Study On Quality Evaluation And Formula Granules Of Persimmon Calyx

Persimmon Calyx is the dry calyx of Diospyros kaki Thunb.It has the effects of qi-depressing,nausea,vomiting and suppressing hiccups.As a commonly used Chinese medicine,Persimmon Calyx has abound resources,its quality is different because of different harvest seasons and different growth environments,which leads to different efficacy.At present,there is no content determination in the 2015 edition of the Chinese Pharmacopoeia under the Persimmon Calyx,and the intrinsic quality of the Persimmon Calyx medicinal materials can not be guaranteed.This article aims to improve the quality standard of the Persimmon Calyx medicinal materials and evaluate the quality of the Persimmon Calyx medicinal materials.A total of 12 batches of Persimmon Calyx medicinal materials were collected in different origins,the thin layer identification and inspection items were determined according to the Pharmacopoeia and all were in line with the requirements.The determinaton limit of the extract was increased.The method of content determination of the gallic acid in Persimmon Calyx was established,and the methodological investigation was carried out,which provided the basis for the quality evaluation of the Persimmon Calyx.In addition,the HPLC fingerprint method of Persimmon Calyx was also established,and a total of 12 common peaks were founded.Among them,8 samples had a similarity of more than 0.9,and the other 4 batches were between 0.8 and 0.9,the method is specific,can be more comprehensive and effectively control the quality of the Persimmon Calyx.Chinese medicine formula granules are made from high quality herbal slices with modern pharmaceutical technology under the guidance of Traditional Chinese Medicine theory,which has the characteristics of small dose,definite efficacy,safety and hygiene,easy to carry and store.This article explored the preparation process of Persimmon Calyx formula granules and studied its quality.Based on the standard decoction,the extraction,concentration,drying and granulation technology of the Persimmon Calyx were investigated.Taking the ratio of extraction,contents of gallic acid and effective transfer rate as indexs,the orthogonal test was used to prepare Persimmon Calyx formula granules.The results show that the best preparation of formula granules is soaking 1 hour and extracting 2 times for 1 hour respectively.The first added amount of water is 12 times,and the second added amount is10 times.The concentrated method is decompression concentration;dry method for spray drying,no supplementary material;the granulation method is the dry granulation.The pilot test was carried out and the result showed that this process was feasible.The influencing factor tests,accelerated tests and long-term tests were conducted on the pilot granules.Inspected the changes in character,thin layer identification,inspection items,leachables and content and the results showed that the stability was good.