Asarone drug composition for injection or inhalation

A technology of asarone and composition, which is applied in the field of asarone pharmaceutical composition, and can solve problems such as turbidity, decreased content, and poor resolubility

Inactive Publication Date: 2016-10-12
HAINAN LEVTEC PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Asarone is insoluble in water, in order to solve the dissolution problem, the contriver surprisingly finds that use can increase the solubility and the stability of Asarone using a composite solvent composed of ethanol, Polyethylene Glycol 400 and water. When the asarone composition is made into an injection, buffer salt is used to control the pH value within a certain range and carry out dissolved oxygen control (nitrogen filling protection) in the preparation process, which can well solve the problem of crystallization and oxidation of asarone defect and improve the stability of this product; therefore the above combination solves the problem of asarone injection crystallization, turbidity, poor resolubility causing unqualified clarity, and content decline in storage, thereby obtaining high-quality asarone medicine and ensuring quality and stability of medicines

Method used

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  • Asarone drug composition for injection or inhalation
  • Asarone drug composition for injection or inhalation
  • Asarone drug composition for injection or inhalation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1: asarone composition freeze-dried powder injection

[0052]

[0053]

Embodiment 1、2

[0054] Embodiment 1, 2 Preparation process: a. Weigh water for injection, put it into concentrated irrigation, add mannitol and polysorbate-80 in the prescribed amount, dissolve and stir evenly, add an appropriate amount of buffered saline solution to adjust the pH value of the solution Get solution I at 5.0~5.8; b, take the prescription amount of ethanol and polyethylene glycol 400, add asarone, stir to dissolve completely, and obtain solution II; c, add the prepared solution II to the total amount of the prescription in time In solution I, add water for injection to the full amount, add 0.1% activated carbon of the above total amount, stir and circulate for 30 minutes under nitrogen protection, and circulate and stir for 30 minutes through a microporous filter element to obtain an intermediate solution; d, take the intermediate solution for inspection , filled after meeting the requirements; e, freeze-dried, plugged, and out of the box to obtain the freeze-dried powder inject...

Embodiment 3

[0055] Embodiment 3 asarone injection

[0056]

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PUM

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Abstract

The invention discloses an asarone drug composition for injection or inhalation. The asarone drug composition for injection or inhalation is prepared from a composite solvent prepared from ethanol, polyethylene glycol 400 and / or propylene glycol and water and an active ingredient asarone. When the asarone drug composition is prepared into an injection, a pH value is regulated with buffer salt, freeze-dried powder can be prepared by adding mannitol, sorbitol and other injectable auxiliary materials as excipients. The problem of unqualified clarity caused by poor devitrification, turbidity and redissolution when the asarone drug composition is prepared into the injection is solved, accordingly the quality and stability of drugs are ensured, the quality of the product stored for 2 years under the shading room temperature condition meets the requirements, the using requirements for industrialized mass production and clinical use can be met, and the injection can be atomized for inhalation medication.

Description

technical field [0001] The invention relates to an asarone pharmaceutical composition, in particular to an asarone pharmaceutical composition for injection or inhalation, and belongs to the technical field of medicines. Background technique [0002] Asarone, also known as α-Asarone, is the extract of Araceae plant Shichangpu, English name: Asarone, chemical name: 2,4,5-trimethoxy-1-propenylbenzene, molecular formula is C 12 h 16 O, molecular weight 208.26, soluble in ethanol, ethyl acetate, ether and chloroform, insoluble in water. [0003] Asarone is a commonly used antitussive and expectorant drug in clinical practice. It resists histamine and acetylcholine, relieves bronchospasm, and has an antiasthmatic effect. It also has a strong inhibitory effect on the cough center; it can cause increased secretions and thin sputum. , reduce sputum viscosity, easy to cough up; similar to aminophylline to relax bronchial smooth muscle. It can also increase the electrical stimulatio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/09A61K47/10A61K9/72A61P11/06A61P11/14A61P11/10
CPCA61K31/09A61K9/0019A61K9/0078A61K9/19A61K47/10
Inventor 翁贤坤庞京团龙娇
Owner HAINAN LEVTEC PHARMA
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