Preparation Of Tranexamic Acid Modified-Release Tablets And Quality Standard Research

Objective:The hydrophilic matrix sustained-release materials hydrophilic methyl cellulose, a kind of high efficiency, low toxicity, good stability, compliance3.1class drug tranexamic acid modified-release tablets for the treatment of Heany Menstrual Bleeding was developed in this work. The prescription process, quality standard, stability, and preclinical work was to be researche. The organization and summarise of the required experiment data and literature data were to be done before application of clinical regesteration. The approval documents for new drugs and hospital clinical was to be abtained. This work was to fulfill the domestic blank, and reduce medical costs.Method:The hydrophilic matrix sustained-release materials hydrophilic methyl cellulose, a kind of high efficiency, low toxicity, good stability, compliance3.1class drug tranexamic acid modified-release tablets for the treatment of Heany Menstrual Bleeding was developed in this work. The prescription process, quality standard, stability, and preclinical work was to be researche. The organization and summarise of the required experiment data and literature data were to be done before application of clinical regesteration. The approval documents for new drugs and hospital clinical was to be abtained. This work was to fulfill the domestic blank, and reduce medical costs.1The factors such as dosage and tableting pressure were tested through vitro release of tranexamic acid modified-release. The prescription and process were screened according to the results of the research.2The character, identification, impurity and quantitative determination of the establishment of methodology were quality controlled,through the establishment of methodology, chromatography for perfect and feasible and controllable quality standards.3The stability of the tranexamic acid modified-release tablets was tested, through the affecting test, accelerated test and long-term test.Results1HPMC was Select as sustained-releasing hydrophilic gel matrix. The best prescription:tranexamic acid,650mg, microcrystalline cellulose28mg; micro silica gel2g; the starch31mg of hydroxypropyl methyl cellulose (K4)155g; polyvinylpyrrolidone (K30)53mg; stearic acid20mg; magnesium stearate11mg.2According to the second method of the CP2010Edition appendix XD. Experimental results showed that the tranexamic acid sustained-release tablets could reach the required release quantity within the specified time. The method was as followers:water,0.1mol/L HCl, pH4.5acetate buffer and pH6.8phosphate buffer as release medium, the release of tranexamic acid sustained release tablets was calculated in different media by RP-HPLC method. Drug released-degree in vitro:The sustained-release tablets drug40～50%in15～45min,90%in45～90min,98～100%in120～150min。3According to the CP appendix, we confirmed the quality standard of the Tranexamic acid sustained-release tablets and investigated the tablets stability of3lots product. The result as following the Tranexamic acid sustained-release tablets have stability quality after6months accelerated test,24months long-term test.4The main indexe of the tranexamic acid Modified-release tablets after inspection was closed to import modified-release tablets.The method was establish to establish the the quality standard of tranexamic acid Modified-release tablets using RP-HPLC. The excipient had no effect of tranexamic acid modified release tablets. The method was proved to be easy, rapid, accurate, reproducible and highly specific. The results showed the method could be a quality control standard for tranexamic acid modified-release tablets.