Sustained-release drug containing active biological factors and preparation method thereof

A technology for sustained-release drugs and biological factors, which is applied in the directions of medical preparations containing active ingredients, pharmaceutical formulas, and medical preparations with non-active ingredients, etc. rate, burst release rate, etc., to achieve good sustained release effect, reduce the number of medication, low burst release rate effect

Pending Publication Date: 2020-12-18
杭州生物医药创新研究中心
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to solve the shortcomings of high burst release rate and unsatisfactory sustained release effect in the chitosan sustained release microsphere carrier in the prior art, the present invention uses chitosan and starch to prepare the slow release microsphere carrier, which greatly reduces the sustained release rate. The burst release rate of the microsphere carrier, and the carrier has a good sustained release effect

Method used

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  • Sustained-release drug containing active biological factors and preparation method thereof
  • Sustained-release drug containing active biological factors and preparation method thereof
  • Sustained-release drug containing active biological factors and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1: Preparation of chitosan sustained-release microspheres

[0031] In this field, chitosan microsphere carrier is generally prepared by spray drying method and emulsification crosslinking method. Considering that the active biological factor used belongs to protein / polypeptide, it has the characteristics of not being resistant to high temperature and easy to be inactivated and denatured. Therefore, this embodiment The chitosan microsphere carrier was prepared by emulsification and cross-linking method.

[0032] Existing studies have shown that the preparation of slow-release microsphere carriers with chitosan alone has the disadvantages of easy burst release of active substances and insufficient encapsulation efficiency. Sodium phosphate, albumin, collagen, sodium alginate and other microsphere carrier materials were mixed, and sodium tripolyphosphate was used as a crosslinking agent to prepare microspheres. The results showed that only when chitosan was mixe...

Embodiment 2

[0053] Example 2: Determination of cell proliferation activity of FGF-2 sustained-release microsphere carrier

[0054] Since the active FGF-2 has cell proliferation activity, the activity of the microsphere carrier was tested by the proliferative ability of the FGF-2 slow-release microsphere carrier on Balb / c3T3 cells.

[0055] Specific steps are as follows:

[0056] Get the Balb / c3T3 cells in the logarithmic growth phase and dilute them to 5-6×10 with 1640 medium containing 10% calf serum 4 100 μl per well was inoculated in a 96-well plate, no cells were added to the edge wells, only medium was added as a cell-free blank, 37°C, 5% CO 2 Cultivate in the incubator for 8 hours to allow the cells to adhere to the wall, then wash the 96-well plate cells twice with 1640 medium containing 0.5% calf serum, add 100 μl of 1640 medium containing 0.5% calf serum and culture for 48 hours, pass through the serum Starvation keeps cells in a quiescent state. During this period, the 1640 m...

Embodiment 3

[0058] Embodiment 3: FGF-2 sustained-release microsphere carrier stability

[0059] The purpose of this example is to study the influence of the FGF-2 slow-release microsphere carrier on the stability of FGF-2. The experiment is divided into the following three groups: placed at 4°C, placed at room temperature, and placed at 40°C. The samples were measured at 5, 10, 20, 30 days for each biological activity, and compare the assay results.

[0060] FGF-2 sustained-release microsphere carrier preparation method is as follows: get 150mg chitosan (100kDa) and 50mg starch (experimental group), or separate 150mg chitosan (kDa) (control group) is dissolved in the 20mL / L acetic acid of 9ml respectively In the solution, dissolve 10 μg FGF-2 in 1 ml of 4 mmol / L HCl solution, mix the above two solutions to obtain a mixed solution, slowly add the mixed solution to 90 mL of octanol solution containing 5 ml / l Tween-80, and magnetically Stir with a stirrer for 2 hours, add 100 g / L sodium tri...

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Abstract

The invention aims to provide a sustained-release drug containing active biological factors and a preparation method of the sustained-release drug. The drug contains a sustained-release carrier, and the sustained-release carrier is starch and / or chitosan, preferably chitosan and starch. The sustained-release drug is prepared through an emulsification crosslinking method, the preparation method issimple, and the obtained sustained-release drug can greatly reduce burst release rate of active biological factors, can obtain longer sustained-release capacity, has good drug loading capacity and encapsulation efficiency, is suitable for clinical popularization of the active biological factors, and has huge application value.

Description

technical field [0001] The invention belongs to the field of active biological factors, in particular to a slow-release medicine containing active biological factors and a preparation method thereof. Background technique [0002] Fibroblast growth factor is an important cytokine, which has a variety of physiological functions and plays an important role in life activities. The fibroblast growth factor family is currently known to include 23 members, with 30-80% homology among family members. The current research on fibroblast growth factors mainly focuses on FGF-1 (a-FGF, acidic fibroblast growth factor), FGF-2 (b-FGF, basic fibroblast growth factor), FGF-13, FGF-21, etc. [0003] FGF-2, namely basic fibroblast growth factor, was originally isolated from bovine pituitary gland and brain tissue extracts, which can promote the division and proliferation of 2T3 cells. Subsequent studies have shown that FGF-2 is widely distributed in the body, from the pituitary gland, brain, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/18A61K9/16A61K47/36
CPCA61K38/1825A61K9/1652
Inventor 李校堃林丽张宏宇冯治国肖健龚方华杨丽珠
Owner 杭州生物医药创新研究中心
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