Study On Preparation Technology And Quality Standard Of Qiwei Chanshen Granules

Objective:To study on the preparation technology and quality standard of Qiwei Chanshen Granules,and lay a foundation for the development of new Chinese medicine for the treatment of gastric cancer.Methods:1.Based on the metastasis rate of the anti-tumor components of each medicine and the extraction rate of the cream,the single factor method was used to optimize the best extraction solvent.In order to optimize the preparation process of Qiwei Chanshen formula,pharmacodynamics method was used to compare the preparation materials obtained by the optimal extraction solvent of single drug and the preparation materials obtained by the combined extraction process with water of the whole formula.2.The granule was wet granulated.The excipient of Qiwei Chanshen Granules was optimized by single factor experiment.The key technological parameters were determined by Plackett-Burman design.The molding process was optimized by combining Box-Behnken design and AHP-CRITIC mixed weighting method.The physical quality properties of granules were characterized by physical fingerprint method.3.The preliminary quality standard of Qiwei Chanshen Granules was established by studying the TLC identification,content determination and HPLC fingerprint.Results:1.The optimal extraction solvent for each single drug were as follows:Geckos,Panacis quinquefolii radix,Agrimoniae herba and Ganoderma were extracted with water,and dried toad skin,Fagopyri dibotryis rhizoma and Camptotheca acuminate fruit were extracted with ethyl alcohol.The optimal material preparation process of Qiwei Chanshen formula was as follows:seven herbs were extracted with10 times of water,extracted for 3 times,1 h each time,combined the filtrate,and filtrate was concentrated under pressure and dried under pressure.2.The optimal preparation process of Qiwei Chanshen Granules was as follows:dextrin as diluent,stevia as flavour-correcting agent,the dosage ratio of drug to adjuvant was1:0.78:0.02,85%ethanol was the wetting agent,and the dosage of wetting agent was26%.The critical relative humidity of the particles obtained was 72%.The granules similarity of different batches was greater than 0.85 when the physical fingerprint of control was taken as reference.The specification was 14 g/bag.3.TLC identification of dried toad skin,Fagopyri dibotryis rhizoma,Camptotheca acuminata fruit,Panacis quinquefolii radix and Agrimoniae herba was specific and had no negative interference.It is tentatively determined that each bag of Qiwei Chanshen Granules contains no less than 0.40,2.10,1.60,26.85 mg of cinobufagin(C₂₆H₃₄O₆),epicatechin(C₁₅H₁₄O₆),camptothecin(C₂₀H₁₆N₂O₄)and ginsenoside Rb₁(C₅₄H₉₂O₂₃),respectively.Using camptothecin peak as reference peak,17 common peaks were calibrated.The granules similarity of different batches was greater than 0.85 when the HPLC fingerprint of control was taken as reference.Conclusion:The preparation process of Qiwei Chanshen Granules is stable and feasible,and the quality standard is initially established,which can lay a foundation for the new drug research and development of Qiwei Chanshen Granules.