Preparation technology and quality standards of the classic formula,Shashen Maidong Granule
Objective To prepare the classic formula Shashen Maidong Granule(SSMDG)and establish its quality standards.Methods The reflux extraction process of Shashen Maidong Decoction was optimized by entropy weight method and orthogonal experiment,compared with the traditional decoction process,and the molding process of granules was further screened.High performance liquid chromatography(HPLC)was used to establish the fingerprint of SSMDG and the content determination method of liquiritin and acid glycyrrhizinate.The similarity of fingerprint and transfer rate of liquiritin in the reference sample(decoction,freeze-dried powder)and each link of granule production(extract,intermediate,finished product)were investigated.Thin layer chromatography(TLC)was used to identify Maidong(Ophiopogonis Radix),Sangye(Mori Folium),Tianhuafen(Trichosanthis Radix),Baibiandou(Lablab Semen Album),and Gancao(Glycyrrhizae Radix Et Rhizoma).Results The optimized reflux extraction process involved soaking for 0 h,extracting twice,adding 10 and 8 times of water,and extracting for 2.0 h and 1.5 h,respectively.The molding process was as follows:90%ethanol was used as wetting agent,20%dextrin for soft material,extruded and granulated by 16 mesh sieve,dried at 60℃,and granulated by 80 mesh sieve to prepare SSMDG.The similarity of fingerprints of 10 batches of SSMDG,reference samples,and each link of granule production was greater than 0.90.The transfer rates of liquiritin in the standard decoction,freeze-dried powder,extract,intermediate,and finished product were 75.60%,75.24%,91.67%,90.22%,and 73.57%,respectively.The TLC characteristic spots of 5 Chinese medicines were clear and negative without interference.Conclusion The results of fingerprint similarity showed that the quality of SSMDG in each batch and each production link was relatively stable and consistent with the reference sample.After reflux extraction,concentration,drying,and granulation,the transfer rate of liquiritin decreased,and the transfer rate of liquiritin in granules was close to that of the original decoction.The preparation process of SSMDG established in this study is stable and reliable,and the quality standard detection method is simple,feasible,and reproducible,hoping to provide reference for the scale production and quality control of SSMDG.
classic formulaShashen Maidong Granulegranulesfingerprintpreparation technologyquality standard
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