Studies On The Suppository Ampicloxicillin

The composition of Suppository Ampicloxicillin are equal weight of Ampicillin (AMP) and Cloxacillin (CLOX), with the base of mixed fatty acid glyceroester and the suitable amount of absorption accelerants. On the base of its prescription , preparation technology and dissolution that had been made , the methods of the products' preparation and package were improved. Moreover , physical character , assay and stability were continued to be studied.The medicine's term of validity were directly influenced by the methods of preparation and package . In this paper, the products were produced by machine which not only was convenient, but could reduce the chance of contamination. And the new method of package should be a kind of air locked one .A reversed phase HPLC method was developed for the quantitative determination of Ampicillin and Cloxacillin. Through the test of methodology, the results of the linearity , specificity , repeatability and recovery were all good.According to Chinese pharmacopoeia(Edition 2000), the stabilities of the products were studied. Influencing factors including high temperature ,high humidity and strong light were investigated. The results showed that the products were sensitive to2003temperature , humidity and light, especially the temperature.During the long term test, the products' color was found changed conspicuously and the contents of AMP, CLOX were ineligible after they were stored for three months at room temperature . While the result of pretesting showed that the contents of AMP , CLOX were still eligible after the products had been stored for two years at room temperature . Therefore , some tests were conducted in order to find the reasons. The results showed that there were two major reasons, including air unlocked package and ineligible of the contents of the accelerants' heavy metal. Moreover, there were some problems in the course of production. All of them could contribute to the instability of the products.