Expansion suppository of clotrimazole or salt thereof, preparation method and detection method

A detection method, the technology of clotrimazole, is applied in the direction of suppository delivery, pharmaceutical formula, medical preparations of non-active ingredients, etc., which can solve the problems of insufficient absorption, easy to pollute clothes, difficult to clean, etc., and achieve simple preparation method and avoid The effect of secondary infection and fewer process steps

Inactive Publication Date: 2013-09-11
HARBIN OT PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The following problems generally exist in the above-mentioned suppositories: 1. It is not easy to clean, and it is easy to contaminate clothes; 2. The contact surface betw...

Method used

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  • Expansion suppository of clotrimazole or salt thereof, preparation method and detection method
  • Expansion suppository of clotrimazole or salt thereof, preparation method and detection method
  • Expansion suppository of clotrimazole or salt thereof, preparation method and detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] Clotrimazole 150mg

[0070] Semi-synthetic fatty acid glycerides 1500mg

[0071] Lanolin 10mg

[0072] Sliver 1000mg

[0073] Preparation:

[0074] a. Weigh semi-synthetic fatty acid glycerides and lanolin according to the prescription amount, and heat and melt in a water bath at 40°C;

[0075] b. Add clotrimazole under continuous stirring, and mix evenly to obtain a mixture;

[0076] c. The mixture in step b is poured into a plastic shaped suppository, inserted into a tampon, cooled and shaped to make a duckbill-shaped suppository.

Embodiment 2

[0078] Clotrimazole 50mg

[0079] Semi-synthetic Palmitate 250mg

[0080] Propylene glycol monostearate 250mg

[0081] Sliver 600mg

[0082] Preparation method: according to the method of Example 1, it is prepared into a bullet shape.

Embodiment 3

[0083] Embodiment 3 torpedo-shaped clotrimazole expansion plug

[0084] Clotrimazole 300mg

[0085] Semi-synthetic Litsea Cubelin 1200mg

[0086] Propylene glycol monostearate 1800mg

[0087] Sliver 1700mg

[0088] Preparation method: according to the method of Example 1, a torpedo-shaped expansion plug is prepared.

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PUM

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Abstract

The invention relates to an expansion suppository of clotrimazole or a salt thereof. The expansion suppository consists of the clotrimazole or the salt thereof, a fat-soluble matrix and an expandable expansion carrier. The invention also relates to a preparation method and a detection method for the expansion suppository. The expansion suppository of the clotrimazole or the salt thereof provided by the invention adopts seven original leading technologies, wherein the addition of the expansion carrier applies six technologies including a suppository disposable filling integration technology, an inner core expansion coefficient control technology, an ergonomic suppository type technology, a treating and cleaning integrated preparation formulation, a vagina-attached administration technology and a side leakage prevention suppository body design; and poloxamer and a sustained-release material in the expansion suppository apply a medicament long-acting layered release technology. The expansion suppository of the clotrimazole or the salt thereof disclosed by the invention has the beneficial effects of having high efficiency, long acting, safety and few side effects, preventing the overflow of medicament liquid, cleaning the vagina, preventing secondary infection and the like.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, and in particular relates to a clotrimazole or its salt expansion suppository, a preparation method and a detection method thereof. Background technique [0002] Clotrimazole, whose chemical name is 1-[(2-chlorophenyl)benzhydryl]-1H-imidazole, is soluble in absolute ethanol and acetone, and is almost insoluble in water. Its structural formula is as follows: [0003] [0004] Clotrimazole or its salt is an imidazole broad-spectrum antifungal drug, which has inhibitory effects on various fungi such as Candida and Candida. It mainly selectively interferes with the activity of fungal cytochrome P-450, thereby inhibiting the biosynthesis of ergosterol on the fungal cell membrane, changing the permeability of the cell membrane, causing the loss of intracellular substances, and causing the death of the fungus. [0005] Clotrimazole or its salts are highly toxic, and oral administration may cause...

Claims

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Application Information

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IPC IPC(8): A61K9/02A61K31/4174A61K47/14A61K47/34A61K47/44A61L15/44A61P31/10A61P15/00
Inventor 邱学良邱明世
Owner HARBIN OT PHARMA
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