Ambroxol injection and preparation method thereof

A technology for injection and ambroxol, applied in the field of ambroxol injection and preparation thereof, can solve problems such as affecting drug quality, poor stability, difficulty, etc., and achieve the effects of ensuring drug quality, strong buffering ability, and ensuring sterility

Active Publication Date: 2010-09-22
云南龙海天然植物药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But because the aqueous solution of ambroxol hydrochloride is not stable enough, especially meets light and easily degrades, on the other hand, the solubility of ambroxol hydrochloride in water is not big enough, and this makes it produce certain difficulty when preparing preparation
[0011] Chinese patent application CN1954808A discloses a kind of injection of ambroxol hydrochloride, comprises ambroxol hydrochloride, lyophilized powder support agent and pH value adjusting agent, yet, the ambroxol hydrochloride injection buffer capacity that adopts this method preparation is not strong, easy Precipitation occurs, poor stability, and since no activated carbon is used for adsorption in the preparation process, the probability of pyrogen contamination is high
[0012] Chinese patent application CN10416956A also discloses a kind of injection of ambroxol hydrochloride, containing ambroxol hydrochloride, sodium dihydrogen phosphate and citric acid; After that, related substances increased significantly, which affected the quality of medicines
In addition, during preparation, the patent application uses 0.1% activated carbon to remove pyrogens, but due to the low amount of activated carbon, the removal of pyrogens is not ideal

Method used

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  • Ambroxol injection and preparation method thereof
  • Ambroxol injection and preparation method thereof
  • Ambroxol injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Ambroxol Hydrochloride 15.0g

[0029] Disodium hydrogen phosphate 2.93g

[0030] Citric acid 2.06g

[0031] Sodium chloride 13.86g

[0032] Appropriate amount of nitrogen

[0033] Add water for injection to 2000ml

[0034] Weigh disodium hydrogen phosphate and citric acid, add appropriate amount of water for injection to dissolve; add ambroxol hydrochloride, stir to dissolve; add sodium chloride to dissolve. Add 0.3% (W / V) activated carbon, stir for 20 minutes, and filter. Filled with nitrogen and sealed in 2ml brown glass ampoule. Sterilize and test for leaks (121°C, 15 minutes), and check for visible foreign matter, and the product is ready.

Embodiment 2

[0036] Ambroxol Hydrochloride 15.0g

[0037] Disodium hydrogen phosphate 3g

[0038] Citric acid 2.1g

[0039] Sodium chloride 13.8g

[0040] Appropriate amount of nitrogen

[0041] Add water for injection to 2000ml

[0042] Weigh disodium hydrogen phosphate and citric acid, add appropriate amount of water for injection to dissolve; add ambroxol hydrochloride, stir to dissolve; add sodium chloride to dissolve. Add 0.3% (W / V) activated carbon, stir for 20 minutes, and filter. Filled with nitrogen and sealed in 2ml brown glass ampoule. Sterilize and test for leaks (121°C, 15 minutes), and check for visible foreign matter, and the product is ready.

Embodiment 3

[0044] Ambroxol Hydrochloride 15.0g

[0045] Disodium hydrogen phosphate 2.7g

[0046] Citric acid 1.8g

[0047] Sodium chloride 14.1g

[0048] Appropriate amount of nitrogen

[0049] Add water for injection to 2000ml

[0050] Weigh disodium hydrogen phosphate and citric acid, add appropriate amount of water for injection to dissolve; add ambroxol hydrochloride, stir to dissolve; add sodium chloride to dissolve. Add 0.3% (W / V) activated carbon, stir for 20 minutes, and filter. Filled with nitrogen and sealed in 2ml brown glass ampoule. Sterilize and test for leaks (121°C, 15 minutes), and check for visible foreign matter, and the product is ready.

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Abstract

The invention provides an ambroxol injection and a preparation method thereof; the injection contains ambroxol and the pharmaceutical acceptable salt thereof, disodium hydrogen phosphate and citrate, wherein the weight ratio of the ambroxol and the pharmaceutical acceptable salt thereof, the disodium hydrogen phosphate to the citrate is 1:0.18 to 0.22:0.12 to 0.16; and preferably, the weight ratio of the ambroxol and the pharmaceutical acceptable salt thereof, the disodium hydrogen phosphate to the citrate is 1:0.20:0.14. The pharmaceutical acceptable salt of the ambroxol is preferred to be hydrochloride. The used amount of active carbon adopted in the preparation is 0.2 to 0.3 percent.

Description

technical field [0001] The invention relates to an ambroxol injection and a preparation method thereof, in particular to an injection comprising ambroxol or a salt thereof, disodium hydrogen phosphate and citric acid and a preparation method thereof. Background technique [0002] Respiratory system disease is a kind of common disease, frequently-occurring disease, its morbidity rate is all high in the world scope, and has the tendency of increasing, it is the second largest factor of population death in our country. The world's population is currently aging, and the elderly over 65 years of age account for a considerable proportion of deaths due to respiratory diseases. The four symptoms of wheezing, coughing, phlegm, and inflammation are common symptoms of respiratory diseases, and they are mutually causal. Phlegm is the product of respiratory inflammation, which can irritate the respiratory mucosa, cause cough and asthma, and aggravate infection. When patients with acute...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/19A61K31/137A61K47/12A61K47/04A61P11/10
Inventor 高春生马璟琪王玉丽刘华
Owner 云南龙海天然植物药业有限公司
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