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Pantoprazole sodium medicinal composition, pellet containing composition and preparation method of pellet

A technology of pantoprazole sodium and composition, applied in the field of pharmaceutical preparations, can solve the problems of unstable pantoprazole sodium, difficult control of the preparation process, decrease in drug content, etc., and achieves reduction of drug oxidation reaction, reduction of discoloration, Prevent the effect of catalysis

Active Publication Date: 2015-06-17
ZHEJIANG UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] At present, when preparing pantoprazole sodium pellets, although common stabilizers and auxiliary materials have been added, pantoprazole sodium is still unstable in the preparation process and storage process, and the pellets are prone to discoloration, drug content decline and related substances. Phenomena such as exceeding the standard
In addition, in the preparation process, in order to reduce the heating process, the method with mature preparation technology such as extrusion-spheronization is generally avoided, and the method of directly coating the drug powder on the surface of the blank core is usually used. This preparation process is more difficult. Control, the surface of the obtained pellet core is relatively rough, which is not conducive to the subsequent coating process

Method used

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  • Pantoprazole sodium medicinal composition, pellet containing composition and preparation method of pellet
  • Pantoprazole sodium medicinal composition, pellet containing composition and preparation method of pellet

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Effect test

Embodiment 1

[0054] The preparation of embodiment 1 pantoprazole sodium pellets

[0055] Weigh the raw materials according to the prescription amount in Table 1, mix them evenly, add an appropriate amount of water to prepare soft materials, add them to an extrusion spheronizer to prepare pellet cores, extrude at a speed of 50 rpm, and spheronize at a speed of 30 rpm for 4 to 5 minutes, then bake at 40 °C Dry for 2 hours, and pass through a 20-24 mesh sieve to obtain drug-containing pellet cores; the obtained drug-containing pellet cores are coated with hypromellose film, and the weight gain of the coating is controlled by the amount of coating material to obtain pantoprazole sodium pellets.

[0056] Table 1 Pantoprazole Sodium Pellet Prescription

[0057]

[0058] Table 1 Prescription of pantoprazole sodium pellets (continued)

[0059]

[0060] From the appearance of the pantoprazole sodium micropills that different formulas make, the micropills that the R13 formula that does not ad...

Embodiment 2

[0061] Drug content and related substance determination in embodiment 2 pantoprazole sodium pellets

[0062] Adopt high-performance liquid chromatography to detect the change of pantoprazole sodium content and related substance content before and after the preparation of pantoprazole sodium pellets and in the placement process, specific methods are as follows:

[0063] Content determination: use octadecylsilane bonded silica gel as filler; use 0.01mol / L dipotassium hydrogen phosphate solution (adjust pH value to 7.0 with phosphoric acid)-acetonitrile (65︰35) as mobile phase; detection wavelength is 289nm . The number of theoretical plates calculated according to the peak of pantoprazole is not less than 2500.

[0064] The preparation of need testing solution: get pantoprazole sodium pellet appropriate, grind, accurately weighed, add the solution dissolving of 0.001mol / L sodium hydroxide solution-acetonitrile (1: 1)) and quantitatively dilute to make each A solution containin...

Embodiment 3

[0074] Before and after the preparation of embodiment 3 and after placing 10 days, the content and related substances of medicine in the pellets change

[0075] Get the pantoprazole sodium raw material, the pantoprazole sodium pellets of 0 days after preparation by each prescription of embodiment 1, and the pantoprazole sodium pellets of placing 10 days under 60 ℃ after the preparation, observe the effect of medicine respectively Appearance, determination of drug content and content of related substances, the measurement results are shown in Table 3.

[0076] Wherein, the assay method of drug content and related substance content is the same as the method in embodiment 2.

[0077] The drug content and related substance content in the pantoprazole sodium raw material are actual measured values.

[0078] The drug content in the pantoprazole sodium pellets after 0 days after preparation and 10 days at 60° C. refers to the ratio of the actually measured drug content to the indica...

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Abstract

The invention provides a stable pantoprazole sodium medicinal composition. The composition comprises the following components in parts by weight: 10 parts of pantoprazole sodium, 0.05-0.6 part of basic amino acid, 0.5-2.0 parts of antioxidant, 0.05-0.6 part of chelating agent, and 1.2-8.0 parts of pH regulating agent. The invention also provides a preparation containing the medicinal composition, a pellet containing the medicinal composition, a preparation containing the pellet and a preparation method of the pellet. According to the medicinal composition, the stability of pantoprazole sodium can be remarkably improved in the preparing process and the storing process.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a stable pharmaceutical composition of pantoprazole sodium, a pellet of the composition and a preparation method thereof. Background technique [0002] Pantoprazole sodium, the chemical name is 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl-1H-benzoimidazole sodium salt, It is a new type of anti-ulcer drug, which directly acts on the parietal cells of the gastric mucosa, thereby inhibiting the secretion of gastric acid. It is suitable for the treatment of gastric ulcer and duodenal ulcer. Vascular bleeding etc. [0003] Pantoprazole sodium has the chemical structure of sulfinyl benzimidazole, which is easily affected by various factors such as high temperature, light, heavy metal ions, oxidizing and reducing components, and is unstable. Especially under acidic conditions, the chemical structure of pantoprazole sodium can undergo destructive ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4439A61K9/16A61K47/18A61K47/12A61P1/04A61P9/00A61P7/02A61P7/04
Inventor 胡富强吴晖袁弘陈眉眉姚忠立李海杰杜永忠游剑赵川平
Owner ZHEJIANG UNIV
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