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Metformin hydrochloride enteric-coated sustained-release pellet and preparation method thereof

A technology of metformin hydrochloride enteric and metformin hydrochloride, which is applied in the field of preparation of metformin hydrochloride enteric-coated sustained-release pellets, can solve the problems of large feeding amount, low drying efficiency, and long operation time, and achieve the effect of small feeding amount and saving dosage

Inactive Publication Date: 2015-03-25
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, the coating pan coating has low equipment requirements, but the drying efficiency is low, the operation time is long, and the process reproducibility is poor; the centrifugal granulation coating enables the pellets to be coated under high-speed rotation, and the coating is uniform and firm, but generally requires The amount of feed is large, which is not suitable for laboratory use; fluidized bed coating is the coating of pellets in a fluidized state

Method used

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  • Metformin hydrochloride enteric-coated sustained-release pellet and preparation method thereof
  • Metformin hydrochloride enteric-coated sustained-release pellet and preparation method thereof
  • Metformin hydrochloride enteric-coated sustained-release pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Prescription and preparation method:

[0053] Coating liquid prescription:

[0054] The components of the coating liquid of each layer of the enteric-coated sustained-release pellets in this example are as follows:

[0055]

[0056] All are parts by weight.

[0057] Preparation:

[0058] 1. Weigh the blank sugar pellets and place them in a fluidized bed coating device, and grind the raw materials through a 120-mesh sieve; use a 5% HPMC-E5 aqueous solution as a binder, weigh the prescription amount of the drug and suspend it in HPMC-E5 In the aqueous solution, fluidized drug application is carried out under continuous stirring. The control temperature is 35~40℃; the atomization pressure is 0.08~0.1MPa; the blowing frequency is 29.5Hz; the spray flow rate is 0.8~1.5ml / min. The prepared pellets were fluidized and dried at 40°C for 1 hour. After drying, the pill was removed and weighed, and the weight gain was about 74%.

[0059] 2. Accurately weigh a part of the pills containing...

Embodiment 2

[0069] Prescription and preparation method:

[0070] The components of the coating liquid of each layer of the enteric-coated sustained-release pellets in this example are as follows:

[0071]

[0072] All are parts by weight.

[0073] Preparation:

[0074] 1. Prepare MH-containing pills in the same way as in step 1 in Example 1.

[0075] 2. Weigh the prescription amount of Opadry and talc, use deionized water as a solvent to prepare a solution with a solid content of 5% of Opadry, and fluidly coat the prepared coating solution onto the pill containing pills under continuous stirring. Coating process: inlet air temperature 35~39℃, blast frequency 29.6Hz, atomization pressure 0.08~0.1MPa, flow velocity 0.5~0.8rpm. The weight gain of the coating is about 2-3%. After coating, the isolation pellets were fluidized and dried in a fluidized bed for 30 minutes.

[0076] 3. Accurately weigh a part of the isolation pill and coat it with a sustained-release layer. Surelease water dispersion (2...

Embodiment 3

[0083] Prescription and preparation method:

[0084] The components of the coating liquid of each layer of the enteric-coated sustained-release pellets in this example are as follows:

[0085]

[0086] All are parts by weight.

[0087] Preparation:

[0088] 1. Prepare MH-containing pills in the same way as in step 1 in Example 1.

[0089] 2. Accurately weigh a part of the pills and coat them with a sustained-release layer. Take part of the deionized water and heat it to 70°C, add the prescribed amount of Tween 80 and triethyl citrate (TEC) and stir well, then add GMS and stir until dissolved. Finally, slowly add it to the stirring RS-30D, configured as RS-30D is a 10% solid content solution. Spray the prepared coating liquid on the drug-containing pellets with a spray gun under continuous stirring, and control the bed temperature to 20-25℃; the atomization pressure is 0.15MPa; the blast frequency is 29.5Hz; the spray flow rate is 0.8-1.2ml / min. The dosage of TEC is 5%, 10%, 20...

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Abstract

The invention belongs to the field of medicinal preparations, and discloses a metformin hydrochloride enteric-coated sustained-release pellet and a preparation method thereof. The preparation method comprises the steps of preparing a metformin hydrochloride active pellet core, coating a sustained-release layer and coating an enteric layer. The preparation method can be used for preparing the metformin hydrochloride enteric-coated sustained-release pellet which has attractive appearance, good fluidity and high bioavailability, can be slowly released in intestinal tracts and is mild in action and low in adverse reaction incidence by screening and optimizing the process.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of metformin hydrochloride enteric-coated sustained-release pellets. Background technique [0002] Diabetes is a lifestyle disease. It is an endocrine and metabolic disease characterized by high blood sugar caused by absolute or relative lack of insulin in the body. [0003] Diabetes can be divided into two types according to whether it is dependent on insulin: insulin-dependent (IDDM, type 1 diabetes) and non-insulin-dependent (NIDDM, type 2 diabetes). In addition to emphasizing diet control and strengthening exercise, the treatment of type 2 diabetes also plays a decisive role in the treatment of type 2 diabetes, mainly oral hypoglycemic drugs. From the perspective of the treatment of diabetes, it can be divided into four categories, namely sulfonylureas, glucosidase inhibitors, thiazolidinediones and biguanides. Diabetes patients need to take medicine...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/155A61P3/10
Inventor 郑春丽宦立娟张雅捷刘建平朱家壁
Owner CHINA PHARM UNIV
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