Research On Zhuang Yao Jian Shen Film Coating Tablet

Zhuang Yao Jian Shen Tablet,a sugar-coated tablet(ZYJS-SC)produced by Zhongshan Hengsheng Pharmaceutical Co.,Ltd.since 1985.It is necessary to improve the technology to obtain a new dosage form to expand the sales.This study is to obtain a film coating tablet ZYJS-FC,meanwhile to improve the manufacturing technique,and to establish the new quality standard to control ZYJS-FC,to formed the new quality standard draft.At the same time,to analyze the chemical components of ZYJS-FC for providing support for pharmacodynamics research and clinical trials future.1.Confirm the original and processing method of the raw materials of TCMUse conference,and description test to confirm the original of the raw material of TCM of ZYJS-FC.To confirm the processing method of Taxilli herba(steam),Ligustri lucidi fructus(steam),Guscutae semen(stir-baked with salt-water),because the method of the quality standard is different of Chp.Record the method in the quality standard of ZYJS-FC.2.Formulation and process studyTo innovate the sugar-coated tablet as film coated tablet,implement the procedure research,including the granulation method,choice the binder material,investigate the hardness,looseness,whether to drop powder,choose film coating materials,coating.3.Improvement of quality standard of ZYJS-FC(1)Delete the identification2,3,4.(2)Increase the TLC method of Radix radsurae coccineae,the method must be validated,include specificity and durability.(3)Study on the specific chromatogram,Specify the attribution of characteristic peaks of the raw materials of TCM,and to be validated the method.(4)Study on the assay,confirm the method of HPLC for protocatechuic acid,and to be validated the method,include certainty,accuracy,specificity,linearity,durability.(5)Drafting the quality standard and the specification of quality standard.Confirm the processing method of the raw materials of TCM,Ligustri lucidi fructus of steam,Ligustri lucidi fructus of steam,Guscutae semen of stir-baked with salt-water,Record the method in the quality standard.Establishment the formulation and process,use 15% sugar to make simple syrup(72%)as binder material,then add the syrup to the dry extract powder,blending.Prepare the film coating solution with red waterborne crimson film coating premix(WK25033)a solid content of 16% with purified water.The tablets were coated with coating pan air inlet temperature of60～70℃,core tablet temperature of 37～52℃,atomization pressure of 0.8 bar,coating pan speed of 10 rpm and coating solution flow rate of 2.3g/min.the weight of plain tablets before coating was 0.28 g,and the weight of coating tablet 0.29 g,with a weight increase of 3.6%.Improvement of quality standard:(1)Microscopical,TLC identification of Taxilli herba.(2)TLC identification of Radix radsurae coccineae.(3)the specific chromatogram,specify the attribution of characteristic peaks of the raw materials of TCM.(4)HPLC for protocatechuic acid,use octadecylsilane of bonded silica gel as the stationary phase and a mixture of acetonitrile and 0.2%phosphoric acid solution of(5:95)as the mobile phase.As detector a spectrophotometer set at 260 nm.Which should good certainty,accuracy,specificity,linearity,durability,all the RSD<2%.The linear range is 0.04918-1.5738 and the relationship is good.(5)Confirm the quality standard.To defined the material basis include 376 compounds,the main material basis was triterpenoids,flavonoids,lignans and phenolic acids.The new formulation and process is useful,and the method of the quality standard are advanced of the ZYJS-FC,improve the quality control level of the product,and lay a working foundation for the application of new dosage forms.