Studies On The Preparation And Quality Standard Of Paeonol Dropping Pills

Aim at high incidence of rheumatoid arthritis at clinic, we choose Paeonol which from Chinese medicine tree peony bark. Based on requirement of market and clinic, using Paeonol we produced pills. This preparation is solid and can take orally. The pills has the advantage of a large surface area, low gastrointestinal irritation and productivity. The main research content is the process and evaluation of preparation.Based on the research of Paeonol's character and stability, we select the best composition of preparation and the optimization of processing technology by orthogonal experimental. Simultaneously, the disperse state of Paeonol was observed. The experiment proved that the processing technology is stable and reasonable. To optimize the best technical parameters throng controlling the different factors. Taking spherical degree and pill weight and index, the above factors were observed by orthogonal test. PEG6000 as matrix, methyl-silicon oil was refrigerant. Internal and external diameter of burette were 4.0mm and 5.0mm, dropping into the refrigerant of 10±5℃. The highest finished product with good quality can be got through this process.The Paeonol pill's quality was estimated synthetically by the study of quality standard research such as identification test, release rate and content determination. The result of quality standard research proved that Paeonol pill is stable and controllable. The pill was identified by three methods chemical color reaction, UV spectrophotometry and HPLC. First, method was established to determine Paeonol by UV spectrophotometry which was accurate, sensitive and could be used in determination of drug release. The pill's release rate is 75% in 50min. Paeonol was determined by HPLC, ODS was used as stationary phase, methanol-water-phosphoric acid (50:50:0.02), the detection wavelength was 274nm. The calibration curves of Paeonol was liner with 2.608～260.8μg/ml. The avera recovery was 99.3%, RSD was 0.95%. The method is simple, accurate and reliable. It can be used for quality control of Paeonol Dropping Pills.Quality of the Paeonol Dropping pills was evaluated by the quality standard and compared with the initial value. Results of the accelerated stability testing(40℃) and long term testing indicated that the pills could be kept stable for 24 months.