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A kind of isosorbide mononitrate controlled release preparation and preparation method thereof

A technology of isosorbide dinitrate and controlled-release preparations, which is applied in pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of drug resistance and curative effect reduction, short-term, etc., and achieve the prevention of drug resistance, Improvement of treatment compliance and improvement of treatment effect

Active Publication Date: 2011-12-28
SHANGAI PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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

Method used

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  • A kind of isosorbide mononitrate controlled release preparation and preparation method thereof
  • A kind of isosorbide mononitrate controlled release preparation and preparation method thereof
  • A kind of isosorbide mononitrate controlled release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] a. Drug-containing layer prescription

[0061] name 1 tablet (mg) isosorbide mononitrate 50 povidone k90 20 lactose 30 silica 1 Magnesium stearate 1

[0062] b. Booster layer prescription

[0063] name 1 tablet (mg) Sodium carboxymethyl starch 72 hypromellose 20 carbomer 10 Sodium chloride 45 Copovidone S630 30

[0064] Iron Oxide Red 1.5 Magnesium stearate 1.5

[0065] c. Isolation gown prescription

[0066] HPMCE590% ethanol solution

[0067] d. Prescription of semi-permeable coating

[0068] Cellulose acetate: polyethylene glycol 400 (3:1) acetone solution

[0069] e. Moisture-proof gown prescription

[0070] name Dosage Opadry 5 water 40mL

[0071] Preparation process: see Figure 8

[0072] Release measurement method:

[0073] Get this product, according to release assay (Chinese Pharmacopo...

Embodiment 2

[0075] a. Drug-containing layer prescription

[0076] name 1 tablet (mg) isosorbide mononitrate 50

[0077] povidone k90 60 EC 40 lactose 70 silica 2 Magnesium stearate 1

[0078] b. Booster layer prescription

[0079] name 1 tablet (mg) sodium alginate 66 hypromellose 20 carbomer 10 Sodium chloride 10 Copovidone S630 30 iron oxide black 1.5 Magnesium stearate 1.5

[0080] c. Isolation gown prescription

[0081] HPMCE590% ethanol solution

[0082] d. Prescription of semi-permeable coating

[0083] Cellulose acetate: povidone k30 (5:2) acetone solution

[0084] e. Moisture-proof gown prescription

[0085] name Dosage Opadry 5 water 40mL

[0086] Preparation process: see Figure 9

[0087] Release measurement method: with embodiment 1, release curve sees attached figure 2 .

Embodiment 3

[0089] a Drug-containing layer prescription

[0090] name 1 tablet (mg) isosorbide mononitrate 50 povidone k90 80 lactose 145 talcum powder 20 Magnesium stearate 5

[0091] [0091] b. Booster layer prescription

[0092] name 1 tablet (mg) Sodium carboxymethyl starch 50 carbomer 20 Mannitol 120 Iron Oxide Red 6 Magnesium stearate 4

[0093] c. Isolation gown prescription

[0094] HPMCE590% ethanol solution

[0095] d. Prescription of semi-permeable coating

[0096] Cellulose acetate: copovidone S630 (5:2) acetone solution

[0097] Preparation method: see Figure 10

[0098] Release measurement method: with embodiment 1, release curve sees attached image 3

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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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K31/34A61K47/32A61K47/34A61K47/36A61K47/38A61P9/10
Inventor 杨怡静甘勇韩建生朱春柳应丽潘弘高科攀
Owner SHANGAI PHARMA GRP CO LTD
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