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目的:研究一种妇科腔道用药中药新制剂“参柏克霉泡沫气雾剂”。方法:采用L9(34)正交试验法,以泡沫稳定时间、苦参碱含量为量效考察指标,对影响制剂成型工艺的关键环节如抛射剂密度、用量、共溶剂和助剂用量4因素进行了优选考察;对雾化效果及其影响因素进行了初步考察。结果:对综合评分影响程度最大的因素为抛射剂密度,最佳成型工艺为:A2B2C3D2,即以密度为0.6 mg.mL-1的丙/丁烷混合气为抛射剂,抛射剂:药液比为5∶5,以吐温-80为助溶剂,以3%两性甜菜碱为发泡剂。结论:该工艺合理、稳定,为中药泡沫气雾剂的研究提供了依据。
OBJECTIVE: To study a new medicine for gynecologic oral medicine, “Pycnogenol”. Methods: L9 (34) orthogonal test was used to evaluate the effect of foam stability time and matrine content on the dose-effect. The key factors affecting the molding process of the formulation, such as the density and dosage of propellant, the amount of co-solvent and auxiliaries Carried out the best investigation; the atomization effect and its influencing factors were initially investigated. Results: The most important factor affecting the comprehensive score was the density of projectile. The optimum forming process was A2B2C3D2, that is, the mixture of propane / butane with a density of 0.6 mg.mL-1 5: 5, with Tween-80 as cosolvent and 3% amphoteric betaine as foaming agent. Conclusion: The process is reasonable and stable, which provides the basis for the research of traditional Chinese medicine bubble aerosol.