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作 者:陈东宇[1] 宋俊生[1] 吴瑛[1] 林力行[1]
机构地区:[1]江苏吴中苏药医药开发有限责任公司,南京210009
出 处:《药学与临床研究》2007年第2期115-117,共3页Pharmaceutical and Clinical Research
摘 要:目的:研究头孢唑啉钠冻干滴眼剂的处方、冻干制备工艺,并建立其质量控制方法。方法:取头孢唑啉钠、羟丙甲基纤维素、活性炭和水制备冻干剂;以氯化钠、硫柳汞和水制备空白滴眼剂。选择合适的内包装使制剂符合贮存和使用上的要求。结果:通过加速试验考察头孢唑啉钠冻干滴眼剂的稳定性。结论:该滴眼剂处方工艺合理,贮存和使用方便,能满足制剂学及临床使用。Objective:To study the preparation and the freezing technique of sodium cefazolin freeze-dried ophthalmic solution and to establish a method of its quality control. Methods: Cefazolin sodium, hydroxypropylmethylcellulose, activated carbon and water for injection were selected to prepare the freeze-dried tablet, while sodium chloride, thiomersalatum and water were used to produce the blank elution. Then, appropriate inner package was selected, in which the solid is easily filled in the button without stained. Results: A HPLC method was established to determine the content, and the stability was evaluated by the accelerated test. Conclusion: The preparation was feasible and convenient.
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