| Objective: The clinical formula "Yi Qi Hua Jie" is given to patients in the form of soup.It is proposed to develop the clinical formula "Yi Qi Hua Jie" into Yi Qi Hua Jie Wan,and conduct research on the preparation process,quality standard and pre-stability to provide a basis for further declaration of new drugs.Methods:(1)Preparation process research: By reviewing the relevant literature and combining the nature of the drug components in the formula,combined with the needs of the preparation molding,select the dosage form and design the process route;the dry paste yield and the transfer rate of mauroisoflavone glucoside as the index,the water addition,extraction times and time as the factors to be investigated,single-factor test,optimization of the water extraction process conditions,mauroisoflavone glucoside transfer rate by using HPLC method was used for analysis.In the molding process research,the nature of the powder,pill mold or pill evaluation index and starting conditions,increasing conditions,drying conditions,etc.were investigated,mainly to investigate the wettability,fluidity,heap density of the powder,the roundness of the pill,particle size,dissolution time limit,etc.(2)Study on quality standard: Microscopic identification analysis was applied to the fried stiff silkworm in the original soup prescription,and qualitative identification of other herbs by TLC;a high performance liquid chromatographic method was established to determine the content of mustard base thiocyanate as the detection index.(3)Pre-stability analysis: Based on the results of accelerated test and long-term test experiments,the pre-stability of the product was comprehensively evaluated.Results:(1)Preparation process: The formula of "Benefiting Qi and resolving knots" was prepared as a pill.In the formula,bran fried white atractylodes,bran fried coix seeds,French semen,fried mustard seeds,fried stiff silkworm,vinegar curcuma,cicada molasses,and orris were mixed and crushed,sieved,and set aside;roasted astragalus,cat’s nest,goat’s milk,golden buckwheat,scabbard seeds,vinegar trigon,and ground dragon were boiled twice with water,the ratio of material to liquid 1:10,decocted for 1.5h/each time,filtered,combined filtrate,concentrated into a thick paste with a relative density of1.30±0.02(60℃),and then put The above medicinal powder was put into it,stirred well,dried between 60℃ and 80℃,then it was crushed and sieved.The total amount is adjusted with appropriate amount of starch and mixed well;molding is done with 60% to 80%ethanol pan pills and dried at 60℃ to 80℃.Small test evidence of dry paste yield was20.74% on average,the transfer rate of mullein isoflavone glucoside was 42.91% on average,and the yield of finished product was 92.53% on average;(2)quality standard study,roasted Astragalus,Atractylodes,fried mustard seeds spot clear and reproducible,negative no interference,the fried stiff silkworm for microscopic identification obviously,can be included in the draft quality standard.The content of mustard seed base thiocyanate was determined by HPLC method.The results showed that the linearity of mustard base thiocyanate was good in the range of 0.0059mg/m L-0.0586mg/m L,the average spiked recovery was 100.40%,the RSD was 1.81%,and the average content of three batches of pilot products was 0.28mg/g;the determination of mustard base thiocyanate content was included in the draft quality standard.(3)The analysis of the accelerated test and long-term test data results showed that the quality was stable.Conclusion: The design route of this study is reasonable,the process is simple and feasible,and the transfer rate of the index components is good.The pills produced meet the specification requirements for each test index and have good stability.The draft method of this quality standard is easy to operate,the results are accurate,and it has a good application prospect,and the method can be used to effectively monitor the quality of Yihuaji pills. |
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