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Preparation method of mesoporous silica-insulin nanometer slowly-released transdermal patch

A mesoporous silica and nano-sustained-release technology, applied in the field of pharmacy, can solve the problems of insulin physiological pain, transient hypoglycemia, and high price, and achieve the effects of avoiding transient hypoglycemia, high drug loading, and improving solubility

Inactive Publication Date: 2018-08-24
FUZHOU UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to solve the problems of insulin injection physiological pain, instantaneous hypoglycemia, fat pad formation by long-term injection, high price, frequent injection, etc.

Method used

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  • Preparation method of mesoporous silica-insulin nanometer slowly-released transdermal patch
  • Preparation method of mesoporous silica-insulin nanometer slowly-released transdermal patch
  • Preparation method of mesoporous silica-insulin nanometer slowly-released transdermal patch

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] A: Dissolve the insulin raw material drug in an alkaline buffer solution with a pH of 7.47, and prepare a raw material drug solution with a concentration of 2 mg / mL for later use;

[0033] Weigh 0.6g CTAB, 10 mL ethylene glycol (EG), 90 mL H 2 O and 2.75 mL ammonia water (Ammonium Hydroxide, AMH), the above solutions were mixed, stirred in an oil bath at 60°C for 30 min, then quickly added 1.2 mL tetraethylsilane (TEOS), continued to stir for 2 h, then aged for 24 h, and the sample was taken out , centrifuged at 13000 rpm for 15 min, washed three times with ethanol and water respectively, then refluxed with 20 mL of acidic ethanol mixture for 24 h, centrifuged at 13000 rpm for 15 min, washed three times with ethanol and water respectively, and freeze-dried to obtain MSN-OH; Weigh 100 mg MSN-OH, ultrasonically dissolve it in 20 mL of absolute ethanol, then add 400 μL of 3-aminopropyltriethoxysilane (APTES), stir and react at room temperature for 24 h, centrifuge the nano...

Embodiment 2

[0037] In vitro release of embodiment 2 ginsenoside / insulin nanogel

[0038] Place 1ml of the drug-loaded layer in a dialysis bag with a molecular weight cut-off of 10,000, and at the same time place the dialysis bag in 30 ml of PBS solution (NaCl, 137 mM; KCl, 2.7 mM, Na 2 HPO 4 ,10 mM; KH 2 PO 4 , 2 mM; pH 7.4), glucose was added to the buffer solution to achieve a higher blood glucose concentration in the human body, and then the PBS buffer solution was placed in a constant temperature shaker at 37°C with a speed of 233min / r. Take a sample of 500 μL, and at the same time add 500 μL of PBS with a higher blood glucose concentration. Use ultraviolet spectrophotometry to detect the wavelength of 276nm, and calculate the cumulative amount. Such as figure 2 As shown, reflecting the full release of insulin within 3 days.

Embodiment 3

[0039] Example 3 In vitro percutaneous absorption experiment

[0040] Prepare 12 complete mouse abdomen skins, use the diffusion cell experiment, and calculate the penetration amount according to the formula

[0041] (Q, μg.cm 2 )

[0042]

[0043] In the formula, Cn is the drug concentration measured at the nth sampling point; Ci is the drug concentration measured at the ith sampling point; A is the effective contact area (cm 2 ); V is the receiving pool volume (ml); V0 is the sampling volume (ml).

[0044] Take the cumulative penetration per unit area (Q) as the ordinate, and time (t) as the abscissa to draw the transdermal absorption experiment, such as image 3 As shown, it shows that the mesoporous silica insulin nanogel has a high transdermal rate.

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Abstract

The invention relates to a mesoporous silica-insulin nanometer slowly-released transdermal patch and a preparation method thereof. The mesoporous silica-insulin nanometer slowly-released transdermal patch is characterized in that a medicine loading layer comprises the components of mesoporous silica-insulin nanometer, a pressure-sensitive glue, a penetration enhancer, a crosslinking agent, a bacteriostatic agent, a substrate, a hydrophilic additive and a freeze-drying protective agent. According to the method, the degradable mesoporous silica entraps insulin to prepare a long-acting slowly-released nano blood sugar reducing patch which has the characteristics of being low in side effects, painless and convenient; insulin is the only hormone capable of reducing blood sugar in a body; silicanano microspheres are capable of adsorbing protein type medicines, so that the silica nano microspheres can be used for loading the protein type medicines, and the problem of application and existingof the protein medicine in the human body can be certainly solved; and meanwhile, the silica nano microspheres are high in degradability, and are safe and stable; the insulin can be protected, and the biology enzyme is prevented from damage, and thus the bioavailability is improved; with the adoption of the patch, the purpose of painless and convenient medicine applying in a slow releasing manneris achieved; the preparation method is simple, and convenient; and the production cost is low.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a mesoporous silicon dioxide-insulin nano transdermal patch and a preparation method thereof. Background technique [0002] Diabetes is a common disease that endangers human health, and the mortality rate caused by diabetes is second only to cardiovascular diseases and tumors. Insulin is the only hormone secreted by pancreatic β cells that can lower blood sugar in the body, and it is also the first-line drug for clinical diabetes. At present, all type I diabetics and diabetics in the later stage of type II must accept insulin injection therapy. At the same time, as a protein drug, insulin is easily destroyed in the human environment due to its large molecular weight, large size, specific tertiary structure, and instability, resulting in protein denaturation and loss of activity. Insulin injections are the most commonly used clinically. To keep blood sugar under co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K38/28A61K47/69A61P3/10
CPCA61K9/7038A61K38/28A61K47/6949A61P3/10
Inventor 邵敬伟邹俊捷郭燕
Owner FUZHOU UNIV
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