Study On The Preparation And Quality Control Of Composite SHI-WEI Film-coated Tablet

In this paper, based on the recipe of composite SHI-WEI powder sourced fromthe ancient book , the composite SHI-WEI film-coated tabletwas prepared with the modern dosage forming technique on Traditional ChineseMedicine (TCM) and the relevant quality control standard was established.The granules were prepared by spary drying method and then pressed to the corefor film-coated tablets. Then, the influences of the factors as inlet air temperature,spraying speed, concentration of the coating material on the product were examined.HPLC was used in the establishment of assay of matrine and quality control standard.As the results showed: at the spray speed of 50 Kg/h, spary pressure of 0.3 Mpa,inlet temperature 100℃ and adjuvant temperature of 65℃, the qualified granule forpresssing the tablet core was prepared. At the parameters of (5.0±0.2)% of loss ondrying, 0.5%~1% of Mg-St, and tablet hardness of 50 kN), the tablet core preparedmeet the requirement for film-coated. At the following parameters: concentration ofthe coating liquid 14% (w/w), coating speed of 16~20 g/min, inlet temperature 75℃,the optimium film-coated tablet was prepared. The assay and quality control standardwere extablished by HPLC at the conditions of : Kromasil KR100-5C18 (4.6 mm x250 mm) column, acetro-0.025 M H3PO4(1:24),adjust to pH 3.5 by triacetamine andthe detection wave 200 nm. There is a good linear relation between the concentrationof matrine and the peak aera at the concentration of 16.01～320.40 μg/mL. Themethod for the assay of matrine was sensitive, accuracy and with good repeatability.As a summary, the manufacture technology establish in the experiment wasstable and the quality control standard was reliable. All of those above ensured thescaled produation of the film-coated tablet of matrine.