| 盐酸氨溴索干粉吸入剂理化性质及其初步稳定性考察 |
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| 引用本文： | 任亚超,李森,彭海生,申志英,于辉,蒋蕾,唐星.盐酸氨溴索干粉吸入剂理化性质及其初步稳定性考察[J].中国药房,2011(29):2735-2737. |
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| 作者姓名： | 任亚超 李森 彭海生 申志英 于辉 蒋蕾 唐星 |
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| 作者单位： | 哈尔滨医科大学;沈阳药科大学药学院; |
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| 基金项目： | 黑龙江省自然科学基金项目(D201031); 黑龙江省教育厅科学研究资助项目(11551178) |
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| 摘 要： | 目的:研究盐酸氨溴索干粉吸入剂的理化性质并考察其稳定性。方法:采用喷雾干燥法制备盐酸氨溴索干粉吸入剂;考察其吸湿性及临界相对湿度;观察其粒径分布、粉末形态;差示扫描量热(DSC)法分析吸入剂及其原料药和各辅料的特征峰;检测其排空率和沉积率;对制剂进行加速试验和长期试验以考察其稳定性。结果:所得干粉吸入剂的临界相对湿度约为64%,平均空气动力学径小于5μm,形态为粒径均匀的球形;DSC提示各样品特征峰未发生明显变化,即在喷雾干燥过程主药与辅料之间未发生相互作用;3批干粉吸入剂排空率均>90%,沉积率均>30%;稳定性试验中各指标在观察期内无明显变化。结论:所制盐酸氨溴索干粉吸入剂适合肺部吸入给药,且具有较好的稳定性。
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| 关 键 词： | 盐酸氨溴索 干粉吸入剂 理化性质 稳定性 |
Study of Physicochemical Property and Stability of Ambroxol Hydrochloride Dry Powder Inhalations |
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| REN Ya-chao,LI Sen,PENG Hai-sheng,SHEN Zhi-ying,YU Hui,JIANG Lei TANG Xing.Study of Physicochemical Property and Stability of Ambroxol Hydrochloride Dry Powder Inhalations[J].China Pharmacy,2011(29):2735-2737. |
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| Authors: | REN Ya-chao LI Sen PENG Hai-sheng SHEN Zhi-ying YU Hui JIANG Lei TANG Xing |
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| Institution: | REN Ya-chao,LI Sen,PENG Hai-sheng,SHEN Zhi-ying,YU Hui,JIANG Lei(Harbin Medical University,Harbin 150086,China) TANG Xing(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China) |
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| Abstract: | OBJECTIVE:To study physicochemical property and stability of Ambroxol hydrochloride dry powder inhalations(AHDI) . METHODS:AHDI were prepared by spray-drying method. The humidity and critical relative moisture of inhalations were investigated. The particle size and powder morphology were also observed. The characteristic peak of inhalations,raw material and excipients were analyzed by DSC. The emptying rate and deposition rate of it were determined. The stability of it was determined by accelerated test and... |
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| Keywords: | Ambroxol hydrochloride Dry powder inhalation Physicochemical property Stability |
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