Cannabidiol self-nanoemulsion buccal membrane preparation as well as preparation method and application thereof
A self-nano and self-nanoemulsion technology of cannabidiol, which is applied in the direction of anti-inflammatory agents, pharmaceutical formulations, emulsion delivery, etc., can solve the problems of low bioavailability and unimproved dissolution rate of cannabidiol, reaching High bioavailability, reduced loss and swallowing, enhanced absorption effect
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Embodiment 1
[0056] Embodiment 1 instrument / equipment and detection method
[0057] 1. Instruments and equipment
[0058] High-performance liquid chromatography (Agilent Agilent, 1260Infinity II), particle size potentiometer (Malvern Malvern, Nano ZS90), transdermal diffusion tester (Shanghai Kaikai Technology Trading Co., Ltd., TK-12D).
[0059] 2. Detection method
[0060] (1) Establishment of cannabidiol analysis method: high performance liquid chromatography
[0061] Instrument: Agilent 1260 Infinity II high performance liquid chromatography was used to separate, analyze and quantify cannabidiol and its preparations.
[0062] condition:
[0063] Chromatographic column: Inertsil ODS-3 5μm 4.6*50mm (UP);
[0064] Mobile phase: A water; B methanol; A:B=22:78v / v;
[0065] Flow rate: 1.0mL / min; Wavelength: 210nm; Injection volume: 20μL.
[0066] (2) Determination of the particle size of the emulsion droplet in the self-nanometer emulsion process and the particle size of the composite ...
Embodiment 2
[0079] Embodiment 2 Cannabidiol self-preparation of nanoemulsion
[0080] 1. Screening of oil phase, surfactant and co-surfactant:
[0081] Determination of the solubility of cannabidiol in different oils, surfactants and co-surfactants: the selected oils, surfactants and co-surfactants were placed in 2mL glass bottles, and excess cannabidiol was added, Sonicate for 2 hours, and keep stirring (100 rpm) in a shaking incubator (37°C) for 72 hours after sealing. After centrifugation (3500rpm, 20min), take the supernatant and filter it with a nylon filter (0.45μm), dilute it with a certain amount of methanol, and use HPLC to measure the saturation solubility of cannabidiol in different oils, surfactants and co-surfactants. The raw material drug of cannabidiol was used as the reference drug. The oils, surfactants and co-surfactants screened included but were not limited to caprylic capric mono-diglycerides, polyoxyethylene (35) castor oil, diethylene glycol monoethyl ether, mediu...
Embodiment 3
[0089] Embodiment 3 Preparation of single-layer buccal adhesion film and double-layer buccal adhesion film (blank film without cannabidiol)
[0090] Preparation of monolayer buccal adhesive membrane:
[0091] Hypromellose (HPMC K4M, HPMC K15M, HPMC K100M, HPMC E4M, HPMC E100M), carbomer (971P, 934P), polycarbophil, sodium alginate, sodium carboxymethylcellulose (CMC -Na 8000, CMC-Na 12000), polyvinylpyrrolidone (PVP K30, PVP K60, PVP K90), etc. were prepared into a single film-forming solution with a mass fraction of 0.5-5%. According to the designed prescription (refer to the formula of cannabidiol self-nano-emulsion oral and buccal film preparation 1-16, just take the film-forming material components listed above, and do not take the ones that are not listed, and mix them according to the content in the formula. The plasticizer is also taken according to the same standard), mix the film-forming materials with different prescription quantities and add the plasticizer (glycer...
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