A kind of metformin hydrochloride sustained-release tablet and preparation method thereof
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A technology of metformin hydrochloride and sustained-release tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., to achieve the effects of small tablet weight differences, excellent water retention, and avoiding the use of solvents
Active Publication Date: 2018-07-31
广东赛康药业有限公司 +1
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However, relevant studies have shown that hot-melt extrusion process parameters have a great influence on the formation of impurities in different formulations, and the hot-melt extrusion temperature and cooling temperature directly affect the impurity content of formulations during hot-melt extrusion
At present, there is no relevant report disclosing the use of hot-melt extrusion technology to prepare metformin hydrochloride sustained-release tablets. Therefore, it is necessary to provide a suitable metformin hydrochloride prescription and prepare metformin hydrochloride sustained-release tablets in combination with hot-melt extrusion technology.
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Embodiment 1-5
[0037] The preparation of embodiment 1-5 and comparative example 1-7 metformin hydrochloride sustained-release tablet
[0038] The composition of embodiment 1-5 and comparative example 1-7 metformin hydrochloride sustained-release tablet is shown in the table below:
[0039] Among them, the viscosity of low-viscosity HPMC is 500-1000 mPa.s; the viscosity of high-viscosity HPMC is 10000-15000 mPa.s.
[0040]
[0041] The formula of comparative example 1-7 metformin hydrochloride sustained-release tablet is basically the same as that of Example 1, and the differences are shown in the table below:
[0042]
[0043]
Embodiment 1
[0044] The preparation of embodiment 1 metformin hydrochloride slow-release tablet comprises the following steps:
[0045] (1) respectively pulverize metformin hydrochloride, low-viscosity HPMC, high-viscosity HPMC, PVP-VA64, lactose, docusate sodium, and high-dispersion silicon dioxide, pass through a 100-mesh sieve, and mix uniformly in proportion to make a physical mixture;
[0046] (2) Set the extrusion temperature of the twin-screw extruder to 150°C, start the screw after the temperature rises to the set temperature, set the screw speed to 80 rpm, and add the physical mixture in step (1) to the extrusion In the machine, it is melted, extruded, and finally extruded in strips;
[0047] (3) After the strip-shaped extrudate is cooled, it is pulverized and passed through a 60-mesh sieve to obtain a drug solid or powder;
[0048] (4) The granules obtained in step (3) are directly compressed into tablets.
[0049] Examples 2-5 and Comparative Examples 1-7 Refer to Example 1 fo...
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Abstract
The invention discloses a metformin hydrochloride sustained-release tablet and a preparation method thereof. The metformin hydrochloride sustained-release tablet is prepared by the following steps of using a hydroxypropyl methylcellulose and PVP-VA64 mixture as the sustained-release material, adding a certain amount of stabilizer and release adjuster, and preparing by a hot melting extrusion technique. The metformin hydrochloride sustained-release tablet has the advantages that the sustained-release material and the metformin hydrochloride are tightly bonded, the medicine is more smoothly and slowly released, the effect is obviously better than the in-vitro release conditions of the sustained-release tablet prepared by the conventional wet type granulating tabletting method and the market product (Glucophage SR), and the stability is better; under the condition of no coating, the adverse odor of the metformin hydrochloride can be covered, and the compliance of a patient is improved; the preparation technology is simple, the energy consumption is less, the solvent residue is avoided, the other impurities are not introduced in the whole process, and the continuous production can be easily realized.
Description
technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a metformin hydrochloride sustained-release tablet and a preparation method thereof. Background technique [0002] Metformin hydrochloride, chemical name: 1,1-dimethylbiguanide hydrochloride, molecular formula: C 4 h 11 N 5 ·HCl, molecular weight: 165.63, is an odorless white crystalline powder. It is a biguanide hypoglycemic drug that can be taken orally and widely used. It is the only oral biguanide antihyperglycemic drug still used in developed countries in the world. The main mechanism of lowering blood sugar is to increase the utilization of glucose by peripheral tissues, increase the anaerobic glycolysis of glucose, reduce the absorption of glucose by the gastrointestinal tract, and reduce body weight. At present, it has become the drug of choice for patients with mild to moderate type 2 diabetes, especially obese patients with type 2 diabetes. Metfo...
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