OBJECTIVE: To evaluate the quality of Curcumin (Cur) solid lipid nanoparticles(SLN) dry powder inhalation (Cur-SLN-DPI) and investigate its preliminary stability. METHODS: According to related requirements of Chinese Pharmacopeia, physical and chemical properties [particle size, solubility, hygroscopicity, critical relative moisture, mobility (repose angle), water content] and quality evaluation index (main component content uniformity, emptying rate and in vitro effective part deposition rate) of powder were investigated. Preliminary stability test of pharmaceutical preparation was conducted, including accelerated test, long-term test and influential factor test. RESULTS: Average value of each index in 3 batches of Cur-SLN-DPI as follows as particle size of 3.35 μm, completely dissolved within 30 s, critical relative humidity of 70%, repose angle of 24.03 °, water content of 4.57%, main component of 100.13%, content uniformity of 3.647, emptying rate of 95.17%, in vitro effective part deposition rate of 28.73%. In accelerated test, after placing for 3 months, emptying rate was below 90% and in vitro effective part deposition rate decreased by about 5%. In long-term trial, each index had no significant change during observation period. In influential factor test, under relative humidity (RH) of 75% for 10 d, in vitro effective part deposition rate decreased by 5%; under RH of 92.5% for 5 d, capsules were softened and weight gain was more than 5%. CONCLUSIONS: The quality of Cur-SLN-DPI is up to related requirement of DPI; Cur-SLN-DPI keeps stable under light and high temperature condition, but can not keep stable under damp and heat condition. Cur-SLN-DPI should be stored in dry closed container.
关键词
姜黄素固体脂质纳米粒干粉吸入剂理化性质质量评价稳定性试验
Keywords
CurcuminSolid lipid nanoparticlesDry powder inhalationPhysical and chemical propertyQuality evaluationStability test