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《Chinese Journal of New Drugs》 2011-10
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Quality of Bajijiasu enteric coated sustained-release tablets with hydrogel matrix

CHEN Di-ling,ZHUANG Man-xian,LIN Li,CHEN Yong-gang,DENG Rui-yun(College of Chinese Materia Medica,Guangzhou University of TCM,Guangzhou 510006,China)  
Objective: To establish the methods to control the quality of Bajijiasu enteric coated sustained-release tablets with hydrogel matrix.Methods: The weight variation of the tablets was measured,and the release rate was detected by ameliorated rotating basket method according to the requirements of Chinese Pharmacopoeia(Appendix IA),the spot of Bajijiasu was identified by thin-layer chromatography(TLC),the content of Bajijiasu was detected by liquid-evaporative light chromatography(HPLC-ELSD).Results: The tablet weight variation and release rate met the needs of Chinese Pgarmacopoeia 2010.The characteristic spot of Bajijiasu was identified by TLC,and no interference was found in the negative sample.The contents of 5 batches of the preparation were among 38.33~40.89mg in each tablet,which were 93.0%~107.0% of labeled content.Conclusion: The preparation indexes meet the needs of the general standard.Bajijiasu can be correctly identified by TLC;the content of Bajijiasu meets the needs,so the quality of the hydrogel matrix and enteric coated sustained release tablet of Bajijiasu can be controlled.The methods are accurate,reliable,reproducible,and can be used to the quality control of the Bajijiasu enteric coated sustained-release tablets with hydrophilic matrix.
【Fund】: 海南省重点科技计划项目(090603)
【CateGory Index】: R944
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