Process Scale-up of Tongmai Zhuyun Granules and Quality Study
Objective:Process scale-up of the preparation of Tongmai Zhuyun Granules and establishment of their quality standards.Methods:Three batches of Tongmai Zhuyun Granules test samples were obtained by sequentially scaling up the small and medial tests of the pellets.The properties of the medial samples were described in a standardized manner.The qualitative identification of Chenpi,Chaobaishao,Chishao and Beichaihu in the pellets was performed by thin-layer chromatography(TLC).The quantitative analysis of peony glycosides was performed by high performance liquid chromatography(HPLC).The chromatographic column was C18(5 μm,4.6 mm×250 mm)with acetonitrile-0.1%phosphoric acid(14∶86)as the mobile phase at a flow rate of 1.0 mL/min and a detection wavelength of 230 nm with a column temperature of 30℃.Results:The process validation of the small trial and the medial test of Tongmai Zhuyun Granules are in compliance with the requirements.The thin layer chromatography of Chenpi,Chaobaishao,Chishao and Beichaihu showed clear main spots and good separation,with no interference in the negative control.Paeoniflorin showed a good linear relationship in the range of 58.3-583.0 ng;the average recovery was 99.97%(RSD=0.35%).Conclusion:The Tongmai Zhuyun Granules is stable and reliable,and the prepared samples have stable properties and uniform quality.The established TLC and HPLC are extremely specialized,repeatable,accurate,and dependable and can efficiently assess Tongmai Zhuyun Granules.
GranulesProcess Scale-upQuality Standard ResearchTLCPaeoniflorin
NETL
NSTL
万方数据
