Fish oil microemulsion preparation and preparation method thereof

An emulsion and fish oil technology, applied in the field of microemulsion preparations, can solve the problems of frequent administration and difficult storage of polypeptide drugs, and achieve the effects of improving bioavailability, enhancing absorption, and reducing the probability of being destroyed

Active Publication Date: 2022-03-29
SUN YAT SEN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] The invention provides a fish oil microemulsion preparation and a preparation method thereof to solve the technical problem that polypeptide drugs require frequent administration and are difficult to preserve

Method used

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  • Fish oil microemulsion preparation and preparation method thereof
  • Fish oil microemulsion preparation and preparation method thereof
  • Fish oil microemulsion preparation and preparation method thereof

Examples

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Effect test

Embodiment 1

[0050]A fish oil microemulsion preparation, belonging to oral preparations, comprising 8.5wt% polypeptide solution, 18.3wt% caprylic capric macrogolglyceride and 73.2wt% fish oil, the mass ratio of fish oil to caprylic capric macrogolglyceride The specific preparation steps for 4:1 are as follows:

[0051] Step 1. Mix the polypeptide drug with pure aqueous solution to prepare a polypeptide solution with a concentration of 1 mg / mL, and the polypeptide drug is PD-1 polypeptide;

[0052] Step 2, mixing and stirring the fish oil and caprylic capric acid macrogolglyceride evenly to obtain the initial mixture;

[0053] Step 3, adding the polypeptide solution drop by drop to the primary mixture, stirring evenly to obtain an oral microemulsion preparation.

Embodiment 2

[0055] A fish oil microemulsion preparation, belonging to oral preparations, comprising 3.5wt% polypeptide solution, 13.65wt% caprylic capric macrogolglyceride and 82.85wt% fish oil, the mass ratio of fish oil to caprylic capric macrogolglyceride 6:1, the specific preparation steps are as follows:

[0056] Step 1. Mix the polypeptide drug with pure aqueous solution to prepare a polypeptide solution with a concentration of 8 mg / mL, and the polypeptide drug is insulin;

[0057] Step 2, mixing and stirring the fish oil and caprylic capric acid macrogolglyceride evenly to obtain the initial mixture;

[0058] Step 3, adding the polypeptide solution drop by drop to the primary mixture, stirring evenly to obtain an oral microemulsion preparation.

Embodiment 3

[0060] A fish oil microemulsion preparation, belonging to oral preparations, comprising 6.54wt% polypeptide solution, 18.69wt% caprylic capric macrogolglyceride and 74.77wt% fish oil, the mass ratio of fish oil to caprylic capric macrogolglyceride 4:1, the specific preparation steps are as follows:

[0061] Step 1. Mix the peptide drug with pure aqueous solution to prepare a peptide solution with a concentration of 6 mg / mL, and the peptide drug is PD-L1 polypeptide;

[0062] Step 2, mixing and stirring the fish oil and caprylic capric acid macrogolglyceride evenly to obtain the initial mixture;

[0063] Step 3, adding the polypeptide solution drop by drop to the primary mixture, stirring evenly to obtain an oral microemulsion preparation.

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Abstract

The invention discloses a fish oil microemulsion preparation and a preparation method thereof, and relates to the field of oral preparations. The microemulsion preparation comprises the following components in percentage by weight: 3.5 wt%-8.5 wt% of small molecular substances; 5 wt% to 18.69 wt% of caprylic / capric polyethylene glycol glyceride; the small molecule substance is a small molecule drug, a polypeptide drug, a protein drug, a nutriment, a skin care product or a beverage. The preparation method comprises the following steps: mixing the fish oil with the caprylic / capric polyethylene glycol glyceride to prepare a primary mixed solution; and dropwise adding the polypeptide solution into the primary mixed solution, and stirring to obtain the microemulsion preparation. The components are natural and safe, the formed emulsion droplet structure can serve as a carrier to wrap small molecular substances such as polypeptide, oral administration, local or parenteral administration, administration route increase and medicine absorption enhancement of the human body are facilitated, the sustained-release effect is achieved, the oral bioavailability of polypeptide medicines is improved, the medicine system stability is good, and the application prospect is wide. The medicine quality can be maintained for a long time.

Description

technical field [0001] The invention relates to the field of microemulsion preparations, in particular to a fish oil microemulsion preparation and a preparation method thereof. Background technique [0002] With the development of biotechnology and peptide synthesis technology, more and more peptide drugs have been approved for clinical treatment. Since peptide drugs have the characteristics of wide indications, high safety and significant curative effect, peptide drugs have been widely used in the prevention, diagnosis and treatment of tumors, hepatitis, diabetes, AIDS and other diseases, and have broad development prospects. Polypeptide drugs are often quite different from chemical drugs in terms of physical and chemical properties, biological properties and process properties. Such drugs have poor stability at room temperature, are easily degraded in the body, and have a short half-life. Therefore, the commonly used dosage forms in clinical practice are Water for injecti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K45/00A61K47/14A61K47/44
CPCA61K9/1075A61K45/00A61K47/14A61K47/44Y02A50/30
Inventor 高艳锋杨欣陈冠宇李淑贞
Owner SUN YAT SEN UNIV
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