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A kind of assay method of dissolution curve of coenzyme q10 capsule

A measurement method and capsule technology, applied in measuring devices, testing pharmaceutical preparations, instruments, etc., can solve problems such as inability to evaluate differences, and achieve the effect of quality assurance

Active Publication Date: 2020-09-04
SHANGHAI PUKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the capsules of this product are almost insoluble in water, so it is impossible to evaluate the difference in in vitro dissolution behavior between it and the original preparation, so as to make predictions for in vivo bioequivalence tests

Method used

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  • A kind of assay method of dissolution curve of coenzyme q10 capsule
  • A kind of assay method of dissolution curve of coenzyme q10 capsule
  • A kind of assay method of dissolution curve of coenzyme q10 capsule

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0040] 1.1 Preparation of dissolution medium

[0041] Weigh an appropriate amount of Triton x-100 and polysorbate 80, add water to dissolve, dilute to 1000mL, and shake well.

[0042] 1.2 Chromatographic conditions:

[0043] Chromatographic column: Waters MicroBondapak C18 (4.6mm×150mm, 10μm) chromatographic column

[0044] Mobile phase: methanol: absolute ethanol = 65:35

[0045] Detection wavelength: 275nm

[0046] Flow rate: 1.0ml / min

[0047] Injection volume: 20μL;

[0048] Column temperature: 30°C;

[0049] Isocratic elution.

[0050] 1.3 Dissolution curve determination method

[0051] After taking the coenzyme Q10 capsules and packing them into the settling basket, adopt the paddle method (the paddle method refers to the dissolution determination method of the four general rules of the Pharmacopoeia 2015 edition), and mix the solutions A (5wt% Triton, water), B (5wt% Triton) respectively. through+0.1wt% polysorbate 80 aqueous solution), C (5wt% triton+0.2wt% polys...

Embodiment 1

[0057] A dissolution curve determination method of coenzyme Q10 capsules, the method specifically comprises the following steps:

[0058] Dissolution medium: mixed solution E (5wt% triton+1wt% polysorbate 80 aqueous solution).

[0059] The dissolution curves of three batches of self-made samples and original research samples with different prescriptions (Table 2) were measured by the dissolution test method in 1.3. The difference in dissolution behavior between different prescriptions is obvious, indicating that this method has a strong distinguishing effect and is suitable for this application. The mensuration of capsule dissolution curve, concrete measurement result is as follows table 3, and dissolution curve sees attached figure 1 .

[0060] Table 2 Sample information

[0061] batch number Homemade sample 1 Q-20190601 Homemade sample 2 Q-20190703 Homemade Sample 3 Q-20190905 Original preparation 85A77S

[0062] Table 3 The result...

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Abstract

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for determining a dissolution curve of a coenzyme Q10 capsule. According to the method, the dissolution rate of the coenzyme Q10 capsule at different time points is measured by adopting a paddle method, then a dissolution curve is drawn, and a dissolution medium is a mixed solution containing triton and polysorbate. The method provided by the invention solves the technical problem that a conventional dissolution rate determination method in the prior art cannot accurately measure the dissolution behavior of the coenzyme Q10 capsule, and can better reflect the quality of the coenzyme Q10 capsule, so that the determination result of the dissolution rate is closer to the in-vivo dissolution effect, and the method has more practical reference significance.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for measuring the dissolution curve of coenzyme Q10 capsules. Background technique [0002] In order to comprehensively improve the quality of domestic generic drugs and achieve the same level as the original drug in vitro and in vivo quality and curative effect, formulating a scientific and reasonable solid preparation dissolution curve is an important step to improve the success rate of in vivo bioequivalence tests The inclusion of characteristic dissolution curves in the corresponding quality standards provides a basis for the consistency of drug quality between batches and the consistency of drug quality before and after process changes. As far as the current domestic synthesis and process level is concerned, impurity control is already at ease, but it is still difficult to achieve in vivo bioequivalence. In order to make predictions for in vivo bioequivalence ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/36G01N30/74G01N33/15
CPCG01N30/02G01N30/06G01N30/36G01N30/74G01N33/15G01N2030/027
Inventor 胡长花赵颖周俊彭娇张伟伟
Owner SHANGHAI PUKANG PHARMA
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