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Metronidazole composition freeze-dried disintegrating tablets for vaginas and preparation method thereof

The technology of a composition and metronidazole is applied in the field of metronidazole composition vaginal freeze-dried disintegrating tablet and its preparation field, which can solve the problems of irritation of inflammatory mucosa, inconvenient transportation and storage, influence on clinical application and the like, and achieve vaginal irritation. Small, improve bioavailability, shorten the effect of dissolution time

Active Publication Date: 2012-11-21
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the suppository is based on polyoxyethylene monoester acid and glycerin, which is inconvenient for transportation and storage. It is required to be stored below 30°C, and its use is limited in some high-temperature and alpine regions.
Effervescent tablets contain acid-base effervescent agents, which often irritate the inflammatory mucosa and affect clinical application

Method used

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  • Metronidazole composition freeze-dried disintegrating tablets for vaginas and preparation method thereof
  • Metronidazole composition freeze-dried disintegrating tablets for vaginas and preparation method thereof
  • Metronidazole composition freeze-dried disintegrating tablets for vaginas and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Prescription: 1000 tablets

[0043]

[0044] Dissolve the prescription amount of medium substituted hydroxypropyl-β-cyclodextrin in purified water of 80% of the total amount of prescription water, heat to 55°C while stirring, slowly add the prescription amount of metronidazole, and continue stirring for 10 Hours, after the medium-substituted hydroxypropyl-β-cyclodextrin clathrates the metronidazole, add the prescribed amount of mannitol and sucralose, and dissolve the prescribed amount of gelatin in purified water with 20% of the prescribed water amount , heated until completely dissolved, combined the above two solutions and stirred evenly, adjusted the pH value to 5.5-6.5 with sodium bicarbonate, according to the specifications of metronidazole composition vaginal freeze-dried disintegrating tablets, after determining the loading amount, the combined The medicinal liquid is divided into medicinal dishes according to the amount of loading, and put into a freeze-dryi...

Embodiment 2

[0046] Prescription: 1000 tablets

[0047]

[0048] Dissolve the prescription amount of medium substituted hydroxypropyl-β-cyclodextrin in purified water of 80% of the total amount of prescription water, heat to 55°C while stirring, slowly add the prescription amount of metronidazole, and continue stirring for 10 Hours, after the medium-substituted hydroxypropyl-β-cyclodextrin clathrates metronidazole, add the prescribed amount of mannitol and sucralose, and dissolve the prescribed amount of gelatin in purified water with 20% of the prescribed water consumption. Heat until completely dissolved, combine the above two solutions and stir evenly, adjust the pH value to 5.5-6.5 with sodium bicarbonate, according to the specifications of metronidazole composition vaginal freeze-dried disintegrating tablets, after determining the filling amount, the combined medicine The solution is divided into medicine-containing dishes according to the content, and put into a freeze-drying box ...

Embodiment 3

[0050] Prescription: 1000 tablets

[0051]

[0052] Dissolve the prescription amount of medium substituted hydroxypropyl-β-cyclodextrin in purified water of 80% of the total amount of prescription water, heat to 55°C while stirring, slowly add the prescription amount of metronidazole, and continue stirring for 10 Hours, after the medium-substituted hydroxypropyl-β-cyclodextrin clathrates metronidazole, add the prescribed amount of mannitol and sucralose, and dissolve the prescribed amount of gelatin in purified water with 20% of the prescribed water consumption. Heat until completely dissolved, combine the above two solutions and stir evenly, adjust the pH value to 5.5-6.5 with sodium bicarbonate, according to the specifications of metronidazole composition vaginal freeze-dried disintegrating tablets, after determining the filling amount, the combined medicine The solution is divided into medicine-containing dishes according to the content, and put into a freeze-drying box to...

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Abstract

The invention provides metronidazole composition freeze-dried disintegrating tablets for vaginas and a preparation method of the freeze-dried disintegrating tablets, relates to the field of a medicine and a medicine preparation method technology and mainly solves the technical problems that the metronidazole suppositories and effervescent tablets are inconvenient to transport and store, the application is limited; and the inflamed mucosas are frequently stimulated by the metronidazole suppositories and effervescent tablets when metronidazole suppositories and effervescent tablets are utilized, and the clinical application is influenced. The metronidazole composition freeze-dried disintegrating tablets are prepared from the following components by weight: 10-24% of metronidazole, 24-50% of mannitol, 2-4% of gelatin, 32-74% of hydroxypropyl-beta-cyclodextrin with medium substitution degree and 50% of purified water. The metronidazole composition freeze-dried disintegrating tablets for vaginas prepared by the above components are easy in preparation process, and simple in components, moreover, the metronidazole composition freeze-dried disintegrating tablets for vaginas have the advantages of being fast to disintegrate, convenient to take, and good in compliance, and the tablets take effect quickly and are fully absorbed; and the disintegrating tablets can be completely disintegrated in the vaginas while meeting water, so that foreign body sensation does not exist in the vaginas.

Description

Technical field: [0001] The invention relates to the technical field of medicines and preparation methods of medicines, in particular to a metronidazole composition vaginal freeze-dried disintegrating tablet and a preparation method thereof. Background technique: [0002] Metronidazole is a nitroimidazole derivative. Its mechanism of action is: (1) It may inhibit the synthesis of bacterial DNA, thereby interfering with the growth and reproduction of bacteria, and eventually leading to the death of bacteria. Metronidazole has a killing effect on cells and anaerobic microorganisms grown under hypoxic conditions, and the metabolites generated when it is reduced in the human body also have an anti-anaerobic effect, and its bactericidal concentration is slightly higher than the bacteriostatic concentration; (2) It can inhibit the redox reaction of amoeba and break the nitrogen chain of the protozoa; (3) In addition, metronidazole also has a strong effect of killing trichomonas. ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4164A61K47/42A61K47/40A61K47/26A61P31/04
Inventor 刘海燕汪六一汪金灿
Owner HAINAN WEI KANG PHARMA QIANSHAN
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