Oral preparation of prostaglandin E1

A preparation and oral technology, applied in the field of sublingual tablets of prostaglandin E1, can solve problems such as inability to take it orally

Inactive Publication Date: 2006-02-01
INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to overcome the PGE in the prior art 1 cannot be taken orally, the inventors have now found that PGE 1 Mixed with cyclodextrin and then mixed with pharmaceutical excipients or carriers to obtain PGE that can be administered orally 1 preparation

Method used

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  • Oral preparation of prostaglandin E1

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1α-CD and PGE 1 Preparation of clathrates:

[0030] Weigh PGE 1 50mg, dissolved in 1ml of absolute ethanol, α-CD 686mg dissolved in 10ml of distilled water, then mixed the two liquids, ultrasonicated for 10 minutes, then placed in a freeze dryer for 24 hours, and the dried product was placed in a vacuum dryer Available in 48 hours. The moisture content of the finally obtained freeze-dried product should be controlled below 1%.

Embodiment 2

[0031] Example 2 HP-β-CD (degree of substitution = 5.0) and PGE 1 Preparation of clathrates:

[0032] Weigh PGE 1 Dissolve 50mg in 1ml of absolute ethanol, dissolve 1.9g of HP-β-CD in 10ml of distilled water, then mix the two liquids, after ultrasonic treatment for 5 minutes, freeze-dry in a freeze dryer for 24 hours, and dry the obtained product in a vacuum Place it in the container for 48 hours. The moisture content of the resulting lyophilizate should be less than 1%.

Embodiment 3

[0033] Example 3 β-CD and PGE 1 Preparation of clathrates:

[0034] Weigh PGE 1 50mg, dissolved in 1ml of absolute ethanol, β-CD 1.6g dissolved in 100ml of distilled water, then mixed the two liquids, after ultrasonic treatment for 5 minutes, placed in a freeze dryer for 24 hours, and the dried product was placed in a vacuum dryer Leave it for 48 hours. The moisture content of the resulting lyophilizate should be less than 1%.

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Abstract

An orally applied prostaglandin E1 in the tablet is disclosed.

Description

Technical field: [0001] The present invention relates to prostaglandin E 1 oral preparations, especially sublingual tablets, buccal patches or buccal lozenges of prostaglandin E1. technical background: [0002] Prostaglandin E 1 (PGE 1 ) also known as Alprostadil (Alprostadil), [0003] Its chemical name is: 11α, 15(S)-dihydroxy-9-keto-13-reprostenic acid, and its structure is: [0004] [0005] PGE 1 Very slightly soluble in water, its chemical properties are unstable, sensitive to pH, humidity and heat. Its structure contains β-hydroxy ketone, which is easy to dehydrate to generate PGA under acid and alkali conditions 1 , and continue to undergo rearrangement reactions under alkaline conditions to generate PGB 1 , thereby losing its physiological and pharmacological activity. [0006] PGE 1 It is an endogenous physiologically active substance with various physiological and pharmacological effects. It can dilate blood vessels, inhibit platelet aggregation, redu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5575A61K9/20A61P9/00A61P15/10A61P11/00A61P1/16A61P1/18A61P3/06A61P3/10A61P13/12
Inventor 高永良谷福根崔福德
Owner INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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