Metformin hydrochloride enteric-coated tablet and preparation method thereof

Abstract

The invention relates to a metformin hydrochloride enteric-coated tablet and a preparation method thereof. The metformin hydrochloride enteric-coated tablet includes a tablet core and an enteric coating layer; the tablet core is prepared from the following raw materials in parts by weight: 430-570 parts of metformin hydrochloride, 5-40 parts of binder, 0 parts of disintegrant ~30 parts and 1~10 parts of lubricant; the enteric coating layer is prepared from the following raw materials by weight: 5~40 parts of enteric material, 0.5~30 parts of plasticizer and 1~30 parts of antisticking agent 10 parts; the binder is at least one of hypromellose, hypromellose and povidone; the enteric material is methacrylic acid-ethyl acrylate copolymer, methacrylic acid copolymer , at least one of hypromellose phthalate and polyvinyl acetate phthalate. The metformin hydrochloride enteric-coated tablet of the present invention can release rapidly under the condition of pH 4.5-5, and has good bioequivalence with the original drug.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a metformin hydrochloride enteric-coated tablet and a preparation method thereof. Background technique [0002] Metformin Hydrochloride, whose chemical name is 1,1-dimethylbiguanide hydrochloride, is a biguanide hypoglycemic drug. At present, there are four dosage forms on the market: ordinary tablets, enteric-coated tablets, enteric-coated capsules, and sustained-release tablets. It not only has the effect of lowering blood sugar, but also has the effect of reducing weight and hyperinsulinemia. It can be effective for some patients with poor curative effect of sulfonylureas, such as combined with sulfonylurea hypoglycemic agents, small intestinal glycosidase inhibitors or thiazolidinedione hypoglycemic agents, the effect is better than that of each alone. It can also be used in patients on insulin therapy to reduce the dosage of insulin. [0003] Metformin is mainly absorbed in the du...

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Problems solved by technology

[0006] The small intestine is composed of the duodenum, jejunum, and ileum. Although metformin enteric-coated tablets disintegrate in the small intestine, the upper part of the small intestine (duodenum and jejunum) is the main absorption site. The length of the duodenum is 20-25 cm. The length of the jejunum is about 2 meters. Compared with the length of the ileum of 5 meters, the ileum accounts for 3 / 5 of the length of the entire small intestine. If metformin hydrochloride enteric-coated tablets are taken orally, the tablets will not be released until they enter the small intestine, which brings the following problems: Metformin Too short a residence and absorption time at this location in the upper small intestine

Although the metformin hydrochloride tablet has good in vitro release behavior in the range of pH5.5~6.8, the release in pH5.5 buffer solution is reduced, more than 80% is released in 45min, and the release rate is slow, which is not conducive to the release of metformin in the small intestine. Absorption at the top

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