克林霉素磷酸酯注射液生产工艺对有关物质的影响  

Influence of manufacturing process of Clindamycin Phosphate Injection on related substances

作　　者：李印秋[1] 宋玉杰[1] 

机构地区：[1]山东新华制药股份有限公司,山东淄博255005

出　　处：《齐鲁药事》2008年第6期363-365,共3页qilu pharmaceutical affairs

摘　　要：目的通过工艺条件的筛选，确定影响克林霉素磷酸酯注射液的有关物质的固素并加以控制。方法分别考察10、20、30、40℃的配制温度；0％、0．1％、0．2％、0．4％的活性炭；80、100℃的灭菌温度；分子截留量为10000的超滤四种不同的工艺条件对克林霉素磷酸酯注射液有关物质的影响。结果随配制温度的升高，有关物质升高，从10℃升至40℃，有关物质升高约1％；有关物质随活性炭比例升高，先降后升，活性炭量控制在总体积的0．1％～0．2％较合适；80℃、100℃分别灭菌20min较灭菌前有关物质分别上升约3．6％和10％；分子截留量为10000的超滤可使本产品有关物质降低0．3％左右。结论以上四种工艺条件分别对克林霉素磷酸酯注射液的有关物质有不同程度的影响，其中温度是关键影响因素。OBJECTIVE The factor influencing the related substance of Clindamycin Phosphate Injection is confirmed and controlled by selecting the process conditions. METHODS The preparation temperature; 10℃, 20℃, 30℃, 40℃ ; the quantity of activated charcoal added ： 0 %, 0. 1%, 0. 2 % and 0. 4 %. Sterilization temperature： 80℃, 100℃ ; cut-off quantity： 10000; Examine the influence of four kinds of process conditions of Clindamycin Phosphate Injection on related substances. RESULTS As the preparation temperature rises,the related substance increases. If the temperature rises from 10℃ to 40℃ ,the related substance increases 1%;the related substances firstly decrease then increases when more activated charcoal is added. It is rather appropriate that the quantity of activated charcoal is controlled within 0.1 ～0.2 % of the total volume of the injection. If the injection is sterilized respectively at 80℃ and 100℃ for 20 minutes,compared to the injection before sterilization,the related substance increases respectively 3.6% and 10%; the ultra filtration of cut-off quantity of 10000 can make the related substance decrease about 0.3 %. CONCLUSION The four kinds of process conditions of Clindamycin Phosphate Injection have influence to some extent on the related substances of Clindamycin Phosphate Injection,in which, the temperature is the key influencing factor.

关 键 词：克林霉素磷酸酯注射液 工艺条件 有关物质 

分 类 号：TQ460.6[化学工程—制药化工]