白芍配方颗粒制备工艺优化及质量控制

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。

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

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(34)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,5μ m)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～ 0.640μ g(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.