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Salbutamol sulfate solution for inhalation and preparation method thereof

A technology of salbutamol sulfate and solution, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. It can solve the problems of unencapsulated, uneven encapsulation, troublesome operation, etc., and achieve Accurate control of inhalation volume, uniform drug content, and less impurity content

Active Publication Date: 2021-10-08
朗天药业(湖北)有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the introduction of other substances, it is easy to cause safety hazards and increase the risk of clinical medication
CN111904954A is used for a salbutamol liposome inhalation for respiratory diseases, utilizes leucine to have hydrophobic and hydrophilic groups, and is enriched on the particle surface in the spray drying process, and produces a hydrophobic surface, due to the presence of leucine The behavior of surfactants reduces the size of the droplets generated during the atomization process, making the deposition effect better, but the operation is cumbersome, and the encapsulation rate is not easy to control, and it is prone to problems of uneven encapsulation or incomplete encapsulation

Method used

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  • Salbutamol sulfate solution for inhalation and preparation method thereof
  • Salbutamol sulfate solution for inhalation and preparation method thereof
  • Salbutamol sulfate solution for inhalation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The composition of the prescription is as follows:

[0032] Salbutamol sulfate 0.5g;

[0033] Lactose 5g;

[0034] Sodium chloride 4g;

[0035] Add water for injection to 1000mL.

[0036] Add sodium chloride to water for injection, stir until it is completely dissolved and blow nitrogen gas for 25 minutes; then add lactose, and use CO 2 Lead into equipment and feed carbon dioxide gas until the pH of the solution reaches 5.6 (in the process, adjust the flow rate of carbon dioxide entering the device body 2 by the flow regulating valve 4 to be 15L / min), then add salbutamol sulfate and stir until completely dissolved, and use sulfuric acid to Adjust the pH value to 4.0; finally, filter the prepared solution through a 0.22 μm microporous membrane to sterilize. After the semi-finished product passes the inspection, it is filled with nitrogen and sealed, and sterilized at 121°C for 15 minutes. After passing the quality inspection, the finished product is ready for inhalati...

Embodiment 2

[0038] The composition of the prescription is as follows:

[0039] Salbutamol sulfate 3g;

[0040] Lactose 8g;

[0041] Glucose 8g;

[0042] Add water for injection to 1000mL.

[0043] Add glucose to water for injection, stir until completely dissolved and blow nitrogen for 35 minutes; then add lactose, and use CO 2 Pass into equipment and feed carbon dioxide gas until the pH of solution reaches 5.6 (in this process, regulate the carbon dioxide flow rate that enters in equipment body 2 by flow regulating valve 4 and be 35L / min), then add albuterol sulfate and stir until completely dissolving, use citrate Citric acid-sodium citrate adjusts the pH value to 5.0; finally, the prepared solution is sterilized by filtration through a 0.22 μm microporous membrane. After passing the test, the finished product salbutamol sulfate solution for inhalation is obtained.

Embodiment 3

[0045] The composition of the prescription is as follows:

[0046] Salbutamol sulfate 2.5g;

[0047] Lactose 7g;

[0048] Magnesium chloride 7.3g;

[0049] Add water for injection to 1000mL.

[0050] Add magnesium chloride to water for injection, stir until it is completely dissolved and blow nitrogen gas for 30 minutes; then add lactose, and use CO 2 Lead into the equipment and feed carbon dioxide until the pH of the solution reaches 5.6 (in this process, the flow rate of carbon dioxide entering the device body 2 is adjusted to be 20L / min by the flow regulating valve 4), then add salbutamol sulfate and stir until completely dissolved, and use acetic acid Adjust the pH value to 5.2; finally, filter the prepared solution through a 0.22 μm microporous membrane to sterilize. After the semi-finished product passes the inspection, it is filled with nitrogen and sealed, and sterilized at 121°C for 15 minutes. After passing the quality inspection, the finished product is ready for i...

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Abstract

The invention discloses a salbutamol sulfate solution for inhalation and a preparation method thereof. A formula of the salbutamol sulfate solution comprises salbutamol sulfate, lactose, an isotonicity regulator, a pH adjusting agent, an antioxidant and the balance of water for injection. In a preparation process, carbon dioxide is introduced as the antioxidant, so that the dissolved oxygen content and the residual oxygen content in the solution are reduced. The added lactose not only is beneficial to the flowability of the medicine component salbutamol sulfate, but also can be used for preventing the salbutamol sulfate from being agglomerated together, so that the salbutamol sulfate can be uniformly dispersed in a solution system. According to the salbutamol sulfate solution for inhalation, the impurity content is low, adverse effects of related substances on human health and drug effects are reduced, the stability is higher, the drug content distribution is uniform, and the treatment effect is facilitated.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a salbutamol sulfate solution for inhalation and a preparation method thereof. Background technique [0002] Salbutamol sulfate [1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol sulfate] is a highly selective bronchial smooth muscle β2 adrenoceptor agonist for relaxation Bronchial smooth muscle has clear activity in relieving bronchial smooth muscle spasm, and its stimulatory effect on myocardial β1 receptor is weak, so it is a safe and effective anti-asthma drug. It acts on the smooth muscle from the main trachea to the terminal alveoli, and has the effect of antagonizing bronchoconstriction. It has a fast onset time, but it is prone to β2 receptor resistance. Clinically, albuterol sulfate is commonly used to treat various types of airway obstruction, such as bronchial asthma, chronic obstructive pulmonary disease, asthmatic bronchitis, and bro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/08A61K31/137A61K47/26A61P11/06
CPCA61K31/137A61K9/08A61K9/007A61K47/26A61P11/06
Inventor 蔡翔黎翩陈景丽张友民石剑芳肖红敏李英蔡和霖方贤贵张显强
Owner 朗天药业(湖北)有限公司
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