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Ambroxol salt

A kind of technology of ambroxol and acid radical, applied in the field of ambroxol salt, can solve problems such as not easy to reconstitute

Inactive Publication Date: 2009-07-29
沈阳华泰药物研究有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Domestically, the lyophilized powder of ambroxol hydrochloride has been listed. The inventors have found that the injection powder made of ambroxol hydrochloride is not easy to redissolve. When the pH of the solution is higher than 7, solids will be separated out. Commercially available The instructions of Ambroxol Hydrochloride Injection also stipulate that it should not be used in combination with other solutions with a pH higher than 6.3.

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0017] The preparation of embodiment 1 ambroxol phosphate monohydrate

[0018] Dissolve free ambroxol in 10 times the volume of acetone solution, add 85% phosphoric acid dropwise under stirring, stir fully until the addition of equimolar phosphoric acid is complete, stir for 0.5 hours, then filter to obtain a white solid, and dry it. Heat reflux with 20 times the volume of 70% ethanol for recrystallization, then heat and reflux with 12 times the volume of water, cool, and precipitate crystals to obtain ambroxol phosphate monohydrate. Melting point: 208-210°C, 1 H-NMR (300MHz, deuterated DMSO as solvent) chemical shift (ppm): 7.53 (d, 1H), 7.33 (d, 1H), 6.14 (broad, about 10H, sometimes 9H, heavy water exchange experiment, the peak position disappear), 3.83 (s, 2H), 3.37 (broad, 1H), 2.61 (broad, 1H), 1.81-1.98 (multi, 4H), 1.05-1.28 (multi, 4H). Differential scanning calorimetry has two heat absorption peaks: 157.22°C (weak) and 212.32°C (strong). Thermogravimetric analysis...

Embodiment 2

[0019] The mensuration of embodiment 2 ambroxol phosphate monohydrate solubility

[0020] 1. Grind the crystals of ambroxol phosphate monohydrate into fine powder, weigh 0.1g of each product at room temperature (25°C), put them into six 10ml test tubes, and number them ①②③④⑤⑥. Add 1ml, 2ml, 3ml, 4ml, 5ml, and 6ml of distilled water to the corresponding test tubes, heat the six samples in a water bath, and all the solids are dissolved. Place it at room temperature to cool naturally. After 20 minutes, test tube ① has crystals precipitated. After 2 hours, test tube ② has a small amount of crystals precipitated. No crystals precipitated in test tube ③④⑤⑥ after 10 days. The solubility should be between 20-30ml / g between.

[0021] 2. Take 0.1g of the fine powder product and place it in a 10ml test tube. Under the condition of 25°C, first add 2ml of distilled water, then add 0.2ml one by one, shake for 30 seconds each time, and add once every 5 minutes. Until the product dissolves,...

Embodiment 3

[0022] The comparison of the solubility of embodiment 3 ambroxol phosphate monohydrate and ambroxol hydrochloride

[0023] Weigh fine powder ambroxol phosphate monohydrate and ambroxol hydrochloride 0.1g respectively, put them in 100ml beakers at 25°C, add distilled water in units of 5ml, add once every 5 minutes, shake vigorously 30 seconds until the product dissolves.

[0024] Use 35-40ml of water for ambroxol phosphate monohydrate, the dissolution rate is relatively fast and the clarity is good; use 95100ml water for ambroxol hydrochloride, the dissolution rate is relatively slow and the clarity is relatively poor.

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Abstract

The invention relates to ambroxol salt with a chemical formula (I). Compared with ambroxol hydrochloride, the ambroxol salt has better solubility and faster dissolving speed and can be compatible with cefoperazone sodium for using.

Description

technical field [0001] The present invention relates to a kind of ambroxol salt. Background technique [0002] The structural formula of ambroxol is as follows: [0003] [0004] Its English name is ambroxol, and there are already hydrochloride products available for purchase, and there are also preparations of ambroxol hydrochloride for injection on the market and tablets thereof. [0005] Generally, injection liquid is unstable compared with powder for injection, and transportation and storage are inconvenient. Common preparation methods of powder for injection include spray drying, subpackaging or making a solution, and then freeze-drying to obtain a freeze-dried powder. [0006] Domestically, the lyophilized powder of ambroxol hydrochloride has been listed. The inventors have found that the injection powder made of ambroxol hydrochloride is not easy to redissolve. When the pH of the solution is higher than 7, solids will be separated out. Commercially available The...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D215/44
Inventor 王鹏
Owner 沈阳华泰药物研究有限公司
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