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Method for refining injection-level ambroxol hydrochloride, product and injection thereof

A technology of ambroxol hydrochloride and refining method, which is applied in the field of refining and purification of ambroxol hydrochloride crude drug, to achieve the effects of improving quality, refining process safety, and increasing stability

Active Publication Date: 2011-08-17
天津市铭泰医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] But in the quality standard of imported ambroxol hydrochloride injection, also only the content of external standard method is calculated impurity to related substance, trans-4-[6,8-dibromo-1,4-dihydroquinazoline-3( H)] the total amount of cyclohexanol hydrochloride (impurity B) and (2-amino-3,5-dibromophenyl) formaldehyde (impurity E) must not be 1% of the marked amount of ambroxol perhydrochloride

Method used

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  • Method for refining injection-level ambroxol hydrochloride, product and injection thereof
  • Method for refining injection-level ambroxol hydrochloride, product and injection thereof
  • Method for refining injection-level ambroxol hydrochloride, product and injection thereof

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Effect test

Embodiment 1

[0026] injection grade ambroxol hydrochloride refining method, get the ambroxol hydrochloride raw material 100g that purity is 99.78%, slowly add the aqueous ethanol solution of 550ml88% under stirring, be heated to 80-85 ℃ after back distillation 20 minutes, Ambroxol hydrochloride is completely dissolved in the solvent; stop heating, place it at 6-8°C for 4 hours and then crystallize; filter off the solvent to obtain crystals, dry at 80°C for 4-8 hours, take out and weigh. With 79g of the refined ambroxol hydrochloride raw material in this step, slowly add 435ml of 88% ethanol aqueous solution under stirring; after heating to 60-65° C. in a water bath for 60 minutes, ambroxol hydrochloride is completely dissolved in the solvent; Stop heating, place at 6-8°C for 4 hours and crystallize out; filter off the solvent to obtain crystals, dry at 80°C for 4-8 hours, then take out.

Embodiment 2

[0027] injection grade ambroxol hydrochloride refining method, get the ambroxol hydrochloride raw material 100g that purity is 99.76%, slowly add the aqueous ethanol solution of 550ml88% under stirring, after heating in 85-90 ℃ of water baths 30 minutes, Ambroxol hydrochloride is completely dissolved in the solvent; stop heating, place it at 3-5°C for 4 hours and then crystallize; filter off the solvent to obtain crystals, dry at 80°C for 4-8 hours, and then take it out.

Embodiment 3

[0028] Injection grade ambroxol hydrochloride refining method, get the ambroxol hydrochloride crude drug 100g that purity is 99.65%, slowly add the ethanol aqueous solution of 760ml81% under stirring, be heated to 85-90 ℃ after back distillation 30 minutes , Ambroxol hydrochloride is completely dissolved in the solvent; stop heating, place it at 6-8°C for 4 hours and then crystallize; filter off the solvent to obtain crystals, dry at 80°C for 4-8 hours, and then take it out.

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Abstract

The invention belongs to fields of a method for refining and purifying compounds and products thereof, and particularly relates to a method for refining and purifying an ambroxol hydrochloride Chinese herbal medicine, a product thereof and the field of application. The method for refining the injection-level ambroxol hydrochloride is characterized by comprising the following steps of: adding 70.2to 88 volume percent of aqueous solution of ethanol (g / ml) into an ambroxol hydrochloride raw material (g) of which the purity is over 99.0 percent in a ratio of 1:(5.5-9.2); heating, and distilling until the ambroxol hydrochloride raw material is dissolved fully; stopping heating, cooling and crystallizing to separate ambroxol hydrochloride out; and filtering the solvent to obtain crystals, and drying to obtain the injection-level ambroxol hydrochloride. In the injection-level ambroxol hydrochloride raw material, an impurity B is less than or equal to 0.03 percent, an impurity E less than orequal to 0.002 percent, and total impurities except for the impurities B and E are less than or equal to 0.03 percent; and the purity is over 99.9 percent.

Description

Technical field: [0001] The invention belongs to the field of compound refining and purification methods and products thereof; in particular, the refining and purification method of ambroxol hydrochloride bulk drug and its products and application fields. Background technique: [0002] The chemical name of ambroxol hydrochloride is: trans-4-[(2-amino-3,5-dibromo-phenyl)methyl-amino]cyclohexanol hydrochloride, and its structure is as follows: [0003] [0004] Ambroxol hydrochloride is a new generation of airway mucus regulator, which has excellent expectorant effect and can significantly promote the synthesis and secretion of alveolar surfactant. Ambroxol hydrochloride can stimulate bronchial mucous glands to secrete more fluid mucus, dilute sputum, reduce viscosity, and increase the production and secretion of pulmonary surfactant, thereby reducing airway resistance and mucus adhesion. Activate mucociliary function and promote mucociliary rotation. Compared with the fi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C215/44C07C213/10A61K31/137A61K9/08A61P11/10
Inventor 梅开忠
Owner 天津市铭泰医药科技有限公司
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