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Tinidazole tablet consistency evaluation method

A technology of tinidazole tablets and evaluation methods, which is applied in the direction of instruments, measuring devices, scientific instruments, etc., can solve the problems of consuming a lot of time and cost, affecting the progress of research and development, etc., and achieve saving time and cost, improving production efficiency, and good dissolution rate effect

Pending Publication Date: 2021-04-30
HAINAN HAILI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The invention provides a method for evaluating the consistency of tinidazole tablets, which is used to solve the problem that in the method for evaluating the consistency of existing tinidazole tablets, only a BE test and an in vitro dissolution curve are used for testing, which needs to consume a lot of time and cost. If the test results are inconsistent, the test needs to be re-tested, which seriously affects the technical problems of the research and development progress

Method used

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  • Tinidazole tablet consistency evaluation method

Examples

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Embodiment 1

[0034] An embodiment of a method for evaluating the consistency of tinidazole tablets provided by the present invention includes in vitro dissolution curves and BE tests, and also includes a pre-evaluation process. The pre-evaluation process includes crystal form, impurity comparison, and dissolution curve determination. Dissolution profiles and BE tests were performed before.

[0035] Comparison of crystal forms using powder diffraction method to compare tinidazole tablets and reference preparations Compared with the crystal forms, one piece of tinidazole tablet (content is 0.5g) and one piece of reference preparation (the content is 0.5g) After being ground into powder respectively, they are pressed into flat tablets in a tablet machine, and the flat tablets are respectively put into an X-ray diffractometer to measure the spectrograms of the two drugs to determine the crystal form.

[0036] It should be noted that powder X-ray diffraction is used to identify the crystal f...

Embodiment 2

[0054] In an embodiment provided by the present invention, the tinidazole tablet to be tested includes a tablet core and a coating, and the tablet core includes 180 parts by weight of tinidazole, 90 parts by weight of a diluent, 12 parts by weight of a binder, and 15 parts by weight of a disintegrant. part, 3 parts by weight of lubricant.

[0055] Prepared by the following process:

[0056] (1) Preparation of adhesive solution: take pregelatinized starch and disperse it evenly in an appropriate amount of purified water, place it in a water bath heating at 90-95°C and stir continuously to make it gelatinized, and the product is obtained;

[0057] (2) Premixing: add tinidazole, diluent, and disintegrant croscarmellose sodium into the mixer for mixing every 3 to 4 minutes, in which the diluent is microcrystalline cellulose and pregelatin a mixture of starches;

[0058] (3) Granulation: Turn on the boiling drying granulator, spray the binder solution prepared in step (1) for gra...

Embodiment 3

[0064] As a further improvement to Example 1, in the comparison of crystal forms, it was observed that tinidazole tablets and If the characteristic peaks of the spectrum are inconsistent, it means that the two currently measured drug crystal forms are inconsistent. You can choose to replace the raw materials of tinidazole tablets from different manufacturers and repeat the production of tinidazole tablets, and then conduct powder diffraction samples to determine whether the crystal forms are consistent. The drug properties of nidazole tablets are changed, and the raw materials and production process are excluded for tinidazole tablets and reference preparations The impact of consistency evaluation; if the crystal form is inconsistent, it means that the efficacy of tinidazole tablets itself is different from that of the reference preparation The efficacy of tinidazole tablets is inconsistent, and the production process of tinidazole tablets needs to be improved again, so th...

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Abstract

The invention discloses a tinidazole tablet consistency evaluation method. The method comprises the following steps: before starting a BE test and an in-vitro dissolution curve, pre-evaluating a tinidazole tablet, evaluating whether the measured tinidazole tablet has consistency or not, and then carrying out the BE test and in-vitro dissolution curve verification so that the failure rate of the BE test is reduced, the time and the cost are saved, and the production efficiency is improved. Through the pre-evaluation process, the stability of the tinidazole tablet can be determined, and the basic composition and the characteristic structure of a tinidazole medicine and a reference preparation Fasigyn are consistent so that the consistency of the medicine effects of the two medicines is judged, and the success rate of the BE test and an in-vitro dissolution curve test is ensured. The method is used for solving technical problems that in an existing tinidazole tablet consistency evaluation method, testing is performed only through the BE test and the in-vitro dissolution curve, a large amount of time and cost need to be consumed, if test results are inconsistent, testing needs to be performed again, and a research and development progress is seriously affected.

Description

technical field [0001] The invention belongs to the technical field of drug consistency evaluation, in particular to a method for evaluating the consistency of tinidazole tablets. Background technique [0002] The current consistency evaluation method for drugs is to evaluate tinidazole tablets and bioequivalence (BE) tests by comparing dissolution profiles and Whether the effect (safety and effectiveness) on patients with a certain disease is the same or similar, where the FDA stipulates that if tinidazole tablets and With bioequivalence, the application process can be carried out according to the abbreviated new drug application (ANDA) instead of the new drug application (NDA), avoiding time-consuming and expensive I and III procedures. phase clinical trials. [0003] Because the BE test and the in vitro dissolution curve test are more complicated, it will consume a lot of time and cost. If the test result is that tinidazole tablets and If there is no consistency, th...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/34G01N30/86
CPCG01N30/02G01N30/34G01N30/8679
Inventor 许丹青余国新耿亮朱亚东
Owner HAINAN HAILI PHARMACEUTICAL CO LTD
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