Study on the dry preparation technology and quality standard of classic Xiaochengqitang granules
Objective:To optimize the dry preparation technology of Xiaochengqitang granules and establish its quality control method.Methods:Taking the one-time forming rate,angle of repose,hygroscopicity and solubility of the granules as the inspection indexes,on the basis of single factor inspection of the tablet pressure of the dry granulator,the proportion of excipients(dextrin:soluble starch)and the amount of silica,combined with the orthogonal test,the best dry preparation technology of Xiaochengqitang granules was optimized.The contents of free and total anthraquinones(including rhein,emodin and chrysophanol)in Xiaochengqitang granules were determined by thin layer chromatography(TLC)and HPLC,and its quality control standard was established.Results:The optimized dry preparation technology of Xiaochengqitang granules was as follows:dry paste powder:excipients=7∶3,excipients(dextrin:soluble starch=1:1),silica dosage 5％,tablet pressure 22 MPa.The TLC identification spots of Rhubarb,Magnolia officinalis and Fructus Aurantii in the granules are clear and negative without interference.The linearity was good in the range of 36.22～362.20 ng for rhein,36.80～368.00 ng for emodin,and 38.44～384.40 ng for chrysophanol(R2=0.999 9).The average recoveries of free rhein,emodin and chrysophanol were 98.46％,102.25％and 99.02％,respectively;The average recoveries of total rhein,emodin and chrysophanol were 95.18％,93.84％and 97.94％respectively.Conclusion:The optimized dry preparation technology conditions are stable,feasible and suitable for large-scale production;The quality control method is simple and accurate,and can be used for the quality control of Xiaochengqitang granules.
Xiaochengqitang granulesdry granulationthin layer chromatography identificationHPLC determinationquality standard
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