Aseptic freeze-dried prostaglandin injection and its preparing method and use

A technology of alprostadil and freeze-drying, applied in freeze-dried delivery, antiviral agents, pharmaceutical formulations, etc., can solve problems such as inconvenient use, and achieve the effects of stable curative effect, stable quality, and stable dosage

Inactive Publication Date: 2003-01-22
蔡海德
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Problems solved by technology

However, at present, there are only separate preparations of the two, whic

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[0029] For further explanation below, the sterile freeze-dried injection of alprostadil of the present invention is made of the following components by weight ratio: (weight unit gram)

[0030] Alprostadil 0.01, 0.1 or 0.2, 0.4;

[0031] α-cyclodextrin is 1, 1.2, 1.5 times the molar number of alprostadil;

[0032] Hydroxypropyl-β-cyclodextrin or γ-cyclodextrin is 1, 2, 3 times the molar amount of alprostadil;

[0033] Thymosin 10, 50, 100;

[0034] Dextran 40, 65, 100.

[0035] The purity of the alprostadil is more than or equal to 99.5%.

[0036] The preparation method of medicine of the present invention comprises the following steps:

[0037] 100mg alprostadil was dissolved in 15ml absolute ethanol;

[0038] Dissolve α-cyclodextrin 1.5 times the molar number of alprostadil in 200ml sterile water for injection, and then add hydroxypropyl-β-cyclodextrin or γ-cyclodextrin 3 times the molar number of alprostadil in, and stir until completely dissolved.

[0039] Add the a...

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Abstract

The present invention relates to a kind of freeze-dried prostaglandin injection and its preparation process and use. It aims at solving the problems of unstable medicine performance and pain produced during injection. The freeze-dried prostaglandin injection consists of prostaglandin, alpha-cyclodextrin, hydroxypropyl-beta-cyclodextrin or gamma-cyclodextrin, Thymosin and Dextran. It has the function of bi-directional immunity regulation, produces less pain, stable quality and stable and high treating effect. It may be also delay released, controlling released and target released.

Description

technical field [0001] The invention relates to a freeze-dried injection, in particular to a sterile freeze-dried injection of alprostadil and its preparation method and application. technical background [0002] Known alprostadil (prostaglandin E 1 , Alprostadil, PGE 1 ) is a non-toxic endogenous drug with definite curative effect, which widely exists in human body fluids and tissue cells, has a wide range of physiological functions, regulates human immunity, improves microcirculation, and can treat cardiovascular and cerebrovascular diseases , Hepatitis A, B, and C are excellent drugs with high curative effect. However, it is insoluble in water, and its performance is extremely unstable, which will easily lead to a decrease in drug content. It needs to be stored and transported in a refrigerator. The storage and transportation are very inconvenient, the cost is high, and the pain during injection is unbearable for patients, which limits clinical application. [0003] It...

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Application Information

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IPC IPC(8): A61K9/19A61K31/5575A61K38/17A61P1/16A61P9/10A61P31/12A61P37/02
Inventor 蔡海德
Owner 蔡海德
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