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Levalbuterol hydrochloride oral controlled release tablet capsule and preparation method thereof

A levosalbutamol hydrochloride and controlled-release tablet technology, which is applied in the field of medicine, can solve the problems of non-toxicity, long preparation cycle, and complicated process, and achieve the effects of convenient treatment, short preparation cycle, and low preparation cost

Inactive Publication Date: 2012-01-11
SHENZHEN JIAXUAN MEDICAL TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In view of the above-mentioned deficiencies in the prior art, the purpose of the present invention is to provide a preparation method of levalbuterol hydrochloride oral controlled-release tablet capsules suitable for the rhythmic characteristics of asthma attacks, aiming at solving the problem of existing controlled-release drug dosage forms for the treatment of asthma. In the preparation method, there are complex processes, long preparation cycle, large use of organic solvents that cannot be harmlessly treated such as paraffin, and high cost defects, so as to facilitate industrial production

Method used

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  • Levalbuterol hydrochloride oral controlled release tablet capsule and preparation method thereof
  • Levalbuterol hydrochloride oral controlled release tablet capsule and preparation method thereof
  • Levalbuterol hydrochloride oral controlled release tablet capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0084] Embodiment 1: the preparation of levosalbutamol hydrochloride pulse tablet

[0085] (1) Preparation of pulsed core

[0086] Levalbuterol Hydrochloride 100g

[0087] Microcrystalline Cellulose KG-801 40g

[0088] Microcrystalline Fiber PH-302 32 g

[0089] Oligomeric Hydroxypropyl Cellulose 40g

[0090] Compressible starch 80g

[0091] Magnesium stearate 8g

[0092] Take by weighing main ingredient, microcrystalline cellulose, oligomeric hydroxypropyl cellulose, compressible starch, magnesium stearate and mix uniformly by prescription quantity, compress tablet, obtain the tablet core of 10mg / tablet.

[0093] (2) Preparation of pulse-coated tablets

[0094] Coat the tablet core with 160g of acrylic resin RS, 100g of acrylic resin L100, 10g of triethyl citrate, 30g of talcum powder, and 1000ml of absolute ethanol in a coating pan.

Embodiment 2

[0095] Embodiment 2: Preparation of Levosalbutamol Hydrochloride Sustained-release Tablets

[0096] (1) Preparation of sustained-release tablet cores

[0097] Levalbuterol Hydrochloride 100g

[0098] Lactose 100g

[0099] Microcrystalline Fiber PH-302 30g

[0100] Oligomeric Hydroxypropyl Cellulose 45g

[0101] Polyvinylpyrrolidone (K30) 15g

[0102] Magnesium stearate 2g

[0103] Talc powder 8g

[0104] 75% ethanol appropriate amount

[0105] Dissolve polyvinylpyrrolidone in an appropriate amount of 75% ethanol, add the prescribed amount of drugs, lactose, microcrystalline fiber PH-302, and soft materials made of oligomeric hydroxypropyl cellulose, pass through a 40-mesh sieve, and ventilate and dry at 60°C. Sieve through a 60-mesh sieve for granulation, add an appropriate amount of magnesium stearate, mix evenly, and press into tablets to obtain a tablet core of 10 mg / tablet.

[0106] (2) Preparation of sustained-release coated tablets

[0107] Coat the tablet core wi...

Embodiment 3

[0108] Example 3: Capsule filling

[0109] Take No. 0 empty gelatin capsules, place them in a capsule filling machine, fill the above-mentioned pulse tablets and sustained-release tablets in each hollow capsule in turn, fill each capsule with one tablet with different drug-release properties, and pack it to obtain this product. Invention of tablet capsules.

[0110] time (h) 1 2 3 4 5 6 7 8 9 Drug release (%) 0 0 0 46.8 63.1 75.3 88.5 92.1 94.7

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Abstract

The present invention discloses levalbuterol hydrochloride oral controlled release tablet capsule and a preparation method thereof. The tablet capsule has a characteristic of drug controlled release according to the human circadian rhythm. The levalbuterol hydrochloride oral controlled release tablet capsule comprises a capsule and tablets inside the capsule. The tablets respectively comprise thelevalbuterol hydrochloride pulsed tablet and the levalbuterol hydrochloride controlled release tablet. In the levalbuterol hydrochloride pulsed tablet and the levalbuterol hydrochloride controlled release tablet, the drug release rate are controlled according to adjustments of the drug carrier, the ratio of the drug carrier to the drug, the material and the thickness of the coating film, such that the levalbuterol hydrochloride is controlledly released on the attack nodes of the asthma patient. The preparation method provided by the present invention has advantages of short preparation period, easy operation, green environmental protection and low preparation cost, and is applicable for the industrial production.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a levosalbutamol hydrochloride oral controlled-release tablet capsule and a preparation method thereof. Background technique [0002] albuterol as beta 2 Selective receptor agonist that selectively stimulates beta on bronchial smooth muscle 2 It relaxes the bronchial smooth muscle and relieves the spasm of the bronchial smooth muscle. It is the drug of choice for the clinical treatment of asthma attacks. In recent years, with the development of chronobiology and chronopharmacology, it has been found that various physiological indicators of human beings and some diseases show rhythmic characteristics. The onset of dyspnea in asthmatic patients varies from day to day, and the early morning is the high incidence period of asthma. Therefore, the ideal administration mode of bronchial antispasmodic drugs should be administered at 12 am and maintained until 8 am. In the prior art, although t...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/137A61P11/06
Inventor 孔翔雷江凌孔徐生刘洋欧荔枝李冬丁国华
Owner SHENZHEN JIAXUAN MEDICAL TECH DEV
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