Method for determining contents of auxiliary materials in lamivudine tablet

A technology for lamivudine tablets and lamivudine tablets, which is applied in the field of determining the content of excipients in lamivudine tablets, and can solve performance differences such as tablet dissolution, content uniformity, and drug stability, and titration methods Problems such as manual operation and low efficiency of titration method can achieve the effect of reducing the probability of defective lamivudine tablets, good quality control of drugs, and high accuracy

Pending Publication Date: 2021-06-25
HINYE PHARM CO LTD
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Problems solved by technology

In the actual production process, it is found that even if the difference of the main active ingredient is controlled to remain unchanged, when there is a slight change in the components of each auxiliary material, the dissolution, content uniformity, and drug stability of the final tablet are limited by the granulation, coating and other processes. There will be large differences in properties such as sex
[0009] For each adjuvant in the

Method used

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  • Method for determining contents of auxiliary materials in lamivudine tablet
  • Method for determining contents of auxiliary materials in lamivudine tablet
  • Method for determining contents of auxiliary materials in lamivudine tablet

Examples

Experimental program
Comparison scheme
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Embodiment 1

[0073] A method for determining auxiliary auxiliary tablet in a lamifer tablet comprising the steps of:

[0074] S1 carboxymeta sodium content detection

[0075] S1.1 solution formulation

[0076] Standard curve solution : The precision amount of sodium standard solution is given, and the sodium containing sodium, 2 μg, 5 μg, 10 [mu] g, 2 μg, 5 μg, 10 μg, and 20 μg, the concentration is the abscissive, and the absorbance is longitudinally. Linear regression , Standard curve of sodium, as follows figure 1 As shown, it is a linear relationship of sodium.

[0077] by figure 1 It can be seen that sodium is in the concentration range of 0-20 μg / ml, with a concentration of a horizontal coordinate, the resulting regression curve is [A] = 0.0091 * [C] -0.0005; the correlation coefficient R is 0.99976, indicating that the analysis method has a good linear relationship in the range of 0-20 μg / ml concentration.

[0078] Test solution solution

[0079] Take 20 pieces of this product to

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Abstract

The invention relates to the technical field of drug content detection, in particular to a method for determining the contents of auxiliary materials in a lamivudine tablet. The method comprises the following steps of: S1, measuring the content of carboxymethyl starch sodium in a lamivudine tablet core; S2, measuring the content of magnesium stearate in the lamivudine tablet core; S3, determining the content of lamivudine; and S4, calculating the content of microcrystalline cellulose according to the following formula: the content of microcrystalline cellulose = 100% - the content of lamivudine - the content of carboxymethyl starch sodium - the content of magnesium stearate. The method for determining the contents of auxiliary materials in a lamivudine tablet is simple to operate and high in accuracy, and the method is beneficial for an enterprise to reduce the defective rate of lamivudine tablets, better control the quality of drugs and realize the consistency of the quality and the curative effect of the lamivudine tablets and an original research drug.

Description

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Claims

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Application Information

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Owner HINYE PHARM CO LTD
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