伊曲康唑静脉注射乳剂的制备及理化性质的考察
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孔蓓蓓1，王思玲1，苏德森1，董 敬2
(1. 沈阳药科大学 药学院，辽宁 沈阳110016；2. 沈阳药大药业有限责任公司，辽宁 沈阳110016)
摘 要： 目的 制备稳定性良好的伊曲康唑(itraconazole, ITZ)静脉注射乳剂。方法 采用乳化匀质法，制备O/W型的ITZ乳剂；测定乳剂的pH值、粒径大小和ζ电位，评价其物理化学稳定性。结果 ITZ静脉注射乳剂的稳定性良好，质量浓度为0.991 2 mg·mL-1，平均粒径为152 nm，ζ电位为-18.95 mV，pH值为7.64，6个月的稳定性考察结果表明:各项性质几乎没有发生变化。结论 ITZ静脉注射乳剂各项性质符合中国药典2005版对乳剂的要求。
关键词： 药剂学；理化性质；药物稳定性；伊曲康唑；静脉注射乳剂
中图分类号：R944.1 文献标识码：A
Studies on preparation and properties of itraconazole emulsion for intravenous administration
KONG Bei-bei1, WANG Si-ling1, SU De-sen1, DONG Jing2
(1. School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China; 2. Shenyang Yaoda Pharmaceutical Corp., Ltd., Shenyang 110016, China)
Abstract: Objective To design a stable emulsion formulation of itraconazole (ITZ) for intravenous administration. Methods The ITZ O/W emulsion was prepared by a high-pressure homogenization method. Emulsion was characterized regarding particle size, pH and Zeta potential measurements. Results ITZ intravenous emulsion was proved to have a good stability with drug content of 0.991 2 mg·mL-1.The mean droplet size, pH and Zeta potential of ITZ emulsion was 152 nm, 7.64 and -18.95 mV, respectively. No changes in the various physicochemical properties were observed after 6 months. Conclusion It is showed that the formulation meets specification in the Pharmacopoeia of China.
Key words: pharmaceutics; physicochemical properties; drug stability; itraconazole; intravenous emulsion
孔蓓蓓1，王思玲1，苏德森1，董 敬2
(1. 沈阳药科大学 药学院，辽宁 沈阳110016；2. 沈阳药大药业有限责任公司，辽宁 沈阳110016)
摘 要： 目的 制备稳定性良好的伊曲康唑(itraconazole, ITZ)静脉注射乳剂。方法 采用乳化匀质法，制备O/W型的ITZ乳剂；测定乳剂的pH值、粒径大小和ζ电位，评价其物理化学稳定性。结果 ITZ静脉注射乳剂的稳定性良好，质量浓度为0.991 2 mg·mL-1，平均粒径为152 nm，ζ电位为-18.95 mV，pH值为7.64，6个月的稳定性考察结果表明:各项性质几乎没有发生变化。结论 ITZ静脉注射乳剂各项性质符合中国药典2005版对乳剂的要求。
关键词： 药剂学；理化性质；药物稳定性；伊曲康唑；静脉注射乳剂
中图分类号：R944.1 文献标识码：A
Studies on preparation and properties of itraconazole emulsion for intravenous administration
KONG Bei-bei1, WANG Si-ling1, SU De-sen1, DONG Jing2
(1. School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China; 2. Shenyang Yaoda Pharmaceutical Corp., Ltd., Shenyang 110016, China)
Abstract: Objective To design a stable emulsion formulation of itraconazole (ITZ) for intravenous administration. Methods The ITZ O/W emulsion was prepared by a high-pressure homogenization method. Emulsion was characterized regarding particle size, pH and Zeta potential measurements. Results ITZ intravenous emulsion was proved to have a good stability with drug content of 0.991 2 mg·mL-1.The mean droplet size, pH and Zeta potential of ITZ emulsion was 152 nm, 7.64 and -18.95 mV, respectively. No changes in the various physicochemical properties were observed after 6 months. Conclusion It is showed that the formulation meets specification in the Pharmacopoeia of China.
Key words: pharmaceutics; physicochemical properties; drug stability; itraconazole; intravenous emulsion
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