健脾颗粒的制备工艺及质量比较

Comparative Study of Preparation Technology and Quality of Jianpi Granule

目的:探索无糖型健脾颗粒的成型处方和制备工艺,确定其可行性和合理性。方法:对无糖型健脾颗粒与健脾颗粒的成型处方和制备工艺进行对比,采用HPLC和TLC对2种颗粒剂进行定量和定性研究。结果:采用乳糖、糊精制备的无糖型健脾颗粒完全符合2010年版《中国药典》要求;2种颗粒均可检出白术、陈皮和枳实;无糖型健脾颗粒中橙皮苷质量分数10.15 mg·g-1,健脾颗粒10.64 mg·g-1。结论:无糖型健脾颗粒可完全替代健脾颗粒,且该制剂的质量稳定、服用剂量小、解除禁糖患者的用药限制,扩大了临床应用范围。

Objective： To explore forming prescription and preparation technology of sugar-free Jianpi granule, and verify its rationality and feasibility. Method： Forming prescription and preparation teehnology of sugar-free Jianpi granule and Jianpi granule were compared, and this two kinds of granule were identified quantitatively and qualitatively by HPLC and TLC. Result： Prepared sugar-free Jianpi granule with lactose and dextrin complied with requirement of 2010 edition ＇Chinese Pharmacopoeia＇; Atractylodes macrocephala, Citrus reticulata and Citrus aurantium from two kinds of granule could be identified by TLC; The mass fraction of hesperidin from sugar-free Jianpi granule was 10. 15 mg-g-1, but hesperidin from Jianpi granule was 10. 64 mg-g- 1 Conclusion： Sugar-free Jianpi granule could completely replace Jianpi granule, because it had advantages of stable quality, low dosage and large scope of clinical application with removing medication restriction of ban sugar patients.