Nose taking powder of prostaglandin E

A preparation and transnasal technology, which is applied in the field of prostaglandin E1 nasal administration preparations, can solve the problems of injections such as obvious vascular irritation, patient pain, and clinical application limitations

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

During clinical application, PGE 1 The injection has obvious vascular irritation, which brings some pain to the patient
In addition, existing PGE...

Method used

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  • Nose taking powder of prostaglandin E

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Example 1 PGE 1 Preparation of -α-CD inclusion complex

[0018] Weigh PGE 1 Dissolve 50mg in 1ml of absolute ethanol, dissolve α-CD 686mg in 10ml of distilled water, then mix the two liquids, after ultrasonic treatment for 10 minutes, freeze-dry in a freeze dryer for 24 hours, and place the dried product in a vacuum dryer Available in 48 hours. The moisture content of the finally obtained freeze-dried product should be controlled below 1%. PGE can be determined by differential thermal analysis, X-ray powder diffraction and nuclear magnetic resonance 1 Formed an inclusion complex with α-CD.

Embodiment 2

[0019] Example 2 PGE 1 - Preparation of HP-β-CD inclusion complex

[0020] Weigh PGE 1 50mg, dissolved in 1ml of absolute ethanol, 1.9g of HP-β-CD (substitution degree = 5.0) was dissolved in 10ml of distilled water, then the two liquids were mixed, ultrasonicated for 5 minutes, and placed in a freeze dryer for 24 hours. The resulting dried product was placed in a vacuum desiccator for 48 hours. The moisture content of the resulting lyophilizate should be less than 1%.

Embodiment 3

[0021] Example 3 PGE 1 - Preparation of β-CD inclusion complex

[0022] Weigh PGE 1 Dissolve 50mg in 1ml of absolute ethanol, dissolve β-CD 1.6g in 100ml of distilled water, then mix the two liquids, after ultrasonic treatment for 5 minutes, freeze-dry in a freeze dryer for 24 hours, and place the dried product 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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PUM

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Abstract

A nasally applied powder of prostaglandin E1 is disclosed.

Description

technical field [0001] The present invention relates to prostaglandin E 1 formulations for nasal administration. technical background [0002] Prostaglandin E 1 (PGE 1 ), also known as Alprostadil (Alprostadil), was first discovered and named by Swedish scientist Von Enler in 1935. In 1957, PGE was first isolated and purified by Bergstrom et al. 1 And clarified its structure in 1962. In 1969, Scheider et al. of Upjoin Company in the United States synthesized PGE chemically. 1 . PGE 1 Since it was first approved for production by the United States in the early 1980s, it has been listed in Germany, the United States, Japan and other countries, and it was also listed in my country in the mid-1980s. [0003] PGE 1 The chemical name is: 11α, 15(S) dihydroxy-9-keto-13-reprostenic acid, and its structure is as follows: [0004] [0005] PGE 1 Very slightly soluble in water, its chemical properties are unstable, sensitive to pH, humidity and heat. Its structure contai...

Claims

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Application Information

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IPC IPC(8): A61K31/5575A61K9/14A61K9/72A61P9/00A61P15/10A61P11/00A61P3/06A61P3/10A61P1/16A61P1/18A61P13/12
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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