Study Of Capecitabine Tablets Prescription And Quality

Capecitabine is the Fluorinated pyrimadine deoxyribonucleoside carbamate,which can translate into5-FU in vivo. It can restrain cell division, interfere thesynthesis of RNA and protein. It can be applied to the further treatment of laterperiod of breast cancer which taxol can not cure. It can be applied to later period ofbreast cancer, rectum cancer and colon cancer. It is be protected by Roche and expirein2013. In order to occupy the market and reduce the cost of patient, we develop theCapecitabine Tablet with the product of Roche as the reference preparation. In thecompatibility, we study the compatibility of Capecitabine with common accessoriesthrough influence factors, the result is good. We take surface, process and in vitrodissolution curve as the evaluate standard, select the proporation of filler, the kindsand amount of adhesives, the water of granual and craft of coating. The finalformulation is Capecitabine500g, microcrystalline cellulose89g, lactose22g,croscarmellose sodium (inner)6.6g, croscarmellose sodium (outer)3.3g,magnesium stearate16.5g, talcum13.2g. With3%hypromellose water solution asadhesives, the granule through the16mess, the granule is dried at40℃. In order toevaluate the reproducibility, we produce three batch products, the quality meet thestandard..During the quality study, we develop UV to determine the dissulotion, verify themethod such as Linearity, precision, recovery, durability and so on. We develop theHPLC in the study of content and related substance and establish rational qualitystandard. The method can control the quality accurately and conveniently.In the study of influence factors, we found high temperature and high humiditycan make related substance higher, but strong light do not influence related substancet.In the accelerated contion for six months and long-term for twelve months, relatedsubstance have added, but in the later, related substance do not add.In the stability,the dissolution decline. Content did not change in all tests. According to the result ofstability, the sample should be stored at cool temperature, dry place, seal.