESULTS： The optimum extraction conditions were to reflux for 3 times with 12 fold water and each time for one hour. The extraction rate of Paeoniflorin was 85.7% and the dried extraction yield was 34.4% .The peak area had a good linearity with the concentration of Paeoniflorin and the linear range was 0.128-0.640μg（r ： 0.999 8） .The average recovery was 100.76% and RSD was 1.26%. CONCLUSION： The preparation process of Paeonia lactiflora formula granules was stable and feasible. The HPLC method for quality control was accurate and suitable.