| Quinolones drugs is such a synthetic anti-bacterial drugs which are widely used, high efficiency and low toxicity. They has grown rapidly since they listed. Currently, they are one of the most widely used clinical antibiotic. MH tablets belongs to the fourth generation quinolone antibacterial drugs. This topic will conduct the imitation research to MH tablets. The research analysis will launch from the following several aspects. For this variety and the similar medicine further development, these works lay certain foundation and provide certain basis.First of all, we conducted a prescription screening. The first step was to evaluate the compatibility of raw materials and accessories. The results indicated they had good compatibility. With the angle of repose, bulk density, maximum hardness, friability and dissolution as the main indicators examined, we studied on MH tablets formulation. After the composition of MH tablets was determined, the preparation craft was carried on the optimization from raw materials grain size, grain drying, granulation screen mesh, core hardness and so on.In order to guarantee this product is consistent with the quality of the drug on the market. In influence factor experiment, this product was placed in the high temperature(60°C), humidity(RH90%±5%), or light(4500Lx ±500Lx) condition for 10 days. As a result, this product had not got significant change compared to 0 days.Next, in order to control the quality of preparation of MH tablets in this topic, we conducted a study on the quality and stability and formulated quality specification draft.The quality research project mainly include properties, identification, weight difference, water content, checking of dissolution and determination of related substances content determination and so on.(1)MH tablets is film-coated with dark red and after deducting the coating it shows yellow. The solubility can be exceeded in 436.4mg/1000 m L in hydrochloric acid(9m Lâ†'1000m L).(2)Two different methods can be used to identify this product. The color reaction and HPLC can be used to identify this product because of without the interference of other components.(3)The determination of moisture content of 3 batches of products results were 2.4%, 2.6% and 2.7%, respectively. The results of weight difference test and polymorphs test were proved to be qualified.(4)This article uses the thick liquid law to inspect the sample dissolution and use ultraviolet spectrophotometric method to determine absorbance of the sample, then to calculate the dissolution. Linear range of MH was 10μg/m L~24μg/m L and the correlation coefficient was 0.9998. The result indicated that the linear relations is good. The dissolution of three batches of products were in line with the provisions.(5)The determination of related substances and content of this product are by HPLC method and they share the chromatographic conditions. In the related substances study, the test of robustness of chromatographic conditions with small variations in some phases such as flow rate, column temperature, detection wavelength, mobile phase ratio, mobile phase p H value and so on, shows that this method has a good robustness and there is no significant effect on the test for related substances. The results of the specificity test show that the product can be completely separated from degradation impurities, which indicates a good specificity of this method. The methodology validation of the test for related substances in the product had also been performed. RSD of the stability was 1.40%. The detection limit was 0.05μg. The results show that this method has high accuracy and good repeatability. In the study of content, the linear range of MH was 0.04mg/m L~0.16mg/m L and the correlation coefficient was 0.9998. The RSDs of the precision, recovery and repeatability were 0.42%, 0.32%, 1.80% respectively. The results show that the method method was accurate, reliable and easy to operate and can be used for the content determination of MH tablets. The results of determination of three batches of products are within the scope 95.0%-105.0%. They are consistent with the requirements of the standards for the registration of imported medicine.In the process of study on the stability, the accelerated testing and long-term experimental results show that appearance, dissolution, related substances, content of MH tablet had no significant change. The quality of MH tablets prepared by the method is stable. This product should be at room temperature, tightly sealed and kept away from light.Finally, based on the above test methods and results, we developed a draft quality standard of MH tablets initially. This draft provides a reliable basis for quality control and data support. |
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