CN104257626A - Secnidazole soft capsule and preparation method thereof - Google Patents
Secnidazole soft capsule and preparation method thereof Download PDFInfo
- Publication number
- CN104257626A CN104257626A CN201410548310.7A CN201410548310A CN104257626A CN 104257626 A CN104257626 A CN 104257626A CN 201410548310 A CN201410548310 A CN 201410548310A CN 104257626 A CN104257626 A CN 104257626A
- Authority
- CN
- China
- Prior art keywords
- secnidazole
- soft capsule
- preparation
- content
- gelatin
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention provides a secnidazole soft capsule and a preparation method thereof. The soft capsule consists of a capsule content and a capsule shell. The content consists of secnidazole and medicinal auxiliary materials; the capsule shell is formed by gelatin, water, glycerinum, titanium dioxide, a preservative, a disintegrant and the like. The soft capsule can be prepared by the following steps: heating, melting and uniformly stirring the medicinal auxiliary materials, adding secnidazole and stirring after the mixture is cooled, processing the obtained mixture by a colloid mill and uniformly mixing to obtain the content for later use; heating water, glycerinum and the like to a temperature of 70 to 90 DEG C, adding gelatin, titanium dioxide and the like while stirring, carrying out vacuum degassing to obtain capsule shell glue solution after gelatin is completely molten, and pressing the capsule shell glue solution and the prepared contents into the soft capsule by adopting a pressing method. The product has the advantages of being convenient to carry, high in drug stability, high in dissolution speed of effective ingredients and high in response speed.
Description
Technical field
This research relates to medical art, is specifically related to a kind of secnidazole soft capsule and preparation method thereof.
Background technology
Secnidazole belongs to 5-nitro glyoxaline compound, be used for the treatment of the trichomoniasis such as various acute and chronic liver sausage amebiasis and urethra, vagina, male prostate clinically, also can be used for the treatment of giardiasis and partes corporis humani position anaerobic infection, is the medicine of unique single-dose treatment amebic dysentery that WHO recommends.
Secnidazole medicine has the listing of many dosage forms, as: tablet, capsule, dispersible tablet (0.25g/ sheet) etc., good effect has been played in relevant disease treatment, but relevant kind ubiquity a series of unsurmountable defect: the dissolubility (34mg/ml) that medicine is lower in water, cause drug-eluting slower, the curative effect limiting its oral formulations plays, and the drug resistance report causing a disease former constantly occurs, in addition, this crude drug has significant bitterness, also have impact on the compliance that patient takes medicine to a certain extent.
Soft capsule also claims soft gelatin capsule type, is the tablet that continues, a kind of novel form grown up after injection, and softgel shell is suppressed by gelatin and formed, and content is aqueous medicinal liquid, is formed by softgel shell contents of parcel thing.This dosage form has the advantage not available for other dosage form: enter after in body, content discharges rapidly, and bioavailability is higher, rapid-action; Some content odor smell can be hidden; Stability, homogeneity is good, and uniformity of dosage units is desirable.
Therefore, the secnidazole soft capsule prepared, will overcome all deficiencies of existing secnidazole preparation to a certain extent, and expection can play the therapeutical effect of secnidazole more fully.
Summary of the invention
The object of this invention is to provide a kind of take secnidazole as the novel pharmaceutical formulation of the treatment microbial infection disease of effective ingredient, and this dosage form steady quality is effectively easy to use; This studies the preparation method that another object is to provide said preparation.
Invention product is made up of medicinal liquid and softgel shell two large divisions, and medicinal liquid contains the secnidazole of effective dose as effective ingredient, and containing pharmaceutic adjuvant; Containing 10 parts, gelatin in softgel shell, glycerol 4.0-5.5 part (weight ratio), antiseptic and opacifier.Medicinal liquid by weight every containing secnidazole 50-300 milligram, the granularity of secnidazole crude drug is for being less than 100 object powder.
Described pharmaceutic adjuvant is vaseline, paraffin, lecithin and PEG400.
Described antiseptic be following one or more: parabens (p-hydroxybenzene acetoacetic ester, methyl parahydroxybenzoate, propyl p-hydroxybenzoate, Sodium Methyl Hydroxybenzoate), propylene glycol, Oleum Caryophylli, sorbic acid methyl ester, benzoic acid, benzyl alcohol.
Described opacifier is titanium dioxide.
