不同生产厂家双唑泰栓中3种成分含量均匀度考察

摘要

目的：考察不同厂家双唑泰栓中甲硝唑、克霉唑、醋酸氯已定3种成分的含量均匀度。方法采用《中国药典》2010年版（二部）高效液相色谱法测定14个不同厂家14个批次的双唑泰栓中3种成分含量均匀度。结果14个厂家中共有9个厂家双唑泰栓3种成分含量均匀度均符合规定，合格率为64.3％，部分厂家存在3种成分中某成分含量均匀度不合格现象。结论为保证临床用药有效及安全可靠，建议厂家生产双唑泰栓时进行工艺验证并在生产过程中进行多点监测，同时建议在双唑泰栓检验标准中增加含量均匀度考查。%Objective To study the content uniformity of three constituents in metronidazole,clotrimazole and chlo-rhexidine acetate suppositories from different factories. Methods Content uniformity of fourteen batches from fourteen dif-ferent factories was detected according to HPLC method from Chinese Pharmacopeia(edition 2010,Part 2). Results Three Kinds of ingredients content uniformity of nine manufacturers consistented with the standard. The qualification rate was 64. 3%. Some Kind of ingredients content uniformity was irregularity in part of manufacturers. Conclusion To maKe sure the efficient and safety of clinic medicine,it was recommended that the manufacturers should taKe process validation and multiple - point monitoring in productive process. Also it was necessary to add content uniformity investigation in supposito-ries inspection standard.