Clenbuterol aerosol inhalation solution preparation and preparation method thereof

A technology for nebulized inhalation and clenbuterol hydrochloride, which is applied in the preparation of solution preparations for clenbuterol nebulization inhalation, and in the field of solution preparations for clenbuterol nebulization inhalation, which can solve the problem that the drug effect cannot be well exerted , particle floating or sinking, uneven drug distribution, etc., to avoid the first-pass effect, simple preparation method, fast onset of drug effect

Inactive Publication Date: 2019-12-27
SUZHOU HOMESUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But clenbuterol hydrochloride is granular in this kind of suspension type aerosol, it is difficult to inhale from mouth and nose, and there will be particle floating or sinking phenomenon in the suspension, causes the drug distribution in the suspension to be uneven, can not be very good effect

Method used

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  • Clenbuterol aerosol inhalation solution preparation and preparation method thereof

Examples

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Embodiment 1

[0022] A preparation method for clenbuterol solution preparation for nebulized inhalation, comprising the following steps:

[0023] (1) Take 10 mg of clenbuterol hydrochloride and add it to 2000 mL of water for injection, then add 0.125 g of a complex formed by ethylenediaminetetraacetic acid, disodium edetate and sodium calcium edetate, sodium chloride and The complex formed by mannose is 8.9g, wherein the weight ratio of ethylenediaminetetraacetic acid, edetate disodium and edetate sodium calcium is 1:1:1, and the weight ratio of sodium chloride and mannose 1:10, at 25°C, ultrasonically sonicate for 1 hour to dissolve evenly, and then add an appropriate amount of hydrochloric acid, tartaric acid, and potassium citrate mixed pH regulator in a ratio of 2:1:1 by weight to make the pH is 5.4;

[0024] (2) Initially filter with a 0.4 μm filter membrane, and then filter again with a 0.2 μm filter membrane;

[0025] (3) Pack the filtrate into medium-silicon boron brown glass ampo...

Embodiment 2

[0027] A preparation method for clenbuterol solution preparation for nebulized inhalation, comprising the following steps:

[0028] (1) Take 20 mg of clenbuterol hydrochloride and add it to 2000 mL of water for injection, then add 0.25 g of a complex formed by ethylenediaminetetraacetic acid, disodium edetate and sodium calcium edetate, sodium chloride and 17.8 g of complexes formed by mannose, wherein the weight ratio of EDTA, EDTA disodium and EDTA sodium calcium is 1:2.5:2, and the weight ratio of sodium chloride and mannose 1:17, at 27°C, ultrasonically sonicate for 2 hours to make it dissolve evenly, and then add an appropriate amount of hydrochloric acid, tartaric acid and potassium citrate mixed pH regulator with a weight ratio of 2:1:1 to make the pH value is 4.2;

[0029] (2) Initially filter with a 0.4 μm filter membrane, and then filter again with a 0.2 μm filter membrane;

[0030] (3) Pack the filtrate into medium-silicon boron brown glass ampoules according to t...

Embodiment 3

[0032] A preparation method for clenbuterol solution preparation for nebulized inhalation, comprising the following steps:

[0033] (1) Take 30 mg of clenbuterol hydrochloride and add it to 2000 mL of water for injection, then add 0.375 g of a complex formed by EDTA, disodium EDTA and sodium calcium EDTA, sodium chloride and 26.7g of complexes formed by mannose, wherein the weight ratio of EDTA, EDTA disodium and EDTA sodium calcium is 1:3.5:2.5, the weight ratio of sodium chloride and mannose 1:25, at 30°C, use ultrasonic wave for 3 hours to make it dissolve evenly, and then add an appropriate amount of hydrochloric acid, tartaric acid, and potassium citrate mixed pH regulator with a weight ratio of 2:1:1 to make the pH value is 3.2;

[0034] (2) Initially filter with a 0.4 μm filter membrane, and then filter again with a 0.2 μm filter membrane;

[0035] (3) Pack the filtrate into medium-silicon boron brown glass ampoules according to the packaging specification of 2mL / bott...

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Abstract

The present invention provides a clenbuterol aerosol inhalation solution preparation and a preparation method thereof. The clenbuterol aerosol inhalation solution preparation comprises clenbuterol, astabilizer, an osmotic pressure regulator, an appropriate amount of a pH regulator, and water. The clenbuterol aerosol inhalation solution preparation is reasonable in compositions, uses an atomized inhalation manner to conduct direct inhalation from mouth and nose, can avoid a first-pass effect of the liver and destruction and degradation of gastrointestinal tract, greatly reduces drug metabolismprocesses of the liver and kidneys, reduces organ damages to patients, is even in drug distribution, has a drug average particle diameter of about 0.2 [mu]m and a ratio of inhalable particles as highas 74% or more, is quick in taking effect, simple in the preparation method and low in cost, and has a very good development prospect.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a clenbuterol solution preparation for atomized inhalation and a preparation method of the clenbuterol solution preparation for atomized inhalation. Background technique [0002] With the rapid development of industry, the surrounding environmental pollution is becoming more and more serious, and the diseases caused by environmental pollution are also increasing, including chronic bronchitis, bronchial asthma and other respiratory diseases. Patients infected with this respiratory disease often have symptoms such as severe cough, thick sputum, difficulty in expectoration, and tracheal obstruction by sputum. These symptoms not only make the patient uncomfortable, but also affect sleep and even prolong the development of the disease. [0003] Clenbuterol hydrochloride is a potent selective adrenergic β2 receptor agonist, which has a strong and long-lasting effe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/08A61K31/137A61P11/00A61P11/06
CPCA61K9/08A61K9/0078A61K47/183A61K31/137A61P11/00A61P11/06
Inventor 陆红彬樊超杨磊
Owner SUZHOU HOMESUN PHARMA
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