Study On The Quality Of Dirithromycin Enteric-Coated Tablets Domestic

Objective:Dirithromycin was the national basic drugs, the standard of dirithromycin enteric coated tablets that was not unified was currently executed by companies.So this paper developed to lay down quality standard,,and to in-depth study of related substance. It intended to provide the perfect data and reference for inspection agency and manufacturer.Methods:This paper collected the dirithromycin enteric-coated tablets in seven manufacturers, and study on the inspection standards of various enterprises to provide the basis for quality standard draft; Under the optimization of HPLC chromatographic conditions, This paper had on research content of erythromycin in 16R-dirithromycin,and limited relevant substance. With reference to the Japanese ? generics bioequivalence test guidelines ?, this paper chose the pH 6.0 release medium with pH6.8 release media as designated on the release degree contrast research. The study aimed to analysis moisture by Karl Fischer method. We drafted a quality specification protocol according to the experiences;The paper exploratory research on near infrared measuring method, plasticizer, residual solvents and microbial limit method.Results:The methods used in other high-performance liquid chromatography for determination of active ingredients, octadecyl silane for the bonded silica filler; Methanol-phosphate buffer-acetonitrile(19:37: 44) as mobile phase, flow rate of 2.0 ml· min- 1, With a mixture of methanol-acetonitrile(30:70) and injected 20 u L.We calculated C42H78N2O14 content With the sum of 16R-dirithromycin and 16S-dirithromycin peak area.The paper ruled that the content of erythromycylamine was less than 1.5%, the total impurities were less than 5.0%, 16S- dirithromycin isomers was less than 1.5%;and any other single impurities were less than 1.0% under the related substances. The paper calculated the release quantity with its own control method in pH6.8 release medium and increased the moisture content limit of 5.0%.We drafted a quality specification protocol to evaluated seven manufacturers samples and the results conformed to the requirements. The exploratory testing results conformed to the rules.On the whole, The method was sensitive, specific and with a good reappearance,and can control the quality of dirithromycin enteric-coated tablet.Conclusion:The process stability of dirithromycin enteric-coated tablet manufacturers was poorer,and intra- batch was comparatively large,so some parts of processing path should be improved further.We suggested that manufacturers pay attention to the lower limit of feeding and process instability. As the national essential drugs, dirithromycin enteric-coated tablet had been developed in unified quality standards, It made an important role to standard clinical application and safety use.This paper formulated quality standard draft of dirithromycin enteric-coated tablet. It had a positive effect on production enterprises and drug safety system.