CAJ | 학술논문

盐酸克林霉素棕榈酸酯( CPH)现行结晶工艺主要存在主峰下出现四个很小的峰，总杂大于5%，单杂大于1%。采用双溶剂结晶，用丙酮为底物，对不同溶剂二氯甲烷、三氯甲烷、甲醇、乙醇、乙腈、正丁醇进行研究，结果以丙酮正丁醇最好，结晶收率为90%，纯度大于95%，达到总杂小于5%，单杂小于1%。颜色为白色，颗粒疏松，各项工质量指标符合现行USP、 EP要求。
염산극림매소종려산지( CPH)현행결정공예주요존재주봉하출현사개흔소적봉，총잡대우5%，단잡대우1%。채용쌍용제결정，용병동위저물，대불동용제이록갑완、삼록갑완、갑순、을순、을정、정정순진행연구，결과이병동정정순최호，결정수솔위90%，순도대우95%，체도총잡소우5%，단잡소우1%。안색위백색，과립소송，각항공질량지표부합현행USP、 EP요구。
Four small peaks were existed in main current crystallization process of clindamycin palmitate hydrochloride ( CPH) , total impurities was more than 5%, single impurity was greater than 1%. Using adoptdouble solvent cristallization, taking actone as the substrate, the different solvents, such as methylene dichloride, chloroform, methyl alcohol, ethanol, acetonitrile, n-butyl alcohol, were studied, results with acetone n-butyl alcohol was the best. The cristallization yield was 90%, purity was over 95%, total impurities was less than 5%, single impurity was less than 1%, with white color and particles loose. The working quality indexes accorded with the current USP, EP requirement.