Colloidal aqueous solution of dexamethasone nanoliposome, and preparation method and application thereof
A technology of nanoliposome and dexamethasone, which is applied in the field of medicine, can solve the problems of low local bioavailability, large toxic and side effects, and less absorption in lung tissue, and achieves overcoming the low absorption in lung tissue and the content of main drug. Stable and good drug loading effect
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Embodiment 1
[0031] Embodiment 1: the preparation of a kind of colloidal aqueous solution of dexamethasone nano liposome:
[0032] (1), take the following raw materials according to the content of each raw material in the colloidal aqueous solution of dexamethasone nano liposome: dexamethasone 0.13wt%, glyceryl behenate 2.8wt%, propylene glycol monocaprylate 1.2wt%, Polyoxyethylene 40 hydrogenated castor oil 3wt%, glycerin 1.92wt%, balance is water;
[0033] (2), glyceryl behenate and propylene glycol monocaprylate are heated in a water bath to a molten state at 85°C;
[0034] (3), add dexamethasone in the solution that step (2) obtains, after mixing as oil phase;
[0035] (4), polyoxyethylene 40 hydrogenated castor oil and glycerin are dissolved in distilled water, and heated and mixed in a water bath at 85°C as the water phase;
[0036] (5), the solution obtained in step (4) at the same temperature is added dropwise to the solution obtained in step (3) under 300r / min stirring condition...
experiment example 1
[0039] Experimental example 1: Prescription Screening:
[0040] A colloidal aqueous solution of dexamethasone nanoliposomes (DXM-NLCs), the colloidal aqueous solution of the DXM-NLCs is made up of following raw materials: dexamethasone bulk drug (DXM), glyceryl behenate (ATO888), Propylene Glycol Monocaprylate (C90), Polyoxyl 40 Hydrogenated Castor Oil (RH40), Glycerin and Water. On the basis of single factor investigation, the factors that have a greater impact on the encapsulation efficiency (EE%) of DXM-NLCs were screened out: drug-to-lipid ratio (A), solid-to-liquid-to-fat ratio (B) and emulsifier dosage (C). Orthogonal design method, according to L 9 (3 4 ) design table, and use EE% and drug loading (DL%) as evaluation indexes to screen out the optimal prescription. Table 1 is the factor level table, and Table 2 is the result of the orthogonal test.
[0041] Table 1 Factor level table
[0042]
[0043] Table 2 Orthogonal test results
[0044]
[0045]
[00...
experiment example 2
[0048] Experimental example 2: Content determination:
[0049] 1. Chromatographic conditions Chromatographic column: SB-AQ C 18 Column (250mm×4.6mm, 5μm); mobile phase: acetonitrile-water (34:66); flow rate: 1.0ml min -1 ; Detection wavelength: 240nm; Column temperature: room temperature; Injection volume: 20 μl.
[0050] 2. Examine the specificity of DXM-NLCs and the preparation of the blank NLCs test solution: precisely measure 1ml of the colloidal aqueous solution of DXM-NLCs into a 25ml volumetric flask, add methanol for ultrasonic demulsification and dilute to the mark to obtain DXM-NLCs for use Test solution; blank NLCs test solution prepared in the same way; preparation of reference solution: Accurately weigh 10 mg of DXM reference substance, place it in a 50ml volumetric flask, dissolve it with methanol and dilute to the mark as a stock solution. Precisely measure 2ml of the stock solution into a 25ml volumetric flask, dilute with methanol to the volume to obtain t...
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