Procaterol hydrochloride granules and preparation process thereof

A technology of procaterol hydrochloride and preparation process, applied in the field of procaterol hydrochloride granules and preparation technology thereof, can solve the problems of inability to exert its pharmacological effect, missed treatment opportunity, patient injury, etc., achieve high bioavailability, avoid drug Degradable, easy-to-carry effect

Inactive Publication Date: 2016-01-13
HEILONGJIANG LONGDE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For asthmatic patients who need immediate relief of acute symptoms, too low a drug dose will not be able to exert its pharmacological effects and miss the best opportunity for treatment; while for children, the elderly and critically ill patients with weak liver and kidney function, too high a dose will lead to severe Strong toxic and side effects, causing harm to patients
No procaterol hydrochloride granules were found after the CD-ROM search by the State Patent Office

Method used

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  • Procaterol hydrochloride granules and preparation process thereof
  • Procaterol hydrochloride granules and preparation process thereof
  • Procaterol hydrochloride granules and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Procaterol hydrochloride 0.0025g, lactose 15g, mannitol 30g, fructose 0.9g, trehalose 0.8g, maltodextrin 3g, micronized silica gel 0.01g, xanthan gum 0.2g, povidone K300.05g.

[0024] The above-mentioned raw and auxiliary materials are dissolved in 400ml of water, sprayed and freeze-dried, the nozzle diameter is 1.5mm, the atomization pressure is 0.2MPa, the initial freezing temperature is -45°C, the vacuum degree is 7Pa, and the low-temperature sublimation is dried for 8 hours.

Embodiment 2

[0025] Example 2 Procaterol hydrochloride 0.0005g, mannitol 35g, trehalose 4g, maltodextrin 10g, micropowder silica gel 0.02g, xanthan gum 0.05g, polyethylene glycol 4000.5g.

[0026] The above-mentioned raw materials and auxiliary materials are dissolved by adding 500ml of water, spray freeze-drying, nozzle diameter of 1.0mm, atomization pressure of 0.3MPa, initial freezing temperature of -30°C, vacuum degree of 9Pa, and low-temperature sublimation drying for 10 hours.

Embodiment 3

[0027] Example 3 Procaterol hydrochloride 0.003g, mannitol 25g, fructose 1.5g, trehalose 1.7g, maltodextrin 1.7g, micropowder silica gel 0.03g, xanthan gum 0.1g, povidone K300.6g.

[0028] The above-mentioned raw and auxiliary materials are dissolved in 250ml of water, sprayed and freeze-dried, the nozzle diameter is 1.0mm, the atomization pressure is 0.5MPa, the initial freezing temperature is -32°C, the vacuum degree is 10Pa, and the low-temperature sublimation is dried for 5 hours.

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Abstract

The invention relates to procaterol hydrochloride pharmaceutical granules, which have an effect of relieving asthma, and a preparation process of the granules. The procaterol hydrochloride granules belong to an orally rapidly dispersible preparation which is prepared from procaterol hydrochloride and medicinal pharmaceutical excipients, and the preparation is suitable for treating bronchial asthma, asthmatic bronchitis and chronic obstructive pulmonary disease. According to the invention, the prepared granule medicine is rapid to be dissolved and uniform to be dispersed; the medicine can be taken after being dissolved in water and the medicine can be directly taken without water as well; the medicine is delicate and sweet in taste; the medicine is capable of effectively overcoming medication rejecting psychology of patients and meeting a medication requirement during an asthma acute attacking period, and the medicine is especially suitable for children, old people or patients having difficulty in swallowing. Upon detection, the procaterol hydrochloride granules prepared by the invention are quite excellent in static dissolubility, and are obviously better than a preparation of a conventional process in content uniformity; and the procaterol hydrochloride granules effectively guarantee the timeliness, the safety and the effectiveness of clinical treatment, and the procaterol hydrochloride granules are quite high in value of popularization.

Description

technical field [0001] The invention relates to Procaterol Hydrochloride granules prepared from Procaterol Hydrochloride and pharmaceutical auxiliary materials for treating bronchial asthma, asthmatic bronchitis and chronic obstructive pulmonary disease and a preparation process thereof. Background technique [0002] Bronchial asthma (bronchialasthma, referred to as asthma) is a chronic airway inflammation involving a variety of cells, especially mast cells, eosinophils and T lymphocytes; Symptoms such as shortness of breath, chest tightness, and cough are often accompanied by widespread and variable expiratory flow limitation. [0003] Asthmatic bronchitis (asthmatoid bronchitis) generally refers to acute bronchial infection in infants and young children with wheezing performance, mucosal congestion and edema, and spasm of tube wall muscles, which makes the airway relatively narrow and produces wheezing sound. Asthmatic bronchitis can become bronchial asthma after repeated...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4704A61K47/36A61P11/06A61P11/00
Inventor 左军杨晓晖张莉郑佰平闫雪马晶汪红梅
Owner HEILONGJIANG LONGDE PHARMA CO LTD
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