Ornidazole vaginal soft capsule preparations and method of preparing the same

A soft capsule preparation, the technology of ornidazole, applied in the field of medicine, can solve the problems of difficult dosage, inconvenient use, and unstable weight, etc., so as to avoid the first-pass effect of the liver, prevent mildew and deterioration, and have strong patient compliance Effect

Inactive Publication Date: 2009-01-21
QINGDAO DOUBLE WHALE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But at present clinically used ornidazole suppository medicine has prominent shortcomings such as disequilibrium with the matrix and weight instability, unstable quality, inconvenient use and difficult to grasp the dosage.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The preparation of this embodiment specifically includes the following steps:

[0024] 1) Preparation of the contents of the soft capsule: add 200 grams of ornidazole to 1000 grams of PEG400 to dissolve, then add 100 grams of glycerin, stir well and set aside;

[0025] 2) Preparation of soft capsule shell glue: Weigh 510 grams of gelatin, 180 grams of glycerin, 500 grams of water, 15 grams of citric acid, and 2 grams of titanium dioxide; ℃, start stirring, add titanium dioxide until the suspension is uniform, add gelatin and stir until completely melted, keep the temperature at 75 ℃, remove air bubbles in the glue under reduced pressure, and put it in a heat preservation bucket for later use;

[0026] 3) Soft capsule molding: take the prepared soft capsule contents and capsule shell glue, and use a conventional pressing method to prepare 1000 ornidazole vaginal soft capsules.

Embodiment 2

[0028] The preparation of this embodiment specifically includes the following steps:

[0029] 1) Preparation of the contents of the soft capsule: heat 1000 grams of PEG600 and 100 grams of PEG4000 to dissolve into a liquid, add 500 grams of ornidazole and stir to dissolve until uniform, cool to room temperature, and set aside;

[0030] 2) Preparation of soft capsule shell glue: Weigh 500 grams of gelatin, 200 grams of glycerin, 500 grams of water, 10 grams of PEG400, 7 grams of butenedioic acid, 1 gram of ethyl p-hydroxybenzoate, and 10 grams of titanium dioxide. Add water, butenedioic acid, and ethyl p-hydroxybenzoate into the sol tank, raise the temperature to 75°C, start stirring, suspend titanium dioxide, glycerin, and PEG400 evenly, add them to the sol tank, then add gelatin and stir until completely Melt, keep the temperature at 70°C, remove the air bubbles in the glue under reduced pressure, and put it in a heat preservation bucket for later use;

[0031] 3) Soft capsu...

Embodiment 3

[0033] The preparation of this embodiment specifically includes the following steps:

[0034] 1) Preparation of the contents of the soft capsule: heat and melt 500 grams of PEG400, 400 grams of PEG1000 and 200 grams of PEG4000, stir and cool to form a paste, add 300 grams of ornidazole, stir and suspend, grind with a colloid mill, and set aside;

[0035] 2) Preparation of soft capsule shell glue: Weigh 500 grams of gelatin, 200 grams of glycerin, 500 grams of water, 12 grams of sorbitol, 1 gram of sorbic acid, and 6 grams of titanium dioxide. Add it into the sol tank, raise the temperature to 80°C, start stirring, add titanium dioxide and gelatin in turn and stir until completely melted, keep the temperature at 75°C, remove the bubbles in the glue under reduced pressure, and put it in a heat preservation bucket for later use;

[0036] 3) Soft capsule molding: take the prepared soft capsule contents and capsule shell glue, and use a conventional pressing method to prepare 1000 ...

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PUM

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Abstract

The invention relates to an ornidazole vaginal soft capsule preparation and a preparation method thereof. The soft capsule comprises a content and a capsule shell. The content is composed of the ornidazole and auxiliary materials; and the capsule shell is composed of one or a plurality of gelatin, glycerol, water, an opacifier, a preservative and a disintegrating agent. The preparation method comprises the following steps: the ornidazole is dissolved in one or a plurality of auxiliary materials, and uniformly stirred to obtain the content; or one or a plurality of auxiliary materials are heated and melted, and uniformly stirred and cooled to prepare a matrix, fine ornidazole powder is added to the matrix to be stirred, and mixed uniformly with a colloid mill to obtain the content; the water and glycerol and so on are heated to the temperature of 70-90 DEG C, gelatin, titanium dioxide and the like are added while stirring to cause the gelatin to be totally melt, the temperature is kept between 70 to 80 DEG C, and decompression is carried out to remove bubbles in the gelatin solution so as to obtain the gelatin solution of the capsule shell; the prepared content and the gelatin solution of the capsule shell are pressed by a pressing method to prepare the soft capsule. The ornidazole vaginal soft capsule preparation has beautiful appearance, convenient use, quick action, few side effects, good stability and the preparation technology thereof is advanced.

Description

Technical field: [0001] The invention relates to an external dosage form with ornidazole as the main active ingredient in the technical field of medicine and a preparation method thereof, in particular to an ornidazole vaginal soft capsule preparation and a preparation method thereof. Background technique: [0002] According to the incomplete statistics of the World Health Organization, the incidence rate of various gynecological diseases among women is more than 65%. my country's relevant data survey shows that the incidence of gynecological diseases in women of childbearing age is above 70%. Almost 100% of women suffer from different degrees of vaginitis in their lifetime, and more than 5% of them have seriously affected normal work and life because of the illness. Among them, trichomonal vaginitis and bacterial vaginosis are the most common vaginitis, with an incidence rate of about 20%. [0003] Ornidazole is the third-generation nitroimidazole derivative after metroni...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/66A61K31/4164A61P15/02
Inventor 耿仕霞李存福张玉平倪志伟
Owner QINGDAO DOUBLE WHALE PHARMA
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