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Ambroxol hydrochloride liposome injection

A technology for ambroxol hydrochloride and injection, which is applied in the fields of ambroxol hydrochloride injection and ambroxol hydrochloride liposome injection, can solve the problems of decreased drug quality, impurity, poor stability of physical and chemical properties, and inability of products to escape, Achieve the effect of improving stability, protecting form and stability

Inactive Publication Date: 2012-05-02
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Although the prescriptions of the above preparations have been carefully screened, their products still cannot escape. The injections prepared by ordinary methods have poor physical and chemical properties; It will bring hidden dangers to clinical use

Method used

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  • Ambroxol hydrochloride liposome injection
  • Ambroxol hydrochloride liposome injection
  • Ambroxol hydrochloride liposome injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] Example 1 Preparation of Ambroxol Hydrochloride Liposomal Injection

[0072] Prescription: (1000 bottles)

[0073]

[0074] making process:

[0075] (1) Cholesterol 50g, soybean phosphatidylserine 80g, soybean sterol 30g and 20g Tween 80 are dissolved in the phosphate buffer solution that 2000mlpH is 7.2, make blank liposome;

[0076] (2) The blank liposomes prepared above were sterilized by flowing steam, and then ultrasonically treated twice, each time for 20 minutes;

[0077] (3) under aseptic conditions, add ambroxol hydrochloride 15g in the liposome of molten state, add 20g trehalose and 30gPVP under constantly stirring;

[0078] (4) Filter through a 0.45 μm microporous membrane, freeze quickly, then return to room temperature, and fill (2ml / bottle) to obtain ambroxol hydrochloride liposome injection.

Embodiment 2

[0079] Example 2 Preparation of Ambroxol Hydrochloride Liposomal Injection

[0080] Prescription: (1000 bottles)

[0081]

[0082] making process:

[0083] (1) Cholesterol 100g, soybean phosphatidylserine 160g, soybean sterol 60g and 40g Tween 80 are dissolved in 4000mlpH in the phosphate buffered saline solution of 7.2, make blank liposome;

[0084] (2) The blank liposomes prepared above were sterilized by flowing steam, and then ultrasonically treated twice, each time for 20 minutes;

[0085] (3) under aseptic conditions, add ambroxol hydrochloride 30g in the liposome of molten state, add 40g trehalose and 60gPVP under constant stirring;

[0086] (4) Filter through a 0.45 μm microporous membrane, freeze quickly, then return to room temperature, and fill (4ml / bottle) to obtain ambroxol hydrochloride liposome injection.

Embodiment 3

[0087] Example 3 Preparation of Ambroxol Hydrochloride Liposomal Injection

[0088] Prescription: (1000 bottles)

[0089]

[0090] making process

[0091](1) Cholesterol 50g, soybean phosphatidylserine 80g, soybean sterol 30g and 20g Tween 80 are dissolved in the phosphate buffer solution that 2000mlpH is 7.2, make blank liposome;

[0092] (2) The blank liposomes prepared above were sterilized by flowing steam, and then ultrasonically treated twice, each time for 20 minutes;

[0093] (3) under aseptic conditions, add ambroxol hydrochloride 15g in the liposome of molten state, add 20g trehalose and 30gPVP under constantly stirring;

[0094] (4) Filter through a 0.45 μm microporous membrane, fill (2ml / bottle), and directly freeze-dry to obtain ambroxol hydrochloride injection freeze-dried powder.

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Abstract

The invention discloses an ambroxol hydrochloride liposome injection and a preparation method thereof. The liposome injection is prepared from ambroxol hydrochloride, cholesterol, soybean phosphatidylserine, sojasterol, Tween 80, trehalose and PVP (Polyvinylpyrolidone) in a specific weight ratio. The liposome injection has high preparation stability, and a liposome does not crack due to fusion, ice crystals and the like and keeps high entrapment rate simultaneously after being stored for a long time; the solubility of the ambroxol hydrochloride is increased, the quality of a preparation product is enhanced, the toxic and side effects are reduced, the retention time of a medicament in systemic circulation is increased, the bioavailability of the medicament is enhanced, and the curative effect is enhanced remarkably; and moreover, a preparation method is simple, and is suitable for industrial mass production.

Description

technical field [0001] The invention relates to an ambroxol hydrochloride injection, in particular to an ambroxol hydrochloride liposome injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Ambroxol hydrochloride, its chemical name is trans-4-[(2-amino 3.5-dibromobenzyl) amino] cyclohexanol hydrochloride, molecular formula: C 13 h 18 Br 2 N 2 O HCl, molecular weight: 414.57, its structural formula is as follows: [0003] [0004] Ambroxol hydrochloride has the characteristics of promoting mucus elimination and dissolving secretions, which can promote the elimination of viscous secretions in the respiratory tract and reduce the retention of mucus, thus significantly promoting expectoration and improving respiratory conditions. When ambroxol hydrochloride is used for treatment, the secretion of the patient's mucus can return to normal conditions, and the amount of cough and sputum is u...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K9/127A61K31/137A61K47/36A61P11/10
Inventor 陶灵刚公长春廖爱国
Owner HAINAN LINGKANG PHARMA CO LTD
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