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Injectable composite carrier and composition with slow and controlled release drug effect and preparation method

A compound carrier and controlled-release drug technology, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, drug delivery, etc., can solve the problem that the slow-release injections cannot be safe, long-acting, and easy to obtain. Requirements, unable to load macromolecular protein drugs, and unable to be used repeatedly for a long time, to achieve the effects of no toxic side effects, significant clinical value, and a wide range of applications

Active Publication Date: 2022-07-08
ZHEJIANG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is obvious that the use of organic solvents will greatly limit its application fields, not only cannot load most macromolecular protein drugs, but also produce toxic and side effects related to organic solvents, and cannot be used repeatedly for a long time or applied to organic solvents such as ethanol toxic sensitive patients
[0007] To sum up, the materials and preparation technology of drug sustained and controlled release injections currently in use or reported are far from meeting the clinical requirements for the safety, long-acting and easy availability of sustained and controlled release injections.

Method used

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  • Injectable composite carrier and composition with slow and controlled release drug effect and preparation method
  • Injectable composite carrier and composition with slow and controlled release drug effect and preparation method
  • Injectable composite carrier and composition with slow and controlled release drug effect and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Example 1 Preparation of the composition containing recombinant human growth hormone

[0052] Compositions containing polymers and adjuvants and recombinant human growth hormone (hereinafter referred to as growth hormone) were prepared in various formulation compositions listed in Table 1. First, the polymer and the adjuvant are mixed uniformly at 80°C ± 2°C to prepare an injectable composite carrier, and then the recombinant human growth hormone is added at a reduced temperature, and the mixture is mixed until homogeneous to obtain the composition. The resulting composition was translucent liquid in appearance.

[0053] Table 1

[0054]

[0055]

Embodiment 2

[0056] Example 2 In Vitro Release of Compositions Containing Recombinant Human Growth Hormone

[0057] Put 0.4 grams of the seven compositions containing recombinant human growth hormone prepared in Example 1 into different tubes containing 10 mL of phosphate buffered saline (PBS), and shake them at 37°C for in vitro experiments. Release Research. Samples were taken at 3h, 6h, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 9 days, 11 days, 14 days, and fresh PBS was completely replaced. The protein content in the release solution at each time period was analyzed and determined by the BCA protein detection kit, and the cumulative release curve was drawn. The results are shown in figure 1 middle. It can be seen that the composition containing recombinant human growth hormone can stably encapsulate and release the drug for a long time under in vitro release conditions.

Embodiment 3

[0058] Example 3 In vivo release of compositions containing recombinant human growth hormone

[0059] The experimental female SD rats were randomly divided into seven groups, and the rats in each group were subcutaneously injected with 0.4 g of the seven recombinant human growth hormone-containing compositions prepared in Example 1 respectively. Blood samples were taken at 3h, 6h, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 9 days, 11 days and 14 days, and the supernatant was collected by centrifugation. The content of growth hormone in the blood samples of rats at various time periods was analyzed and determined by the recombinant human growth hormone detection kit, and the blank blood samples of rats without the composition were used as the control to draw the blood drug concentration curve. The results are shown in figure 2 middle. It can be seen that the composition containing recombinant human growth hormone can maintain the concentration of growth hormone in...

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Abstract

The invention discloses an injectable composite carrier with slow and controlled release drug action, a composition and a preparation method. The injectable composite carrier consists of a polymer and an adjuvant; the polymer comprises PLA-PEG-PLA, PLGA-PEG-PLGA, PEG-PLA-PEG, PEG-PLGA-PEG, PEG-PLGA, PEG-PLA, One or more of PLGA and PLA; the adjuvant includes one or more of low molecular weight polyethylene glycol, vegetable oil and triglyceride. The injectable composite carrier is free of water and toxic small-molecule organic solvents, is suitable as a carrier for various types of drugs to provide sustained and controlled release and long-acting effects, and has a wide range of applications. The composition is composed of an injectable composite carrier and a drug; the weight percentage of the drug in the composition is 0.01%-60.0%. The composition can realize the controlled and sustained release of the drug. The injectable composite carrier and the composition have a simple preparation process, are easy to obtain, and are convenient for industrialized large-scale production.

Description

technical field [0001] The invention belongs to the field of drug sustained and controlled release preparations, in particular to an injectable composite carrier, a composition and a preparation method that can provide long-acting sustained release for various polypeptide protein biomacromolecular drugs and small molecule drugs. Background technique [0002] In clinical practice, a large number of injectable drugs must be administered repeatedly for a long time or within a long treatment cycle to maintain the therapeutic effect, such as growth hormone used to treat children and adolescents with developmental delay and insulin to control blood sugar in diabetic patients, usually daily. One or more injections, which require many years or even lifelong medication, bring great pain to patients, poor medication compliance, and greatly increase the probability of adverse reactions. Therefore, the research and development of drug sustained and controlled release injection preparati...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K38/27A61K45/00A61K47/10A61K47/14A61K47/34A61K47/44
CPCA61K9/0019A61K38/27A61K47/34A61K47/44A61K47/10A61K47/14A61K45/00
Inventor 邱利焱郑程
Owner ZHEJIANG UNIV
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