Metformin hydrochloride controlled release tablets and preparation method thereof

Abstract

The invention provides metformin hydrochloride controlled-release tablets and a preparation method thereof. The metformin hydrochloride controlled-release tablets contain a main drug namely metforminhydrochloride, an auxiliary material namely a filler, an auxiliary material namely a sustained-release material, and auxiliary materials namely an adhesive and a sustained-release coating, and is characterized in that the metformin hydrochloride, the filler and the sustained-release material are pressed into a tablet core; the sustained-release material in the tablet core and the sustained-releasecoating film outside the tablet core form a double controlled-release system of a controlled-release drug, the sustained-release material is a mixture of octadecanol and polyoxyethylene, the ratio ofthe octadecanol to the polyoxyethylene in parts by weight is 3: 1, and the molecular weight of the polyoxyethylene is 400,000-900,000. The metformin hydrochloride controlled release tablets providedby the invention have a release rate of 7%-10% per hour, can be released at a constant speed for about 10 hours, is clinically verified to have a low adverse reaction rate after being taken by a patient, and obviously improves the tolerance of the patient.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a metformin hydrochloride controlled-release tablet and a preparation method thereof. Background technique [0002] Metformin hydrochloride is used for people with type II diabetes who are not satisfied with simple diet control, especially those who are obese and accompanied by hyperinsulinemia. Insulin-treated patients are used to reduce insulin dosage. [0003] Metformin hydrochloride monopharmaceuticals currently on the market include ordinary tablets, enteric-coated tablets, capsules, sustained-release tablets and controlled-release tablets. As far as the disclosed metformin hydrochloride sustained- and controlled-release tablet technology is concerned, there are two disadvantages: One is that the total weight of the drug is large, the size of the tablet is too large, and it is inconvenient to take it orally; the other is that there is a phenomenon of sudden release or une...

AI Technical Summary

Problems solved by technology

[0003] Metformin hydrochloride monopharmaceuticals currently on the market include ordinary tablets, enteric-coated tablets, capsules, sustained-release tablets and controlled-release tablets. As far as the disclosed metformin hydrochloride sustained- and controlled-release tablet technology is concerned, there are two disadvantages: One is that the total weight of the drug is large, the size of the tablet is too large, and it is inconvenient to take it orally; the other is that there is a phenomenon of sudden release or uneven drug release, which leads to large fluctuations in the blood drug concentration in the patient's body and a high rate of adverse reactions, which in turn leads to poor tolerance of the patient. Adequate doses of medicine will not achieve a good hypoglycemic effect

Fortamet is a reference preparation in the United States, and its corresponding Chinese patent number is CN1158999C. This drug only relies on the solubility of metformin hydrochloride in the tablet core and the semipermeable membrane coating that wraps the tablet core to control drug release, but in the release In the middle and later stages, due to the collapse of the core, burst release phenomenon is very easy to occur

[0005] Publication number is that the Chinese patent application of CN107049980A discloses the metformin hydrochloride slow-release tablet that relies on adding slow-release agent in the tablet core and coating film is set outside the tablet core to reach slow-release effect, and described slow-release agent adopts carmellose sodium and pre- The combination of gelatinized starch, but the sustained release effect of the tablet core is poor, resulting in uneven drug release in the coating film during the drug release process

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