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Production Control Method of Cefaclor Granules

A production control method, the technology of Klo particles, is applied in the direction of using material absorption and weighing, which can solve the problems of unstable product quality and unstable quality, and achieve the feasible and effective effect of the quality control method.

Active Publication Date: 2015-10-07
山东淄博新达制药有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The quality of cefaclor granules is unstable within the expiry date, especially the quality of products produced in summer high temperature and high humidity season is extremely unstable

Method used

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  • Production Control Method of Cefaclor Granules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Materials and instruments: German Binder constant temperature and humidity box KBR series, AE-200 balance, desiccator, round flat glass dish, batch 080421 of cefaclor granules, analytically pure NaOH, purified water.

[0017] Precisely weigh 6 parts of 080241 batches of cefaclor granules, 35g each, and spread them evenly in 6 round flat-bottomed glass dishes, and then put them into 6 dishes with different relative humidity of 40%, 50%, 60%, and 70%. , 80%, 90% (preparing different concentrations of NaOH solutions to obtain relative humidity conditions) in the desiccator, the mouth of the desiccator is sealed with Vaseline. Put the desiccator in a constant temperature and humidity box at 25°C for 7 days to reach an equilibrium state. Then accurately weigh the sample weight, the increased weight of the sample is the equilibrium moisture absorption at each relative humidity, see Table 1 for details. Then take the moisture absorption as the ordinate and the relative humidi...

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Abstract

The invention relates to a pharmaceutical production technology, and in particular relates to a method for controlling quality during the cefaclor granule production process, which can determine the balanced moisture content and critical relative humidity of the cefaclor granule, and thus, the quality of a cefaclor granule product is effectively controlled. By the method, the humidity environment for producing cefaclor granules is determined, the water content of a semi-finished product is controlled to be below 1.0%, the semi-finished product is sealed through a double-layer clean plastic bag, the storage life is not over 5 days, and thus, the quality of the cefaclor granule production is effectively controlled. After the method is adopted, through monitoring the reserved sample, unqualified conditions are not found out during the effective duration, so that the method for controlling the quality during the cefaclor granule production process is effective.

Description

technical field [0001] The invention relates to a production process of medicines, in particular to a production control method of cefaclor granules. Background technique [0002] Cefaclor belongs to the class of antibiotics with β-lactam structure, and the β-lactam structure is easily hydrolyzed. The quality of cefaclor granules is not stable within the expiry date, especially the quality of products produced in the high temperature and high humidity season in summer is extremely unstable. [0003] In order to improve the quality stability of this variety, it is necessary to study the quality stability of this variety. First, start with the equilibrium moisture absorption and critical relative humidity of cefaclor granules to determine the influence of ambient temperature and humidity on the species during the production process, so as to determine the control indicators of the production process conditions. Therefore, it is particularly important to find a suitable qualit...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N5/02
Inventor 冯秀宏王秀萍赵新彦
Owner 山东淄博新达制药有限公司