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Method for conveniently and efficiently monitoring mixing uniformity of calcium carbonate D3 chewable tablet intermediate

A technology of mixing uniformity and intermediates, applied in Raman scattering, material excitation analysis, etc., can solve problems such as time-consuming, low efficiency, and complicated procedures, and achieve the effects of improving sensitivity, simplifying detection operations, and improving economic benefits

Pending Publication Date: 2022-07-08
武汉绿合医药科技有限公司
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Problems solved by technology

[0004] The technical problem to be solved by the present invention is to provide a convenient and efficient method for monitoring the mixing uniformity of calcium carbonate D3 chewable tablet intermediates, which overcomes the complicated procedures, long time-consuming and low efficiency of monitoring by high-performance liquid chromatography in the existing technical standards lack of

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  • Method for conveniently and efficiently monitoring mixing uniformity of calcium carbonate D3 chewable tablet intermediate
  • Method for conveniently and efficiently monitoring mixing uniformity of calcium carbonate D3 chewable tablet intermediate
  • Method for conveniently and efficiently monitoring mixing uniformity of calcium carbonate D3 chewable tablet intermediate

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Embodiment

[0029] A method for monitoring the mixing uniformity of a calcium carbonate D3 chewable tablet intermediate based on surface-enhanced Raman spectroscopy, comprising the following steps:

[0030] (1) Preparation of silver glue solution: Weigh 45mg of silver nitrate and put it in a 500mL three-neck round bottom flask, add 250ml of deionized water to dissolve, heat to boiling, and add 5mL of 1% sodium citrate solution dropwise under constant stirring, Continue to stir for 50min under the boiling state, and cool naturally to obtain gray-green-green silver peptide. The obtained silver colloid solution is centrifuged and concentrated to a concentration of 3 times and used for later use.

[0031] (2) Preparation of vitamin D3 standard solutions of different concentrations: Weigh an appropriate amount of vitamin D3, dissolve it with absolute ethanol, and then dilute it with absolute ethanol to form standard solutions of different concentrations. The concentration gradient can be 10, 15...

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Abstract

The invention relates to a method for conveniently and efficiently monitoring the mixing uniformity of a calcium carbonate D3 chewable tablet intermediate. The method comprises the following steps: (1) preparing a silver colloid solution; (2) preparing vitamin D3 standard solutions with different concentrations; (3) obtaining a linear regression equation of the vitamin D3 standard solution; (4) sampling an intermediate of the calcium carbonate vitamin D3 chewable tablet; (5) preparing a test solution; (6) carrying out surface enhanced Raman spectroscopy measurement on the test sample; (7) calculating the content of vitamin D3 in the intermediate; and (8) judging the mixing uniformity of the intermediate at different time points. The method has the advantages that compared with the traditional method for monitoring the mixing uniformity by adopting a high-performance liquid phase, the analysis and detection time is greatly shortened, the detection operation is simplified, and the economic benefit is greatly improved; through enhancement of the nano-silver particles and enrichment of the filter membrane, a to-be-detected sample with extremely low vitamin D3 content can be effectively targeted; and auxiliary materials which interfere with detection can be effectively removed, so that the detection specificity is provided.

Description

technical field [0001] The invention belongs to the technical field of material mixing degree monitoring, in particular to a method for convenient and efficient monitoring of the mixing uniformity of calcium carbonate D3 chewable tablet intermediates. Background technique [0002] The most common method for evaluating the uniformity of mixed powders is to sample the mixed powders and then determine the drug content in the powders. Generally, the mean and relative deviation (RSD) of the content obtained by sampling and analysis are used as evaluation indicators. The main purpose of testing the mixing uniformity of the mixed powder is to ensure that the mixing process can achieve uniform mixing of the powder, and finally ensure that the content of the finished product is uniform. The specifications of calcium carbonate D3 chewable tablets are calcium: 500mg, vitamin D3: 200 international units, of which the content of vitamin D3 is extremely low, and the mixing uniformity is p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/65
CPCG01N21/658
Inventor 郑滨兴秦志平李天宇万梦
Owner 武汉绿合医药科技有限公司
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