The Study On The Preparation Technology And Quality Standard Of The Liu Wei Zhu Jie Shen Tablet

OBJECTIVEThis study is aimed to prepare liu Wei zhu jie shen tablet,a compound prescription of Traditional Chinese Medicine used to treat rheumatic arthritis and chose the best preparation technologies.Then estabilsh the primary quality standards to provide basic reference for the further research. METHODS 1. Extraction technologySingle factor design was used to investigate the effects of extraction efficiency, including solvent concentration, solid-liquid ratio, extraction time and extraction times. And then, the extracting technique conditions were optimized by orthogonal design with Dry Extract Rate and total saponins content as Indices for Comprehensive Appraisal (weight coefficients were 0.2 and 0.8). 2. Moulding processUsing single factor method to optimize the preparation process with granule characteristics, yield of granules, distribution of particle size (20-80 mesh), angle of repose, surface finish, and rigidity and disintegration time limit as index. 3. Study on quality standardIdentification, inspection, tablet weight difference and content determination were carried out on liu Wei zhu jie shen tablet prepared upon the opimal technological conditions. Some of the constituents, including rhizoma panacis japonica, Clematis henryi, Asiatic toddalia root-bark, Mugua, smilax ferox and Celastrus angulatus in the formulation, were identified by TLC; the total saponins contents in the formulation were determined by colorimetric method; the contents of ginsenoside Ro, the main effective ingredient of rhizoma panacis japonica in the formulation, was determined by HPLC. RESULTS 1. Extraction technologyWith dry extract rate and total saponins contents as indexes, the optimum extraction process of liu Wei zhu jie shen tablet was as follows: The crude drugs were refluxed with 18(10,8) times amount of 75% alcohol as the extraction solvent for two times,1.5h per time. 2. Moulding processThe optimum procedure condition was as follows:the extract powder and MCC were mixed evenly in proportion of 3:1,3%PVPP was added, then prepared granules with 95% ethanol as wetting agent, passed through 16 mesh sieve, dried in 50℃for 2h, and unified with 20 mesh screen, mixed well with 3% CMC-Na and 0.3% magnesium stearate and then tablet pressed. 3. Study on quality standardThe study on quality standard of liu Wei zhu jie shen tablet showed that:the tablet had even color, smooth surface and non-variegation; the identification results showed that the spots of the sample and the control were quite clear; Tablet weight difference was in accordance with the general rule of Chinese Pharmacopoeia; The total saponins contents in the formulation was determined by colorimetric method; The contents of ginsenoside Ro, the main effective ingredient of rhizoma panacis japonica in the formulation, was determined by HPLC. Both methods were good reproducible and high accurate. After the determination of three batches of samples, it could come to the conclusion that the content limit of the total saponins is 23.95mg per tablet and the content limit of ginsenoside Ro is 2.97mg per tablet. CONCLUSIONS1.The preparation technology of liu Wei zhu jie shen tablet in this study was simple and economical, with good selectivity and high efficiency, therefore was suitable for the industrial production.2. All the quality control indexes of liu Wei zhu jie shen tablet were in accord with the relevant provision of the Chinese Pharmacopoeia.