烫骨碎补配方颗粒的提取工艺优选及其含量测定

Extraction Process and Determination of Burning Drynariae Rhizoma Formula Granules

摘要:

目的: 优选烫骨碎补配方颗粒的提取工艺,建立柚皮苷的含量测定方法,为有效控制该制剂的质量提供参考。方法: 以柚皮苷提取量和出膏率为综合评价指标,采用正交试验考察加水量、提取时间和提取次数对烫骨碎补配方颗粒提取工艺的影响。采用HPLC测定柚皮苷含量,流动相甲醇-乙酸-水(35:4:65),检测波长283 nm。结果: 最佳提取工艺为浸泡0.5 h,加10,8倍量水提取2次,每次0.5 h;柚皮苷质量分数0.77%,出膏率12.6%。柚皮苷在0.063~1.575 μg与峰面积呈良好线性关系,平均加样回收率100.70%,RSD 1.2%;暂定本品配方颗粒每1 g含柚皮苷≥5.0 mg。结论: 该提取工艺和含量测定方法稳定可行,有效成分提取效率高,为烫骨碎补配方颗粒的生产和质量控制提供参考。

Abstract:

Objective: To optimize extraction process of burning Drynariae Rhizoma formula granules and establish determination of naringin in this preparation. Method: Taking extracting amount of naringin and yield of dry extract as a comprehensive evaluation index,orthogonal test was adopted to optimize extraction process with the amount of water,extraction time and extraction times as factors.Naringin in this formula granules was determinated by HPLC,mobile phase was methanol-acetic acid-water(35: 4: 65) and detection wavelength was 283 nm. Result: The best extraction technique was as follows:soaked 0.5 h,extracted 2 times with 10,8 times the amount of water for 0.5 h per time.The mass fraction of naringin was 0.77% and yield of dry extract was 12.6%.Calibration curve of naringin was linear in the range of 0.063-1.575 μg,average recovery was 100.70% with RSD of 1.2%.Tentatively per 1 g of this formula particle contained ≥5 mg of naringin. Conclusion: This extraction process and determination are stable and feasible with high extraction efficiency of naringin,which can be scientific basis for production and quality control of burning Drynariae Rhizoma formula granules.