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Pulsatile delivery composition for treating diabetes mellitus and preparation method thereof

A technology of pulse and mixture, which is applied in the direction of drug combination, drug formulation, drug delivery, etc., which can solve the problems of poor stability, short biological half-life, aggravating the physical and psychological burden of patients, etc.

Active Publication Date: 2014-05-21
SHENZHEN XINGYIN PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, exenatide acetate, liraglutide, and pramlintide acetate, as polypeptide drugs, have the disadvantages of polypeptide drugs, that is, poor stability, difficult oral administration, short biological half-life, frequent medication, aggravating the patient's physical and psychological burden

Method used

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  • Pulsatile delivery composition for treating diabetes mellitus and preparation method thereof
  • Pulsatile delivery composition for treating diabetes mellitus and preparation method thereof
  • Pulsatile delivery composition for treating diabetes mellitus and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] The formula of liraglutide combined with insulin for the treatment of type Ⅱ diabetes mellitus pulse controlled release tablets consists of: accurately weigh 400mg liraglutide, 250mg insulin, 100mg sodium carboxymethyl starch, 100mg talcum powder, 800mg ethyl cellulose, 100mg propylene glycol, Polyethylene glycol 100mg, sodium lauryl sulfate 50mg, sucrose 50mg, 200ml 75% ethanol (finally removed). Prepare 1000 pulse controlled-release tablets according to the formula.

[0016] Its preparation process is as follows: (1) Preparation of tablet core: dissolve liraglutide, insulin, sodium lauryl sulfonate, sucrose, and sodium carboxymethyl starch in the formula in soft material made of 75% ethanol, pass through 24 mesh Sieve and granulate, pass through a 20-mesh sieve after drying, add talcum powder, mix evenly, and press into tablets; (2) Preparation of pulse-controlled release tablets: half the amount of ethyl cellulose, propylene glycol, and polyethylene glycol compositio...

Embodiment 2

[0027]Liraglutide combined with insulin in the treatment of type Ⅱ diabetes pulse controlled-release tablets 1000 tablets The formula is composed of: accurately weighed 550mg liraglutide, 250mg insulin, 100mg hypromellose, 120mg talcum powder, 500mg hypromellose, glycerin Triacetate 80mg, polyethylene glycol 100mg, sodium dodecyl sulfonate 50mg, lactose 100mg, 200ml 75% ethanol (finally removed). Prepare 1000 pulse controlled-release tablets according to the formula.

[0028] Its preparation process is as follows: (1) Preparation of tablet core: dissolve liraglutide, insulin, sodium lauryl sulfonate, lactose, and hydroxypropyl cellulose in the formula in 75% ethanol soft material, pass through a 24-mesh sieve Granulate, pass through a 20-mesh sieve after drying, add talcum powder, mix evenly, and compress into tablets; (2) Preparation of pulse-controlled release tablets: a combination of half-dose hypromellose, triacetin, and polyethylene glycol The material is placed in the ...

Embodiment 3

[0040] Liraglutide Combined with Insulin for Treatment of Type Ⅱ Diabetes Pulse Controlled Release Tablets 1000 Tablets The formula consists of: accurately weigh 600mg liraglutide, 300mg insulin, 150mg sodium carboxymethyl starch, 120mg magnesium stearate, phthalic acid Cellulose 400mg, dibutyl phthalate 80mg, povidone 100mg, dioctyl sodium sulfosuccinate 100mg, starch 150mg, 200ml 75% ethanol (finally removed). Prepare 1000 pulse controlled-release tablets according to the formula.

[0041] The preparation process is as follows: (1) Preparation of tablet cores: dissolve liraglutide, insulin, sodium dioctyl succinate sulfonate, starch, and sodium carboxymethyl starch in the formula in soft materials made of 75% ethanol, and pass 24 Mesh sieve granulation, after drying, pass through a 20-mesh sieve for granulation, add talcum powder, mix evenly, and tablet; , the povidone composition is placed in the die, and then the tablet core is placed at the center of the die on the coat ...

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PUM

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Abstract

The invention relates to a pulsatile delivery sustained-release tablet for treating diabetes mellitus and a preparation method thereof. The active components of the pulsatile delivery sustained-release tablet liraglutide, exenatide acetate or pramlintide acetate are respectively combined with insulin, and drugs are released according to a preset time. According to the pulsatile delivery sustained-release tablet, a polymer material is adopted as a coating film, the active components are combined with a swelling coating to serve as a tablet core, and medical auxiliaries are adopted. The dissolution percentage of the composition is further investigated, and an SD (sprague-dawley) diabetes rat model is used as a studying object to detect the fasting blood-glucose, 2hplasmaglucose, number of hypoglycemia times, dawn phenomenon indexes of the rat model, and the treatment effects are investigated.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a pulse-controlled release tablet for treating diabetes and a preparation method thereof. Background technique [0002] Diabetes mellitus is a group of metabolic disorders characterized by hyperglycemia due to defective insulin secretion and / or insufficient insulin action. Diabetes is divided into type Ⅰ diabetes and type Ⅱ diabetes. According to the statistics of the International Diabetes Federation, the number of adults with diabetes worldwide is increasing year by year. It is estimated that by 2025, 380 million people worldwide will suffer from diabetes. Diabetes mellitus is a group of complex metabolic disorders whose pathogenesis is only partially understood. It includes varying degrees of reduced islet β-cell function, insulin resistance in peripheral tissues, and abnormal glycogen metabolism in the liver. Drug therapy is the focus of diabetes treatment. At pres...

Claims

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Application Information

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IPC IPC(8): A61K9/44A61K38/28A61P3/10
Inventor 姚志勇支钦李新宇李云开张建松付玉清邱焕杰马洪季
Owner SHENZHEN XINGYIN PHARML
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