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Stable Montelukast enteric-coated pellet
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A technology of special sodium enteric and soluble pellets, which is applied in the field of montelukast sodium enteric-coated pellets, can solve the problems of no new breakthroughs, ensure rapid absorption, solve unstable acidic environment, and solve problems of poor dissolution Effect
Inactive Publication Date: 2017-03-15
JIANGSU ALPHA PHARM CO LTD
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Embodiment 1
[0029] Embodiment 1 Preparation of pill core containing drug
[0034] According to the above weight, weigh montelukastsodium and PVP K29 / 32, dissolve in 90% ethanol to obtain the medicinal solution. Put the blank sucrose pellet core in the fluidized bed, preheat it for about 5 minutes, adjust the atomization pressure to 1.5Pa, the fluidization pressure to 0.5Pa, the material temperature to 30°C, the speed of the constant flow pump to 10rad / min, apply the medicine, and dry to obtain the pill. core.
Embodiment 2
[0035] Embodiment 2 ball core bag isolation coat
[0036] The drug-containing pellet core made by embodiment 1 is carried out with 3%HPMC to coat the isolation layer
[0041] Weigh 350g of hypromellose (viscosity 3-5cps), add 8500ml of 95% ethanol, stir to disperse evenly, dilute to 10000ml with water, and dissolve it completely, add 120g of talcum powder, homogenize at high speed, The weight of uncoated pellets is placed in the fluidized bed, and the appropriate blast flow rate, atomizing gas pressure and constant flow pump flow rate are adjusted to make the coating liquid atomize well, without any adhesion between the pellets, and the coating 3%-5% weight gain.
[0048] According to the above weight, weigh Eudragit FS 300, triethyl citrate (TEC), and talc powder, dissolve in 90% ethanol, stir evenly, and filter through an 80-mesh sieve to obtain a coating solution. Put the drug-containing pill core in a fluidized bed, preheat for about 5 minutes, adjust the atomization pressure to 1.2Pa, fluidization pressure to 1.2Pa, material temperature to 35°C, constant flow pump speed to 8rad / min, coating, and drying. Enteric-coated pellets were obtained.
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Abstract
The invention discloses a stable Montelukast enteric-coated pellet. The stable Montelukast enteric-coated pellet is characterized in that isolation of Montelukast from other pharmaceutical necessities and light is effectively guaranteed through an isolation gown layer, and stability of the Montelukast to light and humidity is improved. Meanwhile, drugs can be rapidly released in the intestinal tract by the aid of the enteric sustained-release film layer, rapid absorption of the drugs is guaranteed, and problems about unstable acid environment and poor dissolution are solved.
Description
technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a stable enteric-coated pellet of montelukastsodium. Background technique [0002] Asthma has another name called bronchial asthma. Bronchial asthma is a chronic airwayinflammation involving a variety of cells and cell components. This kind of inflammation is often accompanied by increased airway reactivity, leading to recurrent symptoms such as wheezing, shortness of breath, chest tightness, and / or coughing. Occurs at night and / or early morning, affecting about 7% of children and adults in developed countries. As the main fat-soluble inflammatory mediator in the pathophysiological process of asthma, leukotrienes are one of the important targets for asthma treatment. [0003] Leukotrienes include cysteinyl leukotrienes and leukotriene B 4 , is an inflammatory mediator produced by the metabolism of arachidonic acid by 5-lipoxygenase. In the pathophysiology of asthm...
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