Isosorbide mononitrate timing controlled release preparation and preparation method thereof

Abstract

The invention discloses an isosorbide mononitrate timing controlled release preparation and a preparation method thereof. The isosorbide mononitrate timing controlled release preparation of the present invention has certain time-lag and long-acting stationary release, and comprises a semi-permeable membrane with drug release apertures, an isolating coating and a double layer label including a drug contained layer and a boosting layer. The isosorbide mononitrate timing controlled release preparation of the present invention is an osmotic pump tablet with certain time-lag and long-acting stationary release, and can provide a more lasting and stationary plasma concentration and is bioequivalent compared with a sale long-acting preparation Elantan.

Description

technical field [0001] The invention relates to pharmaceutical preparation technology, in particular to a time-selected and controlled-release preparation of isosorbide mononitrate and a preparation method thereof. Background technique [0002] Antianginal drugs are an important category of cardiovascular drugs, accounting for 16% of the eight commonly used cardiovascular drugs. Antianginal drugs include the following categories: ① Nitrates, represented by nitroglycerin and isosorbide mononitrate; ② β receptor blockers, such as propranolol; ③ Calcium antagonists, such as nifedipine, nemo Dipine (see commonly used antihypertensive drugs); ④ other antianginal drugs, such as modidomine, dipyridamole, etc.; or Chinese patent medicines. According to statistics, in 2001, the total amount of Chinese patent medicines used for the prevention and treatment of angina pectoris reached 3.656 billion yuan, of which 54.80% were from hospital terminals and 45.20% from retail terminals. N...

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Problems solved by technology

[0008] The technical problem to be solved by the present invention is not only to overcome the burst release effect of the isosorbide mononitrate sustained and controlled release preparation in the prior art after entering the body, but also to overcome the isosorbide mononitrate sustained and controlled release preparation in the prior art entering the body. There is no time-lag effect after the release, which leads to short-lived, easy-to-produce drug resistance and reduced curative effect during low blood drug concentration (<100ug / ml); and it is consistent with coronary heart disease in the sleep cycle that is gradually extended during the late stage of sleep. Because of the clinical characteristics of being prone to disease, a time-selected and controlled-release preparation of isosorbide mononitrate and its preparation method are provided

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