首页|桑根酮C吸入型粉雾剂的制备与体外性能初步评价

桑根酮C吸入型粉雾剂的制备与体外性能初步评价

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目的 设计制备桑根酮C吸入型粉雾剂,并对其粉体学性质、吸入性能及稳定性等方面进行初步评价。方法 选择聚乳酸-羟基乙酸共聚物为载体材料,以二氯甲烷和乙酸乙酯为溶剂,聚乙烯醇为乳化剂,采用乳化-溶剂挥发法来制备桑根酮C微球,并采用冷冻干燥制备粉雾剂;对粉雾剂的载药量、包封率、粉体学性质、吸入性能及稳定性等进行考察。结果 所制备的桑根酮C微球呈球形,粉雾剂中微球的粒径为(4。86±0。89)μm,zeta电位为(-4。37±1。10)mV,符合吸入制剂要求;水分含量为(3。01±0。59)%,吸湿增重百分率为(1。96±0。57)%,略有引湿性;堆密度为(0。136±0。005)g/mL,休止角为(24。31±2。54)°,粉体流动性良好;能迅速雾化,雾化性能良好,排空率均大于规定值90%;包封率高,约为100%,载药量为(0。764±0。011)%;pH值为中性,且在不同温度下稳定性良好。结论 所制备的桑根酮C吸入型粉雾剂达到了预期目标,为该制剂的后期生物应用提供了一定的实验基础。
Preparation and preliminary evaluation of sanggenon C inhalation powder aerosol
Objective To design and prepare sanggenon C inhalation powder aerosol,and evaluate its powder properties,inhalation performance and stability.Methods Poly(lactic-co-glycolic acid)was used as carrier ma-terial,dichloromethane and ethyl acetate were used as solvent,and polyvinyl alcohol was used as emulsifier.The sanggenon C loaded microspheres were prepared by emulsification-solvent evaporation method,and the powder was prepared by freeze drying method.The drug loading,encapsulation efficiency,powder properties,inhalation properties and stability of the powder were investigated.Results The prepared sanggenon C microspheres were spherical,the particle size of microspheres in the powder was (4.86±0.89 )μm,and the zeta potential was (-4.37±1.10)mV,which met the requirements of inhalation preparation.The moisture content was (3.01±0.59)%,and the weighting percentage of moisture absorption was (1.96±0.57)%. The bulk density was (0.136±0.005)g/ml,and the angle of repose was (24.31±2.54),thus the powder had good fluidity.It could be atomized quickly with good atomization performance,and the emptying rate was more than 90% of the specified value.The encapsulation rate was about 100%,and the drug loading was (0.764±0.011 )%.The pH value was neutral,and it was stable at different temperatures.Conclusion The preparation of sanggenon C inhaled powder has reached the expected goal,which provides a certain experimental basis for the later biological application of this preparation.

sanggenon Cpoly(lactic-co-glycolic acid)microspherespowder aerosols

吴祖芳、吴玉梅、韩薛魏、吴红阳、杨彩婷、袁建容、袁泽利

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遵义医科大学 药学院,贵州 遵义 563006

桑根酮C 聚乳酸-羟基乙酸共聚物 微球 粉雾剂

2024

遵义医科大学学报
遵义医科大学

遵义医科大学学报

CSTPCD
ISSN:2096-8159
年,卷(期):2024.47(12)