扶正口服液的制备及质量标准的研究

Study on Preparation and Quality Standard for Fuzheng Oral Liquid

目的 :研究扶正口服液的最佳工艺条件及质量标准。方法 :1采用 L9(34 )正交试验法 ,以总固体为筛选指标。 2用薄层色谱法对丹参、女贞子、人参、枸杞等进行鉴别。结果 :煎煮次数 (D)对总固体含量有显著性影响 (P<0 .0 1)。并建立其质量标准。结论 :优选得到的工艺稳定、可行 ;鉴别方法简单、重现性好 ,可做为该制剂质量控制标准。

Objective To study the optimum extraction conditi ons and the quality standard for Fuzheng oral liquid.Methods ①T he orthogonaldesign L 9(34) was used.The content of total solid is taken as s cr eeningindex.②Danshen,Nuzhenzi,Renshen and Gouqi were identified by TLC. Re sults Times of extraction(D) has significant influence on the total solid( P<0.01).The quality standard was constituted.Conclusion This optim izedprocess is stable and efficient.These identification methods are simpleand r eproducible.They may be used for the quality control of preparation.