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Oral insulin medicinal preparation and preparation method thereof

A technology for pharmaceutical preparations and insulin, applied in the field of biomedicine, can solve the problems of low bioavailability and achieve the effect of improving the absorption rate

Pending Publication Date: 2020-04-10
GUANGDONG PHARMA UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The primary purpose of the present invention is to improve the problem of low bioavailability of existing insulin oral preparations, and provide an oral insulin pharmaceutical preparation, which can adhere to the colon and achieve colon-specific drug release, improving the oral bioavailability of insulin

Method used

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  • Oral insulin medicinal preparation and preparation method thereof
  • Oral insulin medicinal preparation and preparation method thereof
  • Oral insulin medicinal preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Example 1 Preparation of Oral Insulin Positioned Drug-Release-Coated Double-Layer Tablets

[0059] The preparation method of the oral insulin positioning drug-release coating double-layer tablet of the present embodiment includes the following steps:

[0060] (1) Preparation of insulin microemulsion freeze-dried powder

[0061] Get 1.0g insulin and be dissolved in the HCl of 80.0mL 0.01mol / L, and the drug solution is gradually added with ethyl oleate as oil phase, with mass ratio of 2:1 polyoxyethylene castor oil and polyethylene glycol- The mixture of 15 hydroxystearate is in the lipid mixture of surfactant (total 5.0g), and wherein, the mass ratio of oil phase and surfactant is 8:9, stirs into O / W type microemulsion; Slowly Add 0.1 mol / L NaOH solution dropwise to adjust the pH of the microemulsion to 5.5, and continue stirring for 2 hours; add lyophilization protective agents—mannitol and dextrin (2%, m / v) respectively, shake to dissolve completely, add water to dilu...

Embodiment 2

[0073] Example 2 Preparation of Oral Insulin Positioned Release Coated Double Layer Tablets

[0074] The preparation method of this example is the same as that of Example 1, the difference is that the drug-positioned drug release coating material of the back-coated double-layer tablet is prepared from a 95% ethanol solution with a mass ratio of Eudragit L100 and Eudragit S100 of 1:4. For a solution with a mass concentration of 10%, a series of tablets with different localized drug release coating thicknesses of 50, 90, 110, 140, and 160 μm were also prepared.

Embodiment 3

[0075] Example 3 Preparation of Oral Insulin Positioned Release Coated Double Layer Tablets

[0076] The preparation method of this example is the same as that of Example 1, the difference is that the drug-positioned drug release coating material of the back-coated double-layer tablet is prepared from a 95% ethanol solution with a mass ratio of Eudragit L100 and Eudragit S100 of 1:2. For a solution with a mass concentration of 10%, a series of tablets with different localized drug-release coating thicknesses of 50, 90, 110, 140, and 160 μm were also prepared.

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Abstract

The invention discloses an oral insulin medicinal preparation and a preparation method thereof. The medicinal preparation comprises: (a) an inner core layer comprising insulin or a biologically active derivative thereof as an active ingredient; (b) an adhesive outer core layer formed on the inner core layer; and (c) a backing coating layer formed on the outer core layer; and (d) a localized drugrelease coating layer formed on the backing coating layer, wherein the backing coating layer is selected from one or more of ethyl cellulose, Eudragit RS (Reed-Solomon) or wax; and the localized drugrelease coating layer comprises Eudragit L100 and Eudragit S100 which are mixed in a mass ratio of (0-1): (1-4) and are used as a localized drug release coating substrate material. The oral insulin medicinal preparation is an intestinal tract terminal localized release preparation, effectively prevents insulin from being damaged by a strongly acidic environment in the stomach, improves the oral bioavailability of insulin, and is a new breakthrough of oral administration of insulin.

Description

technical field [0001] The invention belongs to the technical field of biomedicine. More specifically, it relates to an oral insulin pharmaceutical preparation and its preparation method. Background technique [0002] In recent years, the incidence of diabetes is on the rise, and the number of diabetic patients in the world has reached 200 million, of which more than 10% are in China. With the rapid economic growth and changes in dietary structure, the number of diabetic patients in China will continue to rise. [0003] Insulin has been used for clinical treatment of diabetes for about 90 years, and it is still the drug of choice for insulin-dependent diabetic patients. The commonly used clinical dosage form of insulin is injection, which requires frequent and long-term administration, which brings pain and adverse reactions to patients, and may cause lipoatrophy at the injection site, which ultimately leads to poor medication compliance of patients. Therefore, researcher...

Claims

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Application Information

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IPC IPC(8): A61K38/28A61K9/36A61K47/38A61K47/32A61P3/10
CPCA61K9/2886A61K9/2866A61K9/2846A61K9/2086A61K9/2018A61K38/28A61P3/10
Inventor 朱春娥王荣昌周奕先
Owner GUANGDONG PHARMA UNIV
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