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Alprostadil composite medicine, preparation method thereof, quality controlling method thereof, and purpose thereof

A technology for alprostadil and medicine, which is applied in the field of alprostadil combination medicine and its preparation quality control, and can solve the problems of affecting curative effect, producing side effects, poor stability of preparation quality and the like

Inactive Publication Date: 2012-02-01
蔡海德
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to its active chemical properties, the quality stability of the preparation is poor, and the content decline affects the curative effect and produces side effects, so the content decline, injection pain, and refrigerator storage and transportation are the three major international problems of alprostadil preparations

Method used

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  • Alprostadil composite medicine, preparation method thereof, quality controlling method thereof, and purpose thereof
  • Alprostadil composite medicine, preparation method thereof, quality controlling method thereof, and purpose thereof
  • Alprostadil composite medicine, preparation method thereof, quality controlling method thereof, and purpose thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] The weight ratio of each component raw material of a kind of alprostadil combination medicine of the present invention is as follows:

[0051] (1) High-purity alprostadil 0.77

[0052] (2) lysine pirin: sodium salicylate weight ratio is 90-95: 5-10 mixture 210

[0053] (1) Dextran 40 and 2-hydroxypropyl-β-cyclodextrin

[0054] Weight ratio 12-18:1 mixture mixture 500

[0055] (4) Disodium dimercapto 2.00

[0056] (5) Pentetic acid 10

[0057] (6) Activated carbon for injection (activated) 50

[0058] (7) 0.05M phosphate buffer pH value 5.0-7.5 8000

[0059] The present invention also provides the preparation method of described alprostadil combination medicine:

[0060] Operating process and process conditions:

[0061] (1) Vial unscrambling, cleaning, and sterilization

[0062] The 5ml vials are sterilized by the UV lamp from the transfer cabinet and transported into the unscrambling room, where the unscrambled bottles are unscrambled, and the sorted vials are ...

Embodiment 2

[0080] The weight ratio of each component raw material of a kind of alprostadil combination medicine of the present invention is as follows:

[0081] (1) High-purity alprostadil 2.31

[0082] (2) Lysine pirin: sodium salicylate weight ratio is 90-95: 5-10 mixture 300

[0083] (1) Dextran 40 and 2-hydroxypropyl-β-cyclodextrin

[0084] 12-18:1 mixture mixture by weight 580

[0085] (4) Disodium dimercapto 3.00

[0086] (5) Pentetic acid 15

[0087] (6) Activated carbon for injection (activated) 60

[0088] (7) 0.05M phosphate buffer pH value 5.0-7.5 9000

[0089] The present invention provides that the preparation method of the alprostadil combination medicine is the same as that in Example 1.

Embodiment 3

[0091] The weight ratio of each component raw material of a kind of alprostadil combination medicine of the present invention is as follows:

[0092] (1) High-purity alprostadil 1.96

[0093] (2) Lysine pirin: sodium salicylate weight ratio is 90-95: 5-10 mixture 265

[0094] (1) Dextran 40 and 2-hydroxypropyl-β-cyclodextrin

[0095] 12-18:1 mixture mixture by weight 530

[0096] (4) Disodium dimercapto 2.50

[0097] (5) Pentetic acid 12

[0098] (6) Activated carbon for injection (activated) 55

[0099] (7) 0.05M phosphate buffer pH value 5.0-7.5 8600

[0100] The present invention provides that the preparation method of the alprostadil combination medicine is the same as that in Example 1.

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Abstract

The invention relates to an alprostadil composite medicine comprising high-purity alprostadil and a mixture of aspirin-DL-lysine and sodium salicylate, wherein a weight ratio of aspirin-DL-lysine to sodium salicylate is 90-95:5-10. The invention also provides a weight ratio of the raw materials of the composite medicine. The invention also provides a preparation method of the alprostadil composite medicine, and a quality controlling method of the alprostadil composite medicine. With a pharmaceutically acceptable alprostadil composite medicine dosage, the medicine can be prepared into lyophilized injections, oral preparations, aerosols, suppositories, or enemas of the acceptable alprostadil composite medicine. The invention discloses chromatographic conditions for determining the contents of alprostadil, prostaglandin A1 and prostaglandin B1. Three peaks before an alprostadil peak are characteristic peaks of alprostadil composite medicine auxiliary materials. The alprostadil composite medicine is used for treating and preventing diseases such as coronary heart disease, myocardial infarction, brain infarction, hypertension, hyperlipemia, atherosclerosis, angiitis, tumour, hepatitis, diabetic angiopathies, kidney insufficiency, bronchial asthma, pancreatitis, gastric ulcer, and vertebrobasilar insufficiency.

Description

technical field [0001] The invention relates to an alprostadil combination medicine and its preparation quality control and use. Background technique [0002] Alprostadil, formerly known as prostaglandin E 1 , referred to as PGE 1 . It is an endogenous drug with wide physiological activity and high efficiency. It is used to treat and prevent coronary heart disease, myocardial infarction, cerebral infarction, hypertension, hyperlipidemia, arteriosclerosis, vasculitis, tumor; it can also treat hepatitis, diabetic vascular disease and renal insufficiency; it can treat refractory bronchial asthma, Pancreatitis, gastric ulcer, and vertebral fundus insufficiency have miraculous effects. It has the characteristics of small dosage, broad-spectrum drug with definite curative effect, short half-life, no accumulation in the body, and no harmful side effects. It will be a good medicine for a century. However, due to its active chemical properties, the quality stability of the prepa...

Claims

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Application Information

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IPC IPC(8): A61K31/5575A61K47/40A61K47/04A61K47/10A61K47/16A61K47/20A61K9/19A61P9/10A61P9/12A61P3/06A61P35/00A61P1/16A61P29/00A61P3/10A61P13/12A61P11/06A61P1/18A61P1/04G01N30/32
Inventor 蔡海德
Owner 蔡海德
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