Study On Preparation Technology And Quality Standard Of Aifu Nuangong Granules

Aifu Nuangong granules are taken from Aifu Nuangong pills,a prescription preparation recorded in the Pharmacopoeia in 2020.In the prescription,artemisiae argyi folium,cyperi rhizoma warm palace warm meridian disperse cold mainly drug;Euodlae fructus and cinnamomi cortex are auxiliary drugs to warm meridian,disperse cold and pass through veins.Angelicae sinensis radix,chuanxiong rhizoma,paeoniae radix alba all into the liver meridian,can promote blood circulation,remove blood stasis,nourish blood and regulate meridian,astragali radix、rehmanniae radix tonifying blood qi,nourish Yin and nourish blood,dipsaci radix promoting blood circulation and meridians are adjuvants,the combination of various medicines plays the effect of regulating qi and nourishing blood,warming the palace and regulating the meridian.The emergence and emergence of TCM granules is an inevitable trend of TCM modernization.The extraction and refining of active ingredients into granules has stable quality,small dosage,and more convenient to take.Compared with traditional pills,the effect is faster.In this project,the combination of the long-verified formulae of pharmacopoeia with modern dosage forms was made to produce a new product with convenient use,remarkable curative effect and stable preparation.This topic in the Aifu Nuangong granules extraction process and forming process research,in this topic to Aifu Nuangong granules volatile oil extraction rate as examining index,of his own medicine soak time,water ratio and extracting time orthogonal experiment is conducted on the basis of the single factor investigation,to determine the best Aifu Nuangong granules volatile oil extraction process;The active components of Chinese medicinal materials from Aifu Nunangong granules were extracted by central point design-response surface methodology.The content of total polysaccharide was used as the evaluation standard of water extraction process,and the content of paeoniflorin and saponins of dipterocarpus japonicus Ⅵ were used as the evaluation standard of alcohol extraction process,so as to select the best extraction process.Then investigate the density of extract extract,the type of excipients,the amount and the proportion of mixing,and select the best molding process.In order to effectively control the quality of preparation products,the quality standard of Aifu Nuangong granules was established during the experiment,thin layer chromatography(TLC)was used to identify paeoniae radix alba,dipsaci radix and Angelicae sinensis radix-chuanxiong rhizmoa in Aifu Nuangong granules.The volatile components in Aifu Nuangong granules were identified by gas chromatography-mass spectrometry(GC-MS).HPLC method was used to determine the content of paeoniflorin and saponins of dipterocarpus japonicus Ⅵ,and the methodology was investigated.The quality standard system of Aifu Nuangong granules was established.In this topic,a preliminary stability experiment was carried out for Aifu Nuangong granules.The physical and chemical indexes of Aifu Nuangong granules,such as properties,content of active components and solubility,were respectively carried out within the specified time check.The results showed that all the inspection items of Aifu Nuangong granules were in accordance with the quality standard and the general rules of pharmacopoeia granules,and the stability was good.In this topic the effective component extraction and molding process of Aifu Nuangong granules were studied in depth for the first time,and the quality standard of Aifu Nuangong granules was created,and the preliminary stability study of Aifu Nuangong granules was investigated,which provides a scientific basis for the wide application of Aifu Nuangong granules in the future.