Methods to reduce complications of intra-articular steroid
A steroid and intra-articular technology, applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve problems such as no observation, worsening of arthritis symptoms, and interruption of therapeutic effects
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Embodiment 1
[0067] Example 1: Preparation of Lipid Mixture
[0068] Lipid solutions were prepared by solvent injection method. The lipids, including DOPC, DOPG and cholesterol, were mixed and dissolved in 99.9% ethanol at about 40° C. in a flask at a molar ratio of 67.5:7.5:25 to form a lipid solution. Lipid dissolution was performed using a tabletop ultrasonic bath.
[0069] The dissolved lipid solution was added to the 1.0 mM sodium phosphate solution by a peristaltic pump at 100 mL / min to form a pro-liposome suspension. The pro-liposome suspension was then passed 6 to 10 times through a polycarbonate membrane with a pore size of 0.2 μm. A liposome mixture was obtained, the liposomes having an average vesicle diameter of about 120-140 nm (measured by Malvern ZetaSizer Nano ZS-90, Malvern Instruments Ltd, Worcestershire, UK).
[0070] The liposome mixture was passed with Millipore Pellicon 2Mini Ultrafiltration ModuleBiomax-100C (0.1m 2 ) tangential flow filtration system (Millipore ...
Embodiment 2
[0072] Embodiment 2: the preparation of pharmaceutical composition
[0073] The pharmaceutical composition according to the present disclosure is obtained by combining the lipid mixture described in Example 1 with a DSP solution (which contains 13.2 mg / mL dexamethasone sodium phosphate (DSP) (C 22 h 28 FNa 2 o 8 P, molecular weight: 516.41 g / L) and 4 mg / mL sodium citrate) were prepared by mixing, thereby obtaining a liposomal DSP composition having a final concentration of DSP of 12.0 mg / mL (23.2 mM).
Embodiment 3
[0074] Example 3: In Vivo Evaluation of Pharmaceutical Compositions to Reduce Side Effects of Different Doses of Joint Steroids
[0075] An in vivo study was performed using beagle dogs to evaluate the effect of the pharmaceutical composition on reducing the side effects of different doses of IA steroids. Vehicle controls were prepared by mixing the lipid mixture described in Example 1 with 0.9% sodium chloride solution.
[0076] Beagle dogs were divided into five groups and each knee received the following IA injections:
[0077] Group A (n=8): Single IA injection of saline (1.5 mL of 0.9% NaCl per knee)
[0078] Group B (n=8): Single IA injection of vehicle control (1.5 mL of lipid mixture suspension without DSP per knee)
[0079] Group C (n=8): single IA injection of the liposomal DSP composition of Example 2 (0.34 mL of pharmaceutical composition containing 4 mg DSP per knee)
[0080] Group D (n=8): single IA injection of the liposomal DSP composition of Example 2 (1.0 ...
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