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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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AI Technical Summary

Problems solved by technology

However, at present, there are only separate preparations of the two, which can only be used in combination clinically, which is inconvenient to use

Method used

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Embodiment Construction

[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...

Claims

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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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