Study On The Preparation Technology And Quality Standards Of Yuyetang Granules

Objective:This study is based on the systematic examination of the documentary records of the classical formula Yuye Decoction,the systematic study of its extraction process and molding process,the preparation of Yuye Decoction granules,and the study of quality standards,to lay the foundation for the research and development and clinical application of the classical formula.Methods:The ancient literature was reviewed to examine the prescription source,usage and dosage,efficacy and main treatment of Yuye Decoction,the base source of the prescription herbs,and the prescription dosage.Study on extraction technology:Using the total extraction of Astragaloside and Puerarin as the indicators,the effects of three factors on the indicators,namely extraction time,extraction frequency and water addition,were investigated by L₉（3⁴）orthogonal test method,and the best aqueous extraction process of Yuye Decoction granules was preferably selected.Study on molding process:The soft material properties were used as indicators to screen the concentration of wetting agent ethanol;the granule forming rate,moisture absorption rate,melting time,and resting angle were used as indicators to comprehensively evaluate and screen the types of excipients and the ratio of medicine and excipients to prepare Yuye Decoction granules.Study on quality standard:The Yuye Decoction granules were examined accordingly with reference to the“Chinese Pharmacopoeia”;the identification of Kudzuvine Root,Yam,Schisandra and Radix Trichosanthis in the granules was carried out by TLC method;the content of Astragaloside and Puerarin in the granules was determined by HPLC method,and the quality standard of Yuye Decoction granules was determined.Result:1.Prescription verification:The seven herbs in c are all consistent with the base source of herbs included in the“Chinese Pharmacopoeia”.According to Zhang Xichun’s theoretical ideas on the treatment of diabetes and the analysis of the prescription herbs of Yuye Decoction,the formula uses wild Kudzuvine Root for Kudzuvine Root and northern Schisandra for Schisandra.The modern dosage of the prescription is raw yam（36.2g）,raw astragalus（18g）,Zhi Mu（21.6g）,raw inner membrane of chicken gizzard（7.2g,pounded fine）,kudzuvine root（5.4g）,Schisandra（10.8g）,and radix trichosanthin（10.8g）.2.Extraction process:Add 10 times the amount of water（12 times the amount of water added for the first time）and decoct 3 times for 90 min each time.3.Molding process:Dosing according to the ratio of 1:1.5 of dry paste powder and dextrin,adding 80%～85%of ethanol to prepare soft material,sieving and granulating,drying at 60℃,whole granule,packing,15g/bag.4.Study on quality standard:TLC method was used for the thin layer identification of Kudzuvine root,Yam,Radix Trichosanthin and Schisandra Chinensis in the prescription,the established thin layer identification method is clear,scientific and feasible,and can be used for the identification of each herb in Yuye Decoction granules;HPLC method for the determination of Astragaloside and Puerarin content,it is clear that each bag of Yuye Decoction granules contains Astragaloside and Puerarin not less than 0.74mg and 19.0mg respectively.The fingerprints of Yuye Decoction granules were established,and four peaks of Puerarin,Mangiferin,Calycosin-7-glucoside and Schizandrin were identified.The established method is stable and feasible,the similarity of 10 batches of samples was within98%,can be used for the quality evaluation of Yuye Decoction granules.Conclusion:Yuye Decoction is a classic formula of the Qing Dynasty.This study determined the base source of the prescription herbs and the modern conversion dose through documentary evidence,and selected a stable and feasible preparation process for Yuye Decoction granules through systematic study of the extraction process and the molding process,and formulated a scientific and feasible quality standard through the quality standard study,which provides a scientific basis for the further development of Yuye Decoction.