Study On The Preparation And Quality Standard Of Standard Decoction And Formula Granule Of Akebiae Fructus

Background Traditional Chinese medicine formula granules are a new form of medication derived from the modern development of traditional Chinese medicine,and are of great significance to the standardized production of traditional Chinese medicine preparations and clinical standardized medication.Its development space is vast,its policy advantages are significant,and its market benefits are increasing year by year.However,its quality standard research,traceability system establishment,and pharmacodynamic research are still key problems to overcome.Objective Through the research on the quality analysis and preparation technology of all aspects of traditional Chinese medicine Akebiae Fructus decoction pieces,Akebiae Fructus standard decoction,and Akebiae Fructus formula granules,preliminary drafting of the sources of decoction pieces that can be used for the preparation of Akebiae Fructus formula granules,and the extraction process of Akebiae Fructus standard decoction is optimized.Drafting the quality standards of Akebiae Fructus formula granules,provides a certain scientific basis and theoretical parameters for the standardization of the production process and product quality of Akebiae Fructus formula granules.Methods（1）A total of 15 batches of Akebiae Fructus pieces from 5 different origins were collected.According to the requirements of Akebiae Fructus item in the first part of the2020 version of CP,the quality evaluation of their traits,identification,inspection,and determination of the active ingredientα-Hederin saponin was carried out.The characteristic chromatogram of Akebiae Fructus pieces was established by HPLC,and the source of decoction pieces that can be used for the preparation of formula granules were determined.（2）Take the soaking time,the amount of water added,and the decoction time as the investigative factors to conduct a single-factor investigation.The L₉（3⁴）orthogonal test was designed to screen out the best extraction process of Akebiae Fructus standard decoctions based on the extraction rate,the content ofα-Hederin saponin and its transfer rate.According to the best extraction process,15 batches of Akebiae Fructus standard decoctions were prepared.Establish the characteristic chromatogram of Akebiae Fructus standard decoction and conduct a methodological investigation on it.（3）Taking the types of excipients,the ratio of adjuvants and wetting agents as influencing factors,the forming process of formula particles was investigated.The molding rate,fluidity,and hygroscopicity of the granules are used as evaluation indicators to establish the optimal formulation granule preparation process,and prepare 15 batches of Akebiae Fructus formula granules.（4）With reference to"Technical Requirements for Quality Control and Standard Formulation of Traditional Chinese Medicine Formula Granules",Design traits,identification,inspection,content determination,characteristic chromatogram and other check items to systematically evaluate the quality control of Akebiae Fructus formula granules,and draft the quality standard of predictive sub-prescription granules.Results（1）The properties of 15 batches of Akebiae Fructus pieces are all in line with the description of the pharmacopoeia.Among them,there are more oblong tablets from Hubei and Yunnan,which are related to the processing of the origin.The pieces of decoction produced in Jiangsu and Anhui are relatively large.TLC identification showed that 15 batches of test products showed spots of the same color in the corresponding positions of the chromatography of reference medicinal materials and reference substances.In the inspection items,the moisture range is again 8.4%to 10.3%;the total ash content is again 3.4%to 5.3%;the residual sulfur dioxide range is 21.8 to 33.3μg/g,and the content ofα-Hederin saponin is between 0.31%and 0.61%,All meet CP standards.There are six characteristic peaks in the characteristic chromatogram of Akebiae Fructus pieces,and the specified values are:Peak 1（5.816）,Peak 2（6.489）,Peak 3（8.608）,Peak 4（9.134）,Peak 5（11.084）,Peak 6（13.422）.（2）According to the results of orthogonal experiments,the best extraction process of Akebiae Fructus standard decoction was selected as follows:the volume of water added for the first time is 12 times the weight of the pieces,after soaking for 40 minutes,decoct for 120 minutes,filter,add 10 times water to the filter residue,decocting for 60 minutes,filtering,and combining the two filtrates.There are five characteristic peaks in the characteristic chromatogram of Akebiae Fructus standard decoction,the specified values are:peak 1（5.491）,peak 2（6.135）,peak 3（8.108）,peak 4（8.618）,peak 5（12.699）.（3）The best molding process for standard decoction is:standard decoction（dry paste powder）and dextrin are uniformly mixed in a ratio of 1:0.8,sprayed with an appropriate amount of 80%ethanol as a wetting agent,and granulated by wet extrusion.Dry it in an oven at 60℃,mix and granulate,and then get it.（4）With reference to the"Technical Requirements",the relevant quality control items of Akebiae Fructus granules were designed,and the reference value range was given through the quality evaluation,and the quality standard of Akebiae Fructus granules was initially established.Conclusion（1）The quality evaluation of 15 batches of Akebiae Fructus pieces was completed,and the suitable raw material drug production area was selected.（2）The standard decoction extraction process and formula granule forming process were determined,and 15batches of standard decoction and formula granules were prepared.（3）Established a quality evaluation system for Akebiae Fructus formula granules and stipulated corresponding reference values,drafting the"Akebiae Fructus Formula Granules Quality Standard".