Ambroxol hydrochloride injection and preparation method thereof

Abstract

The invention provides an ambroxol hydrochloride injection and a preparation method thereof. The ambroxol hydrochloride injection comprises 75 mg of ambroxol hydrochloride, 16-30 mg of a pH buffer pair, 0.8-6.2 mg of a stabilizer and 80-84 mg of an osmotic pressure regulator, and water for injection added to 10 ml, and the injection has a pH value of 4.8-5.2. The preparation method comprises the following steps: removing residual oxygen from the water for injection by adopting a physical means such as simultaneously regulating and controlling temperature and pressure intensity and introducing nitrogen, taking 45-90% of water for injection, adding the pH buffer pair according to the formula amount, stirring for 10-30 minutes to completely dissolve, and controlling pH to be 4.8-5.2; adding ambroxol hydrochloride according to the formula amount, and stirring for dissolving; adding the stabilizer, the osmotic pressure regulator according to the formula amount and the residual water for injection, stirring for 10-40 min, filtering with a 0.22 mu m microporous filter membrane, filling, introducing nitrogen for protection in the whole preparation and filling process, and sterilizing at 121 DEG C for 15 min to obtain the injection. The ambroxol hydrochloride injection can effectively promote elimination of sputum of a patient, and is small in adverse reaction; meanwhile, has good storage stability, simple process and low cost.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an ambroxol hydrochloride injection and a preparation method thereof. Background technique [0002] Ambroxol Hydrochloride, Ambroxol Hydrochloride, chemical name: trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride, molecular formula: C13H18Br2N2O·HCl, molecular weight: 414.57. Ambroxol hydrochloride is a new generation of mucus dissolving agent, which was first listed in Germany in the early 1980s. It can promote the secretion of pulmonary surfactant, the secretion of airway fluid and the movement of cilia, reduce the retention of mucus, and can significantly promote excretion. Phlegm, improve respiratory conditions, definite curative effect, less toxic and side effects, has been widely used in clinical practice, has been listed in Italy, Switzerland, Argentina, Japan, France, Spain, Singapore, Thailand and other countries. [0003] Approved...

AI Technical Summary

Problems solved by technology

This invention has the following disadvantages: the water for injection needs to be boiled and nitrogen gas is introduced for a long time, and the cost is high; at the same time, the prescription does not contain antioxidants, and the stability during storage is relatively poor

This invention has the following disadvantages: high initial purity requirements for ambroxol hydrochloride, slow dissolution rate, long time consumption, and poor stability under the light of the injection

This invention has the following disadvantages: the composition is complicated, the amount of auxiliary materials is large and contains sodium pyrosulfite, which is easy to cause adverse reactions; at the same time, sodium pyrosulfite and glutathione remove the oxides produced by residual oxygen in water for injection, so that the safety of the final product sex is difficult to guarantee

This invention has the following disadvantages: the quality requirements of the raw material ambroxol hydrochloride are extremely high, and the edetate used is likely to cause adverse reactions; at the same time, amino acid antioxidants react with residual oxygen, making the quality of the product difficult to control

Images