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Content determination method of sodium ferulate, aspirin, cinnarizine and vitamin B1

A technology of aspirin and sodium ferulate, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problem that aspirin is lower than the standard requirements, and achieve the reduction of inspection labor costs, reduction of systematic errors and accidental errors, and good repeatability Effect

Inactive Publication Date: 2017-03-15
LIVZON GROUP LIVZON PHARMA FACTORY
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Problems solved by technology

[0004] In "Simultaneous Determination of Sodium Ferulate, Cinnarizine, Aspirin, and Vitamin B1 in Compound Sodium Ferulate Aspirin Capsules by HPLC" published by Lan Xianquan and others, a method for the one-time detection of four components by HPLC is disclosed, which saves time , but as mentioned in the article, using the initial ratio of mobile phase methanol-acetonitrile-acetic acid water (25:20:55) to dissolve the sample during the ultrasonic process will cause the coating of the sample to agglomerate, making it difficult to dissolve the cinnarizine in the sample, and the content detection Result is far lower than production theoretical value and gravimetric method measurement result; Need testing product solution preparation method in this document at the same time: need testing product grinds finely, mixes evenly, and precision takes powder appropriate amount, adds initial ratio mobile phase appropriate amount, ultrasonic filtration, Because the mobile phase contains 55% aqueous phase and the ultrasound lasts for 15 minutes, the aspirin in the sample will be rapidly hydrolyzed to produce a large amount of salicylic acid, which will cause the aspirin in the sample to be lower than the standard requirement. In summary, Lan Xianquan et al. The disclosed method is not applicable to the content detection of cinnarizine and aspirin in compound sodium ferulate aspirin capsules

Method used

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  • Content determination method of sodium ferulate, aspirin, cinnarizine and vitamin B1
  • Content determination method of sodium ferulate, aspirin, cinnarizine and vitamin B1
  • Content determination method of sodium ferulate, aspirin, cinnarizine and vitamin B1

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Experimental program
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Embodiment 1

[0038] Sample Pretreatment Screening

[0039] (1) Experimental group A: Refer to 2.2.1 of the "solution preparation" section of "Simultaneous Determination of Sodium Ferulate, Cinnarizine, Aspirin, and Vitamin B1 in Compound Sodium Ferulate Aspirin Capsules by HPLC Method" published by Lan Xianquan et al. Prepare the test solution, 2.2.2 mixed reference solution, and 2.2.3 negative test solution.

[0040] Chromatographic conditions: Octadecylsilane bonded silica gel as filler (recommended: Yuexu Xtimate C184.8×250mm, 5um); mobile phase: phase A is acetonitrile-tetrahydrofuran-glacial acetic acid-water (20:5:5 :70), B phase is methanol-0.2% triethanolamine-triethylamine (80:20:0.4) of pH=6.6, the gradient elution method of A phase and B phase is: 0-12.00min, A phase 100%; 12.01-25.00min, phase B 100%; 25.01-35.00min, phase A 100%; flow rate: 1.0mL / min; detection wavelength: 276nm; column temperature: 30°C; injection volume: 10ul;

[0041] (2) Experimental group B: the method ...

Embodiment 2

[0055] Embodiment 2 chromatographic condition screening

[0056] (1) Experimental group D: The optimal experimental conditions were optimized by referring to "Simultaneous Determination of Sodium Ferulate, Cinnarizine, Aspirin, and Vitamin B1 in Compound Sodium Ferulate Aspirin Capsules by HPLC Method" published by Lan Xianquan et al.

[0057] (2) Experimental group E: the method described in the present invention. Chromatographic column: octadecylsilane bonded silica gel as filler; mobile phase: acetonitrile-tetrahydrofuran-glacial acetic acid-water (20:5:5:70) as mobile phase A, methanol-0.2% triethanolamine-tri Ethylamine (80:20:0.4) was adjusted to PH=6.6 with 3mol / L hydrochloric acid solution as mobile phase B, and gradient elution was carried out in the following table 2; the detection wavelength was 276nm, and the test was carried out with the gradient in the following table 2.

[0058] The preparation method of the experimental solution in this embodiment is: accurate...

Embodiment 3

[0066] Embodiment 3: mobile phase gradient screening

[0067] Chromatographic column: octadecylsilane bonded silica gel as filler; mobile phase: acetonitrile-tetrahydrofuran-glacial acetic acid-water (20:5:5:70) as mobile phase A, methanol-0.2% triethanolamine-tri Ethylamine (80:20:0.4) was adjusted to PH=6.6 with 3mol / L hydrochloric acid solution as mobile phase B, and gradient elution was carried out in the following table; Compare different gradient time changes of mobile phases to optimize better chromatographic conditions.

[0068] The preparation method of the experimental solution in this embodiment is: accurately weigh about 50 mg of the sodium ferulate reference substance, about 20 mg of the aspirin reference substance, and about 25 mg of the cinnarizine reference substance in a 100ml measuring bottle, add 1% glacial acetic acid methanol solution Ultrasonic for 2 minutes to dissolve and dilute to the mark, shake well, as the reference solution.

[0069] Table 5 Comp...

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Abstract

The invention relates to a content determination method of sodium ferulate, aspirin, cinnarizine and vitamin B1 in compound sodium ferulate-aspirin capsules. The method comprises the following steps: using an octadecylsilane bonded silica gel as a filler and a phase A and a phase B as mobile phases, wherein the phase A is a mixed solvent of acetonitrile, tetrahydrofuran, glacial acetic acid and water, the phase B is a mixed solvent of methanol, triethanolamine and triethylamine, and the pH value is 6.0-7.0; preparing a test sample solution, a mixed reference substance solution and a negative reference substance solution; and respectively absorbing 10 mu l of the test sample solution, mixed reference substance solution and negative reference substance solution, injecting into a liquid chromatograph, determining, recording the chromatogram, and calculating the percents of the compositions according to the peak area by an external standard process. The method has the advantages of short detection time and one-step sample treatment, and can greatly lower the system errors and random errors caused by complex sample treatment in the current processes. The method can better control the quality of the compound sodium ferulate-aspirin capsules.

Description

technical field [0001] The invention relates to a content determination method of sodium ferulate, aspirin, cinnarizine and vitamin B1, in particular to a content determination method of sodium ferulate, aspirin, cinnarizine and vitamin B1 in compound sodium ferulate aspirin capsules . Background technique [0002] Compound Sodium Ferulate Aspirin Capsules is a third class new drug of western medicine developed by Limin Pharmaceutical Factory of Livzon Group (each capsule contains 50mg sodium ferulate, 20mg aspirin, cinnarizine 25mg and 10mg vitamin B1), 4 kinds of this product The ingredients sodium ferulate, cinnarizine, aspirin and vitamin B1 have different mechanisms of action in anti-platelet aggregation, anticoagulation, lowering blood viscosity, thrombolysis, vasodilator, and maintaining normal cardiovascular and cerebrovascular functions. This product has strong anti-platelet aggregation, obvious inhibition of experimental thrombosis and strong anti-experimental thr...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/14
CPCG01N30/02G01N30/06G01N30/14G01N2030/027G01N2030/062
Inventor 李高照梁秋华范玲玲向双
Owner LIVZON GROUP LIVZON PHARMA FACTORY
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