Medicinal new dosage form containing SA liposome as medicine carrier
A technology for liposomes and drugs, applied in the fields of medicine and pharmacy, can solve the problems of toxicity, unfavorable industrial production, rapid preparation, and expensive delivery system.
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[0047] The preparation method of SA liposome is known, for example, it can be prepared into small single lipid bilayer liposome by ultrasonic method in water bath.
[0048] SA liposomes can usually be stored at 4°C and have a stable period of more than 6 months. A commonly used lipid form is an aqueous suspension at a concentration of 2 mg / ml, sterile.
[0049] pharmaceutical composition
[0050] The pharmaceutically active ingredients that can be used in the present invention are not particularly limited, and may be those known or unknown in the art. Particularly preferred active ingredients are polypeptides, proteins and nucleic acids.
[0051] When the active ingredients are polypeptides or proteins, they may be natural, recombinant or artificially synthesized. In the pharmaceutical composition of the present invention, the weight ratio of polypeptide or protein to SA liposome is usually 1:10-1:300 (w:w), preferably 1:10-1:100. As used herein, the term "nucleic acid" in...
Embodiment 1
[0064] Preparation of SA cationic liposomes
[0065] Take 5 mg SA (SIGMA) and 5 mg DOPE (SIGMA) (10 mg / ml) in a ground-mouthed round-bottomed flask, dry the organic solvent with high-purity nitrogen (about 2 to 3 hours), and freeze-dry (Labconco, the United States) for 2 to 3 hours. hour, add 20ml Millipore sterile water, fill with nitrogen, stopper and seal, ultrasonicate in an ice-water bath (CQ-50 ultrasonic generator from Shanghai Ultrasonic Instrument No. , covered with nitrogen gas during sonication. 100,000g 4°C ultracentrifugation for 30 minutes (Centrikon ultracentrifuge), take the supernatant, 159,000g 4°C ultracentrifugation for 5 hours, take the middle layer, filter it with a microporous sterile filter membrane with a pore size of 0.22μm (Millipore), fill with nitrogen Pack and store at 4°C.
Embodiment 2
[0067] Sustained release and half-life prolongation of SA liposome-calcitonin complex
[0068] 2.1 Formation of SA liposome-calcitonin complex
[0069] 1 μg of salmon calcitonin (SIGMA) was diluted to 300 μl with normal saline, and the SA liposome containing 60 μg was diluted to 300 μl with normal saline.
[0070] 2.2 Formation of SA liposome-calcitonin analog I or II complex
[0071] 1 μg of human calcitonin analog I (hCT-I) or human calcitonin analog II (hCT-II) was diluted to 300 μl with physiological saline, respectively. Dilute the SA liposome containing 60 μg to 300 μl with normal saline, mix the two evenly, let stand at room temperature for 20-30 minutes, and then dilute to 24 ml with normal saline.
[0072] 2.3 Test method
[0073] Comparison of human calcitonin analog I, II potency and half-life before and after the action of SA liposome by intraperitoneal injection. Male Wistar rats were fasted for 18 hours and fed only double distilled water. Inject SA liposome ...
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