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Bromhexine hydrochloride freeze-dried powder injection for injection and preparation method of bromhexine hydrochloride freeze-dried powder injection

A technology of bromhexine hydrochloride and freeze-dried powder injection, which is applied in the field of bromhexine hydrochloride freeze-dried powder injection and its preparation, which can solve the problems of poor solubility and pain, and achieve reduced surface tension, increased solubility, and increased compliance Effect

Pending Publication Date: 2021-03-26
HEBEI ZHITONG BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The present invention proposes a bromhexine hydrochloride freeze-dried powder for injection and its preparation method, which solves the problems of poor solubility and pain during intramuscular injection in the prior art

Method used

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  • Bromhexine hydrochloride freeze-dried powder injection for injection and preparation method of bromhexine hydrochloride freeze-dried powder injection
  • Bromhexine hydrochloride freeze-dried powder injection for injection and preparation method of bromhexine hydrochloride freeze-dried powder injection
  • Bromhexine hydrochloride freeze-dried powder injection for injection and preparation method of bromhexine hydrochloride freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] prescription:

[0030]

[0031] (1) Take bromhexine hydrochloride, add it to 20kg of ethanol at 60°C, and stir until completely dissolved. Take α-cyclodextrin and add 80kg of water, stir until completely dissolved;

[0032] (2) Add bromhexine hydrochloride ethanol solution into α-cyclodextrin aqueous solution, and stir for 3 hours.

[0033] (3) Add mannitol and citric acid buffer to adjust the pH to 6.0.

[0034] (4) Add water to make up to 108L, and stir evenly.

[0035] (5) Filter and fill with a 0.22 μm PES sterilizing filter.

[0036] (6) Freeze-drying: Based on the heat transfer oil outlet, keep warm for 2 hours below -40°C, then vacuumize; raise the temperature to 0°C, keep warm until the sublimation of free water is completed; heat up to the product temperature of 20-30°C, analyze again for 3 hours, freeze dry end.

Embodiment 2

[0038] prescription:

[0039]

[0040] (1) Take bromhexine hydrochloride, add 50kg of hot water at 70°C, and stir until fully dissolved; add 50kg of water to hydroxypropyl beta-cyclodextrin, and stir until fully dissolved;

[0041] (2) Add bromhexine hydrochloride aqueous solution to hydroxypropyl beta cyclodextrin aqueous solution, and stir for 6 hours;

[0042] (3) Add mannitol and citric acid buffer to adjust the pH to 6.3;

[0043] (4) Add water to make the volume to 108L, and stir evenly;

[0044] (5) Filter and fill with a 0.22 μm PES sterilizing filter;

[0045] (6) Freeze-drying: Based on the heat transfer oil outlet, keep warm at -40°C for 2 hours, then vacuumize; heat up to 0°C, keep warm until the sublimation of free water ends; heat up to product temperature 20-30°C, analyze again for 4 hours, freeze dry end.

Embodiment 3

[0047] prescription:

[0048]

[0049] (1) Take bromhexine hydrochloride, add 10kg of hot ethanol at 60°C, and stir until fully dissolved; add 90kg of soybean lecithin, and stir until fully dissolved;

[0050] (2) adding bromhexine hydrochloride ethanol solution in soybean lecithin aqueous solution, colloid mill mixing 2 hours;

[0051] (3) adding glycine and phosphate buffer to adjust the pH value to 5.5;

[0052] (4) Add water to make the volume to 108L, and stir evenly;

[0053] (5) Filter and fill with a 0.22 μm PES sterilizing filter;

[0054] (6) Freeze-drying: Based on the heat conduction oil outlet, keep warm for 2 hours below -40°C, and then vacuumize; heat up to 5°C, keep warm until the sublimation of free water ends; heat up to product temperature 25-35°C, analyze again for 3 hours, freeze dry end;

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Abstract

The invention relates to the technical field of medicines, and provides a bromhexine hydrochloride freeze-dried powder injection for injection. The bromhexine hydrochloride freeze-dried powder injection comprises bromhexine hydrochloride, an inclusion agent, an acidity regulator, an excipient and water for injection, wherein the molar ratio of the bromhexine hydrochloride to the inclusion agent is1-3 times, and the excipient accounts for 2%-10% of the total mass. The invention also provides a preparation method of the bromhexine hydrochloride freeze-dried powder injection for injectio. The preparation method comprises the following steps: S1, adding the bromhexine hydrochloride into hot water or hot ethanol, and performing stirring until the bromhexine hydrochloride completely dissolves;S2, adding water into the inclusion agent and an auxiliary agent, and performing stirring until the inclusion agent and the auxiliary agent dissolve to prepare an aqueous solution; S3, mixing the twoaqueous solutions of S1 and S2, adding the excipient and the acidity regulator, and regulating the pH value to 5.0-8.0, preferably 5.5-6.5; S4, adding the water to a constant volume; and S5, performing sterile filtration, performing subpackaging, performing freeze-drying and performing capping to obtain a finished product. Through the technical scheme, the problems of poor solubility and pain during intramuscular injection in the prior art are solved.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a bromhexine hydrochloride freeze-dried powder for injection and a preparation method thereof. Background technique [0002] Bromhexine hydrochloride is an expectorant drug, mainly suitable for patients with sticky sputum caused by chronic bronchitis, asthma, etc. In the case of chronic bronchitis and other respiratory diseases such as asthma, bronchiectasis, silicosis and other patients with sticky sputum that is difficult to cough up. Bromhexine hydrochloride is slightly soluble in water, soluble in hot ethanol or hot water, and there is a problem that it is difficult to dissolve in the preparation process of bromhexine hydrochloride injection. At present, the main solution is to form a salt by adjusting the pH value of the solution to acidity , increase its solubility, such as the patent "a bromhexine hydrochloride freeze-dried powder injection and its preparation method" (...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/137A61K47/20A61K47/24A61K47/69A61P11/10
CPCA61K31/137A61K9/19A61K9/0019A61K47/6951A61K47/6949A61K47/20A61K47/24A61P11/10
Inventor 许峰欧晖齐兴忠李金红俞东升张电追侯磊夏彤
Owner HEBEI ZHITONG BIOLOGICAL PHARMA
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