夏枯草配方颗粒制备及质量测定研究

Study on Preparation and Quality of Prunella vulgaris Formula

摘要: 目的：筛选夏枯草配方颗粒制备工艺及进行颗粒剂中齐墩果酸含量测定研究。方法：采用正交实验优化方法筛选出最佳颗粒剂制备工艺，HPLC法测定颗粒剂中齐墩果酸的含量，同时对制成的九批夏枯草颗粒进行微生物限度检查。结果：筛选出了夏枯草配方颗粒的最佳制备工艺。齐墩果酸在0.8 μg3.2 μg范围内呈良好线性关系，线性方程为y =577891x − 826.9，相关系数r = 0.9998，平均回收率100.25%，RSD 1.5%。九批夏枯草颗粒的微生物限度检查结果均符合药典颗粒剂项下微生物限度相关规定。结论：该工艺稳定可控操作简便，可为夏枯草配方颗粒制备及质量研究提供实验依据。

Abstract: Objective: To screen the preparation technology of Prunella vulgaris formula granules and determine the content of oleanolic acid in the granules. Methods: Orthogonal experiment was used to op-timize the preparation process of the granules. The content of oleanolic acid in the granules was determined by HPLC, and the microbial limit of nine batches of Prunella vulgaris granules was examined. Results: The best preparation technology of Prunella vulgaris formula granules was screened out. Oleanolic acid showed a good linear relationship in the range of 0.8 μg~3.2 μg. The linear equation is y = 577891x − 826.9, the correlation coefficient is r = 0.9998, the average recovery is 100.25%, RSD 1.5%. The microbial limit test results of nine batches of Prunella vulgaris granules were in line with the relevant provisions of the pharmacopoeia on microbial limit of gran-ules. Conclusion: The process is stable, controllable and simple, which can provide experimental basis for the preparation and quality study of Prunella vulgaris formula granules.