Amoxicillin tablets and preparation method thereof

A technology of amoxicillin tablets and amoxicillin, which is applied in the fields of pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of complex preparation process and poor stability, shorten the process flow and ensure stability performance, quality improvement

Inactive Publication Date: 2018-10-16
宁波蒙曼生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Aiming at the deficiencies of the prior art, the present invention intends to provide an amoxicillin tablet with low content of related substances and better stability, so as to solve the problems of poor stability and complicated preparation process in the prior art

Method used

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  • Amoxicillin tablets and preparation method thereof
  • Amoxicillin tablets and preparation method thereof
  • Amoxicillin tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1: a kind of amoxicillin sheet has following composition composition, calculates in parts by weight, and concrete preparation method is:

[0033] 100 pieces

[0034]

[0035] The preparation method is:

[0036] (1) Dissolve 12.5g of hydroxypropyl-β-cyclodextrin in an appropriate amount of water to make a saturated aqueous solution, take 25g of amoxicillin through an 80-mesh sieve, and dissolve in an appropriate amount of citric acid-citron with a pH value of 5 Amoxicillin solution was prepared when it was in sodium phosphate solution. Under magnetic stirring, the alcohol solution of amoxicillin was added to the saturated aqueous solution of hydroxypropyl-β-cyclodextrin. After all the addition was completed, stirring was continued at room temperature for 2 hours. Put it into a shallow tray and put it in the freezer of the refrigerator. The pre-freezing time is 12 hours and the temperature is -50°C. When the temperature of the cold trap in the freeze-drying...

Embodiment 2

[0038] Embodiment 2: a kind of amoxicillin sheet has following composition composition, calculates in parts by weight, and concrete preparation method is:

[0039] 100 pieces

[0040]

[0041] The preparation method is:

[0042] (1) Dissolve 112.5g of hydroxypropyl-β-cyclodextrin in an appropriate amount of water to make a saturated aqueous solution, take 25g of amoxicillin through an 80-mesh sieve, and dissolve in an appropriate amount of citric acid-citron with a pH value of 6 Amoxicillin solution was prepared in the alkaline solution of sodium bicarbonate, under magnetic stirring, the alcohol solution of amoxicillin was added to the saturated aqueous solution of hydroxypropyl-β-cyclodextrin, after all the addition was completed, the stirring was continued at room temperature for 4 Hour. Put it into a shallow tray and put it in the freezer of the refrigerator. The pre-freezing time is 12 hours and the temperature is -50°C. When the temperature of the cold trap in the fr...

Embodiment 3

[0044] Embodiment 3: a kind of amoxicillin sheet has following composition composition, calculates by weight g, and concrete preparation method is:

[0045] 100 pieces

[0046]

[0047] The preparation method is:

[0048] (1) Dissolve 62.5g of hydroxypropyl-β-cyclodextrin in an appropriate amount of water to make a saturated aqueous solution, take 25g of amoxicillin through an 80-mesh sieve, and dissolve in an appropriate amount of citric acid-citric acid with a pH value of 5.5 Amoxicillin solution was prepared in the alkaline solution of sodium, under magnetic stirring, the alcohol solution of amoxicillin was added to the saturated aqueous solution of hydroxypropyl-β-cyclodextrin, after all the addition was completed, the stirring was continued at room temperature for 3 Hour. Put it into a shallow tray and put it in the freezer of the refrigerator. The pre-freezing time is 12 hours and the temperature is -50°C. When the temperature of the cold trap in the freeze-drying b...

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Abstract

The invention provides amoxicillin tablets and a preparation method thereof. According to the method, hydroxypropyl-beta-cyclodextrin and amoxicillin form an inclusion compound, and then, the inclusion compound is granulated, dried and tableted. The prepared amoxicillin tablets have the advantages of good stability, high dissolubility and low related substance content, an auxiliary material formula is optimized, the mixed powder fluidity is good, and sticking is avoided in the tableting process; by means of the preparation method, the technological process is effectively shortened, the production cycle and exposure time of the medicine in the air are shortened, the stability of the medicine is guaranteed, and the product quality is further improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an amoxicillin tablet and a preparation method thereof. Background technique [0002] The chemical name of amoxicillin is (2S,5R,6R)-3,3-dimethyl-6-[(R)-(-)-2-amino-2-(4-hydroxyphenyl)acetamido] -7-Oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate, molecular formula C 16 h 19 N 3 o 5 S·3H 2 O, the molecular weight is 419.46. The properties of amoxicillin are off-white or white powder, crystalline, slightly bitter taste, insoluble in ethanol, slightly soluble in water, specific rotation in the range of +290°~+315°, and its chemical structural formula is: [0003] [0004] Amoxicillin is suitable for upper respiratory tract infections such as otitis media, sinusitis, pharyngitis, tonsillitis, etc. Urogenital tract infections caused by Bacteria, Proteus mirabilis or Enterococcus faecalis, acute bronchitis, pneumonia and other lower respiratory tract infecti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/69A61K47/26A61K31/43A61P31/04
CPCA61K9/205A61K9/2018A61K31/43A61K47/6951A61P31/04
Inventor 高正春
Owner 宁波蒙曼生物科技有限公司
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