Ambroxol hydrochloride injection and preparation method thereof

A technology of ambroxol hydrochloride and injection, which is used in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., can solve problems such as poor stability, adverse reactions, slow dissolution speed, etc. High stability and safety, low adverse reaction rate, suitable heating temperature

Active Publication Date: 2021-06-04
朗天药业(湖北)有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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

Method used

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

Examples

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Effect test

Embodiment 1

[0031] An ambroxol hydrochloride injection, which contains 75 mg of ambroxol hydrochloride, 14 mg of sodium citrate, 4 mg of citric acid, 0.8 mg of methionine, and water for injection is added to 10 ml.

[0032] The preparation method comprises: (1) taking 75% of the prescribed amount of water for injection, adding the prescribed amount of sodium citrate and citric acid, stirring at 150 rpm for 15 minutes to completely dissolve it, and controlling the pH to 4.8; (2) adding the prescribed amount of hydrochloric acid Ambroxol, stirred at 200rpm for 25min; (3) Add the prescribed amount of methionine and the remaining water for injection, stir for 30min, filter through a 0.22 μm microporous membrane, fill, and fill with nitrogen protection during the whole preparation and filling process, Sterilize at 121°C for 15 minutes.

Embodiment 2

[0034] An ambroxol hydrochloride injection, which contains 75 mg of ambroxol hydrochloride, 18 mg of disodium hydrogen phosphate, 12 mg of phosphoric acid, 90 mg of sodium chloride, 1.2 mg of cysteine, and water for injection is added to 10 ml.

[0035] The preparation method comprises: (1) taking 85% of the formula quantity of water for injection, adding disodium hydrogen phosphate and phosphoric acid in the prescription quantity, stirring at 200 rpm for 10 minutes to completely dissolve it, and controlling the pH to be 4.9; (2) adding the formula quantity of ammonium bromide hydrochloride (3) Add the prescribed amount of cysteine, sodium chloride and the remaining water for injection, stir for 35 minutes, filter through a 0.22 μm microporous membrane, fill, and fill with nitrogen during the entire preparation and filling process Protected and sterilized at 121°C for 15 minutes.

Embodiment 3

[0037] An ambroxol hydrochloride injection, containing 75 mg of ambroxol hydrochloride, 18 mg of disodium hydrogen phosphate, 8 mg of citric acid, 100 mg of glucose, 1.0 mg of L-proline, and 10 ml of water for injection.

[0038] The preparation method comprises: (1) taking 65% of the prescribed amount of water for injection, adding the prescribed amount of disodium hydrogen phosphate and citric acid, stirring at 180 rpm for 12 minutes to completely dissolve it, and controlling the pH to 4.9; (2) adding the prescribed amount of hydrochloric acid Ambroxol, stirred at 160rpm for 25min; (3) Add prescription amount of L-proline, glucose and remaining water for injection, stir for 25min, filter through 0.22 μm microporous membrane, fill, and fill in the whole preparation and filling process Nitrogen protection, sterilized at 121°C for 15 minutes, ready to use.

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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...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/12A61K47/02A61K47/18A61K47/36A61K47/04A61K31/137A61P11/10
CPCA61K9/08A61K9/0019A61K47/12A61K47/02A61K47/183A61K47/36A61K31/137A61P11/10
Inventor 黎翩蔡翔余帮海蔡华李平冯廷松皮培培蔡和霖方贤贵张显强
Owner 朗天药业(湖北)有限公司
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