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Alprostadil and quality standard of preparation thereof

A technology of alprostadil and quality standards, applied in the field of quality standards of alprostadil raw materials and preparations thereof, can solve the problems of low quality standards, addition of abnormal toxicity measurement items, incompleteness and the like

Active Publication Date: 2012-06-20
蔡海德
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] 6. Increase the abnormal toxicity measurement item, the existing pharmacopoeia alprostadil crude drug standard does not have this item regulation, the present invention increases this item, when this item is unqualified, must not be used for preparing its preparation;
[0018] 11. The quality standards of the existing alprostadil emulsion injections encapsulated with phospholipids and emulsion freeze-dried injections are even lower and incomplete, and must be improved and fully supplemented

Method used

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  • Alprostadil and quality standard of preparation thereof
  • Alprostadil and quality standard of preparation thereof
  • Alprostadil and quality standard of preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0118] The weight ratio of the ingredients of the Alprostadil combination medicine of the present invention is as follows:

[0119] (1) High purity alprostadil meets the quality standard of alprostadil of the present invention 0.77

[0120] (2) Lysine: sodium salicylate

[0121] The weight ratio is 90-95: 5-10 mixture 210

[0122] (3) Dextran 40 and 2-hydroxypropyl-β-cyclodextrin

[0123] Weight ratio 12-18:1 mixture mixture 500

[0124] (4) Disodium dimercaptobutane 2.00

[0125] (5) Pentylic acid 10

[0126] (6) Activated carbon for injection (activated) 50

[0127] (7)0.05M phosphate buffer pH value 5.0-7.5 8000

[0128] Operation process and technological conditions:

[0129] (1) Unscramble, clean and sterilize vials

[0130] Carry 5ml vials from the transfer cabinet to the bottle unscrambler room after being sterilized by the ultraviolet lamp, unscramble the bottles in the unscramble room, put the arranged vials in the fixed position in the bottle washing room; sterilize the GMSU-400W tun...

Embodiment 2

[0148] The weight ratio of the ingredients of the Alprostadil combination medicine of the present invention is as follows:

[0149] (1) High-purity Alprostadil meets the quality standard of Alprostadil 2.31

[0150] (2) Lysine: sodium salicylate

[0151] The weight ratio is 90-95: 5-10 mixture 300

[0152] (3) Dextran 40 and 2-hydroxypropyl-β-cyclodextrin

[0153] Weight ratio 12-18:1 mixture mixture 580

[0154] (4) Disodium dimercaptobutane 3.00

[0155] (5) Pentic acid 15

[0156] (6) Activated carbon for injection (activated) 60

[0157] (7)0.05M phosphate buffer pH value 5.0-7.5 9000

[0158] The present invention provides the preparation method of the alprostadil combination drug as in Example 1.

Embodiment 3

[0160] The weight ratio of the ingredients of the Alprostadil combination medicine of the present invention is as follows:

[0161] (1) High purity alprostadil meets the quality standard of alprostadil 1.96

[0162] (2) Lysine: sodium salicylate

[0163] The weight ratio is 90-95: 5-10 mixture 265

[0164] (1) Dextran 40 and 2-hydroxypropyl-β-cyclodextrin

[0165] Weight ratio 12-18:1 mixture mixture 530

[0166] (4) Disodium dimercaptobutane 2.50

[0167] (5) Pentylic acid 12

[0168] (6) Activated carbon for injection (activated) 55

[0169] (7)0.05M phosphate buffer pH value 5.0-7.5 8600

[0170] The present invention provides the preparation method of the alprostadil combination drug as in Example 1.

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Abstract

The invention discloses a quality standard of alprostadil; freeze-dried injection prepared from alprostadil bulk drug that conforms to this quality standard; a quality standard of alprostadi for injection disclosed by the invention, and a quality standard of alprostadi liposome for injection of the invention. The invention points out the prior art for producing alprostadi, alprostadi for injection and alprostadi liposome for injection; and carries out quality and pharmacodynamics validation.

Description

Technical field [0001] The invention relates to the quality standard of alprostadil bulk medicine and its preparation. technical background [0002] The drug Alprostadil, the English name is Alprostadil, and the chemical name is 11α, 15(S)-dihydroxy-9-carbonyl-13-transprostadil acid. [0003] The structural formula is as follows: [0004] [0005] The molecular formula is C 20 H 34 O 5 , The molecular weight is 354.48. [0006] The 2010 edition of the "Chinese Pharmacopoeia" has been published and implemented in China, and the quality standards for the raw material drug Alprostadil have been clearly stipulated. According to the research of the present invention, the domestic and foreign pharmacopoeias still have defects in the quality standards of alprostadil as follows: [0007] 1. Alprostadil is a chemically very active substance. The research of the present invention found that it is easily converted into impurity prostaglandin A under the catalysis of light, heat, acid and alkali ...

Claims

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Application Information

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IPC IPC(8): G01N30/02C07C405/00A61K31/5575A61K9/127
Inventor 蔡海德
Owner 蔡海德