The Tablet Of Tong Zhi Su Run Jiang Of Study On The Preparation And Quality Standard

The tablet of Tong zhi su run jiang is consist of colchicine, the Secretary ComforSpin Virginia fat, saffron, senna, myrobalan meat box fruit, Padan Ren7taste refined Chinese herbal medicine processing from the Uighur Medicine, rheumatoid arthritis and other good effect, Padan-jen, the main oil-bearing components in the ratio is about23.1%of the prescriptions contained in the fatty acid content as high as45%, which seriously affects the forming and the hardness of tablets, leading to subsequent coating can not be normal carried out. The preparation process, quality standards and the initial stability test system is reserached in this study.1.Study on the PreparationResearch of ethanol extract process:Considering gallic acid content and Extract production rate as the main assessment indicators,using L9(34) orthogonal design, set up4investigated factors:the expedition ethanol consumption, ethanol concentration, extraction time and frequency, optimize process conditions mentioned alcohol. The result indicated puts forward the most superior condition is mellowly: medicinal herbs plus10times the amount of90%ethanol, extract3times, each time2hours.Oil absorbent filter: Other components and absorbent amount of the fixed prescription is unchanged, the choice of different absorbers, hardness and disintegration time for the main index and attach the tablet form factor, the results showed that the silica powder, oil absorbent tablet, tabletsgreater hardness and disintegration is ideal,the appearance of the tablet is more clean and complete uniform.Screening of diluent: Other components and diluting agent in the fixed prescription is unchanged, different diluent is used, results show that the use of microcrystalline cellulose and powdered sugar diluent maximum hardness, disintegration is better, and the appearance is.smooth and uniformScreening of the disintegrating agent: Fixed prescription dosage of the other component and disintegrant is unchanged, the disintegration time of tablets appearance of the factors considered as the main index and additional carboxymethyl starch sodium (CMS-Na), the results show that the selection of the most rapid disintegration when the disintegrant,and the disintegration of the particles is relatively small conducive to drug absorption.Optimization of the preparation process:Step granulation method on the basis of L9(34) orthogonal test, the system of the tablet hardness evaluation results show-that about5%of the silica powder and drug powder mixed to the system of oily ingredients, and then to join the other mass with the help of the adhesives to manufacture particles, to dry particulate of water content to5.5%, the preparation process is the most reasonable preparation.2Study on quality standardSenna, myrobalan meat in the main component of gallic acid, saffron qualitative is identified by TLC; gallic acid is determined by HPLC, used octadecylsilane keybonded silica as a filler, and0.1%phosphoric acid solution (3:97) as the mobile phase, the detection wavelength is218nm, flow rate is0.9ml/min, column temperature is25°C, the injection volume is5μl. The results show that the spot separation of the TLC statutory identification of the three herbs is clear, interference-free negative; Gallic sub-acid injection volume within the range of20.4to204ng is in good linear relationship between peak area (r=0.999998), with an average recovery is99.89%, precision inspection results (RSD) is0.10%, stability-test RSD=0.76%, reproducibility experiments RSD=0.95%, indicating that the quality control method is simple, accurate, specific, which can be used as the quality control standard of stagnation Surun Jiang piece3Study on preliminary stabilityAccelerated testing for three months under the conditions of the bottle of medicine at room temperature for six months and the temperature is controled between37-40℃, and the relative humidity is75%, finally demonstrated the sample each quality testing target conforms to the stipulation in the normal room temperature stability and in the acceleration stable inspection time, Indicated the sample stability is good, initially speculated that this product is valid for18months.