Vonoprazan fumarate pharmaceutical composition and preparation method thereof

A composition, fumaric acid technology, applied in the directions of drug combination, pharmaceutical formulation, drug delivery, etc., can solve the problems of easy melting and affect the stability of the drug vonolax fumarate, so as to control growth and ensure stability. sexual effect

Pending Publication Date: 2022-02-18
JILIN HUIKANG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, the melting point of polyethylene glycol 6000 is 55-63°C (Handbook of Pharmaceutical Excipients (Sixth Edition): 517-522), which is prone to melting in the accelerated test, thus affecting the stability of the drug vonorasan fumarate sex

Method used

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  • Vonoprazan fumarate pharmaceutical composition and preparation method thereof
  • Vonoprazan fumarate pharmaceutical composition and preparation method thereof
  • Vonoprazan fumarate pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Prescription ingredients and ratio:

[0069] table 3

[0070]

[0071]

[0072] Preparation method: same as Comparative Example 1.

[0073] Investigation of influencing factors: same as Comparative Example 1.

Embodiment 2

[0074] Embodiment 2 Influencing Factors Investigation Result Determination

[0075] Related Substance Detection Method

[0076] The prepared samples were tested for changes in known impurities and unknown impurities in the raw vonolamin fumarate tablets of Comparative Example 1 and Example 1 before and after setting out. By HPLC method, water: acetonitrile mixture (3:1) was used as solvent to extract related impurities for determination. HPLC test condition is as follows:

[0077] Detector: UV absorption spectrophotometer (measurement wavelength: 230nm)

[0078] Chromatographic column: Octadecylsilane bonded silica gel column [MGIIC18 (4.6×100mm, 3μm)]

[0079] Mobile phase A: 0.025mol / L phosphoric acid-acetonitrile-methanol mixture (14:1:5)

[0080] Mobile phase B: 0.025mol / L phosphoric acid-acetonitrile mixture (3:7)

[0081] Mobile phase: Gradient elution by changing the mixing ratio of mobile phase A and mobile phase B as follows:

[0082] Table 4

[0083]

[008...

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Abstract

The invention provides a Vonoprazan fumarate pharmaceutical composition with high stability under high temperature, high humidity and intense illumination, the composition comprises a coating containing copovidone and a tablet core containing Vonoprazan fumarate, and the weight ratio of copovidone in the coating is 5-30%. By adding the copovidone into the coating, the prepared coated tablet can keep good coating film stability under high temperature, high humidity and strong light, so that not only is the stability of the Vonoprasone fumarate under the illumination condition ensured, but also the growth of related substances at high temperature is effectively controlled, A powerful guarantee is provided for providing a high-quality and long-term stable Vonoprazan fumarate preparation.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a vonolaxan fumarate pharmaceutical composition and a preparation method. Background technique [0002] Vonolasan fumarate was jointly researched and developed by Japan's Takeda Pharmaceutical and Otsuka Pharmaceutical. It was approved for marketing by the Japan Pharmaceuticals and Medical Devices Agency on December 26, 2014. It is used for gastric ulcer, duodenal ulcer, and reflux esophagus. Inflammation, erosive esophagitis, gastroesophageal reflux disease, Helicobacter infection and peptic ulcer treatment. [0003] CN102743330A discloses that Vonorasan fumarate is sensitive to light. In addition to adding a chain organic acid to the preparation composition, 5-30wt% of titanium dioxide and a specific plasticizer polyethylene glycol (polyethylene glycol) are also added to the coating. Diol 6000) to prepare a specific coating shade to improve the stability ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K47/32A61K31/4439A61K45/06A61P1/04A61P31/04
CPCA61K9/284A61K31/4439A61K45/06A61P1/04A61P31/04A61K2300/00
Inventor 张玲玲东新新李巧霞程森
Owner JILIN HUIKANG PHARM CO LTD
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