Preparation method is divided into following steps::
The preparation of content: stir after pharmaceutic adjuvant heating being dissolved, after cooling, adds secnidazole fine powder and stirs and crosses colloid mill and mix afterwards for subsequent use.
The preparation of softgel shell: water, glycerol, antiseptic are heated to 70-90 DEG C, add titanium dioxide again and in distilled water, soak swelling gelatin in advance, stir while adding, gelatin is made to dissolve uniformly shape completely, keep temperature 70-80 DEG C again, vacuum outgas, puts into the adjustable steady glue bucket of temperature, for subsequent use.
The preparation of soft capsule: get the content and softgel shell that prepare, adopts pressing to make soft capsule, sizing, dry, clean, select, pack and get final product.
Detailed description of the invention
By but be not limited to following detailed description of the invention, the present invention is further described in detail.
Embodiment 1
Preparation method:
1. content preparation: pharmaceutic adjuvant PEG400, glycerol heating are stirred after dissolving, after cooling, adds secnidazole fine powder and stirs and crosses colloid mill and mix afterwards for subsequent use.
2. softgel shell glue preparation: distilled water, glycerol, ethylparaben are heated to 70-90 DEG C, add titanium dioxide again and in distilled water, soak swelling gelatin in advance, stir while adding, gelatin is made to dissolve uniformly shape completely, insulation degree 70-80 DEG C, by the bubble in reduced vacuum removing glue, put into the adjustable steady glue bucket of temperature, for subsequent use.
3. the preparation of soft capsule: get the content and softgel shell that prepare, adopts pressing to make soft capsule, sizing, dry, clean, select, pack and get final product.
Embodiment 2
Preparation method:
1. content preparation: stir after the heating of pharmaceutic adjuvant vaseline, liquid Paraffin and lecithin being dissolved, after cooling, adds secnidazole fine powder and stirs and crosses colloid mill and mix afterwards for subsequent use.
2. soft capsule shell glue preparation: distilled water, glycerol, ethylparaben are heated to 70-90 DEG C, add titanium dioxide again and in distilled water, soak swelling gelatin in advance, stir while adding, gelatin is made to dissolve uniformly shape completely, keep temperature 70-80 DEG C again, by the bubble in reduced vacuum removing glue, put into the adjustable steady glue bucket of temperature, for subsequent use.
3. the preparation of soft capsule: get the content and softgel shell that prepare, adopts pressing to make soft capsule, sizing, dry, clean, select, pack and get final product.
Embodiment 3
Preparation method:
1. content preparation: stir after pharmaceutic adjuvant PEG400 and glycerol heating being dissolved, after cooling, adds secnidazole fine powder and stirs and crosses colloid mill and mix afterwards for subsequent use.
2. soft capsule shell glue preparation: distilled water, glycerol, propylene glycol are heated to 70-90 DEG C, add titanium dioxide again and in distilled water, soak swelling gelatin in advance, stir while adding, gelatin is made to dissolve uniformly shape completely, keep temperature 70-80 DEG C again, by the bubble in reduced vacuum removing glue, put into the adjustable steady glue bucket of temperature, for subsequent use.
3. the preparation of soft capsule: get the content and softgel shell that prepare, adopts pressing to make soft capsule, sizing, dry, clean, select, pack and get final product.
Claims (6)
1. a secnidazole soft capsule, be made up of content and softgel shell two parts, content contains the secnidazole of effective dose, and containing pharmaceutic adjuvant; Containing 10 parts, gelatin, glycerol 4.0-5.5 part (weight ratio) in softgel shell, antiseptic and opacifier.
2. secnidazole soft capsule as claimed in claim 1, is characterized in that, by weight, every contains secnidazole 50-300 milligram, and average 250 milligrams, the granularity of secnidazole crude drug is for being less than 100 object powder.
3. secnidazole soft capsule as claimed in claim 1, is characterized in that described pharmaceutic adjuvant is vaseline, paraffin, lecithin and PEG400.
4. secnidazole soft capsule as claimed in claim 1, it is characterized in that described antiseptic be following one or more: parabens (p-hydroxybenzene acetoacetic ester, methyl parahydroxybenzoate, propyl p-hydroxybenzoate, Sodium Methyl Hydroxybenzoate), propylene glycol, Oleum Caryophylli, sorbic acid methyl ester, benzoic acid, benzyl alcohol.
5. secnidazole soft capsule as claimed in claim 1, is characterized in that described opacifier is titanium dioxide.
