A kind of levofloxacin hydrochloride tablet
A technology of levofloxacin hydrochloride tablets and levofloxacin hydrochloride, which is applied in directions such as pharmaceutical formulations, inorganic non-active ingredients, pill delivery, etc., can solve the problems of easy aggregation of levofloxacin hydrochloride, poor solubility of levofloxacin hydrochloride, easy aggregation of levofloxacin hydrochloride, etc. The effect of stable dissolution profile, no decrease in in vitro dissolution rate, and small batch-to-batch variation
Active Publication Date: 2019-07-12
NANJING ZENKOM PHARMA
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- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
Levofloxacin hydrochloride is a BCSI compound, but levofloxacin hydrochloride is easy to aggregate, and the aggregated levofloxacin hydrochloride has poor solubility. The poor solubility caused by the aggregation of levofloxacin hydrochloride is the key factor affecting the difference in clinical efficacy
The existing technology adopts various methods to solve the technical obstacle of easy aggregation of levofloxacin hydrochloride, but none of them can solve the tendency of easy aggregation and dissolution rate decline of levofloxacin hydrochloride during long-term storage.
[0007] 104288112A discloses a levofloxacin hydrochloride tablet, which adopts talcum powder and stearic acid to add in a specific compatibility ratio, and shows excellent quality controllability in the large-scale production test of levofloxacin hydrochloride tablet, the prepared levofloxacin hydrochloride tablet It has good safety and effectiveness, but it fails to solve the tendency of levofloxacin hydrochloride tablets to aggregate and decrease in dissolution rate during long-term storage
Method used
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Examples
Experimental program
Comparison scheme
Effect test
Embodiment 1
[0020] prescription:
[0021]
[0022] Preparation method: Mix levofloxacin hydrochloride and micro-powder silica gel evenly, dry granulate, mix with lactose, microcrystalline cellulose, and magnesium stearate to form tablets.
Embodiment 2
[0024] prescription:
[0025]
[0026]
[0027] Preparation method: Mix levofloxacin hydrochloride and micro-powder silica gel evenly, dry granulate, mix with dextrin, microcrystalline cellulose, and magnesium stearate to form tablets.
Embodiment 3
[0029] prescription:
[0030]
[0031] Preparation method: Mix levofloxacin hydrochloride and micro-powder silica gel evenly, dry granulate, mix with dextrin, microcrystalline cellulose, and magnesium stearate to form tablets.
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Abstract
The invention relates to a levofloxacin hydrochloride tablet, belongs to the new technological field of medicine manufacturing and in particular relates to the levofloxacin hydrochloride tablet and a preparation method thereof. The levofloxacin hydrochloride tablet takes levofloxacin hydrochloride as a main ingredient and is formed by carrying out direct compression on a levofloxacin hydrochloride composition and auxiliary materials, wherein the levofloxacin hydrochloride composition is prepared by adopting the method comprising the following steps: uniformly mixing levofloxacin hydrochloride with micropowder silica gel, and carrying out dry granulation, and the weight ratio of levofloxacin hydrochloride to the micropowder silica gel is 10:(1-2). The levofloxacin hydrochloride tablet provided by the invention has the advantages that descending trend of in vitro dissolution of the levofloxacin hydrochloride tablet is solved, pharmaceutical effect is improved, and more ideal treatment effect is realized.
Description
technical field [0001] The invention belongs to the field of new medicine manufacturing technology, and in particular relates to a levofloxacin hydrochloride tablet and a preparation method thereof. Background technique [0002] Levofloxacin Hydrochloride is suitable for those caused by sensitive bacteria: 1. Genitourinary system infection, including simple and complicated urinary tract infection, bacterial prostatitis, Neisseria gonorrhoeae urethritis or cervicitis (including those caused by enzyme-producing strains) To whom). 2. Respiratory tract infection, including acute attack of bronchial infection and lung infection caused by sensitive gram-negative bacilli. 3. Gastrointestinal infection, caused by Shigella, Salmonella, enterotoxigenic Escherichia coli, Aeromonas hydrophila, Vibrio parahaemolyticus, etc. 4. Typhoid fever. 5. Bone and joint infection. 6. Skin and soft tissue infection. 7. Septicemia and other systemic infections. The chemical name of levofloxacin...
Claims
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IPC IPC(8): A61K9/20A61K47/02A61K31/5383A61P31/04
CPCA61K9/2009A61K31/5383
Inventor 徐卓业祁艳
Owner NANJING ZENKOM PHARMA