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Metformin hydrochloride sustained-release tablet and preparation method thereof

A metformin hydrochloride and sustained-release tablet technology, which is applied in the field of medicine, can solve the problems of narrow absorption range, non-absorption, and decreased bioavailability in the gastrointestinal tract, and achieve easy absorption, low hygroscopicity, and avoidance of burst release. Effect

Inactive Publication Date: 2016-11-09
SHIJIAZHUANG HUAXIN PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The purpose of the present invention is to solve the problem that metformin hydrochloride is released too fast in the upper part of the gastrointestinal tract, resulting in a decrease in bioavailability, and the absorption range in the gastrointestinal tract is narrow, and it is not absorbed in the middle and lower parts of the small intestine, and to provide a method that can effectively improve the bioavailability of metformin hydrochloride. Metformin Hydrochloride Extended Release Tablets

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Prescription, see Table 1:

[0032] Table 1 Example 1 prescription component list

[0033]

[0034] Preparation method:

[0035] (1) Sterilize the reactors, filters, utensils, etc. used. Add 1000g of crude metformin hydrochloride into a 15L three-neck flask, add 8000mL of water, stir, heat to reflux to dissolve, then add 2400mL tetrahydrofuran and 5600mL tert-butanol to the solution, then slowly cool down to 4°C, stir and crystallize, filter, and wash with ether , dried under vacuum at 90° C. to obtain 953 g of metformin hydrochloride as a dry product, with a yield of 95.3%;

[0036] (2) The metformin hydrochloride obtained in step (1) is mixed with a filler and an absorption accelerator for subsequent use, the adhesive is formulated into a 5% aqueous solution, and the prepared adhesive solution is added to the mixed material and mixed uniformly to prepare Soft materials, granulated through a 18-mesh sieve;

[0037] (3) drying the granules obtained in step (2) at 4...

Embodiment 2

[0055] Adjust the prescription according to the ratio in the following table, and prepare the products of Examples 2 to 5 in the same way.

[0056] Table 4 Embodiment 2~5 prescription composition list

[0057]

[0058] The preparation method is the same as in Example 1, only the auxiliary materials are replaced according to the actual situation in Table 2.

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Abstract

The invention relates to a metformin hydrochloride sustained-release tablet and a preparation method of the metformin hydrochloride sustained-release tablet, belonging to the technical field of medicines. The metformin hydrochloride sustained-release preparation is composed of a tablet core and a sustained-release coating. With the adoption of the prepared metformin hydrochloride sustained-release tablet, the problems that metformin hydrochloride releases suddenly on the upper part of the gastrointestinal tract and an absorption window is narrow are solved, while metformin hydrochloride slowly releases stably within 10h, and can be effectively absorbed and utilized.

Description

technical field [0001] The invention relates to a sustained-release tablet and a preparation method thereof, in particular to a metformin hydrochloride sustained-release tablet and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Metformin hydrochloride (Metformin hydrochloride), chemical name is 1,1-dimethylbiguanide hydrochloride, molecular formula C 4 h 11 N 5 ·HCl, molecular weight 165.63; white crystal or crystalline powder, odorless; easily soluble in water, soluble in methanol, slightly soluble in ethanol, insoluble in ether or chloroform. Metformin hydrochloride is a biguanide hypoglycemic drug, which is widely used in the treatment of type 2 diabetes due to its small adverse drug reactions. Metformin hydrochloride is an extremely water-soluble drug (dissolution >300mg / mL at 25°C). Common tablets need to be taken 2 to 3 times a day. Clinical application of metformin requires large doses of repeated medica...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K31/155A61K47/34A61P3/10
CPCA61K9/2853A61K9/0002A61K9/2031A61K31/155
Inventor 李志鹏李明海周如亮马海波
Owner SHIJIAZHUANG HUAXIN PHARMA
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