Pioglitazone hydrochloride gastric residential sustained release tablet and preparation method thereof

Abstract

A pioglitazone hydrochloride gastric residential sustained release tablet adopts pioglitazone hydrochloride as a raw material and is prepared by the following components by weight percent: 10-20% of the pioglitazone hydrochloride, 50-80% of gel formed polymer, 9-30% of foaming agent and the balance of other pharmaceutic adjuvants. The tablet has the advantages that after entering in gastric juice via oral administration, the tablet floats on the gastric juice, is not influenced by gastric emptying, enables drugs to reach absorption sites to be absorbed in a solution state as much as possible, improves bioavailability and prolongs drug action time; the tablet can realize slow and durable release, better absorption effect after administration, steady blood concentration and few administration times; and as the pioglitazone hydrochloride is a weak base salt, and the solubility thereof in an acidic condition is higher than the solubility thereof in a neutral environment or a basic environment, the tablet in the invention can improve the in-vivo dissolution performance of the pioglitazone hydrochloride, and realizes durance release and absorption of the drugs in stomach so as to improve the bioavailability of the drugs.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to an oral preparation of pioglitazone hydrochloride gastric retention sustained-release tablets for treating diabetes. Background technique [0002] Pioglitazone is a thiazolidinedione antidiabetic drug, which is an insulin sensitizer. Its mechanism of action is to highly selectively activate peroxisome growth factor-activated receptors, adjust insulin control genes to strengthen the action of insulin in surrounding muscles, adipose tissue and liver, and promote the consumption of glucose and 2-deoxyglucose, thereby Improve the metabolism of glucose and lipids, have obvious anti-glucagon effect, reduce the level of insulin in plasma, and also inhibit the generation of glucose in the liver, reduce glyceride in blood, inhibit the synthesis of cholesterol in vivo and increase the oxidation of fatty acid effect. Clinical studies have shown that pioglitazone can improve insulin sensitiv...

AI Technical Summary

Problems solved by technology

The Chinese patent publication number is CN101219122A, which discloses a pioglitazone hydrochloride dispersible tablet and its preparation method that is made into tablets by adding an appropriate amount of auxiliary materials to achieve rapid and complete drug dissolution and is suitable for long-term storage, but has poor absorption and blood concentration. Defects of instability, low bioavailability, and frequent doses

Chinese Patent Publication No. is the patent application of CN101269040A, discloses a kind of pioglitazone hydrochloride slow-release drop pill and preparation method thereof, utilizes hydrophilic skeleton material and hydrophobic skeleton material as matrix, makes solid dispersant together with pioglitazone hydrochloride, makes The drug is dispersed in the matrix in the form of molecules, colloids or microcrystals, the total surface area of ​​the drug is increased, the bioavailability is improved, and it has long-acting characteristics. However, pioglitazone hydrochloride belongs to the second class of biological classification drugs, and has low solubility and High permeability, short retention time in the body, easy to be emptied, resulting in poor dissolution and absorption in the body

Images