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Stable bromhexine hydrochloride liquid preparation composition and preparation method thereof

A technology of bromhexine hydrochloride and liquid preparation is applied in the treatment of refractory pulmonary mucus, parenteral administration of liquid preparation bromhexine hydrochloride composition and the field of preparation thereof, can solve problems such as bromhexine precipitation, and achieve high quality The effect of stability, saving industrial production cost and ensuring safety

Active Publication Date: 2019-04-16
CHENGDU XINJIE HIGH TECH DEV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0025] The technical problem to be solved by the present invention is to overcome the problem that the existing known bromhexine hydrochloride injection causes bromhexine to separate out due to changes in the pH value of the medicinal solution during clinical administration, and to provide a more stable bromhexine hydrochloride injection and its preparation method

Method used

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  • Stable bromhexine hydrochloride liquid preparation composition and preparation method thereof
  • Stable bromhexine hydrochloride liquid preparation composition and preparation method thereof
  • Stable bromhexine hydrochloride liquid preparation composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063]

[0064] The bromhexine hydrochloride injection containing pharmaceutical stabilizer adopts following method to prepare among the present invention:

[0065] (1) Dissolve D-mannitol and L-tartaric acid in 60% of the prescribed amount of water for injection by weighing the prescribed amount, stir to dissolve and clarify, and filter with a 0.22 μm filter membrane.

[0066] (2) In addition, take the prescribed amount of 35% injection water and bromhexine hydrochloride, add the prescribed amount of sulfobutylbeta cyclodextrin sodium under stirring, and stir to clarify.

[0067] (3) Add the solution in step (2) to the solution in step (1) under stirring, stir for 15-30 minutes, lower the temperature to below 30°C, measure the content of intermediates, and monitor the pH of the solution to be 2.6± 0.02, if the pH value of the liquid medicine is not within this range, it can be adjusted to this range with hydrochloric acid solution (1mol / L) or sodium hydroxide solution (1mo...

Embodiment 2

[0070]

[0071] The bromhexine hydrochloride injection containing pharmaceutical stabilizer in the present embodiment is prepared with the preparation method of embodiment 1.

Embodiment 3

[0073]

[0074] The bromhexine hydrochloride injection containing pharmaceutical stabilizer in the present embodiment is prepared with the preparation method of embodiment 1.

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Abstract

The invention discloses a stable bromhexine hydrochloride liquid preparation composition and a preparation method thereof. The liquid preparation composition is prepared from bromhexine hydrochloridewith the pharmaceutically-acceptable dose, an osmotic pressure modifier with the pharmaceutically-acceptable dose, a stabilizer with the pharmaceutically-acceptable dose, a pH value buffer solution with the pharmaceutically-acceptable dose, and injection water. The stabilizer is a chemically-modified derivative of cyclodextrin or salt of the derivative. The chemically-modified derivative of the cyclodextrin or the salt of the derivative is selected as the stabilizer, by means of the properties of the chemically-modified derivative of the cyclodextrin or the salt of the derivative, the stabilizer is used for helping solubilization of the bromhexine hydrochloride, the bromhexine hydrochloride can be kept stable within the pH range of 1-14, bromhexine cannot be separated out, and the safety of clinical medication is guaranteed.

Description

technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a parenteral administration liquid preparation bromhexine hydrochloride composition and a preparation method thereof. The medicine is a bronchitis treatment, and is used for dissolving mucus of acute and chronic bronchial diseases and treating refractory bronchiectasis Mucus in the lungs. Background technique [0002] Bromhexine hydrochloride has a strong effect of dissolving mucus, which can crack polysaccharide cellulose in sputum and dilute sputum. Inhibit the synthesis of glycoproteins by goblet cells and mucus glands, reduce the sialic acid in sputum, reduce the viscosity of sputum, and facilitate discharge. Bromhexine hydrochloride still has the effect of promoting the ciliary movement of the respiratory mucosa. Bromhexine hydrochloride enters the human body and is widely distributed in various tissues of the whole body. After 10-20 minutes of intravenous infu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/137A61K47/40A61K47/10A61K47/02A61P11/10
CPCA61K9/08A61K31/137A61K47/02A61K47/10A61K47/40A61P11/10
Inventor 蒲洪黄汉伟刘晓琳朱鹏卓建伟
Owner CHENGDU XINJIE HIGH TECH DEV CO LTD
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