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Moxifloxaci gelatin capsule and preparation process thereof

A technology of gelatin capsule and moxifloxacin, which is applied in the field of pharmaceutical preparation of moxifloxacin, can solve the problems of in vitro dissolution behavior change and the like

Active Publication Date: 2006-02-22
JIANGSU TIANYISHI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] So far, there are no reports of changes in in vitro dissolution behavior or decreased dissolution of moxifloxacin or its salts and / or hydrate gelatin capsules during storage in the literature.

Method used

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  • Moxifloxaci gelatin capsule and preparation process thereof
  • Moxifloxaci gelatin capsule and preparation process thereof
  • Moxifloxaci gelatin capsule and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～17

[0075] Embodiment 1~17 and comparative example

[0076] According to the dosage of each component listed in the following Table 1 and Table 2, sodium sulfite, sodium bisulfite, oligomeric anthocyanins, tea polyphenols, tocopherol, ascorbic acid, isoascorbic acid, L-glutathione, Sesame polyphenols, vitamin B1, vitamin B2, β-carotene, soybean isoflavones, L-cysteine, sodium pyrophosphate, and calcium polyphosphate were used as additives, and no additives (comparative example) were added to prepare molybdenum hydrochloride. Gelatin capsule of cifloxacin.

[0077] Preparation method and stability inspection: take the raw materials and auxiliary materials in the amounts stated in Table 1 and Table 2, mix them evenly, fill them into gelatin capsule shells, pack them in aluminum-plastic blisters, and investigate the dissolution rate after a 10-day stability test at 60°C .

[0078] The results show that after 10 days, the dissolution rate of the capsules added with the above-mention...

Embodiment 18～42

[0086] Composition: as shown in Table 3 to Table 8

[0087] Preparation method: take the amount of raw materials and auxiliary materials mentioned in the table, mix well, and fill the capsules.

[0088] Stability investigation: the capsules prepared above were put into a composite aluminum foil bag and sealed. After three months of accelerated stability investigation at 40°C and a relative humidity of 75%, the dissolution rate was investigated. The dissolution rate was measured according to the test example 1. method of determination.

[0089] The results showed that the dissolution rate was greater than 80%.

[0090] Table 3. (Amount of ingredients per capsule, in mg)

[0091]

[0092] Table 4 (the amount of components per capsule, in mg)

[0093]

[0094] Table 5 (the amount of components per capsule, in mg)

[0095]

[0096] Table 6 (the amount of ingredients per capsule, in mg)

[0097]

[0098] Table 7 (the amount of components per capsule, in mg)

[009...

Embodiment 43～47

[0102] Composition: as shown in Table 8

[0103] Preparation method: Take the amount of raw materials, auxiliary materials (except oligocyanidin), part of magnesium stearate, part of micropowder silica gel as stated in the table, mix well, dry granulate, add oligocyanidin and remaining stearic acid Magnesium, micronized silica gel, mix well, fill gelatin capsules.

[0104] Stability investigation: the capsules prepared above were put into a composite aluminum foil bag and sealed. After three months of accelerated stability investigation at 40°C and a relative humidity of 75%, the dissolution rate was investigated. The dissolution rate was measured according to the test example 1. method of determination.

[0105] The results showed that the dissolution rate was greater than 80%. The specific results are shown in Table 8

[0106] Table 8 (the amount of components per capsule, in mg)

[0107]

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Abstract

The invention discloses a moxifloxacin gelatin capsule, whose contents comprises moxifloxacin or its salts and / or its hydrate and additive, the additive is at least one selected from the following substances: sodium sulfite, sodium acid sulfite, low-molecular proanthocyanidin, L-glutathion, sesame polyphenols, green tea polyphenols, tocopherol, ascorbic acid, isoascorbic acid, vitamin B1, vitamin B2, beta-carotene, soybean isoflavones, L-sulfo-aminolactic acid, pyrophosphoric acid, polyphosphoric acid and their medicinal salts.

Description

technical field [0001] The invention relates to a pharmaceutical preparation of moxifloxacin, specifically, the invention relates to a gelatin capsule of moxifloxacin or a salt thereof and / or a hydrate thereof and a preparation method thereof. Background technique [0002] Moxifloxacin (moxifloxacin) is a new generation of fluoroquinolone antibacterial drugs, which are currently approved abroad for upper and lower respiratory tract infections caused by sensitive microorganisms, such as acute exacerbation of chronic bronchitis, community-acquired pneumonia, acute bacterial sinusitis and Treatment of uncomplicated skin and soft tissue infections. [0003] At present, moxifloxacin oral preparations only have moxifloxacin hydrochloride tablets. The Chinese patent "Moxifloxacin Pharmaceutical Preparations", patent No. 99813124.5, discloses the oral pharmaceutical tablet and its preparation method. The water binder and lactose are granulated with water, the granules are then mixe...

Claims

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Application Information

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IPC IPC(8): A61K31/4725A61K9/48A61P31/04A61P11/00
Inventor 赵冰奇傅雪琦赵邦爱
Owner JIANGSU TIANYISHI PHARMA
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