A kind of ambroxol hydrochloride injection and preparation method thereof

Abstract

The invention discloses an ambroxol hydrochloride injection and a preparation method of the injection. The ambroxol hydrochloride injection per piece comprises 15mg ambroxol hydrochloride, 2-4mg ascorbic acid, 7-10mg disodium hydrogen phosphate, 15-30mg sodium chloride, 1.5-3mg glutathione, 0.5-0.8mg sodium pyrosulfite and 2ml injection water. The ambroxol hydrochloride injection takes ascorbic acid and disodium hydrogen phosphate as a pH (potential of hydrogen) buffer pair, ascorbic acid is an antioxidant, and two antioxidants, namely glutathione and sodium pyrosulfite, are added to avoid ascorbic acid oxidization, so that ambroxol hydrochloride is double protected, the ambroxol hydrochloride injection is ensured in an oxygen-free environment in a whole production process, and the stability is significantly improved. In addition, the ambroxol hydrochloride injection requires no nitrogen protection, so that the cost is reduced, a contamination risk is reduced, and nitrogen dissolved in the injection can be prevented from entering blood when the injection is injected.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to an ambroxol hydrochloride injection and a preparation method thereof. Background technique [0002] Respiratory diseases are generally manifested as cough, phlegm, wheezing, and inflammation, especially increased sputum volume and difficulty in expectoration are symptoms of many respiratory diseases such as chronic obstructive pulmonary disease (COPD), bronchial asthma, and cystic pulmonary fibrosis (CF). Common symptoms, children and the elderly often have difficulty spitting, which interferes with people's daily life in mild cases, and even endangers the lives of patients in severe cases. At the same time, in the case of thoracic and abdominal operations, patients often produce a large amount of sputum, which can block the respiratory tract, easily cause coughing, wheezing, and even difficulty in breathing. Sputum obstructs the respiratory tract, leading to uneven distribut...

AI Technical Summary

Problems solved by technology

[0012] At present, the production technology, stability and quality of ambroxol hydrochloride injection vary from good to bad, which cannot guarantee the safety of clinical medication. The main manifestations are that ambroxol hydrochloride is unstable to light and oxygen in the solution, and is prone to degradation and damage. , the stability is not high, which affects the quality of medicines and drug safety. When the existing products are in use, because of the high solubility of ambroxol in acidic solutions, hydrochloric acid is used when preparing with other high pH (pH>7) liquids Ambroxol will be separated out and become turbid, which will cause safety problems and limit the combination of drugs. Therefore, it is necessary to develop ambroxol hydrochloride injection to make it more stable and more applicable

[0013] In summary, the current ambroxol hydrochloride injection mainly ensures the stability of the ambroxol hydrochloride injection, the stability of the pH value, and the injection The stability of liquid to light and heat, although these prior art have also considered that ambroxol hydrochloride is also unstable to oxygen in solution, and it is easy to degrade and destroy under aerobic conditions, but this problem has not been paid enough attention to

These existing technologies are usually filled with nitrogen for protection during the production process, and considering the cost, most of the preparation methods do not inject nitrogen in the early stage of the liquid preparation, so that the production of the injection is not in an oxygen-free environment throughout the process , resulting in the stability of ambroxol hydrochloride injection can not be greatly improved

In addition, the nitrogen filled with nitrogen is filtered and sterilized, which will increase the risk of bacterial contamination. At the same time, the nitrogen dissolved in the liquid medicine will enter the blood when the product is injected, affecting the oxygen content of the blood. When the nitrogen content of the blood in the human body increases, it will cause restlessness , Mental excitement, so there is a threat of adverse reactions

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