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目的:建立郎氏扶正颗粒的制备方法及质量标准。方法:采用水提醇沉工艺制备郎氏扶正颗粒;采用高效液相色谱法对黄芪甲苷和斯皮诺素进行含量测定;采用薄层色谱法对黄芪和白术进行定性鉴别。结果:采用高效液相色谱测定黄芪甲苷和斯皮诺素的含量:黄芪甲苷和斯皮诺素分别在0.476~7.616μg(r=0.9994)、0.0771~1.2339μg(r=0.9999)的线性范围良好,加样回收试率分别为97.45%(n=6)、101.93%(n=5)。采用薄层色谱法对方中黄芪和白术的薄层色谱进行定性鉴别,特征性强,重现性好。结论:本制剂制备方法合理、简便、可行,所建立的质量标准可为郎氏扶正颗粒的临床应用疗效提供保证。
Objective: To establish the preparation method and quality standard of Lang’s Fuzheng granule. METHODS: Langfuzhengzheng granule was prepared by water extraction and alcohol precipitation. The contents of astragaloside Ⅳ and spinosin were determined by HPLC. The qualitative identification of Astragalus membranaceus and Atractylodes macrocephala was carried out by TLC. Results: The contents of astragaloside and spinosin in astragaloside and spinosin were determined by high performance liquid chromatography (HPLC) with the linearity of 0.476 ~ 7.616μg (r = 0.9994) and 0.0771 ~ 1.2339μg (r = 0.9999) The range was good, and the sample recovery rates were 97.45% (n = 6) and 101.93% (n = 5), respectively. By TLC, the TLC and HPLC of Astragalus membranaceus and Atractylodes macrocephalae were identified qualitatively and reproducibly. Conclusion: The preparation method of this preparation is reasonable, simple and feasible. The established quality standard can provide the guarantee for the clinical application of Langzifuzheng granule.