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Glimepiride aqueous solution administration system and preparation method thereof

A technology for glimepiride and preparations, applied in sublingual spray, glimepiride aqueous solution drug delivery system and its preparation field, can solve the problem of poor stability, low dissolution rate and low bioavailability of glimepiride solid oral preparations and other problems, to achieve the effect of simple and feasible preparation process, avoiding the first-pass effect of the liver, and avoiding the effect of the digestive tract

Active Publication Date: 2011-10-05
BEIJING HUMANWELL JUNWEI PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The first technical problem to be solved by the present invention is to overcome the problems of poor stability, dissolution rate and low bioavailability of existing glimepiride solid oral preparations, and to provide a high bioavailability, fast onset, stable quality, Glimepiride solution drug delivery system with good hypoglycemic effect

Method used

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  • Glimepiride aqueous solution administration system and preparation method thereof
  • Glimepiride aqueous solution administration system and preparation method thereof
  • Glimepiride aqueous solution administration system and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1: Glimepiride Sublingual Spray

[0041] 1. Components:

[0042] Glimepiride 10g

[0043] Tween 80 6g

[0044] Meglumine 45g

[0045] Poloxamer 188 2g

[0046] Hydroxypropyl-β-cyclodextrin 1g

[0047] Glycerin 200ml

[0048] Steviol Glycosides 0.4g

[0049] Double distilled water to 1000ml

[0050] 2. Preparation method:

[0051] First pass the glimepiride and meglumine through a 100-mesh sieve, mix the glimepiride and the prescribed amount of meglumine first, add an appropriate amount of water, and after ultrasonication for about 20 minutes, heat and dissolve in a water bath at 70±10°C until clear After the solution, add Tween 80, poloxamer 188, glycerin, hydroxypropyl-β-cyclodextrin, steviol glycoside in turn respectively in the prescribed amount, add an appropriate amount of redistilled water, and after ultrasonic mixing, add water to 1000ml, Then filter, can, seal, pack, and pass the inspection to be the finished product.

Embodiment 2

[0052] Example 2: Glimepiride Sublingual Spray

[0053] 1. Components:

[0054] Glimepiride 10g

[0055] Meglumine 25g

[0056] Tween 80 6g

[0057] Hydroxypropyl-β-cyclodextrin 1g

[0058] Glycerin 200ml

[0059] Aspartame 0.4g

[0060] Double distilled water to 1000ml

[0061] 2. Preparation method:

[0062] First pass the glimepiride and meglumine through a 100-mesh sieve, mix the glimepiride and the prescribed amount of meglumine first, add an appropriate amount of water, and after ultrasonication for about 20 minutes, heat and dissolve in a water bath at 70±10°C until clear After the solution, add the prescribed amount of Tween 80, glycerin, hydroxypropyl-β-cyclodextrin, and aspartame in turn, add an appropriate amount of double-distilled water, and after ultrasonic mixing, add water to 1000ml, then filter and pack , sealing, packaging, and inspection is the finished product.

Embodiment 3

[0063] Example 3: Glimepiride Sublingual Spray

[0064] 1. Components:

[0065] Glimepiride 10g

[0066] Meglumine 50g

[0067] Tween 80 10g

[0068] Hydroxypropyl-β-cyclodextrin 1g

[0069] Ethanol 200ml

[0070] Steviol Glycosides 1g

[0071] Double distilled water to 1000ml

[0072] 2. Preparation method:

[0073] First pass the glimepiride and meglumine through a 100-mesh sieve, mix the glimepiride and the prescribed amount of meglumine first, add an appropriate amount of water, and after ultrasonication for about 20 minutes, heat and dissolve in a water bath at 70±10°C until clear After the solution, add Tween 80, ethanol, hydroxypropyl-β-cyclodextrin, and steviol glycoside in turn in the prescribed amount, add an appropriate amount of double-distilled water, mix evenly with ultrasound, add water to 1000ml, then filter, can, Sealing, packaging, and passing the inspection is the finished product.

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Abstract

The invention relates to a glimepiride aqueous solution administration system and a preparation method thereof, which belong to the technical field of medicaments. A glimepiride aqueous solution preparation consists of an active component glimepiride and a pharmaceutically acceptable adjuvant, and each 100 milliliters of the preparation contains 0.1 to 10 grams of the glimepiride, preferably 0.1 to 5 grams, and most preferably 0.1 to 2 grams. The glimepiride aqueous solution administration system and the preparation method have the advantages of successfully solving the problem that the glimepiride is extremely difficult to dissolve, and greatly improving the stability of a solution through a series of prescription screening works. The system or a composition performs administration in a sublingual spraying mode to avoid the action of alimentary canals, the reactions of gastrointestinal tracts and the liver first pass effect; besides, the system or the composition has quick response and high bioavailability, is particularly suitable for controlling the postprandial blood sugar, and can be used for treating the type 2 diabetes which cannot be appropriately controlled by dietary restriction and sports. The system or the composition also has the following advantages that: the use is convenient, the dosage can be adjusted as required, the compliance is good, the system or the composition is particularly suitable for old people and the patients who cannot swallow conveniently, the preparation process is simple and practicable and is suitable for industrial production, and the like.

Description

technical field [0001] The invention relates to a glimepiride aqueous solution administration system and a preparation method thereof, preferably a sublingual spray, and belongs to the technical field of medicine. Background technique [0002] Diabetes is a systemic chronic metabolic disorder of sugar, fat, and protein caused by relative or absolute insufficiency of insulin in the body. At first, it is asymptomatic for a long time, and then there will be elevated blood sugar and sugar in the urine. "One less" symptoms (that is, polydipsia, polyuria, polyphagia, and body weight loss), if the blood sugar cannot be maintained close to the normal level for a long time, it is easy to be complicated by cardiovascular, kidney, retina, nerve, skin and other tissue and organ lesions and become disabled or dead . The 5th International Diabetes Federation Conference once pointed out that the number of type 2 diabetes patients diagnosed in the world has reached 130 million. In the 21st...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/64A61P3/10
Inventor 高永良汤菁菁刘娟王晋李劲彤
Owner BEIJING HUMANWELL JUNWEI PHARM TECH CO LTD
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