| Taibi granule is a prove clinical effective recipe which have been used several years by First Affiliated Hospital of Guangxi Medical College. It consists of 11 traditional Chinese medicines include of Polygonum Cuspidatum, Trachelospermi jasminoides, Cibotium barometz, Eucommia ulmoides, prepared rehmannia root, etc. It has expelling wind and dampness,stasis analgesic efficacy, clinically proven, is effective in treating rheumatoid arthritis. According to the needs of modern medication, the subject regards traditional Chinese medicine theory as the guiding principle, use of modern pharmaceutical technology prototype converted into granules. Meanwhile, it has done researches on systematic experimental studies for preparation process, quality standards and preliminary stability test by using modern pharmaceutical technology.Objective: To optimize the optimal preparation process of Taibi Granules; To establish a method for quality control; Investigate the preliminary stability of preparation, to provide the experimental evidence for the new drug research in the future.Methods: With dry extract yield, contents of polydatin and emodin as the indexes,taking the amount of water, extraction times and time as factors, arranging the experience by L9(34) orthogonal test. To analyzes the date by Comprehensive Evaluation of Multiple marks, and optimize the water-extraction process.With dry extract yield, contents of polydatin and emodin as comprehensive evaluation indexes, L9(34) orthogonal test was adopted to optimize purification technology process by taking the liquid relative density,the concentration of ethanol and time length of precipitation as factors. Taking the contents of Polydatin and Emodin as index to optimize the concentration conditions. With the forming rate, fluidity, hygroscopicity and dissolubility as indexes, using wet granulating technology to investigate the formulation technique; Establish the quality standard of Taibi Granule:Using the method of TLC qualitative research to identified of five flavor herbs in the granule include Polygonum Cuspidatum, Trachelospermi jasminoides, Cibotium barometz, Eucommia ulmoides, prepared rehmannia root; and the content of polydatin and emodin quantitative were determined by HPLC; Carry out long-term stability and accelerated stability trials of Taibi Granule for 6 months. Investigated the traits,identification, examination(granularity, moisture, dissolubility) and the content of polydatinand emodin, respectively.Results: The optimum condition of water-extraction:6 times water, extracted 1 hour for 3 times. The optimum condition of purification: Liquid relative density is 1.15, the concentration of ethanol is 50%, and precipitation for 12 hours. The optimum condition of concentration: 60℃ at-0.08~-0.10 MPa. The optimum condition of formulation: Extract is concentrated to a relative density of 1.32~1.35, mixed with proper amount of soluble starch :dextrin(1:2) as excipients, made of soft material, pelletizing, drying, forming. Quality standards, the relevant spots of five flovars of herbs on TLC plates were clear without the interference of the blank control. The content of polydatin showed a good linearity in the rang of 19.72~197.18 mg·L-1, r = 0.9998. The average recovery was 101.845%, and RSD was 2.20%(n=6). The content of emodin showed a goodlinearity in the rang of 4.965~49.65mg·L-1, r = 0.9991. The average recovery was 99.622%, and RSD was 1.99%(n=6).Long-term test and accelerated test,the investigation results of three batch samples showed that each index with the regulation and the Taibi Granule was stable.Conclusions: The preparation process is feasible and good reproducibility, the quality standard of is controllable and the quality of Taibi Granule is stable. |
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