Study On Quality Evaluation And Formula Granules Of Cirsii Japonici Herba

Cirsii japonica herba belongs to Cirsium japonicum fisch.ex DC.It has the function of cooling blood to stop the bleeding and removing blood stasis and detoxification.It is used for blood stasis,hematemesis,hematuria,hematochezia,metrorrhagia,traumatic hemorrhage,carbuncle swollen sore.Cirsii herba belongs to Circium setosum(Willd.)MB.The characters of the two are very similar,difficult to identify and often confuse the use of drugs.Therefore,this article studies the medicinal materials of Cirsii japonica herba.And provide the basis for the comprehensive and effective control of the quality of Cirsii japonica herba.Cirsii japonica herba and Cirsii herba medicinal materials were collected respectively in ten batches,including character identification,microscopic identification and thin layer identification.The experiment establishes the specific chromatogram of Cirsii japonica herba and conducts a methodological study.The solvent peak has no interference with the sample determination.The method has good precision and repeatability.It provides a basis for a comprehensive assessment of the quality of Cirsii japonica herba,and it also clarifies the distinguishing features between Cirsii japonica herba and Cirsii herba.With reference to the corresponding provisions of the 2015 Chinese Pharmacopoeia,the moisture of Cirsii japonica herba,acid insoluble ash,extract and content were determined.It is the basis for the quality evaluation of Cirsii japonica herba medicine.Traditional Chinese medicine granules is extracted and refined from the single Chinese herbal medicine,with small size,easy to carry and save,stable quality controllable,etc.The preparation process and quality standard of Cirsii japonica herba formula granules are studied in this paper,which lays the foundation for mass production and quality control of Cirsii japonica herba formula granules.Based on the standard decoction,the technology of extracting,concentrating,drying and granulating of the Cirsii japonica herba formula particles was investigated.The preparation process of Cirsii japonica herba formula granules was determined by using the rate of extraction and wear fish willow leaf glycosides transfer rate as indexs.Soaking for 60 min,extract two times,the first time the amount of water is 15 times,the second time the water is 13 times,each time 30 min;The concentrated method is decompression concentration;drying method for spray drying;The granulation method is the dry legal grain.Factors affecting test,accelerated test and long-term test were investigated on the pilot samples.Changes in traits,thin layer identification,content determination,inspection items,and leachables were examined,and the results were of good stability.