Study On The Preparation Technology And Quality Standard Of Yiwei Shu Tablets

Yiwei shu tablet is a tablet made from the main raw materials of corydalis tuber,Bletilla and Ophiopogon japonicus.It has the symptoms of treating gastric ulcer and alleviating stomach discomfort.There are fewer extracts from both foreign and domestic,so the extract has a promising market future.Study on the extraction process of yiweishu tablet:according to the characteristics of Chinese medicinal materials,and according to the principle of extraction equipment,the effective components of Chinese medicinal herbs were leached out as far as possible,so as to determine the process route of extracting the effective components of Chinese medicinal materials.In this paper,the orthogonal experiment method was used to study the content of ephedrine as the test index,and the number of acetic acid and the number of decoration needed for the decoration of the decoration was studied.Alcohol precipitation conditions were used to optimize the concentration of alcohol,liquid concentration and static time.It is known that the extraction process of yiweishu tablet is stable and feasible.Preparation process:this part studies the preparation of granule by one-step granulation,and the selection and dosage of the auxiliary materials are used to investigate the factors of granulation.The results show that the preparation process of the tablet is stable and feasible,and the conditions are reasonable and reliable,which can be produced in large quantities.Quality standard study:TLC method was used to identify the ingredients of medicinal herbs.HPLC method was used to determine the main effective components in polyanthus,and the related regulations of finished tablets were examined.Stability study:according to the requirements of new drug research and development,the initial stability test of yiweishu tablet was carried out,the stability test was accelerated,and the appearance traits,identification,examination and content determination were examined for 6 months.The results showed that the optimal extraction process was:extraction of polyanthus by acetic acid extraction method,the number of glacial acetic acid,glacial acetic acid concentration and decoration of boiling liquid was investigated,and the extraction process was finally determined to add 6 times of water,5%glacial acetic acid concentration,and 3 times of decoration.The concentration mode is concentrated under reduced pressure.In the study of the quality standard of preparation,the TLC identification of corydalis tuber,Bletilla and Ophiopogon japonicus was established and detected,and the results showed that the TLC identification was clear and easy to be excused,and the reproduction was good,and the negative control was not interfered.The results of the determination of the content of the intercourse:in the sample,the linear regression equation of the standard curve graph is y ＝16219x-19.335,r = 0.9999,RSD = 0.61%,the recovery yield is 99.87%,RSD = 0.41%.This study shows that the preparation process of yiweishu tablet is stable,the quality standard is comprehensive,the stability result is good,the science is feasible,and the ability supports mass production.