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Pramlintide acetate slow release microballoon preparation and preparation method thereof

A technology of pramlintide acetate and microspheres, which is applied in the field of medicine, can solve problems such as short half-life, poor compliance, failure, etc., achieve stable preparation process, improve drug efficacy and economic benefits, and prolong the effect of drug action time

Inactive Publication Date: 2010-08-11
HUALIYUAN SHANGHAI BIOMEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because the half-life of pramlintide acetate in the body is very short (about 29 minutes), it needs to be administered multiple times a day for several weeks. Such frequent injections will undoubtedly bring great pain to the patient's body and mind. Due to poor compliance, it is very easy to lead to the failure of midway treatment

Method used

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  • Pramlintide acetate slow release microballoon preparation and preparation method thereof
  • Pramlintide acetate slow release microballoon preparation and preparation method thereof
  • Pramlintide acetate slow release microballoon preparation and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0023] Accurately weigh 50mg of pramlintide acetate and dissolve it in 0.25ml pH7.4 PBS buffer to form an internal aqueous phase. Dissolve 400mg of PLGA (Mw=15000, 75:25) in 2ml dichloromethane to form an organic phase. Add the internal water phase to the organic phase, disperse and emulsify at a high speed at 10000rpm to form W / O colostrum. Place 120ml of 2% PVA solution (containing 10% NaCl) in a stirring vessel, and stir the colostrum at high speed (22000rpm ) In the case of 2% PVA solution 120ml (containing 10% NaCl) fully homogenized into W / O / W double emulsion, 2 minutes later, reduce the speed to 400rpm, and stir at low temperature (4~10℃) for 4 hours , After the microspheres are hardened, they are centrifuged and washed, and dried under vacuum at low temperature (4~10℃).

Embodiment 2

[0025] Accurately weigh 50mg of pramlintide acetate and dissolve it in 0.25ml pH7.4 PBS buffer to form an internal aqueous phase. Dissolve 400mg of PLGA (Mw=15000, 75:25) in 1.5ml dichloromethane to form an organic phase. Add the above internal water phase to the organic phase, disperse and emulsify at a high speed at 10000rpm to form W / O colostrum, place 120ml of 2% PVA solution (containing 10% NaCl) in a stirring vessel, and stir the colostrum at high speed ( 16000rpm) in the case of 2% PVA solution 120ml (containing 10% NaCl) fully homogenized into W / O / W double emulsion, after 2 minutes, reduce the speed to 400rpm, and stir at low temperature (4~10℃) 4 After hours, the microspheres are hardened by centrifugation and washed, and then vacuum dried at low temperature (4~10℃).

Embodiment 3

[0027] Accurately weigh 50mg pramlintide acetate and dissolve it in 0.25ml pH7.4 PBS buffer to form an internal aqueous phase. Dissolve 400mg PLGA (Mw=15000, 75:25) in 1ml dichloromethane to form an organic phase. Add the internal water phase to the organic phase, disperse and emulsify at a high speed at 10000rpm to form W / O colostrum. Place 120ml of 2% PVA solution (containing 10% NaCl) in a stirring vessel, and stir the colostrum at high speed (10000rpm ) In the case of 2% PVA solution 120ml (containing 10% NaCl) fully homogenized into W / O / W double emulsion, 2 minutes later, reduce the speed to 400rpm, and stir at low temperature (4~10℃) for 4 hours , After the microspheres are hardened, they are centrifuged and washed, and dried under vacuum at low temperature (4~10℃).

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Abstract

The invention discloses a pramlintide acetate slow release microballoon preparation and a preparation method thereof. The method comprises the following steps of: dissolving pramlintide acetate in a PBS (phosphate buffer solution) solution to form an inner water phase; dissolving a polylactic acid-glycollic acid (PLGA) copolymer in an organic solvent to form an organic phase; mixing the inner water phase with the organic phase and emulsifying into a W / O (water-in-oil) primary emulsion through ultrasound or mixing; then adding the primary emulsion to an outer water phase PVA (Polyvinyl Acetate) aqueous solution under a stirring condition and emulsifying into a W / O / W (water-in-oil-in-water) compound emulsion; stirring at a low speed to ensure that the organic solvent is completely volatilized; and centrifuging, washing, collecting microballoons and drying in vacuum at low temperature to obtain finished microballoon products. The microballoons prepared by adopting the method have rounding shapes, smooth surfaces and good flowabilities; and in vitro medicine release properties of the microballoons can conform to the characteristics of prolonged action preparations.

Description

Technical field [0001] The invention relates to the technical field of medicine, and is a new dosage form of pramlintide acetate-microsphere preparation and a preparation method thereof. Background technique [0002] Pancreatic amyloid polypeptide is a polypeptide hormone composed of 37 amino acid residues. It is released by pancreatic β cells after a meal. It has a variety of physiological functions, such as slowing down the absorption of food (including glucose) in the small intestine, and inhibiting high Glucagon reduces the production of glycogen, reduces the appetite of patients, assists the body in regulating blood sugar levels, etc. (Yong AA, Gedulin BR, Rink TJ. Dose-response for the slowing of gastric emptying in a rodent model byglucagons-like peptide(7-36 ) NH2, amylin cholecystokinin, and other possible regulator of nutrient uptake. Metabolism, 1996, 45(1): 1-3). However, natural amylin is not stable in solution, easy to hydrolyze, and has the characteristics of high...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K38/16A61K47/34A61P3/10A61K38/22
Inventor 张国华
Owner HUALIYUAN SHANGHAI BIOMEDICAL TECH
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