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Metformin hydrochloride sustained-release tablets and preparation method thereof

A technology of metformin hydrochloride and sustained-release tablets, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve problems such as easy to forget to take, missed doses, and large fluctuations in blood drug concentration. , to achieve the effect of convenient administration, stable blood concentration and prolonged half-life

Active Publication Date: 2012-05-09
ZHEJIANG WAN SHENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the time of taking the medicine must be regularly spaced to ensure that the blood drug concentration maintains the therapeutic level, and there are disadvantages such as inconvenience for patients to take, easy to forget to take, missed dose, and large fluctuations in blood drug concentration.

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
Comparison scheme
Effect test

Embodiment 1

[0022] 0.5% hypromellose solution and 10% magnesium stearate solution were prepared with 70%, 75%, and 95% ethanol respectively;

[0023] Weigh 500 mg of metformin hydrochloride, 175 mg of hypromellose, and 175 mg of sodium carboxymethyl cellulose, mix and sieve. Add the prepared hypromellose pulp, then add the magnesium stearate pulp, granulate and dry.

[0024] Ethanol concentration (%)

Embodiment 2

[0026] The type of hypromellose has a relatively large impact on the sustained release effect. In this example, hypromellose-50, hypromellose-1000 and hypromellose-4000 are used as binders . Analysis of several common models, the results are as follows:

[0027] components

[0028] The results show that: HPMC-4000 can release the drug more slowly than other hypromellose models.

Embodiment 3

[0030] In order to consider the sustained-release effect of the key excipients hypromellose and sodium carboxymethylcellulose on the tablet, the applicant conducted research on the addition ratio. When making soft materials at one time, select povidone K30 to replace hypromellose pulping to increase the viscosity, and reflect the slow release effect through the tablet release rate. The preferred ratio of hypromellose to sodium carboxymethylcellulose is 1: 1.

[0031]

[0032]

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PUM

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Abstract

The invention discloses metformin hydrochloride sustained-release tablets which are characterized in that: every 10000 tablets are prepared from medicine materials and auxiliary materials of, by weight: 5000g of metformin hydrochloride, 1750g of hypromellose, 1750g of sodium carboxymethyl cellulose, 180g of stearic acid, 200g of magnesium stearate, and an appropriate amount of 75% ethanol. The metformin hydrochloride sustained-release tablets can be slowly released in vivo. With the tablets, stability of blood drug level can be maintained, and a half-life period is prolonged. The tablets are safe, can be used for treating type II diabetes, and are advantaged in high efficiency, low toxicity, and convenient administration. The invention also provides a preparation method of the metformin hydrochloride sustained-release tablets.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a metformin hydrochloride slow-release agent for treating type II diabetes and a preparation method thereof. Background technique [0002] According to data, the incidence of diabetes among adults in my country was less than 1% in 1979, and it had risen to 2.65% in 1997, and it has increased rapidly at a rate of 0.1% every year in recent years. The results of a large-scale epidemiological survey of more than 40,000 people in 11 provinces and cities across the country show that among the people aged 20 to 74 in my country, the incidence rate of diabetes is 2.2%, and those with impaired glucose tolerance (pre-diabetes) The incidence rate is as high as 3.8%, which means that there are more than 20 million diabetic patients in the 20-74 age group in my country, and there are as many as 30 million people in the "reserve army". And 90% of them are type 2 diabet...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/155A61K47/38A61P3/10
Inventor 杜军鲍黎
Owner ZHEJIANG WAN SHENG PHARMA CO LTD
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