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Rectal administration composite containing 5-phosphodiesterase inhibitor

A type of phosphodiesterase, rectal administration technology, applied in the direction of drug combination, medical preparations containing active ingredients, active ingredients of heterocyclic compounds, etc., to achieve the effect of strong practicability, good stability, and difficult crystal transformation

Inactive Publication Date: 2011-04-27
梁超峰 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] Therefore, simple oral systemic administration is not an ideal route and method of administration

Method used

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  • Rectal administration composite containing 5-phosphodiesterase inhibitor
  • Rectal administration composite containing 5-phosphodiesterase inhibitor
  • Rectal administration composite containing 5-phosphodiesterase inhibitor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] The preparation of embodiment 1 suppository A

[0040] 1. Prescription A (quantity of 100 suppositories)

[0041]

[0042] 2. The preparation method of suppository A

[0043] 1) Take the main ingredients in the prescription and pass through a 200-mesh sieve, and other solid materials through a 100-mesh sieve;

[0044] 2) The matrix is ​​melted, filtered, and sterilized at 45-70°C; the main drug in the prescribed amount is miscible with the enhancer (auxiliary, latent) solvent and / or absorption enhancer or is properly heated and melted to form a liquid dispersion;

[0045] 3) Weigh the above-mentioned melted matrix of the prescribed amount, keep warm at 45-55°C, add other excipients of the prescribed amount under stirring and mix evenly, continue to add the above-mentioned liquid dispersion containing the main drug under stirring, and fully mix under the condition of heat preservation. Homogenize to obtain the whole material mixture;

[0046] 4) Inject the above-m...

Embodiment 2

[0048] The preparation of embodiment 2 suppositories B

[0049] 1. Prescription B (amount of 100 suppositories)

[0050]

[0051]

[0052] 2. Preparation method of suppository B

[0053] With embodiment 1.

Embodiment 3

[0054] The preparation of embodiment 3 suppositories C

[0055] 1. Prescription C (amount of 100 suppositories)

[0056]

[0057] 2. The preparation method of suppository C

[0058] With embodiment 1.

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Abstract

The invention discloses a rectal administration composite containing a 5-phosphodiesterase inhibitor (PDE-5i). The rectal administration composite contains an effective quantity of the PDE-5i or pharmaceutically acceptable salts, esters and hydrates thereof or pharmaceutical precursors thereof, active metabolites, and the like and contains the following components by weight ratio: PDE-5i:matrix:solubilizers:sorbefacients:additives=1:1-3000:0-165:0-80:0.001-260, wherein the effective quantity is equivalent to 1.25-400mg of the PDE-5i, and the weight of each unit preparation is 0.8-4 grams. Through rectal administration, the rectal administration composite can not only overcome the defects of poor systematic administration treatment effect, high toxic and side effects, irregular absorption, low bioavailability, and the like of oral preparations, and the like, but also shorten the effectual time of pharmaceuticals, prolong the action time of the pharmaceuticals, promote the release and the absorption of the pharmaceuticals and enhance ten efficiency of the pharmaceuticals reaching a target organ, thereby providing better treatment means for medical personnel and patients; and in addition, the invention has simple production process and is suitable for industrialized batch production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a composition for rectal administration containing a 5-type phosphodiesterase inhibitor, and the composition is used in the preparation and treatment of erectile dysfunction and lower urinary tract symptoms (especially benign prostatic hyperplasia) Urination disorders caused by) drug application. Background technique [0002] Type 5 phosphodiesterase (Phosphodiesterase Type 5, PDE-5) inhibitors (Phosphodiesterase 5inhibitor, PDE-5i) include approved marketing sildenafil citrate (sildenafil, Viagra, Pfizer), other Danafil (tadalafil, Cialis, Cialis, Eli Lilly / ICOS), vardenafil hydrochloride (vardenafil, Levitra, Levitro, Levitra, Bayer / GlaxoSmithKline), Udena Non (udenafil, Zydena, Dong-A Pharmaceutical understand love company), etc., its chemical information is as follows: [0003] [0004] [0005] These drugs or their medicinal precursors...

Claims

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Application Information

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IPC IPC(8): A61K31/519A61K31/53A61K31/4985A61K47/34A61K47/22A61K47/10A61K47/28A61K47/18A61K9/02A61P15/10A61P13/02A61P13/08A61K47/14
Inventor 梁超峰钟鸣陈凤仪
Owner 梁超峰
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