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Bergenin osmotic pump tablet and preparation method thereof

A technology of petracenin and osmotic pump tablets, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the cumbersome preparation process of double-layer osmotic pump preparations and the fluctuation of blood drug concentration Larger, more times of medication, etc., to achieve the effect of improving bioavailability, reducing the number of medications, and reducing the number of medications

Inactive Publication Date: 2011-03-30
CHENGDU MEDICAL COLLEGE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The currently reported petracenin preparations still have the following defects: 1. Patients need to take medication three times a day; 2. It is impossible to avoid the phenomenon of large fluctuations in blood drug concentration caused by the application of ordinary oral preparations; 3. It is not yet effective Solve the problem of fast metabolism and poor curative effect of the drug
However, compared with primary accelerators, the preparation process of double-layer osmotic pump formulations is relatively cumbersome.

Method used

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  • Bergenin osmotic pump tablet and preparation method thereof
  • Bergenin osmotic pump tablet and preparation method thereof
  • Bergenin osmotic pump tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Embodiment 1 Preparation of petracenin osmotic pump tablet of the present invention

[0053] 1. Preparation process of petracenin osmotic pump tablets

[0054] Take petracenin (187.5mg / tablet) and osmotically active substance mannitol (150mg / tablet), PEO (average molecular weight 5.5 million, its consumption is 45% of tablet core weight), PVP k30 (90mg / tablet) and mix well, use 95% ethanol solution as binder, make soft material, granulate through 20 mesh sieve, dry at 40°C for 4h, granulate with 20 mesh sieve, add 0.5% magnesium stearate for lubrication agent, and compress the tablet core (each containing 187.5 mg of petogenin) with a single-punch tablet press. Use the acetone:ethanol (95:5) solution of cellulose diacetate and PEG1500 as the coating solution, the coating temperature is 40-50°C, and the rotation speed is 30r min -1 , the weight gain of the coating was 10%, and it was left to solidify naturally, and then dried in an oven at 40° C. for 12 hours to remove...

Embodiment 2

[0059] Example 2 Forming Process of Petgenin Inclusion Complex Osmotic Pump Tablets

[0060] 1 Experimental equipment and reagents

[0061] 1.1 Instrument

[0062] RCZ-5A Intelligent Drug Release Tester (Tianjin University Precision Instrument Factory); UV-1102 UV-Vis Spectrophotometer (Shanghai Tianmei Scientific Instrument Co., Ltd.); BY300A Small Coating Machine (Shanghai Huanghai Drug Testing Instrument Factory); TDP single punch Tablet machine (Shanghai No. 1 Pharmaceutical Machinery Factory); electronic balance (F1004, Shanghai Jinke balance); digital constant temperature water bath (HH-2, Guohua Electric Co., Ltd.); stirrer (JJ-11 booster electric stirrer , Jintan City Medical Instrument Factory).

[0063] 1.2 Reagent

[0064] Brutin reference substance (batch number: 111532-200202, National Institute for the Control of Pharmaceutical and Biological Products); Brutin raw material drug (batch number: 20070311, content 99.1%, Xichang Jiexiang Pharmaceutical Raw Materia...

Embodiment 3

[0121] Embodiment 3 Petrogenin Solid Dispersion Osmotic Pump Tablet Forming Process

[0122] 1 Experimental equipment and reagents

[0123] 1.1 Instrument

[0124] RCZ-5A Intelligent Drug Dissolution Apparatus (Tianjin University Precision Instrument Factory), UV-1102 UV-Vis Spectrophotometer (Shanghai Tianmei Scientific Instrument Co., Ltd.), BY-300A Small Coating Machine (Shanghai Huanghai Drug Inspection Instrument Co., Ltd.), TDP Single punch tablet machine (Shanghai No.1 Pharmaceutical Machinery Factory), electronic balance (F1004, Shanghai Jinke Tianping), HH-S constant temperature water bath (Jiangsu Guosheng Experimental Instrument Factory), ultrasonic cleaner (Tianjin Autosaiens Instrument Co., Ltd.), JJ-11 booster electric stirrer (Jintan Medical Instrument Factory).

[0125] 1.2 Reagent

[0126] Brutin raw material drug (content 99.1%, Xichang Jiexiang Pharmaceutical Raw Materials Co., Ltd., batch number: 20070311), Brutin reference substance (for content determi...

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Abstract

The invention provides a bergenin osmotic pump tablet. The bergenin osmotic pump tablet is prepared by coating bergenin, a penetration enhancer and an auxiliary material suppressant tablet core with a controlled release film and punching, wherein the penetration enhancer is polyethylene oxide PEO and mannitol, the tablet core contains 8.3-37.5wt% of bergenin, 3.5-45wt% of polyethylene oxide PEO and 20-45wt% of mannitol. The invention also provides a preparation method of the bergenin osmotic pump tablet. The invention improves the solubility of a slightly soluble drug of the bergenin by utilizing a Beta-cyclodextrin inclusion technology, and further the bergenin is prepared into a single layer osmotic pump type controlled release tablet so as to decrease the drug release speed, reduce the dosage frequency, improve the bioavailability and greatly simplify the process; compared with the common bergenin tablet, the solubility of the prepared bergenin solid dispersoid osmotic pump tablet is obviously enhanced, and the drug is released according to a zero order release speed, and the blood drug level is more moderate and stable, thereby improving the bioavailability, enhancing the clinic curative effects, reducing the dosage frequency and increasing medicine-taking compliance of a patient so that the bergenin is applied more widely in medicine.

Description

technical field [0001] The invention relates to a petracenin osmotic pump tablet, which belongs to the field of medicines. Background technique [0002] Bergenin, also known as Bergenin, Bergenin, Bergenin, Bergenin, Bergenin, Bergenin, Bergenin, etc., white loose needle crystal or crystalline powder, exposed to light and heat Discoloration, soluble in methanol, slightly soluble in water or ethanol. Petgenin was isolated as early as 1880, but its structure was not determined until 1958. Its physiological activity is remarkable, and "Pharmacopoeia of the People's Republic of China" 2005 edition is included as an antitussive and expectorant drug for the treatment of chronic bronchitis, and it has been made into tablets for clinical use. In recent years, scholars at home and abroad have conducted extensive research on it, from the aspects of plant source, extraction process, content determination, pharmacological action, dosage form and its derivatives. Because it is slightly...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K31/366A61K47/38A61K47/40A61K47/34A61K47/32A61K47/10A61P11/00A61P11/10A61P11/14
Inventor 吴敏
Owner CHENGDU MEDICAL COLLEGE
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