Metformin hydrochloride sustained-release tablets and preparation method thereof

A technology for metformin hydrochloride and sustained-release tablets, which is applied in pharmaceutical formulations, coatings, and pill delivery. It can solve problems such as quality risks, easy contamination of tablets, and burst release phenomena, and achieve burst release or non-release. And quality risk, cheap material selection, low cost effect

Inactive Publication Date: 2017-08-18
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This patent has the following problems: ①The main ingredient metformin hydrochloride accounts for a large proportion (up to 500mg), and the tablet is heavy, which is not conducive to the compliance of patients taking the medicine; ②The in vitro release rate is 10-60% in 1-3h, and there is a burst release phenomenon
[0006] Patent No. 200910104099.9 discloses a metformin hydroch

Method used

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  • Metformin hydrochloride sustained-release tablets and preparation method thereof
  • Metformin hydrochloride sustained-release tablets and preparation method thereof
  • Metformin hydrochloride sustained-release tablets and preparation method thereof

Examples

Experimental program
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preparation example Construction

[0033] A preparation method of metformin hydrochloride sustained-release tablet, comprising the following steps:

[0034] S1: Metformin hydrochloride, carmellose sodium, pregelatinized starch, and hypromellose are weighed according to the proportion, and set aside, wherein, the proportion of each component is by weight: metformin hydrochloride 120-180 parts, carboxymethyl cellulose 10-20 parts of cellulose sodium, 20-60 parts of pregelatinized starch, 2-4 parts of hypromellose;

[0035]S2: taking the hypromellose weighed in step S1 to prepare a binder solution, wherein the solvent is purified water, and the mass fraction of the binder is 3-5%;

[0036] S3: Weigh ethyl cellulose and other components according to the ratio, and set aside; the other components are polyethylene glycol 6000 and cetyl alcohol, wherein ethyl cellulose: other components = 1: 0.8-1.0 , polyethylene glycol 6000: cetyl alcohol = 1: 0.8-1.2; under stirring, successively add the ethyl cellulose, polyethyl...

Embodiment 1

[0039] Embodiment 1: A metformin hydrochloride sustained-release tablet, wherein the weight ratio of each component is shown in Table 1.

[0040] Table I

[0041]

[0042]

[0043] The qualified rate of metformin hydrochloride sustained-release tablets in Example 1 was 99.5%.

Embodiment 2

[0044] Embodiment 2: metformin hydrochloride sustained-release tablet, wherein the weight ratio of each component is shown in Table 2.

[0045] Table II

[0046] Plain sheet components weight distribution ratio Metformin Hydrochloride 180 Carmellose Sodium 10 pregelatinized starch 60 hypromellose 2 Coating solution components weight distribution ratio Ethyl cellulose 30 polyethylene glycol 6000 14 cetyl alcohol 16 95% ethanol Appropriate amount, add ethanol until the concentration of the coating solution is 7%, (coating solution-solvent) / coating solution.

[0047] The qualified rate of metformin hydrochloride sustained-release tablets in Example 2 was 99.3%.

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Abstract

The invention discloses metformin hydrochloride sustained-release tablets and a preparation method thereof. The sustained-release tablets achieve a slow release effect by means of a slow release agent and a coating, wherein the slow release agent is a composition prepared from sodium carboxymethyl cellulose and pregelatinized starch; a coating solution is prepared by dissolving ethyl cellulose and other components in ethanol with mass fraction of 95%, wherein other components comprise polyethylene glycol 6000 and hexadecanol; hydroxypropyl methylcellulose is dissolved in purified water so as to be prepared into adhesive. The metformin hydrochloride sustained-release tablets can enable medicines to be slowly released in a human body and maintain an effective blood concentration, thus improving the compliance and safety of patients who take the medicines. The preparation method of the product is safe and reliable, and can realize large-scale production.

Description

technical field [0001] The invention relates to an oral tablet, in particular to a metformin hydrochloride sustained-release tablet and a preparation method thereof. Background technique [0002] Metformin hydrochloride is the main biguanide hypoglycemic drug used clinically. Because of its small adverse reactions, it is also the first-line drug for controlling hyperglycemia in patients with type Ⅱ diabetes recommended in many national diabetes guidelines and the basic drug in combination drugs. Metformin hydrochloride is an extremely water-soluble drug with low bioavailability (50-60%) and short half-life with large fluctuations (0.9-2.6h). Clinically, large doses of repeated medication are required to maintain the effective blood concentration (3 times a day, 500 mg each time), and the patient's compliance is poor. The main side effect after taking the drug is gastrointestinal reactions, and lactic acidosis is caused after overdose. [0003] Sustained-release preparations...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/26A61K47/38A61K31/155A61P3/10
CPCA61K9/0002A61K9/2054A61K9/2077A61K9/2866A61K31/155
Inventor 冉诗念陈用芳何伟杨绪凤
Owner CHONGQING CONQUER PHARML
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