胆胰康泰胶囊的研制及质量控制

Preparation and quality control of danyi kangtai capsule

目的研制胆胰康泰胶囊并建立其质量控制方法。方法选用最佳处方,并通过鉴别、含量测定等进行质量控制,其中含量测定采用高效液相色谱法,检测波长为280 nm。结果胆胰康泰胶囊符合胶囊剂的质量要求。结论胆胰康泰胶囊处方工艺简单,成品质量稳定,质量控制方法简便快捷。

Objective To develop Danyi Kangtai capsule and establish of its quality control methods. Methods The best prescription was determined, and the quality control was established through the identification, determination of content, etc. And the content was determined by HPLC, with the detection wavelength 280 nm. Results Danyi Kangtai capsule was in line with quality requirements. Conclusion The prescription process of Danyi Kangtai capsule was simple, products quality was stable, quality control method was simple and fast.