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盐酸氮斯汀鼻喷雾剂的研制 被引量：1

Azelastine hydrochloride nasal spray:research and development
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摘要 目的:制备盐酸氮斯汀鼻喷雾剂,并进行稳定性考察。方法:以含量为指标,采用正交设计筛选处方;考察3批样品的稳定性。结果:制备的3批样品在市售包装条件下经加速、室温留样试验考察,质量稳定。结论:优化了盐酸氮斯汀鼻喷雾剂的最佳处方,该处方设计合理。 Objective: To prepare azelastine hydrochloride nasal spray and to study its stability. Methods: The method orthogonal design duplication test was adopted and the content was taken as the parameters to design the formulation. Results: The preparation in commercial packing was stable after acceleration test and storage at room temperature. Conclusion: The formulation is reasonable and the best one for azelastine nasal spray.
作者 付桂英 温明铃 赵颖 高振梅 孙燕 吴坤
机构地区 军事医学科学院附属医院
出处 《军事医学科学院院刊》 CSCD 北大核心 2005年第2期156-158,194,共4页 Bulletin of the Academy of Military Medical Sciences
关键词 盐酸氮zhuo斯汀 鼻喷雾剂 抗变态反应药 剂型 azelastine hydrochloride nasal spray anti-allergic agents dosage forms
分类号 R943 [医药卫生—药剂学]
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参考文献2

  • 1李明.氮（艹卓）斯汀鼻喷雾剂用于治疗过敏性鼻炎[J].国外医药合成药生化药制剂分册,1997,18(6):355-355.
  • 2倪永兴 丁峻 韩可琴.药学应用数理统计[M].北京:军事谊文出版社,1999.145.

同被引文献10

  • 1U.S. Food and Drug Administration. Draft guidance for industry: bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action[EB/OL]. (2003-04-02)[2010-02- 10]. http: //www. fda. gov/downloads/Drugs/Guidance Com- pliance Regulatory Informtion/Guidamus/UCM070111. pdf.
  • 2FERREIRA SL, BRUNS RE, FERREIRA HS, et al. Box- Behnken design: an alternative for the optimization of analytical methods[J]. Anal Chim Acta, 2007, 597(2) : 179-186.
  • 3NGUYEN NK, BORKOWSKI JJ. New 3-level response surface designs constructed from incomplete block designs[J]. J Stat Plan Infer, 2008, 138(1) : 294-305.
  • 4PENNINGTON J, PANDEY P, TAT H, et ol. Spray pattern and droplet size analyses for high-shear viscosity determination of aqueous suspension corticosteroid nasal sprays[J]. Drug Dev Ind Pharm, 2008, 34(9): 923-929.
  • 5SUMAN JD, LAUBE BL, LIN TC, et ol. Validity of in vitro tests on aqueous spray pumps as surrogates for nasal deposition [J]. Pharm Res, 2002, 19(1): 1-6.
  • 6GUO C, STINE K J, KAUFFMAN JF, et al. Assessment of the influence factors on in vitro testing of nasal sprays using Box- Behnken experimental design [J]. Eur J Pharm Sei, 2008, 35 (5) : 417-426.
  • 7GUO C, DOUB WH. The influence of actuation parameters on in vitro testing of nasal spray products[J]. J Pharm Sci, 2006, 95 (9) : 2029-2040.
  • 8DAYAL P, SHAIK MS, SINGH M. Evaluation of different para- meters that affect droplet-size distribution from nasal sprays using the Malvern Spraytec[J]. J Pharm Sci, 2004, 93 (7): 1725-1742.
  • 9DAYAL P, PILLAY V, BABU JR, et al. Box-Behnken experi- mental design in the development of a nasal drug delivery system of model drug hydroxyurea: characterization of viscosity, in vitro drug release, droplet size, and dynamic surface tension[J]. AAPS Pharm Sci Tech, 2005, 6(4): E573-E585.
  • 10沈志红,程松林,翟志慧.鲑降钙素鼻喷雾剂的研制[J].中国医药工业杂志,2002,33(8):395-396. 被引量：9

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军事医学科学院院刊
2005年 第2期

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