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Quality control method of almagate suspension

A quality control method, the technology of adding aluminum and magnesium, is applied in the direction of aluminum/calcium/magnesium active ingredients, medical preparations of non-active ingredients, liquid transportation, etc. Risk of non-conformance, simplified inspection process, time and cost savings

Active Publication Date: 2016-08-31
YANGZHOU YIYANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The relative density and content determination methods in the statutory standard WS1-(X-074)-2004Z are extremely cumbersome

Method used

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  • Quality control method of almagate suspension
  • Quality control method of almagate suspension

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0025] Quality control method of aluminum-magnesium plus suspension

[0026] (1) Quality control in the suspension stage

[0027] Take purified water, heat it to 60-65°C, add 10g of sucrose per 1L of purified water, stir to dissolve, and obtain a sugar aqueous solution; add aluminum and magnesium at a rate of 200g per 1L of sugar aqueous solution, Stir for 15 minutes under the condition of 100-105 ℃ to get the primary suspension of aluminum and magnesium; add glycerin at the ratio of 120 g per 1 L of primary suspension of aluminum and magnesium, and stir for 15 minutes under the condition of 100-105 ℃; from the 16th minute, gradually cool down while Gradually increase the stirring speed until the 30th minute; from the 31st minute, gradually increase the temperature while gradually reducing the stirring speed until the 45th minute; take a sample and measure the sedimentation volume ratio F, F should be ≥ 95.0%; if the F value meets the above standards , enter the next step: ad...

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Abstract

The invention relates to a quality control method of an almagate suspension, and the method is easy and convenient to operate. The method comprises the steps of (1), quality control of a suspension phase: the sedimentation volume ratio F is measured, and the F should be larger than or equal to 95.0%; (2) quality control before filling: absorption of acid is measured, the consumption of each 1g of almagate suspension on a hydrochloric acid volumetric solution (0.1 mol / L) should be larger than or equal to 23.0 mL; viscosity is measured, and the measured viscosity coefficient eta should be 1,200+-400 mPa.s. The preparation process of the almagate suspension is subjected to quality control with the method, preventive measures are taken in advance, the rick of unqualified finished products is reduced greatly, and clinical medicine is ensured to be safe and effective.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a quality control method of an aluminum-magnesium suspension. Background technique [0002] Aluminum magnesium plus (Almagate), its chemical name is: fourteen hydroxy aluminum magnesium carbonate hydrate. Molecular formula: Al 2 Mg 6 (OH) 14 (CO 3 ) 2 4H 2 O. Molecular weight: 630.02. [0003] Aluminum-magnesium plus is an antacid with fast action and strong ability to neutralize gastric acid, which can maintain the pH value in the stomach at 3-5 for a long time. For the treatment of gastric and duodenal ulcers, gastritis, bile reflux esophagitis, hiatal hernia and indigestion related to excessive gastric acid secretion. [0004] Al-Mg is insoluble in water and is often prepared as a suspension for clinical use. [0005] Almagate Suspension (Almagate Suspension) is a commonly used drug for neutralizing stomach acid in clinical practice. It is implemented in the Nati...

Claims

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Application Information

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IPC IPC(8): G01N21/78G01N11/14A61K33/10A61K9/10A61K47/26A61P1/04A61P1/14A61P1/00
CPCA61K9/10A61K33/10A61K47/26G01N11/14G01N21/78
Inventor 李曙东季伟陈亚舟
Owner YANGZHOU YIYANG PHARMA
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