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

A technology of metformin hydrochloride enteric and metformin hydrochloride, which is applied in the field of metformin hydrochloride sustained-release pellets and its preparation, can solve problems such as adverse reactions and non-absorption by the human body, so as to avoid gastric irritation, improve medication compliance, and reduce side effects Effect

Active Publication Date: 2018-12-07
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, scientific research has also found that after oral administration of metformin, about 40% is absorbed in the upper small intestine (duodenum and proximal jejunum), and only about 10% is absorbed in the ileum and large intestine. Even if metformin is released in the stomach, it is hardly absorbed. Metformin absorbed by the body and released in the stomach can cause the aforementioned adverse reactions

Method used

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

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Prescription

[0036]

[0037]The preparation method is as follows:

[0038] 1) Raw and auxiliary materials are crushed and sieved

[0039] Metformin hydrochloride is pulverized on a pulverizer and sieved; the slow-release material is sieved on a vibrating sieve; raw materials and auxiliary materials are weighed according to the prescription.

[0040] 2) Wet mixing granulation

[0041] Put the weighed metformin hydrochloride and HPMC K100M into the wet granulator in sequence, mix at low speed for 600 seconds, atomize and add 20% of the above solid weight purified water, finish adding within 90 seconds, continue to stir for 30 seconds, and start at the same time Cutter at low speed to make wet granules and discharge.

[0042] 3) Extrusion, spheronization, drying, sieving

[0043] Put the wet granules into the rotary granulator respectively, select a screen with an aperture of 0.8mm, the extrusion speed is 70rpm, the spheronization speed is 550rpm, the spheronizati...

Embodiment 2

[0052] Prescription

[0053]

[0054] 1) Raw and auxiliary materials are crushed and sieved

[0055] Metformin hydrochloride is pulverized on a pulverizer and sieved; the slow-release material is sieved on a vibrating sieve; raw materials and auxiliary materials are weighed according to the prescription.

[0056] 2) Wet mixing granulation

[0057] Put the weighed metformin hydrochloride and HPC JXF into the wet granulator in sequence, mix at a low speed for 600 seconds, atomize and add 20% of the above solid weight purified water, finish adding within 120 seconds, continue to stir for 30 seconds, and start at the same time Cutter at low speed to make wet granules and discharge.

[0058] 3) Extrusion, spheronization, drying, sieving

[0059] Put the wet granules into the rotary granulator respectively, select a screen with an aperture of 0.8mm, the extrusion speed is 70rpm, the spheronization speed is 500rpm, the spheronization time is 3min, and the strips with uniform le...

Embodiment 3

[0068] In vitro dissolution test

[0069] Prepare pH1.0, pH5.0 and pH6.8 solutions according to the regulations of Chinese Pharmacopoeia. The prepared pellets release less than 2% after 100rpm in pH1.0 medium for 2 hours, and the acid resistance is good, which meets the requirements.

[0070] The release situation in pH5.0 and pH6.8 media is as follows figure 1 and figure 2 As shown, it can be seen from the in vitro dissolution results that the acid resistance of the prepared metformin enteric-coated pellets meets the requirements, and can reach about 30% after rapid release in pH5.0 and pH6.8 media, and then continue to release slowly Maintained at 24h to release completely.

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Abstract

The invention provides metformin hydrochloride enteric-coated sustained-release pellets and a preparation method thereof. The sustained-release pellets are successively composed of a sustained-releasepellet core, a quick release layer, an isolating layer and an enteric-coated layer from inside to outside. The pellets are characterized in that by organically combining double mechanisms of frame sustained release and enteric-coated controlled release and an extrusion roller process, laminated delivery and a fluidized bed coating process, the key process parameters are controlled strictly. The metformin hydrochloride enteric-coated sustained-release pellets are prepared by adopting the process, so that irritation of metformin hydrochloride to human stomach is avoided, a sustained-release long-acting characteristic is achieved too, so that the drug is effective within 24 hours, the compliance of a patient is improved, and the side effect is reduced.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a metformin hydrochloride sustained-release pellet and a preparation method thereof. Background technique [0002] Metformin hydrochloride is a biguanide hypoglycemic drug. It is used for patients with type II diabetes who are not satisfied with simple diet control, especially those who are obese and accompanied by hyperinsulinemia. Using this drug not only has hypoglycemic effect, but also may reduce weight and hyperinsulinemia. effect of blood. With the increase in the number of diabetic patients, more and more patients choose metformin hydrochloride as a therapeutic drug, and the sales volume of metformin hydrochloride increases year by year. However, the currently commercially available metformin hydrochloride enteric solution needs to be taken 2-3 times a day, and the number of times of taking is too much, and gastrointestinal discomfort is prone to occur after...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/62A61K9/58A61K47/38A61K47/32A61K47/02A61K47/14A61K47/12A61K31/155A61P3/10
CPCA61K9/501A61K9/5015A61K9/5026A61K9/5047A61K9/5073A61K9/5089A61K31/155A61K47/38A61P3/10
Inventor 孙学惠张志刚林创生龚明鹏张婧媛杨嘉琪祁红林黄肖艳谢斌陈新民
Owner 珠海润都制药股份有限公司
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