High dose Ambroxol hydrochloride freeze-dried preparation and preparation method

A technology for ambroxol hydrochloride and freeze-dried preparations, which is applied in the field of high-dose ambroxol hydrochloride freeze-dried preparations and its preparation, and can solve the problems of insufficient solubility and difficulties of ambroxol hydrochloride

Inactive Publication Date: 2007-05-02
CHANGZHOU NO 4 PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because the aqueous solution of ambroxol hydrochloride is not stable enough, especially easy to degrade when exposed to light, on the other hand, the solubility of ambroxol hydrochloride in water is not large enough, at room temperature, 1 milliliter of water can only dissolve about 15 mg of ambroxol hydrochloride , Therefore, it is very difficult to prepare the ambroxol hydrochloride injection of high dosage specifications by conventional methods, especially the high freeze-dried preparation of stability

Method used

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  • High dose Ambroxol hydrochloride freeze-dried preparation and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Preparation of a lyophilized preparation containing 250 mg of ambroxol hydrochloride per bottle

[0035] The composition of the preparation containing 250mg of ambroxol hydrochloride per bottle:

[0036] Ambroxol hydrochloride 250g

[0037] Xylitol 150g

[0038] Anhydrous citric acid 50g

[0039] Sodium hydroxide 20g

[0040] Dissolve in water for injection and dilute to 5000ml

[0041] 1000 bottles

[0042] In water for injection, add xylitol, anhydrous citric acid, sodium hydroxide, stir and dissolve. Add micronized ambroxol hydrochloride to the solution, heat to 70°C, dissolve, cool, and dilute to 5000ml with water for injection. The pH of the resulting solution is 5.0. Decolorization with activated carbon, sterile filtration through 0.22μm microporous membrane, 5ml aliquoted into cillin bottles, freeze-dried, the highest drying temperature can reach 45 ℃, each bottle contains 250mg of ambroxol hydrochloride freeze-dried product. Add 1...

Embodiment 2

[0043]Example 2 Preparation of a lyophilized preparation containing 200 mg of ambroxol hydrochloride per bottle

[0044] The composition of each bottle containing 200mg of ambroxol hydrochloride:

[0045] Ambroxol hydrochloride 200g

[0046] Mannitol 200g

[0047] Sodium dihydrogen phosphate 50g

[0048] Sodium hydroxide 2g

[0049] Dissolve in water for injection and dilute to 5000ml

[0050] 1000 bottles

[0051] In water for injection, add mannitol, anhydrous citric acid, sodium hydroxide, stir and dissolve. Add micronized ambroxol hydrochloride to the solution, heat to 70°C, dissolve, cool, and dilute to 5000ml with water for injection. The pH of the resulting solution is 4.5. The subsequent process is the same as in Example 1. Each bottle contains 200mg of ambroxol hydrochloride lyophilized product. Add 10ml of water for injection to this product, it will be completely dissolved in about 20 seconds, the solution is clear, and the pH = 4.6.

Embodiment 3

[0052] Example 3 Preparation of a lyophilized preparation containing 200 mg of ambroxol hydrochloride per bottle

[0053] The composition of each bottle containing 200mg of ambroxol hydrochloride:

[0054] Ambroxol hydrochloride 200g

[0055] Xylitol 150g

[0056] Anhydrous citric acid 38g

[0057] Sodium hydroxide 16g

[0058] Dissolve in water for injection and dilute to 5000ml

[0059] 1000 bottles

[0060] The preparation process is the same as in Example 1. The pH of the solution after constant volume is 5.0. Add 10ml of water for injection to this product, it will be completely dissolved in about 20 seconds, the solution is clear, and the pH=5.1.

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PUM

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Abstract

A freeze-dried powder injection of high-dosage (500mg) ambroxol hydrochloride and its preparing process are disclosed.

Description

Technical field [0001] The invention relates to the technical field of pharmaceutical preparations. Specifically, it relates to a high-dose ambroxol hydrochloride freeze-dried preparation and a preparation method thereof. Background technique [0002] The chemical structure of ambroxol hydrochloride is as I: [0003] [0004] It is an expectorant drug. It is widely used clinically in the treatment of acute and chronic bronchitis with abnormal secretion of the respiratory tract and asthmatic bronchial asthma. The first patent of the drug was applied for by the German company BoehringIngelhelm. For related content, see US Patent 3,536,713 (1970). In 1984, the drug was used clinically in the form of hydrochloride. So far, the preparation types of ambroxol hydrochloride are mainly various oral preparations and low-dose water injections. The packaging and specifications of the aqueous injection are 2 ml of aqueous solution in brown ampoule bottles, each bottle containing 15 mg of am...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K9/19A61P11/06A61P11/10
Inventor 葛纪龙屠永锐葛旭东刘建安房燕冬庄苏静
Owner CHANGZHOU NO 4 PHARMA FACTORY
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