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Ciliary neurotrophic factor nasal drug delivery system and its preparation method and application

A technology for ciliary neurotrophic and nasal administration preparations, applied in the field of medicine, can solve the problems of prolonging the half-life of CNTF, increasing protein stability, impermeability of the blood-brain barrier, etc., and achieving the effect of improving bioavailability

Active Publication Date: 2020-12-01
SHAANXI MICOT TECH LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, the injection of CNTF also has defects in clinical application, such as being unable to pass through the blood-brain barrier, and has certain immunogenicity. About 70% of patients produce antibodies in the body after subcutaneous injection. Its defect has been improved, as CN200710198546.2 (CN101185762A) discloses a kind of method that adopts the ciliary neurotrophic factor of polyethylene glycol polymer modification, adopts hydrophilic polyethylene glycol and CNTF to bind covalently, prolong CNTF The half-life of the action in the body increases the stability of the protein and reduces the immunogenicity, but there is no research report on the blood-brain barrier; CN201010552864.6 (CN102462662A) discloses a recombinant human ciliary neurotrophic protein wrapped in liposomes Factor method, after intravenous injection of recombinant human CNTF encapsulated in liposomes to mice, the drug reaching the brain of mice increased significantly
However, the preparation process of the above-mentioned method is more complicated and the cost is higher.

Method used

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  • Ciliary neurotrophic factor nasal drug delivery system and its preparation method and application
  • Ciliary neurotrophic factor nasal drug delivery system and its preparation method and application
  • Ciliary neurotrophic factor nasal drug delivery system and its preparation method and application

Examples

Experimental program
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Effect test

Embodiment 1

[0043] Embodiment 1: CNTF nasal drops

[0044] 1. Composition: CNTF 0.015g, hydroxypropyl-β-cyclodextrin 25g, mannitol 0.1g and PBS buffer (pH 7.4) 100ml.

[0045] 2. Preparation method:

[0046] 1) PBS buffer preparation method: weigh 2.457g of sodium dihydrogen phosphate and dissolve it in 50ml of water to make 0.315M solution A; weigh 5.6405g of disodium hydrogen phosphate and dissolve it in 20ml of water to make solution B; B liquid to PH = 7.4; B liquid volume to 50ml. When used, take 10ml and add 0.45g sodium chloride to dilute to 50ml, the concentration is 0.063M, and set aside.

[0047] 2) Treatment of CNTF: take 32ml of CNTF stock solution (provided by China Institute for the Control of Pharmaceutical and Biological Products in Beijing, the same below) and place it in the liquid storage tube of the ultrafiltration centrifugal device, divide it into three times, centrifuge at 6500r at 4°C for 30min; add distilled water to the filtrate 10ml, centrifuge for 30min, and...

Embodiment 2

[0049] Embodiment 2: CNTF nasal drops

[0050] 1. Composition: CNTF 0.015g, polysorbate 20 10g, lactose 0.1g and PBS buffer (pH7.4) 100ml.

[0051] 2. Preparation process:

[0052] PBS damping fluid and CNTF processing method are the same as embodiment 1;

[0053] Dissolve the polysorbate and lactose in the formula amount in PBS buffer solution, place in the bottle of the nasal drug delivery device, then put CNTF in the storage rack of the nasal drug delivery device, cover the bottle cap, and set aside.

Embodiment 3

[0054] Embodiment 3: CNTF nasal drops

[0055] 1. Composition: CNTF 0.030g, polyethylene glycol stearate 15 14.29g, lactose 0.1g, PBS buffer (pH7.4) 100ml.

[0056] 2. Preparation process:

[0057] PBS damping fluid and CNTF processing method are the same as embodiment 1;

[0058] The polyethylene glycol stearate 15 of formula quantity, lactose are dissolved in the PBS damping fluid, are placed in the bottle body of nasal applicator, then CNTF is placed in the storage rack of nasal applicator, cover Good bottle cap, spare.

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Abstract

Disclosed is a CNTF intranasal preparation for treatment of obesity with an absorption enhancer added, improving the bioavailability of biomacromolecular drug nasal administration, wherein a macromolecular protein drug may be delivered into blood, reaching and exceeding the effective injection blood drug concentration. It shows significant weight loss effects on normal mice, diet-induced obesity (DIO) mice, and DIO rat body weight, more effective than subcutaneous administration and positive drugs in the market, in a dose dependent manner. Pharmacodynamic results show that the weight loss stability was significantly better than that of subcutaneous administration, and antibody production was significantly reduced, without causing weight rebound and anorexia reaction. The formulation significantly improves the bioavailability compared to ordinary intranasal formulations, and has a simple preparation process, and stable and controllable quality, and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a ciliary neurotrophic factor (CNTF) nasal drug delivery system and a preparation method and application thereof. Background technique [0002] The incidence of obesity is on the rise worldwide. There are currently at least 1.2 billion obese patients in the world, and the proportion of obese people in China was about 33.4% in 2011. Obesity will increase the incidence of cardiovascular and cerebrovascular diseases, diabetes, fatty liver, tumors, endocrine and other diseases. [0003] Drugs are one of the main measures for weight loss to treat obesity. The commonly used weight loss drug sibutramine has been suspended or withdrawn from the market in 68 countries around the world in 2011 because of serious cardiovascular risks; fenfluramine can cause heart valve damage It was withdrawn from the market in 1997; pancreatitis and oxalate nephropathy may occur in orlistat (currently...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/18A61K9/72A61P3/04
CPCA61K38/18
Inventor 解荷芝范蔷薇
Owner SHAANXI MICOT TECH LTD
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