醋酸洗必泰冲洗剂的制备及质量控制  

Preparation and quality control of chlorhexidine acetate irrigation solution

作　　者：王宗春[1] 刘红[2] 

机构地区：[1]武汉大学人民医院药学部,武汉430060 [2]湖北大学生命科学学院

出　　处：《山西医科大学学报》2015年第2期166-168,共3页Journal of Shanxi Medical University

摘　　要：目的进行醋酸洗必泰冲洗剂的配制并建立其质量控制方法。方法参考《湖北省医疗机构制剂规范》(2011年版)中醋酸洗必泰洗剂制备方法,制备醋酸洗必泰冲洗剂,对其性状、鉴别、检查、含量测定进行检验,考察稳定性。用两个不同厂家的鲎试剂对3批醋酸洗必泰冲洗剂进行细菌内毒素干扰试验,验证醋酸洗必泰冲洗剂细菌内毒素检查法的适用性。结果制剂质量稳定,质量浓度为0.50 mg/ml的醋酸洗必泰冲洗剂对鲎试剂与细菌内毒素之间的凝集反应既无抑制作用,也无增强作用。结论醋酸洗必泰冲洗剂制备工艺简便,性质稳定。细菌内毒素检查法适用于醋酸洗必泰冲洗剂质量控制,无需进行热原检查。Objective To prepare the chlorhexidine acetate irrigation solution and establish its quality control method. Methods The chlorhexidine acetate irrigation solutions were prepared according to chlorhexidine acetate lotion in the Preparation Specifications for Medical Institution in Hubei Province （2011 edition ）. The characteristics, identification, inspection, content determination, stability of chlorhexidine acetate irrigation solutions were studied. The interference experiments of bacterial endotoxins for 3 batches of samples were carried out using tachypleus amebocyte lysates（TAL） produced by two manufactures to validate the feasibility of bacterial endotoxins test for chlorhexidine acetate irrigation solution. Results Prepared samples were stable. The results of interference experiments showed that the samples at the concentration of 0.50 mg/ml had no inhibition or enhancement effects on the congregating reactivity between tachypleus amebocyte lysate and bacterial endotoxins. Conclusion Chlorhexidine acetate irrigation solutions are easy to prepare and stable. Bacterial endotoxins test is feasible for the quality control of chlorhexidine acetate irrigation solution, suggesting that there is no need of pyrogen test.

关 键 词：醋酸洗必泰 制备 质量控制 稳定性 细菌内毒素检查 

分 类 号：R927.12[医药卫生—药学]