Research Report On Preparing Process And Quality Control Of Tangwang Mingmu Granules

At present,there is a lack of the traditional Chinese medicine for Diabetic Retinopathy.This prescription is derived from the "Buddleja officinalis Prescription"with many years of clinical experience.This paper studies the preparation technology,quality standard and stability of three aspects of Tangwang Mingmu granules.Using modern Chinese medicine extraction and preparation technology,establish its quality standard.Preparation process research:Firstly,the active components of drugs were analyzed and the process route was designed.The flavonoids were extracted from astragalus,glossy privet fruit,buddleja officinalis.The effective components such as polysaccharide are extracted from the water of medicinal residue.The effective constituents of alkaloids were extracted from the alcohol solution of the rhizoma coptidis and motherwort.Orthogonal experiment and single factor experiment were used to determination of astragaloside,berberine,polysaccharide content and dry paste extraction rate.Optimum extraction solvent consumption,extraction time,extraction times.The forming process of granules was studied and the spray granulation technology was used.The relative density of the extract and the proportion of auxiliary materials were investigated.Determine its yield and moisture.Optimize the inlet temperature-material temperature,spray rate and atomization pressure.Quality standard study:TLC method was used to identify the five Chinese herbs(astragalus,rhizoma coptidis,motherwort,glossy privet fruit and buddleja officinalis.HPLC was used to determine the content of astragaloside and berberine.Preparation stability study:Investigate the stability of the preparation for 6 months.The best extraction process of this preparation is:Astragal us,glossy privet fruit and buddleja officinalis are extracted 1.5 h for 2 times each time with 10 times 50%ethanol.The medicinal residue are extracted 1.5 h for 2 times each time with water.Rhizoma coptidis and motherwort are extracted 1.5 h for 3 times each time with 12 times 50%ethanol.Concentration process result:Astragalus alcohol extract and water extract,such as in 60-80℃ concentrated extract to relative density is 1.10～1.20;The alcohol extraction such as rhizoma coptidis,60-80℃ concentrated extract to relative density is 1.02～1.04,combine the above three extracts.Results of preparation process:Choose dextrin as the auxiliary material for the granule(the ratio of dry paste to the auxiliary material is 58:42).Packed with aluminum-plastic composite membrane.Quality standard result:TLC identification standard for five kinds of Chinese medicine was established.HPLC was used to determine the content of berberine and astragaloside.Each bag contains astragaloside(C41H68O14)not less than 0.9 mg.The content of berberine(C20H17NO4·HCl)is not less than 12.0 mg.Stability result:According to the quality standards established above,in this preparation,three batches of samples were tested for 6 months of accelerated stability and long-term stability.The results showed that the characteristics,identification,examination and content determination were not changed compared with that of 0 months,and the preparation had good stability.The study used the modern Chinese medicine preparation technology.Through the research on extraction,enrichment,molding process,the preparation of Tangwang Mingmu granules.lt is stable and feasible,through the establishment of quality standard and stability study,provide the basis for its quality control.The process is suitable for industrial production through three batches of pilot scale production.