ABSTRACT
Objective To investigate the parameter of technical shaping process of Muxiang Shunqi Wan and select appropriate auxiliary materials to enhance the time limit of dissolution. Method Select parameter of technical shaping process by orthogonal test and choose the best dosage of disintegrant by well-proportioned design. Results The best preparation and technical shaping process of Muxiang Shunqi Wan is as follows:the drug powder is refined with CMS-Na 1.4%, CCNa 0.5%, 60 ℃ dry. Conclusion Pills made by this technical process appear round and smooth, the colour and luster are equal and conformable, the dissolving time limit is short and the quality is good, therefore, they are up to the GMP requirements.
ABSTRACT
Objective To set up the quality standard of Wanbile Wan. Method s Fructus Psoraleae, Radix Puerariae, Radix paeoniae Alba and Radix Glycyrrhiza e Preparatae in Wanbile Wan were identified by TLC .Isopsoralen was determined b y TLC scanning. The chromatographic conditions were: high performance silica gel G plate as lamellated plate, n- hexane - ethyl acetate (8 ∶ 2)being the exp ander, serrated scanning with single- wavelength reflection, beam stricture of 0.4? 0.4 mm, linear parameter SX=3 and scanning wavelength at 300 nm. Results The TLC spots were highly specific, clear and concentrated without interferen ce of the presence of negative controls. Isopsoralen showed a good linearity wit hin the range of 0.064～ 1.536 ? g, r=0.9980, average recovery rate was 100.7 % , and RSD was 2.0% .Conclusion This method can be used for the quality co ntrol of Wanbile Wan.