Ambroxol injection and preparation method thereof

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...

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

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