Propranolole hydrochloride sustained-release pellets and preparation method thereof

A technology of propranolol hydrochloride sustained-release pellets and propranolol hydrochloride, which can be used in pharmaceutical formulations, medical preparations of non-active ingredients, and bulk transportation, etc., and can solve inconvenience in packaging, transportation, storage, and drug release Low stabilizing effect and large gastrointestinal irritation, etc., to achieve the effect of improving bioavailability, small individual differences, and reducing irritation

Inactive Publication Date: 2016-02-03
HARBIN SHENGJI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, among the drugs for the treatment of angina pectoris on the market, there are disadvantages such as low stable effect of drug release, high irritation to the gastrointestinal tract, low bioavailability, inconvenient packaging, transportation and storage, and complicated preparation methods.

Method used

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  • Propranolole hydrochloride sustained-release pellets and preparation method thereof
  • Propranolole hydrochloride sustained-release pellets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A kind of propranolol hydrochloride sustained-release pellets, comprising a coating layer and drug-containing pellets; the coating layer is wrapped on the outside of the drug-containing pellets; the coating layer includes: 35-175mg Eudragit NE- 30D, 5-53mg talcum powder; the drug-containing pellets include: 40mg propranolol hydrochloride, 80mg blank ball core, 160-210mg filler, 10-50mg lubricant, 5-25mg binder.

[0028] The coating layer also includes trace amounts of one or both of sodium lauryl sulfate and polyethylene glycol.

[0029] The preferred weight ratio in the coating layer is: 132mg Eudragit NE-30D, 7mg talcum powder.

[0030] The preferred weight ratio of the drug-containing pellets is: 40mg propranolol hydrochloride, 80mg blank ball core, 190mg filler, 30mg lubricant, 10mg binder.

[0031] The filler is microcrystalline cellulose, the lubricant is talcum powder, and the binder is hypromellose.

Embodiment 2

[0033] Its production method includes the following steps:

[0034] Step 1: material preparation: according to the above mass ratio, pulverize propranolol hydrochloride with a pulverizer, and pass through a 100-mesh sieve;

[0035] Step 2: Mixing: Weigh propranolol hydrochloride and microcrystalline cellulose according to the above mass ratio, put them into a three-dimensional mixer and mix for 30 minutes to make a fine powder of the drug, and take it out for later use;

[0036] Step 3: Preparation of adhesive: Weigh an appropriate amount of hypromellose according to the above mass ratio, add an appropriate amount of hot water to prepare an adhesive with a concentration of 2%, and set aside;

[0037] Step 4: Pill making: Put the drug fine powder into the feeding tank of the centrifugal pill making machine, put the adhesive into the liquid supply tank, put the blank pellet core into the centrifugal pill making machine, turn on the machine, adjust the parameters, and start Spra...

Embodiment 3

[0043] Indications:

[0044] 1. As a secondary prevention, reduce the mortality rate of myocardial infarction.

[0045] 2. Hypertension (alone or in combination with other antihypertensive drugs).

[0046] 3. Exertional angina pectoris.

[0047] 4. Control supraventricular tachyarrhythmia and ventricular arrhythmia, especially related to catecholamines or arrhythmia caused by digitalis. It can be used to control the ventricular rate of atrial flutter and atrial fibrillation where digitalis is not effective, and it can also be used to improve the symptoms of patients with intractable premature contractions.

[0048] 5. Reduce outflow tract pressure difference in hypertrophic cardiomyopathy, relieve symptoms such as angina, palpitations and fainting.

[0049] 6. Cooperate with α receptor blockers to control tachycardia in patients with pheochromocytoma.

[0050] 7. It is used to control the rapid heart rate of hyperthyroidism, and it can also be used to treat thyroid storm. ...

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Abstract

The invention discloses propranolole hydrochloride sustained-release pellets and a preparation method thereof. The propranolole hydrochloride sustained-release pellets comprise a coating layer, medicine-containing pellets, Eudragit NE-30D, powdered steatile, sodium dodecyl sulfate or polyethylene glycol; propranolole hydrochloride, blank pellets, a filler, a lubricant and an adhesive. The method employs a novel sustained release preparation and a pellets preparation, slow release means delay of drug release rate of the medicine in a dosage form, absorption rate of medicine in the body can be reduced, more stable treatment effect can be realized; pellets can increase the distribution area of the medicine on the surface of the gastrointestinal tract, irritation is reduced, bioavailability is increased, influence due to stomach evacuation factor is not generated, medicine can be uniformly absorbed in the body, individual difference is little, and simultaneous application of two advanced technologies enhances the technical advantage of the propranolole hydrochloride sustained-release pellets.

Description

technical field [0001] The invention belongs to the field of chemical medicine sustained-release preparations, and in particular relates to propranolol hydrochloride sustained-release pellets and a preparation method thereof. Background technique [0002] Angina pectoris is a clinical syndrome mainly characterized by paroxysmal chest pain or chest discomfort caused by coronary insufficiency, myocardial acute, temporary ischemia and hypoxia. It is characterized by paroxysmal and compressive pain in the anterior chest, which may be accompanied by other symptoms. The pain is mainly located at the back of the sternum and can radiate to the precordial area and left upper limb. It often occurs during labor or emotional agitation, and each attack lasts for 3 to 5 minutes. , It can be once a few days, or several times a day, and disappear after rest or nitrate preparations. The disease is more common in men, most of whom are over 40 years old. Fatigue, emotional agitation, overeati...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/58A61K31/138A61P9/10A61P9/12A61K47/32A61K47/04
Inventor 马玉国张昕任萃文江延辉马凌风王海涛
Owner HARBIN SHENGJI PHARMA
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