Rubescensin preparation and preparation method and use of same
A pharmaceutical preparation and solvent technology, applied in the field of oridonin A preparation and its preparation and application, can solve the problems of low drug loading efficiency, affecting the safety of injection preparations, etc.
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[0036] In a preferred embodiment, the preparation method according to the diterpene drug preparation of the present invention comprises the following steps:
[0037] Use organic solutions containing diterpenoids and aqueous solutions containing surface active substances to prepare oil-in-water emulsions;
[0038] The organic solvent is removed, the diterpene drug and the surface active substance are self-assembled to form a micelle-like self-assembled structure, and the diterpene drug injection is prepared.
[0039] Optionally, in the above method, some surface active substances may also be added to the organic solution of the diterpene drug, so as to enhance the dissolution of the diterpene drug.
[0040] In some embodiments, the organic solvent can be selected from water immiscible or low miscible organic solvents or mixtures thereof, preferably selected from one or more of the following: chloroform, diethyl ether, dichloromethane, ethyl acetate Esters and their mixtures. ...
Embodiment 1
[0070] Embodiment 1 Oridonin A Injection
[0071] The concentration of oridonin was 1 mg / ml, polysorbate and pluronic F68 were selected as surface active substances, the total concentration was 4 mg / ml, and normal saline was used as solvent. The specific preparation method is as follows: dissolve 100 mg oridonin and 100 mg dehydrated polysorbate in 30 ml chloroform as the oil phase; dissolve 300 mg pluronic F68 in deionized water, and dilute to 100 ml as the water phase. Mix the two phases of oil and water isothermally at 40°C, use a tissue homogenizer with a rotation speed of 10,000rpm to mix for 3 minutes, and quickly remove chloroform by rotary evaporation in a water bath at 40°C, and then you can obtain a clear and clear Oryx chinensis with a concentration of 1mg / ml A drug injection, the average particle size of drug-loaded micellar particles is 150nm.
[0072] Take 2ml of the prepared 1mg / ml Oridonin A injection, put it into a dialysis bag with a molecular weight cut-off...
Embodiment 2
[0074] Embodiment 2 Rubescensine A Injection
[0075] The concentration of oridonin was 0.5 mg / ml, Pluronic F68 and polyoxyethylene hydrogenated castor oil were selected as surface active substances, the total concentration was 8 mg / ml, and deionized water was used as solvent. The specific preparation method is as follows: dissolve 50 mg oridonin and 2 mg polyoxyethylene hydrogenated castor oil in 40 ml chloroform as the oil phase; dissolve 6 mg Pluronic F68 in deionized water, and make it to 100 ml as the water phase Mutually. The two phases of oil and water were mixed isothermally at 40° C., and mixed for 3 minutes using a tissue homogenizer with a rotating speed of 10,000 rpm. In a water bath at 50°C, the chloroform was quickly removed with nitrogen gas. A clear oridonin injection with a concentration of 0.5 mg / ml and an average diameter of 120 nm can be obtained.
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Abstract
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