Preparation method of injectable polyethylene glycol hydrogel loaded with alendronate sodium and application thereof

A technology of sodium alendronate and polyethylene glycol, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, and can solve problems such as side effects, large dosage, and increased dosage , to achieve the effect of maintaining bone structure, improving mineralization process, and convenient operation

Inactive Publication Date: 2020-08-21
GENERAL HOSPITAL OF PLA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because oral preparations are easily damaged by the internal environment such as gastric acid, the amount of absorption varies from person to person, and it is difficult for the drug absorbed into the body to directly reach the affected part. Drug concentration, which not only results in excessive dosage, but also may lead to many side effects

Method used

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  • Preparation method of injectable polyethylene glycol hydrogel loaded with alendronate sodium and application thereof
  • Preparation method of injectable polyethylene glycol hydrogel loaded with alendronate sodium and application thereof
  • Preparation method of injectable polyethylene glycol hydrogel loaded with alendronate sodium and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Weigh 300 mg of four-arm-polyethylene glycol-amino and 0.1 mg of alendronate sodium, mix and dissolve in 1 mL of pure water, then weigh 350 mg of four-arm-polyethylene glycol-aldehyde and dissolve in another 1 mL of pure in water, such as figure 1 As shown, draw a mixed solution with one of the double-barrel syringes, inject the gel into the sample bottle with the double-way syringe, then invert the sample bottle, and record the time. The time when the gel will not flow back is the gelation time. .

[0042] Two gels (four-armed polyethylene glycol hydrogel and four-armed polyethylene glycol hydrogel loaded with alendronate sodium) were subjected to hydrogel toxicity assay:

[0043] (1) The cytotoxicity of hydrogel was determined by CCK-8 kit.

[0044] (2) Prepare rabbit P3-PB-MSCs suspension, inoculate in 96-well plate at a density of 2×103 cells / 100 μL / well, and culture in an incubator at 37°C and 5% CO2 for 12 hours to obtain a monolayer paste parietal cells.

[0...

Embodiment 2

[0049] Weigh 800mg of four-arm-polyethylene glycol-amino and 1mg of alendronate sodium, mix and dissolve in 2mL of pure water, then weigh 1000mg of four-arm-polyethylene glycol-aldehyde and dissolve in another 2mL of pure water In the middle, use one of the double-barreled syringes to draw a mixed solution, and use the double-barrelled syringe to inject it into the bilateral femurs of the osteoporosis rabbits (that is, the drug-loaded gel group), and detect the bone density of the rabbits after 3 months (QCT). The results showed that the bone mineral density of the femoral head in the drug-loaded gel group was significantly higher than that in the blank control group (normal saline), the blank gel group (without alendronate sodium) and the systemic administration group (without gel-forming components) . The results are shown in Table 1.

[0050] Table 1. Comparison table of QCT bone mineral density in each group after treatment

[0051]

Embodiment 3

[0053] Weigh 2000mg of four-arm-polyethylene glycol-amino and 5mg of alendronate sodium, mix and dissolve in 4mL of pure water, then weigh 2400mg of four-arm-polyethylene glycol-aldehyde and dissolve in another 4mL of pure water In the study, one of the double-barrel syringes was used to draw a mixed solution, and the double-barrel syringe was used to inject it into the left femur of the osteoporotic sheep (that is, the drug-loaded gel group), and the bone density of the sheep was detected after 3 months. (DEXA). The results showed that the bone mineral density of the left femoral head of the drug-loaded gel group was higher than that of the blank control group (normal saline), the blank gel group (without alendronate sodium) and the systemic administration group (without gel-forming components). obviously increase.

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Abstract

The invention discloses a preparation method of an injectable polyethylene glycol preparation loaded with alendronate sodium and an application thereof. The preparation at least comprises two independent solutions, wherein a solution 1 is prepared from four-arm-polyethylene glycol-aldehyde group; a solution 2 containsg four arms-polyethylene glycol-amino groups; the hydrogel is dissolved in the solution 1 or the solution 2, or is independently dissolved to form a solution 3; wherein the pH value of the mixed solution of the preparation obtained by mixing the solutions is 4.0-9.0. The four-arm-polyethylene glycol-aldehyde groups and four-arm-polyethylene glycol-amino groups are adopted for in-situ gelling through Schiff base bonds, intraoperative operation is convenient, and the gelling speed is high. Meanwhile, amino on collagen on the surface of the tissue and alendronate sodium in the solution can be quickly and chemically bonded with the four-arm-polyethylene glycol-aldehyde group through a Schiff base bond.

Description

technical field [0001] The invention belongs to the technical field of injectable polyethylene glycol hydrogel, and relates to a preparation method and application of an injectable polyethylene glycol hydrogel loaded with alendronate sodium. Background technique [0002] China has entered an aging society, and it is a huge challenge to pay attention to and understand the occurrence and development of osteoporosis. Osteoporotic fracture is a serious complication of osteoporosis. Once an osteoporotic fracture occurs, it will bring great trauma and economic burden to the patient, so the current treatment of osteoporosis mainly emphasizes its prevention. The anti-osteoporosis drugs currently on the market are all systemic drugs, which can be used to enhance the bone density and bone strength of the whole body, but they have no special strengthening effect on the areas prone to osteoporotic fractures, such as the hip, column and distal forearm , it has no significant effect on ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K47/10A61K47/18A61K31/663A61P19/10A61P19/08
CPCA61K9/0019A61K9/06A61K31/663A61K47/10A61K47/18A61P19/08A61P19/10
Inventor 李大伟周瑾陈嘉一王星李柯马远征
Owner GENERAL HOSPITAL OF PLA
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