医疗机构制剂补肾生精片质量标准提升研究

Research on improving the quality standards of Bushen Shengjing tablets for medical institution preparations

目的 优化潘茂名验方医院制剂注册申请品种补肾生精片的质量标准。方法 采用薄层色谱法(TLC)对补肾生精片中君臣药味淫羊藿、盐巴戟天、熟地黄进行定性鉴别。采用高效液相色谱法(HPLC)对补肾生精片中有效成分淫羊藿苷进行含量测定。结果 定性鉴别中淫羊藿、盐巴戟天、熟地黄三味药材的薄层斑点清晰,分离度好,且阴性对照无干扰。定量检测中淫羊藿苷在0.025~0.300 mg/ml区间内呈良好的线性关系(线性回归方程为y=13524.5915x-22.6651,R^(2)=0.9999),加样回收率为103.51%(RSD=1.44%)。结论 补肾生精片优化后的质量标准方法简单可行,结果稳定可靠,重复性好,能够很好地用于实际生产中该制剂品种的质量控制。

Objective To optimize the quality standards of Bushen Shengjing tablets for the application of registration of hospital preparation variety of the proven recipe of the descendant of Pan Maoming.Methods Thin layer chromatography(TLC) was used to add the qualitative identification of monarch and ministerial medicinal herbs such as epimedium,morinda officinalis processed with salt and raw morinda officinalis,and radix rehmanniae praeparata in Bushen Shengjing tablets.High-performance liquid chromatography(HPLC) was used to determine the content of the effective component epimedium in Bushen Shengjing tablets.Results The thin layer spots of the newly added herbs of epimedium,morinda officinalis processed with salt and raw morinda officinalis,and radix rehmanniae praeparata in qualitative identification were clear,with good separation and no interference in the negative control.In the quantitative test,epimedium showed a good linear relationship in the range of 0.025-0.300 mg/ml(linear regression equation:y=13524.5915x-22.6651,R^(2)=0.9999).The recovery rate of the sample loading was 103.51%(RSD=1.44%).Conclusion The optimized quality standard method for Bushen Shengjing tablets is simple and feasible,with stable and reliable results,and good repeatability,and can be well used for quality control of this preparation variety in actual production.