Ofloxacin vaginal swelling suppository, as well as preparation method and detection method thereof

A technology of vaginal expansive suppository and ofloxacin, which is applied in the fields of suppository delivery, pharmaceutical formulations, material inspection products, etc. It can solve the problems of easy-to-contaminate clothes, unfavorable use, and difficult to clean, so as to avoid secondary infection and prevent outflow Effect

Active Publication Date: 2014-04-30
哈尔滨田美药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Ofloxacin is a white to light yellow crystalline powder; odorless and tasteless; gradually changing color when exposed to light, poor stability; poor water solubility, less absorption, and low bioavailability; it is mainly used clinically for the treatment of bacterial vaginosis
Among the currently marketed preparations, the dosage forms of ofloxacin mainly include tablets, capsules, ointments and suppositories; after the tablets are inserted into the vagina, ofloxacin is difficult to dissolve and play a role; the same problem exists i

Method used

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  • Ofloxacin vaginal swelling suppository, as well as preparation method and detection method thereof
  • Ofloxacin vaginal swelling suppository, as well as preparation method and detection method thereof
  • Ofloxacin vaginal swelling suppository, as well as preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0109]

[0110] Preparation:

[0111] 1) Preparation of drug-containing matrix:

[0112] a. heating and melting alginic acid and polyethylene glycol 6000 in a water bath to obtain a melt;

[0113] B. mixing ofloxacin and the melt of step a evenly to obtain a drug-containing matrix;

[0114] 2) Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 conical suppositories, each weighing about 3.6g.

Embodiment 2

[0116]

[0117] Preparation:

[0118] 1) Preparation of drug-containing matrix:

[0119] a. placing sodium carboxymethyl cellulose and glycerinated gelatin in a water bath for heating and melting to obtain a melt;

[0120] b. Take silicon dioxide and add 3 times the amount of water, fully grind to a paste with a moisture content of less than 5%, add ofloxacin under grinding, mix well, and freeze-dry to obtain a mixture;

[0121] c. mixing the mixture of step b and the melt of step a evenly to obtain a drug-containing matrix;

[0122] 2) Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 cylindrical suppositories, each weighing about 4.4g.

Embodiment 3

[0124]

[0125] Preparation method: make 100 rod-shaped suppositories according to the method in Example 2, each weighing about 3.3g.

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PUM

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Abstract

The invention relates to an ofloxacin vaginal swelling suppository, as well as a preparation method and a detection method thereof. The swelling suppository comprises ofloxacin, a drug-containing matrix formed by a matrix, and a swelling carrier, wherein an inclusion complex is formed by ofloxacin and beta-cyclodextrin, so that the solubility and stability of ofloxacin can be improved; the hygroscopicity of ofloxacin can be reduced due to addition of calcium glycerophosphate in the drug-containing matrix, and the stability of the suppository can be improved; the drug-containing matrix of the suppository further comprises a specific hardening agent. The ofloxacin vaginal swelling suppository provided by the invention adopts six original advanced technologies, is high in stability and durable in curative effect, and has the beneficial effects of preventing a liquid medicine from draining, avoiding secondary infection and the like.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to an ofloxacin vaginal expansion suppository and a preparation method and detection method thereof. Background technique [0002] Ofloxacin is a white to slightly yellow crystalline powder; odorless and tasteless; it changes color when exposed to light, and has poor stability; poor water solubility, low absorption, and low bioavailability; it is mainly used clinically for the treatment of bacterial vaginosis. Among the currently marketed preparations, the dosage forms of ofloxacin mainly include tablet, capsule, ointment and suppository; after the tablet is inserted into the vagina, ofloxacin is difficult to dissolve and is difficult to play a role; the same problem exists in the capsule; and the ointment also It is unfavorable for intravaginal use, so the application of suppositories is the most extensive at present, and is accepted by the majority of patients. There are not ...

Claims

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Application Information

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IPC IPC(8): A61K9/02A61K31/5383A61K47/38A61K47/32A61K47/04A61P15/02A61P31/04A61P31/02G01N33/15G01N5/04
Inventor 邱学良邱明世
Owner 哈尔滨田美药业股份有限公司
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