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Medicinal composition containing repaglinide and metformin hydrochloride and preparation method thereof

A technique for metformin hydrochloride and its composition, which is applied in the field of pharmaceutical compositions containing repaglinide and metformin hydrochloride and its preparation, and can solve the problem of poor compatibility between poloxamer and repaglinide and increased process difficulty And control points, difficult to control product quality and other issues, to achieve the effect of reducing the types and usage of excipients, slowing growth, and reducing impact

Inactive Publication Date: 2017-05-31
BEIJING BEILU PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, it is difficult to control product quality using this process
In CN201310219926.5 and CN201310312240.0, poloxamer is selected as the solubilizer, and the compatibility experiment of excipients proves that the compatibility between poloxamer and repaglinide is not good, which may easily cause instability of product quality
Among them, in CN201310219926.5, the repaglinide granules contain binders and the repaglinide granules need to be further ground into a fine powder with a particle size of less than 80 meshes, which increases equipment requirements, increases process difficulty and control points, and easily causes material loss

Method used

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  • Medicinal composition containing repaglinide and metformin hydrochloride and preparation method thereof
  • Medicinal composition containing repaglinide and metformin hydrochloride and preparation method thereof
  • Medicinal composition containing repaglinide and metformin hydrochloride and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1~4

[0055] Embodiments 1-4: Pharmaceutical compositions 1-4 containing repaglinide and metformin hydrochloride

[0056] 1. Prescription of pharmaceutical composition 1~4 (Table 1)

[0057]

[0058] 2. Preparation method

[0059] (1) Weighing: Weigh each raw material and auxiliary material according to the prescription amount, and the actual weighing is shown in the table above.

[0060] (2) Prepare a solution of repaglinide and meglumine and add it to the uniformly mixed material.

[0061] (3) Mixing and granulation;

[0062] (4) Wet granulation;

[0063] (5) drying;

[0064] (6) dry whole grain;

[0065] (7) final mix

[0066] Add sodium carboxymethyl starch or croscarmellose sodium and magnesium stearate to the prepared material and mix evenly.

[0067] (8) Tablet

[0068] Use 16*8mm shallow concave special-shaped punch, the hardness is above 8kg.

[0069] (9) Coating

[0070] Use a coating pan to coat, and the weight of the coating will increase by 2~4%.

Embodiment 5~8

[0087] Embodiments 5-8: Pharmaceutical compositions 5-8 containing repaglinide and metformin hydrochloride

[0088] 1. Prescription of pharmaceutical composition 5-8 (Table 3)

[0089]

[0090] 2. Preparation method

[0091] (1) Material pretreatment: crush metformin hydrochloride and sorbitol respectively and pass through 60 and 80 mesh sieves;

[0092] (2) Weighing: Weigh the specified amount of each raw material and auxiliary material separately;

[0093] (3) Preparation of repaglinide granules

[0094] ①Preparation of drug-loaded solution

[0095] Add meglumine to water, stir to dissolve, add repaglinide to ethanol, stir to make it uniform, add the meglumine aqueous solution to the repaglinide ethanol solution, and stir to make it uniform;

[0096] ② Mixing and granulation

[0097] Add microcrystalline cellulose and sorbitol into the wet mixing granulator respectively, stir; add drug-loading solution; granulate;

[0098] ③ Wet granulation: pharmaceutical compositi...

Embodiment 9

[0115] Embodiment 9: Pharmaceutical composition 9 containing repaglinide and metformin hydrochloride

[0116] 1. Prescription of pharmaceutical composition 9 (Table 4)

[0117]

[0118] 2. The preparation method of pharmaceutical composition 9

[0119] (1) Material pretreatment: crush metformin hydrochloride and sorbitol respectively, and pass through a 80-mesh sieve;

[0120] (2) Weighing: Weigh the specified amount of each raw material and auxiliary material separately;

[0121] (3) Preparation of repaglinide granules

[0122] ①Preparation of drug-loaded solution

[0123] Add meglumine to water, stir to dissolve, add repaglinide to ethanol, stir to make it uniform, add the meglumine aqueous solution to the repaglinide ethanol solution, and stir to make it uniform;

[0124] ② Mixing and granulation

[0125] Add microcrystalline cellulose PH101 and sorbitol into the wet mixing granulator respectively, stir; add drug-loading solution; granulate;

[0126] ③Wet sizing: use...

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Abstract

The invention discloses a medicinal composition containing repaglinide and metformin hydrochloride and a preparation method thereof. The medicinal composition is prepared from repaglinide, metformin hydrochloride, meglumine, povidone K30, microcrystalline cellulose, sorbitol, sodium carboxymethyl starch and / or crosslinking carboxymethyl cellulose sodium and magnesium stearate, wherein the microcrystalline cellulose is preferably microcrystalline cellulose PH101. The medicinal composition contains few components, sources are wide, the preparation process is simple and easy to operate, fixed doses can be manufactured, the medicinal composition conforms to the drug listing standards and has good bioavailability, especially repaglinide and metformin hydrochloride compound tablets, and meanwhile the defects in the prior art are avoided.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing repaglinide and metformin hydrochloride and a preparation method thereof, in particular to two types of type 2 diabetes mellitus ( Non-insulin-dependent) active ingredients of the drug: repaglinide and metformin hydrochloride, the pharmaceutical composition combined with certain excipients, especially the formulation and preparation method of the tablet. Background technique [0002] Type 2 diabetes is a group of metabolic diseases characterized by elevated blood sugar caused by defective insulin secretion and / or impaired islet function, and has become a major public health problem that has seriously threatened human health in recent decades. With rapid economic development, increase in life expectancy and changes in lifestyle, the prevalence of diabetes has increased significantly worldwide. According to the statistics of the International Diabetes Federation (IDF) (http: / / www.diabetesa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/451A61K31/155A61K9/28A61K47/38A61K47/26A61K47/32A61P3/10
CPCA61K31/451A61K9/2018A61K9/2027A61K9/2054A61K9/2806A61K31/155A61K2300/00
Inventor 宗利洪承杰刘盛伟周锡钦宋健
Owner BEIJING BEILU PHARM CO LTD