6. secnidazole soft capsule as claimed in claim 1, it is characterized in that, described preparation method comprises the steps:
A) preparation of content: stir after pharmaceutic adjuvant heating being dissolved, after cooling, adds secnidazole fine powder and stirs and crosses colloid mill and mix afterwards for subsequent use.
B) preparation of softgel shell: water, glycerol, antiseptic are heated to 70-90 DEG C, add titanium dioxide under stirring and in distilled water, soak swelling gelatin in advance, treat that gelatin dissolves uniformly shape completely, keep temperature 70-80 DEG C again, by the bubble in reduced vacuum removing glue, put into the adjustable steady glue bucket of temperature, for subsequent use.
C) preparation of soft capsule: get the content and softgel shell that prepare, adopts pressing to make soft capsule, sizing, dry, clean, select, pack and get final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410548310.7A CN104257626A (en) | 2014-10-14 | 2014-10-14 | Secnidazole soft capsule and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410548310.7A CN104257626A (en) | 2014-10-14 | 2014-10-14 | Secnidazole soft capsule and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN104257626A true CN104257626A (en) | 2015-01-07 |
Family
ID=52149288
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410548310.7A Pending CN104257626A (en) | 2014-10-14 | 2014-10-14 | Secnidazole soft capsule and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN104257626A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3648749A4 (en) * | 2017-07-07 | 2020-07-15 | Symbiomix Therapeutics, LLC | Novel secnidazole soft gelatin capsule formulations and uses thereof |
| US11602522B2 (en) | 2014-09-05 | 2023-03-14 | Lupin Inc. | Secnidazole for use in the treatment of sexually transmitted infection |
-
2014
- 2014-10-14 CN CN201410548310.7A patent/CN104257626A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11602522B2 (en) | 2014-09-05 | 2023-03-14 | Lupin Inc. | Secnidazole for use in the treatment of sexually transmitted infection |
| EP3648749A4 (en) * | 2017-07-07 | 2020-07-15 | Symbiomix Therapeutics, LLC | Novel secnidazole soft gelatin capsule formulations and uses thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US11896566B2 (en) | Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof | |
| JP5539713B2 (en) | Tamibarotene capsule | |
| JP2021080279A (en) | Pharmaceutical composition comprising chili pepper | |
| CN104857517A (en) | Enzalutamide soft capsule and preparation method thereof | |
| CN103079552A (en) | Topical pharmaceutical composition comprising flurbiprofen | |
| JP5715400B2 (en) | Loxoprofen-containing pharmaceutical composition | |
| EP3033085A1 (en) | Dosage form comprising enzalutamide | |
| CN104546807A (en) | Olanzapine oral fast dissolving film preparation | |
| CN103784426B (en) | Molten membrane of Aripiprazole mouth and preparation method thereof | |
| CN104257626A (en) | Secnidazole soft capsule and preparation method thereof | |
| WO2005123133A1 (en) | A process for preparing ibuprofen soft gelatin capsules | |
| CN101450038A (en) | Nicarbazin and ethopabate nano suspension agent and preparation method thereof | |
| KR20130124113A (en) | Eutectic composition comprising celecoxib and poloxamer | |
| RU2412687C2 (en) | Stable solid dispersion of vinca alkaloid derivative and method for producing thereof | |
| CN102133179B (en) | Stable cetirizine oral solution | |
| RU2582278C2 (en) | Transdermal agent for treating and preventing joint and soft tissue diseases, method for production thereof and combined transdermal preparation for treating and preventing joint and soft tissue diseases | |
| CN103142622B (en) | Triamcinolone acetonide econazole emulsion-type gel | |
| EA021943B1 (en) | Process for manufacturing vaginal suppository | |
| WO2016137411A1 (en) | Topical spray composition comprising ibuprofen and lidocaine | |
| RU2359691C1 (en) | Agent and hygienic product for hemorrhoids and abirritation preventive maintenance | |
| CN107998072A (en) | clotrimazole cream and preparation method thereof | |
| CN103877025A (en) | Fenbendazole soluble powder and preparation method thereof | |
| CN102370629B (en) | Entecavir liquid capsule and preparation method thereof | |
| CN103974696A (en) | Stable formulations of antiplatelet agents, omega-3 fatty acids and amylose in soft gelatin capsules | |
| CN104173350A (en) | Pharmaceutical composition containing posaconazole and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| WD01 | Invention patent application deemed withdrawn after publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20150107 |